Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of U.S. application Ser. No. 11/906,325, filed on Oct. 1, 2007, which is a continuation-in-part of U.S. application Ser. No. 11/359,667, filed on Feb. 22, 2006, which is a continuation-in-part of U.S. application Ser. No. 10/662,043, filed on Sep. 12, 2003, which is a continuation of U.S. application Ser. No. 10/428,708 filed on May 2, 2003, the complete disclosures of which are hererin incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    This invention relates to analyzing blood for carrying out coagulation studies and other chemistry procedures, including monitoring oral anticoagulant therapy to take into account the platelet count in determining prothrombin times (PT), and providing new Anticoagulant Therapy Factors that are useful in diagnosing and treating individuals in relation to blood conditions. 
         [0004]    2. Description of the Prior Art 
         [0005]    Testing of blood and other body fluids is commonly done in hospitals, labs, clinics and other medical facilities. For example, to prevent excessive bleeding or deleterious blood clots, a patient may receive oral anticoagulant therapy before, during and after surgery. Oral anticoagulant therapy generally involves the use of oral anticoagulants—a class of drugs which inhibit blood clotting. To assure that the oral anticoagulant therapy is properly administered, strict monitoring is accomplished and is more fully described in various medical technical literature, such as the articles entitled “PTs, PR, ISIs and INRs: A Primer on Prothrombin Time Reporting Parts I and II” respectively published November, 1993 and December, 1993 issues of  Clinical Hemostasis Review , and herein incorporated by reference. 
         [0006]    These technical articles disclose anticoagulant therapy monitoring that takes into account three parameters which are: International Normalized Ratio (INR), International Sensitivity Index (ISI) and prothrombin time (PT), reported in seconds. The prothrombin time (PT) indicates the level of prothrombin and blood factors V, VII, and X in a plasma sample and is a measure of the coagulation response of a patient. Also affecting this response may be plasma coagulation inhibitors, such as, for example, protein C and protein S. Some individuals have deficiencies of protein C and protein S. The INR and ISI parameters are needed so as to take into account various differences in instrumentation, methodologies and in thromboplastins&#39; (Tps) sensitivities used in anticoagulant therapy. In general, thromboplastins (Tps) used in North America are derived from rabbit brain, those previously used in Great Britain from human brain, and those used in Europe from either rabbit brain or bovine brain. The INR and ISI parameters take into account all of these various factors, such as the differences in thromboplastins (Tps), to provide a standardized system for monitoring oral anticoagulant therapy to reduce serious problems related to prior, during and after surgery, such as excessive bleeding or the formation of blood clots. 
         [0007]    The ISI itself according to the WHO 1999 guidelines, Publication no. 889-1999, have coefficients of variation ranging from 1.7% to 8.1%. Therefore, if the ISI is used exponentially to determine the INR of a patient, then the coefficients of variation for the INR&#39;s must be even greater than those for the ISI range. 
         [0008]    As reported in Part I (Calibration of Thromboplastin Reagents and Principles of Prothrombin Time Report) of the above technical article of the  Clinical Hemostasis Review , the determination of the INR and ISI parameters are quite involved, and as reported in Part II (Limitation of INR Reporting) of the above technical article of the  Clinical Hemostasis Review , the error yielded by the INR and ISI parameters is quite high, such as about up to 10%. The complexity of the interrelationship between the International Normalized Ratio (INR), the International Sensitivity Index (ISI) and the patient&#39;s prothrombin time (PT) may be given by the below expression (A), 
         [0000]    wherein the quantity 
         [0000]    
       
         
           
             
               
                 
                   [ 
                   
                     
                       
                         Patient 
                         &#39; 
                       
                        
                       s 
                        
                       
                           
                       
                        
                       PT 
                     
                     
                       Mean 
                        
                       
                           
                       
                        
                       of 
                        
                       
                           
                       
                        
                       PT 
                        
                       
                           
                       
                        
                       Normal 
                        
                       
                           
                       
                        
                       Range 
                     
                   
                   ] 
                 
               
               
                 
                   ( 
                   A 
                   ) 
                 
               
             
           
         
       
     
         [0000]    is commonly referred to as prothrombin ratio (PR): 
         [0000]    
       
         
           
             
               
                 
                   INR 
                   = 
                   
                     
                       [ 
                       
                         
                           
                             Patients 
                             &#39; 
                           
                            
                           s 
                            
                           
                               
                           
                            
                           PT 
                         
                         
                           Mean 
                            
                           
                               
                           
                            
                           of 
                            
                           
                               
                           
                            
                           PT 
                            
                           
                               
                           
                            
                           Normal 
                            
                           
                               
                           
                            
                           Range 
                         
                       
                       ] 
                     
                     ISI 
                   
                 
               
               
                 
                   ( 
                   B 
                   ) 
                 
               
             
           
         
       
     
         [0009]    The possible error involved with the use of International Normalized Ratio (INR) is also discussed in the technical article entitled “Reliability and Clinical Impact of the Normalization of the Prothrombin Times in Oral Anticoagulant Control” of E. A. Loeliger et al., published in  Thrombosis and Hemostasis  1985; 53: 148-154, and herein incorporated by reference. As can be seen in the above expression (B), ISI is an exponent of INR which leads to the possible error involved in the use of INR to be about 10% or possibly even more. A procedure related to the calibration of the ISI is described in a technical article entitled “Failure of the International Normalized Ratio to Generate Consistent Results within a Local Medical Community” of V. L. Ng et al., published in Am. J. Clin. Pathol. 1993; 99: 689-694, and herein incorporated by reference. 
         [0010]    The unwanted INR deviations are further discussed in the technical article entitled “Minimum Lyophilized Plasma Requirement for ISI Calibration” of L. Poller et al. published in  Am. J. Clin. Pathol . February 1998, Vol. 109, No. 2, 196-204, and herein incorporated by reference. As discussed in this article, the INR deviations became prominent when the number of abnormal samples being tested therein was reduced to fewer than 20 which leads to keeping the population of the samples to at least 20. The paper of L. Poller et al. also discusses the usage of 20 high lyophilized INR plasmas and 7 normal lyophilized plasmas to calibrate the INR. Further, in this article, a deviation of +/−10% from means was discussed as being an acceptable limit of INR deviation. Further still, this article discusses the evaluation techniques of taking into account the prothrombin ratio (PR) and the mean normal prothrombin time (MNPT), i.e., the geometric mean of normal plasma samples. 
         [0011]    The discrepancies related to the use of the INR are further studied and described in the technical article of V. L. NG et al. entitled, “Highly Sensitive Thromboplastins Do Not Improve INR Precision,” published in  Am. J. Clin. Pathol.,  1998; 109, No. 3, 338-346 and herein incorporated by reference. In this article, the clinical significance of INR discordance is examined with the results being tabulated in Table 4 therein and which are analyzed to conclude that the level of discordance for paired values of individual specimens tested with different thromboplastins disadvantageously range from 17% to 29%. 
         [0012]    U.S. Pat. No. 5,981,285 issued on Nov. 9, 1999 to Wallace E. Carroll et al., which discloses a “Method and Apparatus for Determining Anticoagulant Therapy Factors” provides an accurate method for taking into account varying prothrombin times (PT) caused by different sensitivities of various thromboplastin formed from rabbit brain, bovine brain or other sources used for anticoagulant therapy. This method does not suffer from the relatively high (10%) error sometimes occurring because of the use of the INR and ISI parameters with the exponents used in their determination. 
         [0013]    The lack of existing methods to provide reliable results for physicians to utilize in treatment of patients has been discussed, including in a paper by Davis, Kent D., Danielson, Constance F. M., May, Lawrence S., and Han, Zi-Qin, “Use of Different Thromboplastin Reagents Causes Greater Variability in International Normalized Ratio Results Than Prolonged Room Temperature Storage of Specimens,”  Archives of Pathol. and Lab. Medicine , November 1998. The authors observed that a change in the thromboplastin reagent can result in statistically and clinically significant differences in the INR. 
         [0000]    Considering the current methods for determining anticoagulant therapy factors, there are numerous opportunities for error. For example, it has been reported that patient deaths have occurred at St. Agnes Hospital in Philadelphia, Pa. There the problem did not appear to be the thromboplastin reagent, but rather, was apparently due to a failure to enter the correct ISI in the instrument used to carry out the prothrombin times when the reagent was changed. This resulted in the incorrect INR&#39;s being reported. Doses of coumadin were given to already overanticoagulated patients based on the faulty INR error, and it is apparent that patient deaths were caused by excessive bleeding due to coumadin overdoses. In the St. Agnes Hospital, Philadelphia 2001 INR disaster, an incorrect ISI of 1.01 was used instead of 2.028. As has been recommended by Poller, INR studies should be performed at the INR 2.0 and 3.0 levels. 2.0 to 3.0 is the Therapeutic INR Range recommended for most clotting/thrombotic conditions. These two levels will be used in the following calculations: 
         [0014]    The PRs at INR 2.0 calculation are: 
         [0000]      INR=PR ISI ; log INR=(ISI)(log PR); 
         [0000]      log PR=log INR/ISI; 
         [0000]      log PR=log 2.0=0.301; log PR/ISI=0.301/1.01=0.298 
         [0000]      PR=1.986 
         [0000]      INR=PR ISI =1.986 1.01 =2.00 
         [0000]      INR=PR ISI =1.986 2.028 =4.02 
         [0000]    An INR of 2.00 would have been reported, not the actual 4.02. Warfarin at a reported INR 2.0 level would likely have been administered to an already overanticoagulated patient, but serious consequences may not necessarily have occurred here. Using the erroneous 1.01 ISI with an INR of 3.0 for calculations is drastically different: 
         [0000]      log PR=log INR/ISI=0.477/1.01=0.472 
         [0000]      PR=2.968 
         [0000]      INR=PR ISI =2.968 1.01 =3.00 
         [0000]      INR ISI =2.968 2.028 =9.08 
         [0015]    This incorrectly reported INR of 3.0 would actually have been 9.08. 9.08 is well above INR=6.0 where excessive bleeding is considered to occur. In addition, the five fatal St. Agnes cases, even at INR=9.08, could have even been administered a routine warfarin dose, since it would have been believed it was intended for patients with an INR of 3.0, not 9.08. 
         [0016]    But even in addition to errors where a value is not input correctly, the known methods for determining anticoagulant therapy factors still may be prone to errors, even when the procedure is carried out in accordance with the reagent manufacturer&#39;s ISI data. One can see this in that current methods have reported that reagents used to calculate prothrombin times, may, for healthy (i.e., presumed normal) subjects, give rise to results ranging from 9.7 to 12.3 seconds at the 95th % reference interval for a particular reagent, and 10.6 to 12.4 for another. The wide ranges for normal patients illustrates the mean normal prothrombin time differences. When the manufacturer reference data ranges are considered, if indeed 20 presumed normal patients&#39; data may be reported within a broad range, then there is the potential for introduction of this range into the current anticoagulation therapy factor determinations, since they rely on the data for 20 presumed normal patients. Considering the reagent manufacturer expected ranges for expected normal prothrombin times, INR units may vary up to 30%. This error is apparently what physicians must work with when treating patients. A way to remove the potential for this type of error is needed. 
         [0017]    This invention relates to the inventions disclosed in U.S. Pat. Nos. 3,905,769 (&#39;769) of Sep. 16, 1975; 5,197,017 (&#39;017) dated Mar. 23, 1993; and 5,502,651 (&#39;651) dated Mar. 26, 1996, all issued to Wallace E. Carroll and R. David Jackson, and all of which are incorporated herein by reference. The present invention provides apparatus and methods for monitoring anticoagulant therapy. 
       SUMMARY OF THE INVENTION 
       [0018]    Methods and apparatus useful for processing coagulation studies, and other chemistry procedures involving blood and blood components. The apparatus and methods may be used to determine anticoagulant therapy factors which are designated herein, in particular, to determine new Anticoagulant Therapy Factors (nATF&#39;s) which preferably may replace International Normalized Ratio (INR) in anticoagulation therapy management. Previously, anticoagulation therapy involved the use of International Normalized Ratios (INR&#39;s). The International Normalized Ratio (INR) was utilized in order to arrive at an anticoagulant therapy factor (ATF). The INR based ATF was dependent on the prothrombin time (PT), the prothrombin ratio (PR), a fibrinogen transformation rate (FTR), and a maximum acceleration point (MAP) having an associated time to maximum acceleration (TMA). 
         [0019]    Methods and apparatus are disclosed for determining a new anticoagulant therapy factor (nATF) for monitoring oral anticoagulant therapy to help prevent excessive bleeding or deleterious blood clots that might otherwise occur before, during or after surgery. In one embodiment, a new anticoagulant therapy factor (nATF) is based upon a determination of the fibrinogen transformation rate (FTR) which, in turn, is dependent on a maximum acceleration point (MAP) for fibrinogen (FBG) conversion. The nATF quantity is also based upon the time to maximum acceleration from the time of reagent injection (TX) into a plasma sample, but does not require the difficulty of obtaining prior art International Normalized Ratio (INR) and International Sensitivity Index (ISI) parameters. The International Normalized Ratio (INR) was created to relate all species&#39; clotting material to human clotting material, and nATF can replace INR in anticoagulant therapy management. 
         [0020]    In accordance with other embodiments, methods and apparatus are provided for determining an anticoagulation therapy factor, which do not require the use of a mean normal prothrombin time (MNPT) and ISI data. In other words, the need to obtain and calculate the prothrombin time of 20 presumed normal patients, is not required to determine an anticoagulant therapy factor. 
         [0021]    In accordance with the present invention, there is provided apparatus and methods for carrying out coagulation studies and other chemical procedures and analyses. 
         [0022]    Another embodiment provides methods and apparatus for determining an anticoagulant therapy factor or INR, such as INRn, from the derivation of clotting curve values in connection with a designated area defined by clotting curve data. One preferred embodiment relates to an area defined by clotting curve data that corresponds with the area of a trapezoid formed along the clotting curve. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]      FIG. 1  is a diagram of potentiophotometric apparatus constructed in accordance with one embodiment of the present invention for determining blood chemistry analyses such as coagulation studies, including determination of the new anticoagulant therapy factor (nATF), where the output of the analog/digital (A/D) converter is applied to a computer. 
           [0024]      FIG. 2  is a plot of the various phases of the fibrinogen concentration occurring in a typical plasma clotting process. 
           [0025]      FIG. 3  is another plot of the various phases of the fibrinogen concentration occurring in a typical plasma clotting process. 
           [0026]      FIG. 4  is another plot of the various phases of the fibrinogen concentration occurring in a typical plasma clotting process. 
           [0027]      FIG. 5  is another plot of the various phases of the fibrinogen concentration occurring in a typical plasma clotting process illustrating the fibrinogen lag phase. 
           [0028]      FIG. 6  is another plot of the various phases of the fibrinogen concentration occurring in a typical plasma clotting process involves a trapezoidal configuration formed by points along the clotting curve. 
           [0029]      FIG. 7  is an illustration showing a preferred embodiment of a trapezoidal representation formed based on data from the clotting curve reaction, as shown in  FIG. 6 . 
           [0030]      FIGS. 8 ,  9 ,  10  and  11  are Bland-Altman plots representing data from Table 16. 
       
    
    
     DETAILED DESCRIPTION 
       [0031]    Referring to the drawings, wherein the same reference numbers indicate the same elements throughout, there is shown in  FIG. 1  a light source  4  which may be a low power gas laser, or other light producing device, producing a beam of light  6  which passes through a sample test tube, such as the container  8 , and is received by detection means which is preferably a silicon or selenium generating photocell  10  (photovoltaic cell). Battery  12  acts as a constant voltage DC source. Its negative terminal is connected through switch  14  to one end of variable resistor  16  and its positive terminal is connected directly to the opposite end of variable resistor  16 . The combination of battery  12  and variable resistor  16  provides a variable DC voltage source, the variable voltage being derivable between line  18  at the upper terminal of resistor  16  and wiper  20 . This variable DC voltage source is connected in series with detection means photocell  10 , the positive output of detection means photocell  10  being connected to the wiper  20  of variable resistor  16  so that the voltage produced by the variable voltage DC source opposes the voltage produced by the detection means photocell  10 . The negative output of detection means photocell  10  is connected through variable resistor  22  to line  18 . Thus, the voltage across variable resistor  22  is the difference between the voltage produced by the variable voltage DC source and the voltage produced by the photovoltaic cell  10 . The output of the electrical network is taken between line  18  and wiper  24  of variable resistor  22 . Thus, variable resistor  22  acts as a multiplier, multiplying the voltage produced as a result of the aforesaid subtraction by a selective variable depending on the setting of variable resistor  22 . The potentiophotometer just described embodies the electrical-analog solution to Beer&#39;s Law and its output is expressed directly in the concentration of the substance being measured. 
         [0032]    Wiper  24  is illustrated placed at a position to give a suitable output and is not varied during the running of the test. The output between line  18  and wiper  24  is delivered to an A/D converter  26  and digital recorder  28 . As is known, the A/D converter  26  and the digital recorder  28  may be combined into one piece of equipment and may, for example, be a device sold commercially by National Instrument of Austin, Tex. as their type Lab-PC+. The signal across variable resistor  22  is an analog signal and hence the portion of the signal between leads  18  and wiper  24 , which is applied to the A/D converter  26  and digital recorder  28 , is also analog. A computer  30  is connected to the output of the A/D converter  26 , is preferably IBM compatible, and is programmed in a manner described hereinafter. 
         [0033]    For example, preferably, the detector cell  10  is positioned adjacent an opposite wall of the sample container  8 , and the emitter light source  4  positioned adjacent on opposite wall, so the light  6  emitted from the light source  4  passes through the container  8 . The light source  4  is preferably selected to produce light  6  which can be absorbed by one or more components which are to be measured. 
         [0034]    The apparatus can be used to carry out coagulation studies in accordance with the invention. In accordance with a preferred embodiment of the present invention, the light source  4  may, for example, comprise a light emitting diode (LED) emitting a predetermined wavelength, such as for example, a wavelength of 660 nm, and the detector cell  10  may, for example, comprise a silicon photovoltaic cell detector. Optionally, though not shown, a bar code reader may also be provided to read bar code labels placed on the sample container  8 . The bar code reader may produce a signal which can be read by the computer  30  to associate a set of data with a particular sample container  8 . 
         [0035]    To carry out a coagulation study on blood plasma, the citrated blood is separated from the red blood cell component of the blood. Conventional methods of separation, which include centrifugation, may be employed. Also, the use of a container device such as that disclosed in our issued U.S. Pat. No. 6,706,536, may also be used, and the method disclosed therein for reading the plasma volume relative to the sample volume may also be employed. 
         [0036]    Illustrative of an apparatus and method according to one embodiment is a coagulation study which can be carried out therewith. A reagent, such as, for example, Thromboplastin-Calcium (Tp-Ca), is added to the plasma sample which is maintained at about 37° C. by any suitable temperature control device, such as a heated sleeve or compartment (not shown). The reagent addition is done by dispensing an appropriate amount of the reagent into the plasma portion of the blood. The plasma portion may be obtained by any suitable separation technique, such as for example, centrifugation. In one embodiment illustrated herein, the container  8  is vented when reagent is added. The reagent for example, may comprise thromboplastin, which is added in an amount equal to twice the volume of the plasma. The reagent is mixed with the plasma. It is preferable to minimize air bubbles so as not to interfere with the results. The plasma sample to which the reagent has been added is heated to maintain a 37° C. temperature, which, for example, may be done by placing the container holding the plasma and reagent in a heating chamber (not shown). 
         [0037]    Readings are taken of the optical activity of the components in the sample container  8 . 
         [0038]    Reaction kinematics may be studied by observing changes in the optical density of the plasma layer. For example, an amount of reagent, such as Thromboplastin-Calcium (Tp-Ca), may be added to the plasma sample in the container. The plasma sample in the container may comprise a known amount of volume. Alternately, the plasma volume may be ascertained through the method and apparatus described in our U.S. Pat. No. 6,706,536. A controlled amount of Tp-Ca reagent is added to the plasma sample. The amount of reagent added corresponds to the amount of plasma volume. The detector cell  10  and emitter light source  4  are preferably positioned so the absorbance of the plasma sample may be read, including when the reagent is added and the sample volume is thereby increased. 
         [0039]    With the detection elements, such as the cell  10  and emitter  4 , positioned to read the plasma sample and the reagents added thereto, the reaction analysis of the extended prothrombin time curve can be followed.  FIG. 2  shows a graph of a plot of the various phases of the fibrinogen concentration occurring in a typical plasma clotting process. The change in optical density of the plasma level occurs after reagents have been added. The optical density of the plasma sample is monitored, as optically clear fibrinogen converts to turbid fibrin. 
         [0040]    The coagulation study of the type described above is used to ascertain the results shown in the graph plotted on  FIG. 2 . The description of the analysis makes reference to terms, and symbols thereof, having a general description as used herein, all to be further described and all of which are given in Table 1. 
         [0000]    
       
         
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                 SYMBOL 
                 TERM 
                 GENERAL DESCRIPTION 
               
               
                   
               
             
             
               
                 PT 
                 Prothrombin Time 
                 A period of time calculated from the addition of the 
               
               
                   
                   
                 reagent (e.g., thromboplastin-calcium) to a point where 
               
               
                   
                   
                 the conversion of fibrinogen to fibrin begins (i.e. the 
               
               
                   
                   
                 formation of the first clot). 
               
               
                 TMA 
                 Time to Maximum 
                 The time from PT to a point where the rate of conversion 
               
               
                   
                 Acceleration 
                 of fibrinogen to fibrin has reached maximum and begins 
               
               
                   
                   
                 to slow. 
               
               
                 MAP 
                 Maximum Acceleration Point 
                 A point where the fibrinogen conversion achieves 
               
               
                   
                   
                 maximum acceleration and begins to decelerate. 
               
               
                 EOT 
                 End of Test 
                 Point where there is no appreciable change in the 
               
               
                   
                   
                 polymerization of fibrin. 
               
               
                 TEOT 
                 Theoretical End Of Test 
                 The time to convert all fibrinogen based on the time to 
               
               
                   
                   
                 convert the fibrinogen during the simulated Zero Order 
               
               
                   
                   
                 Kinetic rate. 
               
               
                 TX (or T 2 ) 
                 Time to Map 
                 Time to reach the Maximum Acceleration Point (MAP) 
               
               
                   
                   
                 from point of injection. 
               
               
                 MNTX 
                 Mean Normal Time to Map 
                 The mean of the times of at least 20 normal people to 
               
               
                   
                   
                 reach then Maximum Acceleration Point (MAP). 
               
               
                 FTR 
                 Fibrinogen Transformation 
                 The amount of fibrinogen converted during a particular 
               
               
                   
                 Ratio 
                 time period. This is a percentage of the total Fibrinogen. 
               
               
                 ATF 
                 Anticoagulation Therapy 
                 The calculated value used to monitor the uses of an 
               
               
                   
                 Factor 
                 anticoagulant without a need for an International 
               
               
                   
                   
                 Sensitivity Index (ISI) of a thromboplastin. 
               
               
                 nATF 
                 new Anticoagulation Therapy 
                 A replacement for the INR to provide a standardized 
               
               
                   
                 Factor 
                 system for monitoring oral anticoagulant therapy. (Also 
               
               
                   
                   
                 expressed as ATFt and ATFz) 
               
               
                 PR 
                 Prothrombin Ratio 
                 A value computed by dividing a sample PT by the 
               
               
                   
                   
                 geometric mean of at least 20 normal people (MNPT). 
               
               
                 INR 
                 International Normalized 
                 A parameter which takes into account the various factors 
               
               
                   
                 Ratio 
                 involved in anticoagulation therapy monitoring to provide 
               
               
                   
                   
                 a standardized system for monitoring oral anticoagulant 
               
               
                   
                   
                 therapy. 
               
               
                 ATFt 
                 Anticoagulation Therapy 
                 Utilizing a calculated Theoretical End Of Test value and 
               
               
                   
                 Factor Theoretical 
                 the Natural Log “e” to removed the need for an MNPT. 
               
               
                 XR 
                 Time to MAP Ratio 
                 The value computed by dividing a sample “TX” by the 
               
               
                   
                   
                 geometric mean of at least 20 normal people “MNTX”. 
               
               
                   
               
             
          
         
       
     
         [0041]    Prior patents for obtaining an anticoagulant therapy factor (ATF) relied on the International Normalized Ratio (INR) system which was derived in order to improve the consistency of results from one laboratory to another. The INR system utilized the calculation of INR from the equation: 
         [0000]      INR=(PT patient /PT geometric mean ) ISI    
         [0000]    wherein the PT patient  is the prothrombin time (PT) as an absolute value in seconds for a patient, PT geometric mean  is the mean, a presumed number of normal patients. The International Sensitivity Index (ISI) is an equalizing number which a reagent manufacturer of thromboplastin specifies. The ISI is a value which is obtained through calibration against a World Health Organization primary reference thromboplastin standard. Local ISI (LSI) values have also been used to provide a further refinement of the manufacturer-assigned ISI of the referenced thromboplastin in order to provide local calibration of the ISI value. 
         [0042]    For illustration, the present invention can be employed for accurate determination of a new Anticoagulant Therapy Factor (nATF) from a human blood sample, for use during the monitoring of oral anticoagulant therapy, without the need for an ISI or LSI value, and without the need for an INR value as traditionally determined from the above equation (using a patient&#39;s prothrombin time and the prothrombin time from a geometric mean of individuals). As is known in the art, blood clotting Factors I, II, V, VII, VIII, IX and X are associated with platelets (Bounameaux, 1957); and, among these, Factors II, VII, IX and X are less firmly attached, since they are readily removed from the platelets by washing (Betterle, Fabris et al, 1977). The role of these platelet-involved clotting factors in blood coagulation is not, however, defined. The present invention provides a method and apparatus for a new Anticoagulant Therapy Factor (nATF) which may be used for anticoagulant therapy monitoring without the need for INR. 
         [0043]    The International Normalized Ratio (INR) is previously discussed in already incorporated reference technical articles entitled “PTs, PRs, ISIs and INRs: A Primer on Prothrombin Time Reporting Part I and II respectively,” published in November, 1993 and December, 1993 issues of  Clinical Hemostasis Review . The illustrative example of an analysis which is carried out employing the present invention relies upon the maximum acceleration point (MAP) at which fibrinogen conversion achieves a maximum and from there decelerates, the time to reach the MAP (TX), and the mean normal time to MAP (MNTX), and a fibrinogen transformation rate (FTR), that is, the thrombin activity in which fibrinogen (FBG) is converted to fibrin to cause clotting in blood plasma. 
         [0044]    More particularly, during the clotting steps used to determine the clotting process of a plasma specimen of a patient under observation, a thromboplastin (Tp) activates factor VII which, activates factor X, which, in turn, under catalytic action of factor V, activates factor II (sometimes referred to as prothrombin) to cause factor IIa (sometimes referred to as thrombin) that converts fibrinogen (FBG) to fibrin with resultant turbidity activity which is measured, in a manner as to be described hereinafter, when the reaction is undergoing simulated zero-order kinetics. 
         [0045]    From the above, it should be noted that the thromboplastin (Tp) does not take part in the reaction where factor Ia (thrombin) converts fibrinogen (FBG) to fibrin which is deterministic of the clotting of the plasma of the patient under consideration. The thromboplastin (Tp) only acts to activate factor VII to start the whole cascade rolling. Note also that differing thromboplastins (Tps) have differing rates of effect on factor VII, so the rates of enzyme factor reactions up to II-IIa (the PT) will vary. 
         [0046]    Therefore, the prothrombin times (PTs) vary with the different thromboplastins (Tps) which may have been a factor that mislead authorities to the need of taking into account the International Normalized Ratio (INR) and the International Sensitivity Index (ISI) to compensate for the use of different types of thromboplastins (Tps) during the monitoring of oral anticoagulant therapy. It is further noted, that thromboplastins (Tps) have nothing directly to do with factor Ia converting fibrinogen (FBG) to fibrin, so it does not matter which thromboplastin is used when the fibrinogen transformation is a primary factor. 
         [0047]    The thromboplastin (Tp) is needed therefore only to start the reactions that give factor Ia. Once the factor Ia is obtained, fibrinogen (FBG) to fibrin conversion goes on its own independent of the thromboplastin (Tp) used. 
         [0048]    In one embodiment, the present method and apparatus has use, for example, in coagulation studies where fibrinogen (FBG) standard solutions and a control solution are employed, wherein the fibrinogen standard solutions act as dormant references to which solutions analyzed with the present invention are compared, whereas the control solution acts as a reagent that is used to control a reaction. The fibrinogen standards include both high and low solutions, whereas the control solution is particularly used to control clotting times and fibrinogens of blood samples. It is only necessary to use fibrinogen standards when PT-derived fibrinogens (FBG&#39;s) are determined. In connection with other embodiments of the invention, fibrinogen (FBG) standards are not necessary for the INR determination (such as for example INRz described herein). 
         [0049]    Another embodiment provides a method and apparatus for determining an anticoagulation therapy factor which does not require the use of fibrinogen standard solutions. In this embodiment, the apparatus and method may be carried out without the need to ascertain the mean normal prothrombin time (MNPT) of 20 presumed normal patients. 
         [0050]    Where a fibrinogen standard solution is utilized, a fibrinogen (FBG) solution of about 10 g/l may be prepared from a cryoprecipitate. The cryoprecipitate may be prepared by freezing plasma, letting the plasma thaw in a refrigerator and then, as known in the art, expressing off the plasma so as to leave behind the residue cryoprecipitate. The gathered cryoprecipitate should contain a substantial amount of both desired fibrinogen (FBG) and factor VIII (antihemophilic globulin), along with other elements that are not of particular concern to the present invention. The 10 g/l fibrinogen (FBG) solution, after further treatment, serves as the source for the high fibrinogen (FBG) standard. A 0.5 g/l fibrinogen (FBG) solution may then be prepared by a 1:20 (10 g/l/20=0.5 g/l) dilution of some of the gathered cryoprecipitate to which may be added an Owren&#39;s Veronal Buffer (pH 7.35) (known in the art) or normal saline solution and which, after further treatment, may serve as a source of the low fibrinogen (FBG) standard. 
         [0051]    The fibrinogen standard can be created by adding fibrinogen to normal plasma in an empty container. Preferably, the fibrinogen standard is formed from a 1:1 fibrinogen to normal plasma solution. For example, 0.5 ml of fibrinogen and 0.5 ml of plasma can be added together in an empty container. Thromboplastin calcium is then added to the fibrinogen standard. Preferably, twice the amount by volume of thromboplastin is added into the container per volume amount of fibrinogen standard which is present in the container. The reaction is watched with the apparatus  10 . 
         [0052]    Then, 1 ml of each of the high (10 g/l) and low (0.5 g/l) sources of the fibrinogen standards may be added to 1 ml of normal human plasma (so the cryoprecipitate plasma solution can clot). Through analysis, high and low fibrinogen (FBG) standards are obtained. Preferably, a chemical method to determine fibrinogen (FBG) is used, such as, the Ware method to clot, collect and wash the fibrin clot and the Ratnoff method to dissolve the clot and measure the fibrinogen (FBG) by its tyrosine content. The Ware method is used to obtain the clot and generally involves collecting blood using citrate, oxalate or disodium ethylenediaminetetraacetate as anticoagulant, typically adding 1.0 ml to about 30 ml 0.85% or 0.90% sodium chloride (NaCl) in a flask containing 1 ml M/5 phosphate buffer and 0.5 ml 1% calcium chloride CaCl 2 , and then adding 0.2 ml (100 units) of a thrombin solution. Preferably, the solution is mixed and allowed to stand at room temperature for fifteen minutes, the fibrin forming in less than one minute forming a solid gel if the fibrinogen concentration is normal. A glass rod may be introduced into the solution and the clot wound around the rod. See Richard J. Henry, M.D., et al., Clinical Chemistry: Principals and Techniques (2 nd  Edition) 1974, Harper and Row, pp. 458-459, the disclosure of which is incorporated herein by reference. Once the clot is obtained, preferably the Ratnoff method may be utilized to dissolve the clot and measure the fibrinogen (FBG) by its tyrosine content. See “A New Method for the Determination of Fibrinogen in Small Samples of Plasma”, Oscar D. Ratnoff, M.D. et al., J. Lab. Clin. Med., 1951: V.37 pp. 316-320, the complete disclosure of which is incorporated herein by reference. The Ratnoff method relies on the optical density of the developed color being proportional to the concentration of fibrinogen or tyrosine and sets forth a calibration curve for determining the relationship between optical density and concentration of fibrinogen. The addition of a fibrinogen standard preferably is added to the plasma sample based on the volume of the plasma. 
         [0053]    As is known, the addition of the reagent Thromboplastin C serves as a coagulant to cause clotting to occur within a sample of citrated blood under test which may be contained in a container  8 . As clotting occurs, the A/D converter  26  of  FIG. 1  will count and produce a digital value of voltage at a predetermined period, such as once every 0.05 or 0.01 seconds. As more fully described in the previously incorporated by reference U.S. Pat. No. 5,197,017 (&#39;017), these voltage values are stored and then printed by the recorder as an array of numbers, the printing being from left to right and line by line, top to bottom. There are typically one hundred numbers in the five groups representing voltage values every second and hence, one line represents one-fifth of a second in time (20×0.01 seconds). Individual numbers in the same column are twenty sequential numbers apart. Hence, the time difference between two adjacent numbers in a column is one-fifth of a second. The significance of these recorded values may be more readily appreciated after a general review of the operating principles illustrated in  FIG. 2  having a Y axis identified as Fibrinogen Concentration (Optical Density) and an X axis identified in time (seconds). 
         [0054]      FIG. 2  illustrates the data point locations of a clotting curve related to a coagulation study which illustrates the activation and conversion of fibrinogen to fibrin. In general,  FIG. 2  illustrates a “clot slope” method that may be used in a blood coagulation study carried out for determining a new anticoagulant therapy factor (nATFa). The ATFa represents an anticoagulation therapy factor represented by the expression ATFa=XR (2-nFTR)  wherein a maximum acceleration point is obtained, and nFTR=IUX/IUT, where IUX is the change in optical density from a time prior to the MAP time (t &lt;MAP  which is t MAP  minus some time from MAP) to the optical density at a time after the MAP time (t &gt;MAP  which is t MAP  plus some time from MAP); and wherein IUT=the change in optical density at the time t 1  to the optical density measured at time t EOT , where time t EOT  is the end of the test (EOT). The first delta (IUX) represents the fibrinogen (FBG) for MAP (−a number of seconds) to MAP (+a number of seconds) (that is the fibrinogen (FBG) converted from t &lt;MAP  to t &gt;MAP  on  FIG. 2 ). The (IUT) represents fibrinogen converted from c 1  to c EOT  (that is the fibrinogen converted from t 1  to t EOT , see  FIG. 2 ). The XR for the ATFa expression is XR=TX/MNTX, which is the ratio of time to map (TX) by the mean normal time to map of 20 presumed “normal” patients. 
         [0055]    The study which measures the concentration of the fibrinogen (FBG) in the plasma that contributes to the clotting of the plasma and uses an instrument, such as, for example, the potentiophotometer apparatus illustrated in  FIG. 1 , to provide an output voltage signal that is directly indicative of the fibrinogen (FBG) concentration in the plasma sample under test, is more fully discussed in the previously incorporated by reference U.S. Pat. No. 5,502,651. The quantities given along the Y-axis of  FIG. 2  are values (+ and −) that may be displayed by the digital recorder  28 . The “clot slope” method comprises detection of the rate or the slope of the curve associated with the formation of fibrin from fibrinogen. The “clot slope” method takes into account the time to maximum acceleration (TX) which is the point at which fibrinogen conversion achieves a maximum and from there decelerates. 
         [0056]    As seen in  FIG. 2 , at time to, corresponding to a concentration c 0 , the thromboplastin/calcium ion reagent is introduced into the blood plasma which causes a disturbance to the composition of the plasma sample which, in turn, causes the optical density of the plasma sample to increase momentarily. After the injection of the reagent (the time of which is known, as to be described, by the computer  30 ), the digital quantity of the recorder  28  of  FIG. 1  rapidly increases and then levels off in a relatively smooth manner and then continues along until the quantity c 1  is reached at a time t 0 . The time which elapses between the injection of thromboplastin at to and the instant time t 1  of the quantity c 1  is the prothrombin time (PT) and is indicated in  FIG. 2  by the symbol PT. As shown in  FIG. 2 , the baseline that develops after the thromboplastin (TP) is introduced or injected into the sample generally is thought to represent the “lag phase” of all of the enzymes preceding prothrombin converting to fibrin. The enzymes types and amounts may vary from person to person, and thus, this would demonstrate the potential for prothrombin times to vary between individuals. 
         [0057]    An anticoagulant therapy factor (nATF) is determined. The optical density of a quantity c 1  directly corresponds to a specified minimum amount of fibrinogen (FBG) that must be present for a measuring system, such as the circuit arrangement of  FIG. 1 , to detect in the plasma sample that a clot is being formed, i.e., through the transformation of fibrinogen to fibrin. The quantities shown in  FIG. 2  are of optical densities, which may be measured in instrument units, that are directly correlatable to fibrinogen concentration values. The quantity c 1 , may vary from one clot detection system to another, but for the potentiophotometer system of  FIG. 1 , this minimum is defined by units of mass having a value of about 0.05 grams/liter (g/l). 
         [0058]    Considering the clotting curve of  FIG. 2 , detection of a first predetermined quantity c 1  is illustrated occurring at a corresponding time t 1 , which is the start of the clotting process. In accordance with one or more embodiments, this process may be monitored with the apparatus of  FIG. 1  for determining a new anticoagulant therapy factor (nATF). The time t 1  is the beginning point of the fibrinogen formation, that is, it is the point that corresponds to the beginning of the acceleration of the fibrinogen conversion that lasts for a predetermined time, The acceleration of the fibrinogen conversion proceeds from time (t 1 ) and continues until a time t MAP , having a corresponding quantity c MAP . The time t MAP , as well as the quantity CMAP, is of primary importance because it is the point of maximum acceleration of the fibrinogen (FBG) to fibrin conversion and is also the point where deceleration of fibrinogen (FBG) to fibrin conversion begins. Further, the elapsed time from t 0  to t MAP  is a time to maximum acceleration from reagent injection (TX), shown in  FIG. 2 . Preferably, the conversion of fibrinogen to fibrin is quantified every 0.1 seconds. The time to maximum acceleration from reagent injection (TX) is defined as the point on the clotting curve time line where this conversion has reached its maximum value for the last time, simulating a zero-order kinetic rate. To facilitate ascertainment of the location point of the last maximum value, the delta value of two points at a fixed interval may be measured until this value begins to decrease. This value is tracked for a period of time, such as for example five seconds, after the first decreasing value has been determined. This facilitates ascertainment of the last point of what may be referred to as a simulated zero-order kinetic rate. Referring to  FIG. 3 , a zero order kinetic rate is illustrated by the line (L). 
         [0059]    As shown in  FIG. 2 , a quantity c MAP  and a corresponding time t MAP  define a maximum acceleration point (MAP). Fibrin formation, after a short lag phase before the MAP, occurs for a period of time, in a linear manner. Fibrinogen (FBG) is in excess during this lag phase, and fibrin formation appears linear up to the MAP. 
         [0060]    The deceleration of fibrinogen (FBG) to fibrin conversion continues until a quantity c EOT  is reached at a time t EOT . The time t EOT  is the point where the deceleration of the fibrinogen (FBG) to fibrin conversion corresponds to a value which is less than the required amount of fibrinogen (FBG) that was present in order to start the fibrinogen (FBG) to fibrin conversion process. Thus, because the desired fibrinogen (FBG) to fibrin conversion is no longer in existence, the time t EOT  represents the ending point of the fibrinogen (FBG) to fibrin conversion in accordance with the coagulation study exemplified herein, which may be referred to as the end of the test (EOT). The fibrinogen (FBG) to fibrin conversion has a starting point of t 1  and an ending point of t EOT . The differential of these times, t 1  and t EOT , define a second delta (IUT). 
         [0061]    The “clot slope” method that gathers typical data as shown in  FIG. 2  has four critical parameters. The first is that the initial delta optical density of substance being analyzed should be greater than about 0.05 g/l in order for the circuit arrangement of  FIG. 1  to operate effectively. Second, the acceleration fibrinogen (FBG) to fibrin conversion should be increasing for a minimum period of about 1.5 seconds so as to overcome any false reactions created by bubbles. Third, the total delta optical density (defined by the difference in quantities c 1  and c EOT ) should be at least three (3) times the instrument value in order to perform a valid test, i.e., (3)*(0.05 g/l)=0.15 g/l. Fourth, the fibrinogen (FBG) to fibrin conversion is defined, in part, by the point (t EOT ) where the deceleration of conversion becomes less than the instrument value of about 0.05 g/l that is used to detect the clot point (t 1 ). As with most clot detection systems, a specific amount of fibrinogen needs to be present in order to detect a clot forming. Adhering to the four given critical parameters is an example of how the present apparatus and method may be used to carry out a coagulation study to determine a specific quantity of fibrinogen. In order for that specific amount of fibrinogen to be determined, it is first necessary to detect a clot point (t 1 ). After that clot point (t 1 ) is detected, it logically follows that when the fibrinogen conversion becomes less than the specific amount (about 0.05 g/l for the circuit arrangement of  FIG. 1 ), the end point (t EOT ) of the fibrinogen conversion has been reached. 
         [0062]    One embodiment of the method and apparatus is illustrated in accordance with the clotting curve shown in  FIG. 3 . The clotting curve of  FIG. 3  illustrates the values ascertained in arriving at a new anticoagulation therapy factor (nATFz). The embodiment illustrates the determination of a new anticoagulation therapy factor (nATFz), expressed by the following formula: 
         [0000]      nATFz=XR (2-nFTR)   (1) 
         [0063]    This embodiment utilizes a zero order line (L) to obtain a first delta, in particular IUXz, which is a first differential taken along the simulated zero order kinetic line (L), and preferably along the segment between the start of the simulated zero order kinetic (T 2 S) to the last highest absorbance value (T 2 ) (i.e., preferably, the last highest absorbance value of a simulated zero order kinetic). As previously discussed, the acceleration of the fibrinogen conversion proceeds from a first time, here time (T 1 ) and continues, eventually reaching a time where the last highest delta absorbance value or maximum acceleration point (T 2 ) having a corresponding quantity c T2  is reached. The values for “T” correspond with times, and the values for “c” correspond with quantity, which may be measured in instrument units based on optical density readings (also referred to as optical density or o.d.). The time T 2 , as well as the quantity c T2 , is the point of maximum acceleration of the fibrinogen (FBG) to fibrin conversion and is also the point where deceleration of fibrinogen (FBG) to fibrin conversion begins. In this embodiment, IUXz is the change in optical density preferably from the beginning of the at the time T 2 S at which the simulated zero order kinetic begins to the optical density at time T 2  which is the maximum acceleration point or the last highest delta absorbance value of a simulated zero order kinetic.  FIG. 3  shows the differential IUXz taken between a preferred segment of the zero order line. The second delta in particular (IUTz) is the change in optical density at the time T 2 S to the optical density measured at time T 3 , where time T 3  is the end of the test (EOT). 
         [0064]    The (IUXz) represents the fibrinogen (FBG) converted between time T 2 S and T 2 . The (IUTz) represents fibrinogen converted from the time T 2 S to the end of the test or T 3 . 
         [0065]    The maximum acceleration ratio (XR) for this embodiment is calculated to arrive at the new alternate anticoagulation therapy factor (nATFz). The maximum acceleration ratio (XR) is defined as the time to maximum acceleration from reagent injection (TX) divided by the mean normal TX value of a number of presumed normal specimens (MNTX). For example, the mean normal TX value may be derived based on the value of 20 or more presumed normal specimens. The maximum acceleration ratio (XR) may be expressed through the following formula: 
         [0000]      XR=TX/MNTX  (2) 
         [0066]    The clotting curve of  FIG. 3  illustrates the values ascertained in arriving at the new alternate anticoagulation therapy factor (nATFz). The new alternate anticoagulation therapy factor (nATFz) is preferably expressed by the following formula: 
         [0000]      nATFz=XR (2-nFTR)   (3) 
         [0067]    with FTR being IUXz/IUTz. 
         [0068]    The preferred IBM-compatible computer  30  of  FIG. 1  stores and manipulates these digital values corresponding to related data of  FIG. 3  and is preferably programmed as follows:
       (a) a sample of blood where the plasma is available, such as, for example, a sample of citrated blood, is obtained and placed in an appropriate container, the computer  30 , as well as the recorder  28 , sequentially records voltage values for a few seconds before injection of theromboplastin. As previously discussed, thromboplastin (tissue factor) is one of the factors in the human body that causes blood to clot. Prothrombin is another. Fibrinogen is yet another. Before injection of the thromboplastin, the output from the A/D converter  26  is relatively constant. When thromboplastin is injected into the plasma sample in the container, a significant and abrupt change occurs in the recorded voltage values of both the computer  30  and the recorder  28 . This abrupt change is recognized by both the recorder  28  and, more importantly, by the computer  30  which uses such recognition to establish T o . The computer  30  may be programmed so as to correlate the digital quantities of the A/D converter  26  to the analog output of the detector means photocell  10  which, in turn, is directly correlatable to the fibrinogen (FBG) concentration g/l of the sample of blood discussed with reference to  FIG. 3 ;   (b) the computer  30  may be programmed to look for a digital quantity representative of a critical quantity c 1 , and when such occurs, record its instant time T 1 . (The time span between T o  and T 1  is the prothrombin time (PT), and has an normal duration of about 12 seconds, but may be greater than 30 seconds);   (c) following the detection of the quantity c 1 , the computer  30  may be programmed to detect for the acceleration of fibrinogen (FBG) to fibrin conversion. The computer  30  is programmed to detect the maximum acceleration quantity c MAP  or c T2  as illustrated in  FIG. 3 , and its corresponding time of occurrence t MAP , which is T 2  in  FIG. 3 .   (d) the computer detects a quantity c EOT  occurring at time t EOT . Typically, it is important that the rate of fibrin formation increase for at least 1.5 seconds following the occurrence of (T 1 );   (e) The computer  30  is programmed to ascertain the value for the time to start (T 2 S) which corresponds with the time at which the simulated zero order kinetic rate begins.   (f) following the detection of the acceleration of fibrinogen conversion to detect the start time T 2 S, the computer  30  is programmed to detect for a deceleration of the fibrinogen conversion, wherein the fibrinogen concentration decreases from a predetermined quantity c MAP  to a predetermined quantity c EOT  having a value which is about equal but less than the first quantity c 1 . The computer is programmed to ascertain a first delta (IUTz), by determining the difference between the quantity c T2S  and the quantity c EOT ; and a second delta (IUXz) by determining the difference between the quantity c T2S  and the quantity c 2  (or c MAP ).   (g) the computer  30  manipulates the collected data of (a); (b); (c); (d); (e) and (f) above, to determine the new fibrinogen transfer rate (nFTR). The nFTR may be arrived at based on the principle that if a required amount (e.g., 0.05 g/l) of fibrinogen concentration c 1  is first necessary to detect a clot point (T 1 ); then when the fibrinogen concentration (c EOT ) becomes less than the required amount c 1 , which occurs at time (T EOT ), the fibrinogen end point has been reached. More particularly, the required fibrinogen concentration c 1  is the starting point of fibrinogen conversion of the clotting process and the less than required fibrinogen concentration c EOT  is the end point of the fibrinogen conversion of the clotting process.   (h) The computer now has the information needed to determine the new fibrinogen transfer rate (nFTRz) which is expressed by the following formula:       
 
         [0000]      nFTRz=IUXz/IUTz  (4)       (i) data collected is manipulated by the computer  30  to calculate the maximum acceleration ratio (XR), which is expressed as TX divided by the mean normal TX value of at least 20 presumed normal specimens (MNTX):         
         [0000]      XR=TX/MNTX  (2) 
         [0000]    The MNTX value may be ascertained and stored in the computer for reference.
       (j) the computer  30  now has the information needed to determine the nATFz, (also referred to as INRz) which typically is expressed as:       
 
         [0000]      nATFz or INRz=XR (2-nFTR)   (3) 
         [0079]    where, in the exponent, the value 2 is the logarithm of the total fibrinogen, which, as expressed in terms of the optical density, is 100% transmittance, the log of 100 being 2. 
         [0080]    The new anticoagulation therapy factor (nATFz) does not require an ISI value, as was previously used to determine anticoagulation therapy factors. The new anticoagulation therapy factor (nATFz) uses for its ascertainment the values extracted from the clotting curve (see  FIG. 3 ), in particular (nFTRz) (determined based on IUXz and IUTz), and (TX). In carrying out coagulation studies, the new anticoagulant therapy factor (nATFz) may replace INR in anticoagulant therapy management. 
         [0081]    The apparatus and method for obtaining a new anticoagulant therapy factor, (nATFz), may be accomplished without encountering the complications involved with obtaining the prior art quantities International Normalized Ratio (INR) and International Sensitivity Index (ISI). 
         [0082]    The new anticoagulant therapy factor (nATFz or ATF) preferably is a replacement for the International Normalized Ratio (INR), hence it may be referred to as INRz. Existing medical literature, instrumentation, and methodologies are closely linked to the International Normalized Ratio (INR). The nATFz was compared for correlation with the INR by comparative testing, to INR quantities, even with the understanding that the INR determination may have an error of about ten (10) % which needs to be taken into account to explain certain inconsistencies. 
         [0083]    Table 2, below, includes anticoagulant therapy factors obtained from patients at two different hospitals. The ATFz values were obtained, with GATFz representing one geographic location where patients were located and MATFz being another location. The ATFz was obtained as the new anticoagulant therapy factor, and as illustrated in Tables 4 and 5, below, compares favorably to results obtained for INR determinations. 
         [0084]    Another alternate embodiment for determining a new anticoagulant therapy factor (ATFt) is provided. The alternate embodiment for determining ATFt eliminates the need for determining a mean normal prothrombin time (MNPT) (or MNXT) and ISI, saving considerable time and costs, and removing potential sources of error, as the MNPT (the expected value of MNPT&#39;s depending on the varying  20  presumed normals population) and ISI (generally provided by the manufacturer of the reagent—such as, for example, the thromboplastin, etc.) are not required for the determination of the ATFt. An alternate embodiment for determining ATFt is illustrated in accordance with the clotting curve shown in  FIG. 4 . The clotting curve of  FIG. 4  illustrates values ascertained in arriving at the alternate new anticoagulation therapy factor (nATFt). The alternate new anticoagulation therapy factor (nATFt) is preferably expressed by the following formula: 
         [0000]      nATFt=Value 1*Value 2  (4) 
         [0085]    The alternate embodiment utilizes the zero order line (L) to obtain a first delta, in particular IUXz, which is a first differential taken along the simulated zero order kinetic line (L), and preferably along the segment between the start of the simulated zero order kinetic (T 2 S) to the last highest absorbance value (T 2 ) (i.e., preferably, the last highest absorbance value of a simulated zero order kinetic). As previously discussed, the acceleration of the fibrinogen conversion proceeds from a first time, here time (T 1 ) and continues, eventually reaching a time where the last highest delta absorbance value or maximum acceleration point (T 2 ) having a corresponding quantity c T2  is reached. The time T 2 , as well as the quantity c T2 , is the point of maximum acceleration of the fibrinogen (FBG) to fibrin conversion and also is the point where deceleration of fibrinogen (FBG) to fibrin conversion begins. As illustrated on the clotting chart in  FIG. 4 , IUXz represents a change in optical density (o.d.) preferably from the beginning of the at the time T 2 S at which the simulated zero order kinetic begins to the optical density at time T 2  which is the maximum acceleration point or the last highest delta absorbance value of a simulated zero order kinetic. The value IUXz is generally expressed in instrument units (corresponding to absorbance or percent transmittance) and may generally be referred to as optical density or o.d.  FIG. 4  shows the differential IUXz taken between a preferred segment of the zero order line. The second delta in particular (IUTz) represents a change in optical density at a time T 2 S to the optical density measured at a time T 3 , where time T 3  is the end of the test (EOT). 
         [0086]    The (IUXz) represents the fibrinogen (FBG) converted between time T 2 S and T 2 . The (IUTz) represents fibrinogen converted from the time T 2 S to the end of the test or T 3 . 
         [0087]    The first value V1 corresponds to the value determined for the theoretical end of test (TEOT), which, as illustrated in the clotting curve representation in  FIG. 4 , is where the zero order kinetic line (L) crosses the line y=T 3 . The value TEOT is the elapsed time to convert the total instrument units (TIU) at the zero order kinetic rate, which is representative of the fibrinogen in the sample undergoing the conversion to fibrin. In other words, the expression for the first value (V1), or TEOT, is: 
         [0000]        V 1=TEOT=ZTM/IUXz*IUTz  (5) 
         [0000]    where ZTM is the time between Tmap (i.e., T 2  shown on  FIG. 4 ) and T2S. ZTM may be generally represented by the following expression: 
         [0000]      ZTM= T   2   −T   2   S   (6) 
         [0088]    A second value, V2, also referred to as a multiplier, is determined based on the value T 2 S. In the expression for the ATFt, the second value, V2, may be obtained by taking the value of the time (T 2 S) corresponding to a second time (t2) or the maximum acceleration point (Tmap), and scaling this value. It is illustrated in this embodiment that the multiplier is derived from the natural log base “e”, which is 2.71828, scaled to provide an appropriately decimaled value. The scaling number used in the example set forth for this embodiment is 100. The second value (V2) may be expressed by the following relationship: 
         [0000]        V 2 =T   2   S/ 100 e   (7) 
         [0000]    where T 2 S is the maximum acceleration point for the sample, and 100e is the value 100 multiplied by the natural log base “e” (2.71828) or 271.828. The new anticoagulation therapy factor according to the alternate embodiment may be expressed as follows: 
         [0000]      nATFt=[( T   2   −T   2   S )/IUXz*IUTz]*[ T   2   S/M]   (8) 
         [0000]    where M represents a multiplier. In the present example, the multiplier M, corresponds to the value 271.828 (which is 100 times the natural log base “e”). 
         [0089]    An alternate embodiment of an anticoagulant therapy factor, ATFt2, which does not require the ascertainment of a mean normal prothrombin time (MNPT) or use of an ISI value, is derived using the expression (5), wherein the IUTz is replaced by the expression (IUTz+IULz). In this alternate expression the method is carried out to ascertain the values for Value1 and Value2, in the manner described herein, with Value 1 being obtained through expression (5.1): 
         [0000]        V 1=TEOT=ZTM/IUXz*(IUTz+IULz)  (5.1) 
         [0000]    where IULz is time to convert the lag phase fibrinogen (FBG) measured along the ordinate between T1 and T2S. In expression 5.1, the theoretical end of test (TEOT) is set to include the time to convert the fibrinogen (FBG) in the lag phase of the clotting curve.  FIG. 5  illustrates the fibrinogen lag phase and the TEOT obtained from the line L2, and shows the IULz. ATFt2 is expressed by the following: 
         [0000]      nATFt2=[( T   2   −T   2   S )/IUXz*(IUTz+IULz)]*[ T   2   S/M]   (8.1) 
         [0090]    The apparatus may comprise a computer which is programmed to record, store and process data. The zero order rate may be determined by ascertaining data from analyzing the sample, and optical density properties. One example of how this may be accomplished is using two arrays, a data array and a sub array. A data array may be ascertained by collecting data over a time interval. In one embodiment, for example, the data array may comprise a sequential list of optical densities, taken of a sample by an optical analytical instrument, such as, for example, a spectrophotometer, for a frequency of time. In the example, the frequency of sample data is taken every 100 th  of a second. In this embodiment, a computer is programmed to record the optical density of the sample, every 100 th  of a second. Two values, NOW and THEN, for the data array are provided for ascertaining the Prothrombin Time (PT) (which is the time point T 1 ), maximum acceleration point (MAP), and end of test point (EOT). Two time definitions may be specified, one being the interval between NOW and THEN on the clotting curve, which may be 2.72 seconds (272/100 th  of a second), the second being the size of the filter used for signal averaging. NOW is the sum of the last 20 optical densities and THEN is the sum of the 10 prior data points 2.72 seconds prior to NOW. A graphical illustration is provided in  FIG. 5 . As illustrated in  FIG. 5 , four values are defined: SUM(NOW), SUM(THEN), AVERAGE(NOW) and AVERAGE(THEN). The average is the sum divided by the filter value. 
         [0091]    The sub array may be defined as a sequential list of delta absorbance units. This may begin at T 1 , the prothrombin time (PT), and continue until the last highest delta absorbance (delta A) has been detected, then continues an additional five (5) seconds to insure the last delta A has been found. A determination of T 2 S may be accomplished by locating within the sub array, the first occurrence of when the sub array delta value is greater than or equal to 80% of the highest delta absorbance units. The first derivative is ascertained by computing the difference between (NOW) and (THEN). The PT is ascertained by determining the point prior to the positive difference between AVERAGE(THEN) and AVERAGE(NOW) for a period of 2.72 seconds or 272 ticks. The MAP is the point where the last highest difference between SUM(THEN) and SUM(NOW) has occurred. The computer may be programmed to store this delta A value in the sub array. The EOT may be ascertained by determining the point prior to where the difference between SUM(THEN) and SUM(NOW) is less than one. 
         [0092]    Table 2 illustrates examples of samples, identified by ID numbers, along with corresponding data which compares the ATF values obtained for an ATF determined through the prior method, using ISI and INR values (represented as ATFa), an ATF determined through the use of a zero order kinetic reaction using the MNTX (nATFz), and an ATF determined without using the MNXT or ISI (nATFt). The data in table 2 represents universal laboratory data from combined locations for the patients listed. The data is based on analysis of absorbance data, storage of the data by the computer, such as, for example, with a storage device, like a hard drive, and retrieving the data and processing the data. The data, in the example represented in Table 2 was processed using the definitions and NOW and THEN intervals. 
         [0000]    
       
         
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 2 
               
               
                   
               
               
                 ID 
                 AINR 
                 GINR 
                 GatfA 
                 GatfZ 
                 GatfT 
                 MINR 
                 MatfA 
                 MatfZ 
                 MatfT 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 U0047 
                 2.10 
                 1.70 
                 1.76 
                 1.74 
                 1.62 
                 2.00 
                 2.08 
                 1.78 
                 1.68 
               
               
                 U0048 
                 1.80 
                 1.80 
                 1.84 
                 1.83 
                 1.72 
                 1.90 
                 1.96 
                 1.85 
                 1.82 
               
               
                 U0050 
                 1.80 
                 1.70 
                 1.77 
                 1.80 
                 1.68 
                 1.90 
                 2.00 
                 1.80 
                 1.70 
               
               
                 U0056 
                 1.60 
                 1.50 
                 1.54 
                 1.54 
                 1.40 
                 1.80 
                 1.83 
                 1.61 
                 1.48 
               
               
                 U0058 
                 3.20 
                 2.80 
                 2.93 
                 2.92 
                 2.93 
                 3.30 
                 3.38 
                 3.10 
                 3.29 
               
               
                 U0060 
                 2.20 
                 2.10 
                 2.15 
                 2.17 
                 2.11 
                 2.20 
                 2.21 
                 2.26 
                 2.27 
               
               
                 U0062 
                 2.80 
                 2.60 
                 2.69 
                 2.72 
                 2.69 
                 3.00 
                 3.19 
                 2.86 
                 2.91 
               
               
                 U0415 
                 0.90 
                 0.90 
                 0.88 
                 0.94 
                 0.74 
                 0.90 
                 0.95 
                 0.97 
                 0.83 
               
               
                 U0432 
                 1.80 
                 1.50 
                 1.53 
                 1.42 
                 1.24 
                 1.40 
                 1.39 
                 1.46 
                 1.33 
               
               
                 U0436 
                 2.40 
                 2.40 
                 2.57 
                 2.24 
                 1.99 
                 2.40 
                 2.41 
                 2.28 
                 2.17 
               
               
                 U0438 
                 3.90 
                 3.70 
                 4.25 
                 3.26 
                 3.21 
                 3.80 
                 4.22 
                 3.40 
                 3.55 
               
               
                 U0439 
                 2.30 
                 2.20 
                 2.27 
                 1.94 
                 1.75 
                 2.30 
                 2.32 
                 2.07 
                 2.02 
               
               
                 U0440 
                 5.80 
                 4.80 
                 5.41 
                 4.33 
                 4.50 
                 4.60 
                 4.84 
                 4.55 
                 5.18 
               
               
                 U0441 
                 4.50 
                 4.90 
                 5.58 
                 5.01 
                 4.86 
                 4.40 
                 4.71 
                 4.64 
                 5.35 
               
               
                 U0442 
                 1.80 
                 1.70 
                 1.79 
                 1.65 
                 1.48 
                 1.80 
                 1.84 
                 1.64 
                 1.52 
               
               
                 U0800 
                 2.00 
                 2.00 
                 2.02 
                 1.78 
                 1.64 
                 2.10 
                 2.11 
                 2.12 
                 2.09 
               
               
                 U0843 
                 1.40 
                 1.40 
                 1.43 
                 1.42 
                 1.22 
                 1.40 
                 1.47 
                 1.44 
                 1.31 
               
               
                 U0848 
                 1.30 
                 1.40 
                 1.41 
                 1.31 
                 1.13 
                 1.30 
                 1.37 
                 1.34 
                 1.23 
               
               
                 U0849 
                 2.40 
                 2.30 
                 2.44 
                 1.94 
                 1.77 
                 2.30 
                 2.38 
                 1.98 
                 1.93 
               
               
                 U0855 
                 1.30 
                 1.30 
                 1.29 
                 1.35 
                 1.17 
                 1.20 
                 1.24 
                 1.36 
                 1.22 
               
               
                 U0860 
                 1.00 
                 1.00 
                 0.99 
                 1.00 
                 0.77 
                 1.00 
                 0.97 
                 1.00 
                 0.85 
               
               
                 U0861 
                 2.80 
                 2.90 
                 2.98 
                 2.70 
                 2.58 
                 3.00 
                 2.99 
                 2.88 
                 3.00 
               
               
                 U0863 
                 1.70 
                 1.70 
                 1.70 
                 1.76 
                 1.65 
                 1.70 
                 1.77 
                 1.83 
                 1.79 
               
               
                 U0867 
                 3.20 
                 2.90 
                 3.19 
                 2.64 
                 2.38 
                 3.00 
                 3.10 
                 2.85 
                 2.83 
               
               
                 U0875 
                 2.20 
                 2.00 
                 2.16 
                 1.80 
                 1.60 
                 2.00 
                 2.02 
                 1.81 
                 1.71 
               
               
                 U1198 
                 2.20 
                 2.10 
                 2.17 
                 2.07 
                 1.91 
                 2.00 
                 1.98 
                 2.22 
                 2.22 
               
               
                 U1199 
                 2.80 
                 3.30 
                 3.57 
                 2.79 
                 2.76 
                 3.20 
                 3.21 
                 2.99 
                 3.28 
               
               
                 U1201 
                 1.90 
                 1.90 
                 1.95 
                 1.76 
                 1.62 
                 1.80 
                 1.84 
                 1.82 
                 1.80 
               
               
                 U1202 
                 1.30 
                 1.30 
                 1.35 
                 1.31 
                 1.16 
                 1.40 
                 1.39 
                 1.35 
                 1.20 
               
               
                 U1205 
                 1.60 
                 1.80 
                 1.90 
                 1.71 
                 1.53 
                 1.90 
                 1.90 
                 1.80 
                 1.67 
               
               
                 U1207 
                 1.90 
                 1.90 
                 1.96 
                 1.68 
                 1.49 
                 1.90 
                 1.87 
                 1.78 
                 1.61 
               
               
                 U1218 
                 3.00 
                 2.60 
                 2.86 
                 2.57 
                 2.56 
                 2.80 
                 3.07 
                 2.90 
                 3.08 
               
               
                 U1225 
                 2.20 
                 2.30 
                 2.34 
                 2.01 
                 1.83 
                 2.60 
                 2.40 
                 2.21 
                 2.16 
               
               
                 U1230 
                 1.30 
                 1.40 
                 1.45 
                 1.47 
                 1.32 
                 1.40 
                 1.45 
                 1.50 
                 1.45 
               
               
                 U1575 
                 1.40 
                 1.30 
                 1.30 
                 1.53 
                 1.41 
                 1.40 
                 1.44 
                 1.49 
                 1.35 
               
               
                 U1576 
                 2.20 
                 2.10 
                 2.11 
                 2.10 
                 2.02 
                 2.30 
                 2.32 
                 2.19 
                 2.17 
               
               
                 U1579 
                 1.50 
                 1.70 
                 1.72 
                 1.64 
                 1.49 
                 1.80 
                 1.81 
                 1.61 
                 1.44 
               
               
                 U1581 
                 1.70 
                 1.70 
                 1.74 
                 1.85 
                 1.81 
                 1.70 
                 1.77 
                 1.74 
                 1.73 
               
               
                 U1599 
                 2.00 
                 1.70 
                 1.78 
                 2.01 
                 1.96 
                 2.00 
                 2.14 
                 2.04 
                 1.93 
               
               
                 U1600 
                 3.50 
                 3.30 
                 3.39 
                 3.58 
                 3.63 
                 3.90 
                 4.21 
                 3.37 
                 3.64 
               
               
                 U1649 
                 0.90 
                 0.80 
                 0.80 
                 0.94 
                 0.76 
                 0.90 
                 0.89 
                 0.89 
                 0.74 
               
               
                 U3050 
                 2.70 
                 2.80 
                 3.08 
                 2.34 
                 2.17 
                 2.30 
                 2.34 
                 2.05 
                 2.02 
               
               
                 U3077 
                 1.30 
                 1.40 
                 1.44 
                 1.34 
                 1.17 
                 1.30 
                 1.28 
                 1.31 
                 1.16 
               
               
                 U3083 
                 1.60 
                 1.60 
                 1.58 
                 1.47 
                 1.31 
                 1.60 
                 1.68 
                 1.48 
                 1.37 
               
               
                 U3395 
                 2.70 
                 3.20 
                 3.51 
                 2.80 
                 2.70 
                 2.80 
                 2.90 
                 2.38 
                 2.32 
               
               
                 U3398 
                 1.50 
                 1.70 
                 1.77 
                 1.60 
                 1.47 
                 1.60 
                 1.65 
                 1.61 
                 1.47 
               
               
                 U3408 
                 1.10 
                 1.20 
                 1.18 
                 1.13 
                 0.92 
                 1.10 
                 1.03 
                 1.09 
                 0.94 
               
               
                 U3453 
                 1.10 
                 1.20 
                 1.24 
                 1.19 
                 0.97 
                 1.20 
                 1.18 
                 1.11 
                 1.00 
               
               
                 U3456 
                 1.10 
                 1.00 
                 0.96 
                 0.99 
                 0.81 
                 1.00 
                 0.98 
                 1.04 
                 0.90 
               
               
                 U3457 
                 2.20 
                 2.30 
                 2.38 
                 2.03 
                 1.94 
                 2.10 
                 2.28 
                 1.94 
                 1.86 
               
               
                 U3459 
                 2.90 
                 2.60 
                 2.81 
                 2.40 
                 2.22 
                 2.40 
                 2.53 
                 2.11 
                 2.04 
               
               
                 U3724 
                 2.70 
                 2.40 
                 2.47 
                 2.16 
                 1.95 
                 2.60 
                 2.72 
                 2.31 
                 2.25 
               
               
                 U4471 
                 1.50 
                 1.60 
                 1.67 
                 1.63 
                 1.43 
                 1.70 
                 1.71 
                 1.71 
                 1.62 
               
               
                 U4737 
                 2.90 
                 2.60 
                 2.79 
                 2.42 
                 2.26 
                 2.70 
                 2.87 
                 2.51 
                 2.42 
               
               
                 U4752 
                 1.40 
                 1.50 
                 1.55 
                 1.47 
                 1.26 
                 1.50 
                 1.48 
                 1.46 
                 1.33 
               
               
                 U4757 
                 2.00 
                 2.10 
                 2.09 
                 1.95 
                 1.77 
                 2.00 
                 2.02 
                 2.00 
                 1.92 
               
               
                 U4767 
                 2.60 
                 2.40 
                 2.52 
                 2.16 
                 1.95 
                 2.60 
                 2.56 
                 2.33 
                 2.27 
               
               
                 U4772 
                 2.50 
                 2.70 
                 2.78 
                 2.59 
                 2.58 
                 2.80 
                 2.84 
                 2.55 
                 2.56 
               
               
                 U4801 
                 1.30 
                 1.40 
                 1.41 
                 1.33 
                 1.13 
                 1.50 
                 1.49 
                 1.41 
                 1.22 
               
               
                 U5133 
                 0.90 
                 0.90 
                 0.91 
                 0.92 
                 0.74 
                 1.00 
                 0.97 
                 0.97 
                 0.78 
               
               
                 U5158 
                 5.50 
                 5.10 
                 5.90 
                 5.34 
                 5.64 
                 6.00 
                 6.57 
                 6.50 
                 7.00 
               
               
                 U5169 
                 2.60 
                 2.90 
                 3.16 
                 3.14 
                 3.09 
                 3.20 
                 3.35 
                 3.35 
                 3.67 
               
               
                 U5173 
                 1.10 
                 1.20 
                 1.17 
                 1.19 
                 1.02 
                 1.20 
                 1.21 
                 1.16 
                 1.03 
               
               
                 U5175 
                 1.70 
                 1.80 
                 1.86 
                 1.85 
                 1.67 
                 1.90 
                 1.92 
                 1.82 
                 1.70 
               
               
                 U5178 
                 2.30 
                 2.20 
                 2.28 
                 2.02 
                 1.79 
                 2.60 
                 2.85 
                 2.03 
                 2.01 
               
               
                 U5183 
                 2.90 
                 2.60 
                 2.83 
                 2.43 
                 2.23 
                 3.60 
                 3.86 
                 2.88 
                 3.01 
               
               
                 U5190 
                 2.80 
                 2.70 
                 2.82 
                 2.85 
                 2.70 
                 3.20 
                 3.36 
                 3.00 
                 3.15 
               
               
                 U5193 
                 3.10 
                 3.00 
                 3.13 
                 2.93 
                 2.81 
                 3.60 
                 3.73 
                 3.33 
                 3.30 
               
               
                 U5565 
                 2.70 
                 3.20 
                 3.34 
                 3.16 
                 3.04 
                 3.50 
                 3.48 
                 3.31 
                 3.50 
               
               
                 U5589 
                 1.60 
                 1.80 
                 1.86 
                 1.69 
                 1.52 
                 1.90 
                 1.96 
                 1.64 
                 1.44 
               
               
                 U5591 
                 2.00 
                 2.20 
                 2.33 
                 2.16 
                 1.98 
                 2.30 
                 2.28 
                 2.19 
                 2.24 
               
               
                 U5592 
                 1.10 
                 1.20 
                 1.23 
                 1.26 
                 1.09 
                 1.40 
                 1.35 
                 1.49 
                 1.37 
               
               
                 U5593 
                 1.70 
                 1.80 
                 1.89 
                 1.76 
                 1.55 
                 1.80 
                 1.85 
                 1.76 
                 1.70 
               
               
                 U5594 
                 2.30 
                 2.60 
                 2.79 
                 2.84 
                 2.81 
                 2.80 
                 2.84 
                 2.85 
                 2.96 
               
               
                 U5597 
                 3.30 
                 3.30 
                 3.64 
                 3.25 
                 2.96 
                 4.10 
                 4.03 
                 3.85 
                 4.08 
               
               
                 U5992 
                 1.40 
                 1.40 
                 1.42 
                 1.45 
                 1.29 
                 1.30 
                 1.37 
                 1.37 
                 1.30 
               
               
                 U5993 
                 1.00 
                 0.90 
                 0.94 
                 1.03 
                 0.84 
                 1.00 
                 0.98 
                 1.03 
                 0.84 
               
               
                 U6017 
                 1.00 
                 0.90 
                 0.95 
                 0.99 
                 0.77 
                 0.90 
                 0.89 
                 0.97 
                 0.79 
               
               
                 U6047 
                 2.30 
                 2.30 
                 2.36 
                 2.17 
                 1.97 
                 2.20 
                 2.28 
                 2.23 
                 2.22 
               
               
                 U6056 
                 1.00 
                 1.00 
                 1.01 
                 1.03 
                 0.87 
                 1.00 
                 1.01 
                 1.02 
                 0.85 
               
               
                 U6060 
                 1.90 
                 2.10 
                 2.17 
                 2.10 
                 1.94 
                 2.30 
                 2.00 
                 2.16 
                 2.12 
               
               
                 U6065 
                 3.10 
                 2.80 
                 2.93 
                 2.77 
                 2.60 
                 3.00 
                 3.13 
                 2.74 
                 2.76 
               
               
                 U6928 
                 1.20 
                 1.20 
                 1.17 
                 1.34 
                 1.17 
                 1.20 
                 1.24 
                 1.22 
                 1.05 
               
               
                 U6929 
                 1.20 
                 1.20 
                 1.20 
                 1.23 
                 1.06 
                 1.20 
                 1.19 
                 1.15 
                 0.98 
               
               
                 U6936 
                 2.40 
                 2.50 
                 2.45 
                 3.02 
                 3.15 
                 2.60 
                 2.61 
                 2.51 
                 2.60 
               
               
                 U6938 
                 2.10 
                 2.10 
                 2.12 
                 2.30 
                 2.22 
                 2.30 
                 2.26 
                 2.25 
                 2.21 
               
               
                 U6951 
                 1.50 
                 1.50 
                 1.51 
                 1.59 
                 1.42 
                 1.60 
                 1.66 
                 1.49 
                 1.36 
               
               
                 U6972 
                 2.40 
                 2.40 
                 2.47 
                 2.57 
                 2.49 
                 2.80 
                 2.84 
                 2.54 
                 2.51 
               
               
                 U6977 
                 1.30 
                 1.30 
                 1.34 
                 1.35 
                 1.19 
                 1.30 
                 1.37 
                 1.23 
                 1.08 
               
               
                 U6987 
                 5.10 
                 4.50 
                 4.43 
                 5.29 
                 5.42 
                 5.70 
                 5.44 
                 6.16 
                 6.82 
               
               
                 U7316 
                 1.20 
                 1.10 
                 1.15 
                 1.28 
                 1.14 
                 1.30 
                 1.28 
                 1.26 
                 1.11 
               
               
                 U7317 
                 2.00 
                 1.60 
                 1.68 
                 1.66 
                 1.56 
                 1.90 
                 1.90 
                 1.68 
                 1.56 
               
               
                 U7318 
                 2.80 
                 2.70 
                 2.86 
                 2.71 
                 2.57 
                 3.30 
                 3.40 
                 2.70 
                 2.72 
               
               
                 U7320 
                 2.00 
                 1.90 
                 1.92 
                 2.17 
                 2.13 
                 2.00 
                 2.06 
                 2.12 
                 2.13 
               
               
                 U7321 
                 1.50 
                 1.40 
                 1.38 
                 1.59 
                 1.50 
                 1.60 
                 1.60 
                 1.61 
                 1.51 
               
               
                 U7322 
                 1.80 
                 1.70 
                 1.72 
                 1.63 
                 1.46 
                 1.70 
                 1.76 
                 1.55 
                 1.42 
               
               
                 U7324 
                 1.30 
                 1.20 
                 1.25 
                 1.33 
                 1.17 
                 1.40 
                 1.40 
                 1.30 
                 1.13 
               
               
                 U7440 
                 2.60 
                 3.00 
                 2.98 
                 2.90 
                 2.89 
                 3.00 
                 3.01 
                 3.05 
                 3.37 
               
               
                 U7443 
                 2.00 
                 2.00 
                 2.03 
                 1.87 
                 1.73 
                 2.10 
                 2.17 
                 1.90 
                 1.79 
               
               
                 U7458 
                 1.40 
                 1.40 
                 1.43 
                 1.38 
                 1.20 
                 1.40 
                 1.40 
                 1.40 
                 1.26 
               
               
                 U7465 
                 9.70 
                 7.40 
                 8.12 
                 6.47 
                 7.80 
                 7.10 
                 7.54 
                 7.06 
                 7.63 
               
               
                 U7469 
                 1.10 
                 1.10 
                 1.11 
                 1.11 
                 0.86 
                 1.20 
                 1.14 
                 1.10 
                 0.90 
               
               
                 U7470 
                 3.20 
                 3.40 
                 3.65 
                 3.27 
                 3.12 
                 3.60 
                 3.67 
                 3.62 
                 3.70 
               
               
                 U7707 
                 2.20 
                 2.20 
                 2.27 
                 2.34 
                 2.28 
                 2.30 
                 2.29 
                 2.23 
                 2.22 
               
               
                 U7708 
                 1.60 
                 1.60 
                 1.60 
                 1.73 
                 1.61 
                 1.70 
                 1.73 
                 1.71 
                 1.62 
               
               
                 U7710 
                 2.30 
                 2.50 
                 2.64 
                 2.71 
                 2.73 
                 2.70 
                 2.85 
                 2.75 
                 2.96 
               
               
                 U7713 
                 1.40 
                 1.60 
                 1.59 
                 1.57 
                 1.50 
                 1.60 
                 1.64 
                 1.58 
                 1.48 
               
               
                 U7724 
                 2.40 
                 2.40 
                 2.47 
                 2.62 
                 2.65 
                 2.70 
                 2.73 
                 2.75 
                 2.84 
               
               
                 U7727 
                 1.70 
                 1.70 
                 1.73 
                 1.78 
                 1.68 
                 1.90 
                 1.90 
                 1.91 
                 1.86 
               
               
                 U7738 
                 2.40 
                 2.30 
                 2.45 
                 2.27 
                 2.21 
                 2.40 
                 2.54 
                 2.29 
                 2.32 
               
               
                 U7794 
                 1.90 
                 1.80 
                 1.91 
                 1.72 
                 1.58 
                 1.70 
                 1.78 
                 1.71 
                 1.55 
               
               
                 U8080 
                 3.10 
                 3.60 
                 3.63 
                 3.41 
                 3.54 
                 3.30 
                 3.33 
                 3.18 
                 3.34 
               
               
                 U8087 
                 1.90 
                 1.90 
                 1.95 
                 1.80 
                 1.62 
                 1.90 
                 1.91 
                 1.79 
                 1.74 
               
               
                 U8092 
                 1.70 
                 1.70 
                 1.76 
                 1.67 
                 1.49 
                 1.90 
                 1.93 
                 1.67 
                 1.57 
               
               
                 U8210 
                 2.60 
                 2.90 
                 3.04 
                 2.72 
                 2.63 
                 2.70 
                 2.77 
                 2.54 
                 2.56 
               
               
                 U8221 
                 3.20 
                 3.70 
                 3.99 
                 3.42 
                 3.35 
                 3.50 
                 3.47 
                 3.24 
                 3.46 
               
               
                 U8555 
                 2.60 
                 2.40 
                 2.54 
                 2.56 
                 2.52 
                 2.90 
                 3.09 
                 2.57 
                 2.56 
               
               
                 U8558 
                 2.30 
                 2.20 
                 2.26 
                 2.16 
                 2.15 
                 2.30 
                 2.33 
                 2.31 
                 2.35 
               
               
                 U8559 
                 1.60 
                 1.40 
                 1.45 
                 1.42 
                 1.24 
                 1.60 
                 1.65 
                 1.45 
                 1.28 
               
               
                 U8563 
                 2.20 
                 2.30 
                 2.30 
                 2.32 
                 2.30 
                 2.40 
                 2.43 
                 2.34 
                 2.42 
               
               
                 U8570 
                 1.20 
                 1.20 
                 1.20 
                 1.34 
                 1.23 
                 1.20 
                 1.21 
                 1.35 
                 1.25 
               
               
                 U8575 
                 0.90 
                 0.80 
                 0.84 
                 0.96 
                 0.80 
                 0.90 
                 0.89 
                 0.95 
                 0.78 
               
               
                 U9031 
                 2.10 
                 2.40 
                 2.33 
                 2.42 
                 2.42 
                 2.60 
                 2.38 
                 2.34 
                 2.35 
               
               
                 U9032 
                 1.70 
                 1.70 
                 1.75 
                 1.78 
                 1.58 
                 1.90 
                 1.93 
                 1.68 
                 1.53 
               
               
                 U9034 
                 3.00 
                 2.90 
                 2.82 
                 3.79 
                 3.97 
                 3.40 
                 3.37 
                 3.49 
                 3.80 
               
               
                 U9039 
                 2.70 
                 3.00 
                 3.17 
                 2.99 
                 3.03 
                 3.20 
                 3.20 
                 3.12 
                 3.27 
               
               
                 U9040 
                 1.40 
                 1.40 
                 1.44 
                 1.36 
                 1.20 
                 1.40 
                 1.39 
                 1.33 
                 1.15 
               
               
                 U9049 
                 3.50 
                 3.30 
                 3.46 
                 3.33 
                 3.45 
                 3.60 
                 3.77 
                 3.33 
                 3.72 
               
               
                 U9055 
                 2.40 
                 2.10 
                 2.14 
                 2.15 
                 2.04 
                 2.40 
                 2.39 
                 2.15 
                 2.13 
               
               
                   
               
             
          
         
       
     
         [0093]    A statistical comparison of the above data from Table 2 is presented below in Tables 4 and 5. The value AINR in Table 2 represents the INR value obtained pursuant to the World Health Organization (WHO), using expressions (A) and (B) above. GINR and MINR correspond to INR values used to determine the comparison data set forth in Tables 4 and 5. 
         [0094]    The determination of the new anticoagulant therapy factor (ATFt) may be carried out with a computer. According to one example, the gathering, storing, and manipulation of the data generally illustrated in  FIG. 4 , may be accomplished by computer  30  of  FIG. 1  that receives digital voltage values converted, by the A/D converter  26 , from analog voltage quantities of the photocell  10  detection means. 
         [0095]    In accordance with one embodiment, the IBM-compatible computer  30  of  FIG. 1  stores and manipulates these digital values corresponding to related data of  FIG. 4  and may be programmed as follows:
       (a) a sample of blood where the plasma is available, such as, for example, a sample of citrated blood, is obtained and placed in an appropriate container, the computer  30 , as well as the recorder  28 , sequentially records voltage values for a few seconds before injection of thromboplastin. As previously discussed, thromboplastin (tissue factor) is one of the factors in the human body that causes blood to clot. Prothrombin is another. Fibrinogen is yet another. Before injection of the thromboplastin, the output from the A/D converter  26  is relatively constant. When thromboplastin is injected into the plasma sample in the container, a significant and abrupt change occurs in the recorded voltage values of both the computer  30  and the recorder  28 . This abrupt change is recognized by both the recorder  28  and, more importantly, by the computer  30  which uses such recognition to establish T o . The computer  30  may be programmed so as to correlate the digital quantities of the A/D converter  26  to the analog output of the detector means photocell  10  which, in turn, is directly correlatable to the fibrinogen (FBG) concentration g/l of the sample of blood discussed with reference to  FIG. 3 ;   (b) the computer  30  may be programmed to look for a digital quantity representative of a critical quantity c 1 , and when such occurs, record its instant time T 1 . (The time span between T o  and T 1  is the prothrombin time (PT), and has an normal duration of about 12 seconds, but may be greater than 30 seconds);   (c) following the detection of the quantity c 1 , the computer  30  may be programmed to detect for the acceleration of fibrinogen (FBG) to fibrin conversion. The computer  30  is programmed to detect the maximum acceleration quantity c MAP  or c T2  as illustrated in  FIG. 3 , and its corresponding time of occurrence t MAP , which is T 2  in  FIG. 3 .   (d) the computer detects a quantity c EOT  occurring at time t EOT . Typically, it is important that the rate of fibrin formation increase for at least 1.5 seconds following the occurrence of (T 1 ); the computer determines a theoretical end of test (TEOT) based on the determination of the zero order kinetic rate. The computer may be programmed to determine the zero order rate, which is expressed as a Line (L) in  FIG. 4 . The TEOT may be determined by the corresponding time value (TEOT) along the line L which corresponds with the quantity c EOT  (i.e., that quantity corresponding to the time, T 3 ).   (e) following the detection of the maximum acceleration quantity c T2  (also representing c MAP ) and the time T 2  (also representing t MAP ) both of which define the maximum acceleration point (MAP), and the TEOT, the computer is programmed to determine a new fibrinogen transformation rate (nFTR) covering a predetermined range starting prior to the maximum acceleration point (MAP) and ending after the maximum acceleration point (MAP). The elapsed time from T 0  to T 2  (which is t MAP ) is the time to maximum acceleration (TMA), shown in  FIG. 4 , and is represented by TX (i.e., time to MAP);   The new fibrinogen transformation rate (nFTR) has an upwardly rising (increasing quantities) slope prior to the maximum acceleration point (MAP) and, conversely, has a downwardly falling (decreasing quantities) slope after the maximum acceleration point (MAP).   The computer  30  is programmed to ascertain the value for the time to start (T 2 S) which corresponds with the time at which the simulated zero order kinetic rate begins.   (f) following the detection of the acceleration of fibrinogen conversion to detect the start time T 2 S, the computer  30  is programmed to detect for a deceleration of the fibrinogen conversion, wherein the fibrinogen concentration decreases from a predetermined quantity c MAP  to a predetermined quantity c EOT  having a value which is about equal but less than the first quantity c 1 . The computer is programmed to ascertain a first delta (IUTz), by determining the difference between the quantity c T2S  and the quantity c EOT ; and a second delta (IUXz) by determining the difference between the quantity c T2S  and the quantity c 2(or CMAP). ; the computer also determines the value ZTM by determining the difference between the time T 2  (which is Tmap) and the time T 2 S;   (g) the computer  30  manipulates the collected data of (a); (b); (c); (d), (e) and (f) above, to determine the new fibrinogen transfer rate (nFTR). The nFTR may be arrived at based on the principle that if a required amount (e.g., 0.05 g/l) of fibrinogen concentration c 1  is first necessary to detect a clot point (t 1 ); then when the fibrinogen concentration (c EOT ) becomes less than the required amount c 1 , which occurs at time (t EOT ), the fibrinogen end point has been reached. More particularly, the required fibrinogen concentration c 1  is the starting point of fibrinogen conversion of the clotting process and the less than required fibrinogen concentration c EOT  is the end point of the fibrinogen conversion of the clotting process.   (h) the duration of the fibrinogen conversion of the clotting process of the present invention is defined by the zero order time period between T EOT  and T 2 S and is generally indicated in  FIG. 3  as IUTz. The difference between the corresponding concentrations c T2S  and cT2 is used to define a delta IUXz. The computer now has the information needed to determine the TEOT, which is expressed by the following formula:       
 
         [0000]      TEOT=ZTM/IUXz*IUTz  (5)       The value TEOT may be assigned VALUE 1;   (i) data collected is manipulated by the computer  30  to calculate a second value, VALUE 2, using T 2 S and a multiplier M (which in this example, in expression 7 below, is a fraction). The computer may be programmed to use as a multiplier a value based on the natural log base “e” (which is 2.71828), scaled by a scaling value. Here, the scaling value is 100, and the multiplier may be expressed as follows:         
         [0000]      M=100e  (9)       VALUE 2 is determined using the information which the computer has ascertained and stored, by the following expression:         
         [0000]      VALUE 2 =T 2 S/ 100 e   (7) 
         [0000]    The data may be ascertained and stored in the computer for reference.
       (j) the computer  30  now has the information needed to determine the nATFt, which typically is expressed as:       
 
         [0000]      nATFt=VALUE 1*VALUE 2  (4) 
         [0110]    The computer  30  may be used to manipulate and derive the quantities of expression (4) to determine a new anticoagulant therapy factor nATFt utilizing known programming routines and techniques. The data collected by a computer  30  may be used to manipulate and derive the new anticoagulant therapy factor (nATFt) of expression (4). Similarly, one skilled in the art, using known mathematical techniques may derive the theoretical end of test TEOT of expression (5) and the second value VALUE 2 of expression (7) which, in turn, are used to determine the new anticoagulant therapy (nATFt) of expression (4). In the nATFt determination, the determination is based on the patient&#39;s own sample, and does not rely on the determination of normal prothrombin times for the reagent used (e.g., thromboplastin, innovin or the like). With the nATFt, no longer does the accuracy of the quantities determined depend, in whole or part, on the number of specimens used, that is, the number of stable (or presumed stable) patients. 
         [0111]    The new anticoagulation therapy factor (nATFt) does not require an ISI value, as was previously used to determine anticoagulation therapy factors. The new anticoagulation therapy factor (nATFt) uses for its ascertainment the values extracted from the clotting curve (see  FIG. 4 ), in particular T 2 S, Tmap, TEOT, c T2S , cmap and ceot. In determining the new anticoagulant therapy factor (nATFt), the ISI is not required, nor is the MNPT, or the need to obtain and calculate the prothrombin times (PT&#39;s) for 20 presumed normal patients. In carrying out coagulation studies, the new anticoagulant therapy factor (nATFt) may replace INR in anticoagulant therapy management. In addition, using the sample from the patient, the computer  30  has knowledge of the values obtained for the fibrinogen reaction, to ascertain the (nATFt). 
         [0112]    It should now be appreciated that the present invention provides an apparatus and method for obtaining a new anticoagulant therapy factor (nATF) without encountering the complications involved with obtaining the prior art quantities International Normalized Ratio (INR) and International Sensitivity Index (ISI). 
         [0113]    The new anticoagulant therapy factor (nATFt) preferably is a replacement for the International Normalized Ratio (INR). Existing medical literature, instrumentation, and methodologies are closely linked to the International Normalized Ratio (INR). The nATFt was compared for correlation with the INR by comparative testing, to INR quantities, even with the understanding that the INR determination may have an error of about +/−15%, at a 95% confidence interval, which needs to be taken into account to explain certain inconsistencies. 
         [0114]    The hereinbefore description of the new anticoagulant therapy factor (nATFt) does correlate at least as well as, and preferably better than, studies carried out using the International Normalized Ratio (INR). For some comparisons, see the tables below, and in particular Table 4 and Table 5. 
         [0115]    Table 3 (Part A) and Table 3 (Part B) provide corresponding data for a coagulation study. In Table 3 (Part A and B), the following references are used: 
         [0000]    
       
         
               
               
               
             
           
               
                   
               
               
                 Column 
                 Label 
                 Definition 
               
               
                   
               
             
             
               
                 A 
                 ID 
                 Sample ID 
               
               
                 B 
                 OD@T 2 S 
                 OD at the start of Zero Order Kinetic 
               
               
                 C 
                 OD@Map 
                 OD at the Maximum Acceleration Point 
               
               
                   
                   
                 (MAP) 
               
               
                 D 
                 OD@Eot 
                 OD at the END OF TEST (Eot) 
               
               
                 E 
                 ΔT 2 SMap 
                 Delta of Column B and C creating the IUXz 
               
               
                 F 
                 ΔT 2 SEot 
                 Delta of Column B and D creating the IUTz 
               
               
                 G 
                 FTR od 
                 Ratio of Column E divided by F 
               
               
                   
                   
                 The FTR od is subtracted from 2 creating the 
               
               
                   
                   
                 Exponent that replaces the ISI 
               
               
                 H 
                 Time@T 2 S 
                 Time at the start of Zero Order Kinetics 
               
               
                 I 
                 Time@Map 
                 Time at the Maximum Acceleration Point 
               
               
                   
                   
                 (MAP) 
               
               
                 J 
                 Time@TEot 
                 Time at the Theoretical End of Test (TEOT) 
               
               
                 K 
                 ΔT 2 SMap 
                 Delta of Column H and I creating the IUXz 
               
               
                   
                   
                 (and ZTM) 
               
               
                 L 
                 ΔT 2 STEot 
                 Delta of Column H and J creating the IUTz 
               
               
                 M 
                 FTR Time 
                 Ration of Column K divided by L 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                 TABLE 3 
               
             
             
               
                   
               
               
                 (Part A) 
               
             
          
           
               
                 ID 
                 OD@T2S 
                 OD@Map 
                 OD@Eot 
                 ΔT2SMap 
                 ΔT2SEot 
               
               
                   
               
             
          
           
               
                 A001 
                 3719 
                 3707 
                 3664 
                 12 
                 55 
               
               
                 A002 
                 3713 
                 3704 
                 3686 
                 9 
                 27 
               
               
                 A003 
                 3729 
                 3720 
                 3705 
                 9 
                 24 
               
               
                 A004 
                 3708 
                 3696 
                 3663 
                 12 
                 45 
               
               
                 A005 
                 3727 
                 3715 
                 3700 
                 12 
                 27 
               
               
                 A007 
                 3725 
                 3718 
                 3698 
                 7 
                 27 
               
               
                 A008 
                 3714 
                 3693 
                 3646 
                 21 
                 68 
               
               
                 A009 
                 3727 
                 3716 
                 3697 
                 11 
                 30 
               
               
                 A010 
                 3727 
                 3714 
                 3701 
                 13 
                 26 
               
               
                 A011 
                 3690 
                 3676 
                 3647 
                 14 
                 43 
               
               
                 A012 
                 3728 
                 3716 
                 3695 
                 12 
                 33 
               
               
                 A013 
                 3715 
                 3690 
                 3641 
                 25 
                 74 
               
               
                 A014 
                 3717 
                 3708 
                 3694 
                 9 
                 23 
               
               
                 A015 
                 3726 
                 3718 
                 3706 
                 8 
                 20 
               
               
                 A016 
                 3722 
                 3715 
                 3678 
                 7 
                 44 
               
               
                 A017 
                 3720 
                 3707 
                 3681 
                 13 
                 39 
               
               
                 A018 
                 3723 
                 3709 
                 3697 
                 14 
                 26 
               
               
                 A019 
                 3716 
                 3695 
                 3653 
                 21 
                 63 
               
               
                 A020 
                 3727 
                 3716 
                 3698 
                 11 
                 29 
               
               
                 A021 
                 3727 
                 3720 
                 3694 
                 7 
                 33 
               
               
                 A022 
                 3717 
                 3700 
                 3667 
                 17 
                 50 
               
               
                 A023 
                 3719 
                 3706 
                 3663 
                 13 
                 56 
               
               
                 A024 
                 3717 
                 3702 
                 3661 
                 15 
                 56 
               
               
                 A025 
                 3731 
                 3727 
                 3716 
                 4 
                 15 
               
               
                 A026 
                 3717 
                 3705 
                 3673 
                 12 
                 44 
               
               
                 A027 
                 3714 
                 3698 
                 3667 
                 16 
                 47 
               
               
                 A028 
                 3713 
                 3696 
                 3651 
                 17 
                 62 
               
               
                 A029 
                 3712 
                 3691 
                 3647 
                 21 
                 65 
               
               
                 A030 
                 3716 
                 3695 
                 3635 
                 21 
                 81 
               
               
                 A031 
                 3715 
                 3704 
                 3687 
                 11 
                 28 
               
               
                 A032 
                 3716 
                 3710 
                 3675 
                 6 
                 41 
               
               
                 A033 
                 3718 
                 3704 
                 3671 
                 14 
                 47 
               
               
                 A034 
                 3721 
                 3705 
                 3674 
                 16 
                 47 
               
               
                 A035 
                 3723 
                 3715 
                 3699 
                 8 
                 24 
               
               
                 A036 
                 3722 
                 3710 
                 3681 
                 12 
                 41 
               
               
                 A037 
                 3715 
                 3700 
                 3669 
                 15 
                 46 
               
               
                 A038 
                 3722 
                 3707 
                 3686 
                 15 
                 36 
               
               
                 A039 
                 3721 
                 3712 
                 3698 
                 9 
                 23 
               
               
                 A040 
                 3720 
                 3706 
                 3664 
                 14 
                 56 
               
               
                 A041 
                 3711 
                 3695 
                 3638 
                 16 
                 73 
               
               
                 A042 
                 3722 
                 3709 
                 3687 
                 13 
                 35 
               
               
                 A044 
                 3723 
                 3709 
                 3683 
                 14 
                 40 
               
               
                 A045 
                 3712 
                 3697 
                 3647 
                 15 
                 65 
               
               
                 A047 
                 3716 
                 3697 
                 3668 
                 19 
                 48 
               
               
                 A048 
                 3720 
                 3708 
                 3682 
                 12 
                 38 
               
               
                 A049 
                 3725 
                 3711 
                 3690 
                 14 
                 35 
               
               
                 A050 
                 3724 
                 3712 
                 3685 
                 12 
                 39 
               
               
                 A051 
                 3705 
                 3688 
                 3634 
                 17 
                 71 
               
               
                 A052 
                 3725 
                 3714 
                 3687 
                 11 
                 38 
               
               
                 A053 
                 3724 
                 3717 
                 3696 
                 7 
                 28 
               
               
                 A054 
                 3715 
                 3701 
                 3679 
                 14 
                 36 
               
               
                 A055 
                 3718 
                 3684 
                 3627 
                 34 
                 91 
               
               
                 A056 
                 3710 
                 3689 
                 3624 
                 21 
                 86 
               
               
                 A057 
                 3709 
                 3701 
                 3683 
                 8 
                 26 
               
               
                 A058 
                 3725 
                 3710 
                 3669 
                 15 
                 56 
               
               
                 A059 
                 3722 
                 3712 
                 3696 
                 10 
                 26 
               
               
                 A060 
                 3719 
                 3712 
                 3698 
                 7 
                 21 
               
               
                 A061 
                 3720 
                 3708 
                 3680 
                 12 
                 40 
               
               
                 A062 
                 3719 
                 3701 
                 3651 
                 18 
                 68 
               
               
                 A063 
                 3728 
                 3715 
                 3697 
                 13 
                 31 
               
               
                 A064 
                 3718 
                 3707 
                 3685 
                 11 
                 33 
               
               
                 A065 
                 3721 
                 3704 
                 3680 
                 17 
                 41 
               
               
                 A066 
                 3727 
                 3717 
                 3707 
                 10 
                 20 
               
               
                 A067 
                 3708 
                 3689 
                 3641 
                 19 
                 67 
               
               
                 A068 
                 3726 
                 3712 
                 3686 
                 14 
                 40 
               
               
                 A069 
                 3719 
                 3715 
                 3695 
                 4 
                 24 
               
               
                 A070 
                 3716 
                 3705 
                 3671 
                 11 
                 45 
               
               
                 A071 
                 3714 
                 3696 
                 3660 
                 18 
                 54 
               
               
                 A072 
                 3713 
                 3693 
                 3646 
                 20 
                 67 
               
               
                 A073 
                 3707 
                 3686 
                 3639 
                 21 
                 68 
               
               
                 A074 
                 3699 
                 3684 
                 3665 
                 15 
                 34 
               
               
                 A075 
                 3734 
                 3730 
                 3726 
                 4 
                 8 
               
               
                 A076 
                 3719 
                 3704 
                 3665 
                 15 
                 54 
               
               
                 A077 
                 3718 
                 3694 
                 3634 
                 24 
                 84 
               
               
                 A078 
                 3723 
                 3707 
                 3684 
                 16 
                 39 
               
               
                 A080 
                 3729 
                 3712 
                 3637 
                 17 
                 92 
               
               
                 A081 
                 3710 
                 3694 
                 3626 
                 16 
                 84 
               
               
                 A082 
                 3716 
                 3703 
                 3654 
                 13 
                 62 
               
               
                 A083 
                 3720 
                 3710 
                 3686 
                 10 
                 34 
               
               
                 A084 
                 3731 
                 3721 
                 3667 
                 10 
                 64 
               
               
                 A085 
                 3727 
                 3704 
                 3675 
                 23 
                 52 
               
               
                 A086 
                 3717 
                 3699 
                 3650 
                 18 
                 67 
               
               
                 A087 
                 3715 
                 3694 
                 3654 
                 21 
                 61 
               
               
                 A088 
                 3704 
                 3681 
                 3630 
                 23 
                 74 
               
               
                 A089 
                 3723 
                 3714 
                 3687 
                 9 
                 36 
               
               
                 A090 
                 3714 
                 3685 
                 3588 
                 29 
                 126 
               
               
                 A091 
                 3724 
                 3710 
                 3659 
                 14 
                 65 
               
               
                 A092 
                 3696 
                 3657 
                 3582 
                 39 
                 114 
               
               
                 A093 
                 3730 
                 3716 
                 3693 
                 14 
                 37 
               
               
                 A094 
                 3720 
                 3708 
                 3676 
                 12 
                 44 
               
               
                 A095 
                 3710 
                 3689 
                 3638 
                 21 
                 72 
               
               
                 A096 
                 3725 
                 3717 
                 3700 
                 8 
                 25 
               
               
                 A097 
                 3721 
                 3713 
                 3692 
                 8 
                 29 
               
               
                 A098 
                 3716 
                 3696 
                 3659 
                 20 
                 57 
               
               
                 A099 
                 3720 
                 3712 
                 3685 
                 8 
                 35 
               
               
                 A100 
                 3709 
                 3685 
                 3625 
                 24 
                 84 
               
               
                 A101 
                 3727 
                 3715 
                 3690 
                 12 
                 37 
               
               
                 A102 
                 3722 
                 3708 
                 3661 
                 14 
                 61 
               
               
                 A103 
                 3714 
                 3693 
                 3640 
                 21 
                 74 
               
               
                 A104 
                 3719 
                 3705 
                 3682 
                 14 
                 37 
               
               
                 A105 
                 3725 
                 3706 
                 3660 
                 19 
                 65 
               
               
                 A107 
                 3720 
                 3707 
                 3660 
                 13 
                 60 
               
               
                 A108 
                 3731 
                 3723 
                 3709 
                 8 
                 22 
               
               
                 A109 
                 3727 
                 3711 
                 3689 
                 16 
                 38 
               
               
                 A110 
                 3719 
                 3693 
                 3635 
                 26 
                 84 
               
               
                 A111 
                 3723 
                 3701 
                 3667 
                 22 
                 56 
               
               
                 A112 
                 3714 
                 3695 
                 3614 
                 19 
                 100 
               
               
                 A113 
                 3717 
                 3702 
                 3664 
                 15 
                 53 
               
               
                 A114 
                 3711 
                 3687 
                 3655 
                 24 
                 56 
               
               
                 A115 
                 3716 
                 3697 
                 3652 
                 19 
                 64 
               
               
                 A116 
                 3726 
                 3717 
                 3698 
                 9 
                 28 
               
               
                 A117 
                 3710 
                 3688 
                 3630 
                 22 
                 80 
               
               
                 A118 
                 3729 
                 3721 
                 3699 
                 8 
                 30 
               
               
                 A119 
                 3729 
                 3716 
                 3679 
                 13 
                 50 
               
               
                 A120 
                 3722 
                 3713 
                 3688 
                 9 
                 34 
               
               
                 A121 
                 3730 
                 3722 
                 3704 
                 8 
                 26 
               
               
                 A122 
                 3713 
                 3688 
                 3650 
                 25 
                 63 
               
               
                 A123 
                 3729 
                 3721 
                 3704 
                 8 
                 25 
               
               
                 A124 
                 3721 
                 3712 
                 3696 
                 9 
                 25 
               
               
                 A125 
                 3683 
                 3668 
                 3600 
                 15 
                 83 
               
               
                 A126 
                 3736 
                 3723 
                 3714 
                 13 
                 22 
               
               
                 A127 
                 3715 
                 3703 
                 3640 
                 12 
                 75 
               
               
                 A128 
                 3723 
                 3714 
                 3682 
                 9 
                 41 
               
               
                 A129 
                 3728 
                 3715 
                 3677 
                 13 
                 51 
               
               
                 A130 
                 3715 
                 3700 
                 3656 
                 15 
                 59 
               
               
                 A131 
                 3723 
                 3711 
                 3690 
                 12 
                 33 
               
               
                 A132 
                 3720 
                 3700 
                 3665 
                 20 
                 55 
               
               
                 A133 
                 3728 
                 3706 
                 3673 
                 22 
                 55 
               
               
                 A134 
                 3725 
                 3696 
                 3667 
                 29 
                 58 
               
               
                 A135 
                 3717 
                 3703 
                 3676 
                 14 
                 41 
               
               
                 A136 
                 3725 
                 3712 
                 3659 
                 13 
                 66 
               
               
                 A137 
                 3712 
                 3691 
                 3662 
                 21 
                 50 
               
               
                 A138 
                 3714 
                 3691 
                 3641 
                 23 
                 73 
               
               
                 A139 
                 3717 
                 3700 
                 3642 
                 17 
                 75 
               
               
                 A140 
                 3710 
                 3690 
                 3642 
                 20 
                 68 
               
               
                 A141 
                 3715 
                 3698 
                 3661 
                 17 
                 54 
               
               
                 A142 
                 3729 
                 3719 
                 3706 
                 10 
                 23 
               
               
                 A143 
                 3726 
                 3709 
                 3693 
                 17 
                 33 
               
               
                 A144 
                 3709 
                 3693 
                 3641 
                 16 
                 68 
               
               
                 A145 
                 3704 
                 3688 
                 3639 
                 16 
                 65 
               
               
                 A146 
                 3718 
                 3706 
                 3664 
                 12 
                 54 
               
               
                 A147 
                 3713 
                 3698 
                 3661 
                 15 
                 52 
               
               
                 A148 
                 3714 
                 3701 
                 3646 
                 13 
                 68 
               
               
                 A149 
                 3711 
                 3692 
                 3653 
                 19 
                 58 
               
               
                 A150 
                 3701 
                 3678 
                 3608 
                 23 
                 93 
               
               
                 A151 
                 3701 
                 3668 
                 3587 
                 33 
                 114 
               
               
                 A152 
                 3717 
                 3706 
                 3683 
                 11 
                 34 
               
               
                 A153 
                 3691 
                 3669 
                 3596 
                 22 
                 95 
               
               
                 A154 
                 3706 
                 3690 
                 3645 
                 16 
                 61 
               
               
                 A155 
                 3724 
                 3703 
                 3667 
                 21 
                 57 
               
               
                 A156 
                 3717 
                 3711 
                 3688 
                 6 
                 29 
               
               
                 A157 
                 3717 
                 3702 
                 3678 
                 15 
                 39 
               
               
                 A158 
                 3723 
                 3715 
                 3689 
                 8 
                 34 
               
               
                 A159 
                 3714 
                 3696 
                 3652 
                 18 
                 62 
               
               
                 A160 
                 3717 
                 3690 
                 3655 
                 27 
                 62 
               
               
                 A161 
                 3720 
                 3713 
                 3676 
                 7 
                 44 
               
               
                 A162 
                 3722 
                 3706 
                 3653 
                 16 
                 69 
               
               
                 A163 
                 3725 
                 3715 
                 3683 
                 10 
                 42 
               
               
                 A164 
                 3721 
                 3712 
                 3685 
                 9 
                 36 
               
               
                 A165 
                 3707 
                 3693 
                 3636 
                 14 
                 71 
               
               
                 A166 
                 3704 
                 3683 
                 3631 
                 21 
                 73 
               
               
                 A167 
                 3718 
                 3712 
                 3690 
                 6 
                 28 
               
               
                 A168 
                 3722 
                 3700 
                 3669 
                 22 
                 53 
               
               
                 A169 
                 3705 
                 3694 
                 3624 
                 11 
                 81 
               
               
                 A170 
                 3717 
                 3704 
                 3680 
                 13 
                 37 
               
               
                 A171 
                 3721 
                 3699 
                 3666 
                 22 
                 55 
               
               
                 A172 
                 3726 
                 3719 
                 3691 
                 7 
                 35 
               
               
                 A173 
                 3718 
                 3708 
                 3680 
                 10 
                 38 
               
               
                 A174 
                 3707 
                 3692 
                 3648 
                 15 
                 59 
               
               
                 A175 
                 3689 
                 3671 
                 3642 
                 18 
                 47 
               
               
                 A176 
                 3724 
                 3711 
                 3671 
                 13 
                 53 
               
               
                 A177 
                 3721 
                 3710 
                 3689 
                 11 
                 32 
               
               
                 A178 
                 3716 
                 3700 
                 3655 
                 16 
                 61 
               
               
                 A179 
                 3717 
                 3707 
                 3672 
                 10 
                 45 
               
               
                 A180 
                 3718 
                 3706 
                 3686 
                 12 
                 32 
               
               
                 A181 
                 3722 
                 3703 
                 3676 
                 19 
                 46 
               
               
                 A182 
                 3716 
                 3706 
                 3667 
                 10 
                 49 
               
               
                 A183 
                 3711 
                 3703 
                 3689 
                 8 
                 22 
               
               
                 A184 
                 3717 
                 3705 
                 3661 
                 12 
                 56 
               
               
                 A185 
                 3711 
                 3694 
                 3639 
                 17 
                 72 
               
               
                 A186 
                 3721 
                 3675 
                 3620 
                 46 
                 101 
               
               
                 A187 
                 3715 
                 3704 
                 3668 
                 11 
                 47 
               
               
                 A188 
                 3717 
                 3703 
                 3672 
                 14 
                 45 
               
               
                 A189 
                 3709 
                 3689 
                 3658 
                 20 
                 51 
               
               
                 A190 
                 3718 
                 3709 
                 3688 
                 9 
                 30 
               
               
                 A191 
                 3725 
                 3717 
                 3696 
                 8 
                 29 
               
               
                 A192 
                 3722 
                 3714 
                 3691 
                 8 
                 31 
               
               
                 A193 
                 3727 
                 3718 
                 3685 
                 9 
                 42 
               
               
                 A194 
                 3720 
                 3710 
                 3688 
                 10 
                 32 
               
               
                 A195 
                 3691 
                 3667 
                 3589 
                 24 
                 102 
               
               
                 A196 
                 3718 
                 3707 
                 3673 
                 11 
                 45 
               
               
                 A197 
                 3706 
                 3692 
                 3637 
                 14 
                 69 
               
               
                 A198 
                 3717 
                 3707 
                 3692 
                 10 
                 25 
               
               
                 A199 
                 3720 
                 3705 
                 3684 
                 15 
                 36 
               
               
                 A200 
                 3718 
                 3709 
                 3686 
                 9 
                 32 
               
               
                 A201 
                 3725 
                 3713 
                 3681 
                 12 
                 44 
               
               
                 A202 
                 3723 
                 3713 
                 3694 
                 10 
                 29 
               
               
                 A203 
                 3715 
                 3704 
                 3670 
                 11 
                 45 
               
               
                 A204 
                 3723 
                 3713 
                 3697 
                 10 
                 26 
               
               
                 A205 
                 3717 
                 3706 
                 3674 
                 11 
                 43 
               
               
                 A207 
                 3710 
                 3702 
                 3668 
                 8 
                 42 
               
               
                 A208 
                 3722 
                 3708 
                 3680 
                 14 
                 42 
               
               
                 A209 
                 3725 
                 3709 
                 3682 
                 16 
                 43 
               
               
                 A210 
                 3724 
                 3714 
                 3688 
                 10 
                 36 
               
               
                 A211 
                 3712 
                 3694 
                 3637 
                 18 
                 75 
               
               
                 A212 
                 3727 
                 3711 
                 3689 
                 16 
                 38 
               
               
                 A213 
                 3724 
                 3705 
                 3652 
                 19 
                 72 
               
               
                 A214 
                 3727 
                 3715 
                 3687 
                 12 
                 40 
               
               
                 A215 
                 3715 
                 3703 
                 3668 
                 12 
                 47 
               
               
                 A216 
                 3722 
                 3707 
                 3667 
                 15 
                 55 
               
               
                 A217 
                 3716 
                 3695 
                 3630 
                 21 
                 86 
               
               
                 A218 
                 3699 
                 3665 
                 3583 
                 34 
                 116 
               
               
                 A219 
                 3727 
                 3716 
                 3699 
                 11 
                 28 
               
               
                 A220 
                 3717 
                 3704 
                 3674 
                 13 
                 43 
               
               
                 A222 
                 3713 
                 3704 
                 3684 
                 9 
                 29 
               
               
                 A223 
                 3724 
                 3715 
                 3695 
                 9 
                 29 
               
               
                 A224 
                 3718 
                 3703 
                 3676 
                 15 
                 42 
               
               
                 A225 
                 3721 
                 3707 
                 3683 
                 14 
                 38 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 3 
               
             
             
               
                   
               
               
                 (Part B) 
               
             
          
           
               
                 ID 
                 FTR od 
                 Time@T2S 
                 Time@Map 
                 Time@TEot 
                 ΔT2SMap 
                 ΔT2STEot 
                 FTR time 
                 FTR od 
               
               
                   
               
             
          
           
               
                 A001 
                 0.218 
                 2211 
                 2366 
                 2921 
                 155 
                 710 
                 0.218 
                 0.218 
               
               
                 A002 
                 0.333 
                 2279 
                 2464 
                 2834 
                 185 
                 555 
                 0.333 
                 0.333 
               
               
                 A003 
                 0.375 
                 2329 
                 2523 
                 2846 
                 194 
                 517 
                 0.375 
                 0.375 
               
               
                 A004 
                 0.267 
                 1975 
                 2107 
                 2470 
                 132 
                 495 
                 0.267 
                 0.267 
               
               
                 A005 
                 0.444 
                 2166 
                 2387 
                 2663 
                 221 
                 497 
                 0.444 
                 0.444 
               
               
                 A007 
                 0.259 
                 1838 
                 1931 
                 2197 
                 93 
                 359 
                 0.259 
                 0.259 
               
               
                 A008 
                 0.309 
                 2160 
                 2369 
                 2837 
                 209 
                 677 
                 0.309 
                 0.309 
               
               
                 A009 
                 0.367 
                 2391 
                 2598 
                 2956 
                 207 
                 565 
                 0.367 
                 0.367 
               
               
                 A010 
                 0.500 
                 1716 
                 1925 
                 2134 
                 209 
                 418 
                 0.500 
                 0.500 
               
               
                 A011 
                 0.326 
                 1788 
                 1935 
                 2240 
                 147 
                 452 
                 0.326 
                 0.326 
               
               
                 A012 
                 0.364 
                 2233 
                 2428 
                 2769 
                 195 
                 536 
                 0.364 
                 0.364 
               
               
                 A013 
                 0.338 
                 2409 
                 2667 
                 3173 
                 258 
                 764 
                 0.338 
                 0.338 
               
               
                 A014 
                 0.391 
                 1701 
                 1836 
                 2046 
                 135 
                 345 
                 0.391 
                 0.391 
               
               
                 A015 
                 0.400 
                 1715 
                 1877 
                 2120 
                 162 
                 405 
                 0.400 
                 0.400 
               
               
                 A016 
                 0.159 
                 2233 
                 2336 
                 2880 
                 103 
                 647 
                 0.159 
                 0.159 
               
               
                 A017 
                 0.333 
                 1728 
                 1882 
                 2190 
                 154 
                 462 
                 0.333 
                 0.333 
               
               
                 A018 
                 0.538 
                 1862 
                 2175 
                 2443 
                 313 
                 581 
                 0.538 
                 0.538 
               
               
                 A019 
                 0.333 
                 1756 
                 1927 
                 2269 
                 171 
                 513 
                 0.333 
                 0.333 
               
               
                 A020 
                 0.379 
                 2535 
                 2761 
                 3131 
                 226 
                 596 
                 0.379 
                 0.379 
               
               
                 A021 
                 0.212 
                 2151 
                 2283 
                 2773 
                 132 
                 622 
                 0.212 
                 0.212 
               
               
                 A022 
                 0.340 
                 1900 
                 2089 
                 2456 
                 189 
                 556 
                 0.340 
                 0.340 
               
               
                 A023 
                 0.232 
                 2251 
                 2384 
                 2824 
                 133 
                 573 
                 0.232 
                 0.232 
               
               
                 A024 
                 0.268 
                 2522 
                 2676 
                 3097 
                 154 
                 575 
                 0.268 
                 0.268 
               
               
                 A025 
                 0.267 
                 1708 
                 1775 
                 1959 
                 67 
                 251 
                 0.267 
                 0.267 
               
               
                 A026 
                 0.273 
                 1611 
                 1730 
                 2047 
                 119 
                 436 
                 0.273 
                 0.273 
               
               
                 A027 
                 0.340 
                 1537 
                 1689 
                 1984 
                 152 
                 447 
                 0.340 
                 0.340 
               
               
                 A028 
                 0.274 
                 1780 
                 1927 
                 2316 
                 147 
                 536 
                 0.274 
                 0.274 
               
               
                 A029 
                 0.323 
                 1839 
                 2023 
                 2409 
                 184 
                 570 
                 0.323 
                 0.323 
               
               
                 A030 
                 0.259 
                 2051 
                 2245 
                 2799 
                 194 
                 748 
                 0.259 
                 0.259 
               
               
                 A031 
                 0.393 
                 2107 
                 2321 
                 2652 
                 214 
                 545 
                 0.393 
                 0.393 
               
               
                 A032 
                 0.146 
                 2584 
                 2678 
                 3226 
                 94 
                 642 
                 0.146 
                 0.146 
               
               
                 A033 
                 0.298 
                 2251 
                 2426 
                 2839 
                 175 
                 588 
                 0.298 
                 0.298 
               
               
                 A034 
                 0.340 
                 1909 
                 2107 
                 2491 
                 198 
                 582 
                 0.340 
                 0.340 
               
               
                 A035 
                 0.333 
                 3037 
                 3305 
                 3841 
                 268 
                 804 
                 0.333 
                 0.333 
               
               
                 A036 
                 0.293 
                 2211 
                 2417 
                 2915 
                 206 
                 704 
                 0.293 
                 0.293 
               
               
                 A037 
                 0.326 
                 2173 
                 2335 
                 2670 
                 162 
                 497 
                 0.326 
                 0.326 
               
               
                 A038 
                 0.417 
                 1543 
                 1713 
                 1951 
                 170 
                 408 
                 0.417 
                 0.417 
               
               
                 A039 
                 0.391 
                 1572 
                 1721 
                 1953 
                 149 
                 381 
                 0.391 
                 0.391 
               
               
                 A040 
                 0.250 
                 1959 
                 2119 
                 2599 
                 160 
                 640 
                 0.250 
                 0.250 
               
               
                 A041 
                 0.219 
                 1993 
                 2144 
                 2682 
                 151 
                 689 
                 0.219 
                 0.219 
               
               
                 A042 
                 0.371 
                 2660 
                 2929 
                 3384 
                 269 
                 724 
                 0.371 
                 0.371 
               
               
                 A044 
                 0.350 
                 2657 
                 2858 
                 3231 
                 201 
                 574 
                 0.350 
                 0.350 
               
               
                 A045 
                 0.231 
                 2175 
                 2325 
                 2825 
                 150 
                 650 
                 0.231 
                 0.231 
               
               
                 A047 
                 0.396 
                 2197 
                 2458 
                 2856 
                 261 
                 659 
                 0.396 
                 0.396 
               
               
                 A048 
                 0.316 
                 2535 
                 2783 
                 3320 
                 248 
                 785 
                 0.316 
                 0.316 
               
               
                 A049 
                 0.400 
                 2004 
                 2256 
                 2634 
                 252 
                 630 
                 0.400 
                 0.400 
               
               
                 A050 
                 0.308 
                 2193 
                 2403 
                 2876 
                 210 
                 683 
                 0.308 
                 0.308 
               
               
                 A051 
                 0.239 
                 1745 
                 1867 
                 2255 
                 122 
                 510 
                 0.239 
                 0.239 
               
               
                 A052 
                 0.289 
                 2073 
                 2247 
                 2674 
                 174 
                 601 
                 0.289 
                 0.289 
               
               
                 A053 
                 0.250 
                 2239 
                 2353 
                 2695 
                 114 
                 456 
                 0.250 
                 0.250 
               
               
                 A054 
                 0.389 
                 1816 
                 2005 
                 2302 
                 189 
                 486 
                 0.389 
                 0.389 
               
               
                 A055 
                 0.374 
                 3127 
                 3668 
                 4575 
                 541 
                 1448 
                 0.374 
                 0.374 
               
               
                 A056 
                 0.244 
                 2538 
                 2728 
                 3316 
                 190 
                 778 
                 0.244 
                 0.244 
               
               
                 A057 
                 0.308 
                 2125 
                 2263 
                 2574 
                 138 
                 449 
                 0.308 
                 0.308 
               
               
                 A058 
                 0.268 
                 4120 
                 4529 
                 5647 
                 409 
                 1527 
                 0.268 
                 0.268 
               
               
                 A059 
                 0.385 
                 2164 
                 2358 
                 2668 
                 194 
                 504 
                 0.385 
                 0.385 
               
               
                 A060 
                 0.333 
                 2325 
                 2494 
                 2832 
                 169 
                 507 
                 0.333 
                 0.333 
               
               
                 A061 
                 0.300 
                 2006 
                 2205 
                 2669 
                 199 
                 663 
                 0.300 
                 0.300 
               
               
                 A062 
                 0.265 
                 3718 
                 4058 
                 5002 
                 340 
                 1284 
                 0.265 
                 0.265 
               
               
                 A063 
                 0.419 
                 2231 
                 2584 
                 3073 
                 353 
                 842 
                 0.419 
                 0.419 
               
               
                 A064 
                 0.333 
                 1926 
                 2076 
                 2376 
                 150 
                 450 
                 0.333 
                 0.333 
               
               
                 A065 
                 0.415 
                 2225 
                 2494 
                 2874 
                 269 
                 649 
                 0.415 
                 0.415 
               
               
                 A066 
                 0.500 
                 1761 
                 1968 
                 2175 
                 207 
                 414 
                 0.500 
                 0.500 
               
               
                 A067 
                 0.284 
                 1701 
                 1852 
                 2233 
                 151 
                 532 
                 0.284 
                 0.284 
               
               
                 A068 
                 0.350 
                 1979 
                 2215 
                 2653 
                 236 
                 674 
                 0.350 
                 0.350 
               
               
                 A069 
                 0.167 
                 1935 
                 1998 
                 2313 
                 63 
                 378 
                 0.167 
                 0.167 
               
               
                 A070 
                 0.244 
                 1939 
                 2063 
                 2446 
                 124 
                 507 
                 0.244 
                 0.244 
               
               
                 A071 
                 0.333 
                 1762 
                 1950 
                 2326 
                 188 
                 564 
                 0.333 
                 0.333 
               
               
                 A072 
                 0.299 
                 1723 
                 1912 
                 2356 
                 189 
                 633 
                 0.299 
                 0.299 
               
               
                 A073 
                 0.309 
                 1614 
                 1774 
                 2132 
                 160 
                 518 
                 0.309 
                 0.309 
               
               
                 A074 
                 0.441 
                 1698 
                 1884 
                 2120 
                 186 
                 422 
                 0.441 
                 0.441 
               
               
                 A075 
                 0.500 
                 1489 
                 1620 
                 1751 
                 131 
                 262 
                 0.500 
                 0.500 
               
               
                 A076 
                 0.278 
                 1529 
                 1684 
                 2087 
                 155 
                 558 
                 0.278 
                 0.278 
               
               
                 A077 
                 0.286 
                 2845 
                 3154 
                 3927 
                 309 
                 1082 
                 0.286 
                 0.286 
               
               
                 A078 
                 0.410 
                 1867 
                 2081 
                 2389 
                 214 
                 522 
                 0.410 
                 0.410 
               
               
                 A080 
                 0.185 
                 3548 
                 3924 
                 5583 
                 376 
                 2035 
                 0.185 
                 0.185 
               
               
                 A081 
                 0.190 
                 2698 
                 2853 
                 3512 
                 155 
                 814 
                 0.190 
                 0.190 
               
               
                 A082 
                 0.210 
                 1625 
                 1744 
                 2193 
                 119 
                 568 
                 0.210 
                 0.210 
               
               
                 A083 
                 0.294 
                 1583 
                 1692 
                 1954 
                 109 
                 371 
                 0.294 
                 0.294 
               
               
                 A084 
                 0.156 
                 3394 
                 3647 
                 5013 
                 253 
                 1619 
                 0.156 
                 0.156 
               
               
                 A085 
                 0.442 
                 2416 
                 2867 
                 3436 
                 451 
                 1020 
                 0.442 
                 0.442 
               
               
                 A086 
                 0.269 
                 2111 
                 2293 
                 2788 
                 182 
                 677 
                 0.269 
                 0.269 
               
               
                 A087 
                 0.344 
                 1740 
                 1924 
                 2274 
                 184 
                 534 
                 0.344 
                 0.344 
               
               
                 A088 
                 0.311 
                 1715 
                 1881 
                 2249 
                 166 
                 534 
                 0.311 
                 0.311 
               
               
                 A089 
                 0.250 
                 1876 
                 1981 
                 2296 
                 105 
                 420 
                 0.250 
                 0.250 
               
               
                 A090 
                 0.230 
                 3411 
                 3775 
                 4993 
                 364 
                 1582 
                 0.230 
                 0.230 
               
               
                 A091 
                 0.215 
                 3897 
                 4201 
                 5308 
                 304 
                 1411 
                 0.215 
                 0.215 
               
               
                 A092 
                 0.342 
                 1906 
                 2151 
                 2622 
                 245 
                 716 
                 0.342 
                 0.342 
               
               
                 A093 
                 0.378 
                 2821 
                 3197 
                 3815 
                 376 
                 994 
                 0.378 
                 0.378 
               
               
                 A094 
                 0.273 
                 2447 
                 2600 
                 3008 
                 153 
                 561 
                 0.273 
                 0.273 
               
               
                 A095 
                 0.292 
                 1573 
                 1726 
                 2098 
                 153 
                 525 
                 0.292 
                 0.292 
               
               
                 A096 
                 0.320 
                 1784 
                 1913 
                 2187 
                 129 
                 403 
                 0.320 
                 0.320 
               
               
                 A097 
                 0.276 
                 1374 
                 1479 
                 1755 
                 105 
                 381 
                 0.276 
                 0.276 
               
               
                 A098 
                 0.351 
                 1480 
                 1655 
                 1979 
                 175 
                 499 
                 0.351 
                 0.351 
               
               
                 A099 
                 0.229 
                 1679 
                 1770 
                 2077 
                 91 
                 398 
                 0.229 
                 0.229 
               
               
                 A100 
                 0.286 
                 1538 
                 1705 
                 2123 
                 167 
                 585 
                 0.286 
                 0.286 
               
               
                 A101 
                 0.324 
                 2137 
                 2344 
                 2775 
                 207 
                 638 
                 0.324 
                 0.324 
               
               
                 A102 
                 0.230 
                 2473 
                 2657 
                 3275 
                 184 
                 802 
                 0.230 
                 0.230 
               
               
                 A103 
                 0.284 
                 1868 
                 2069 
                 2576 
                 201 
                 708 
                 0.284 
                 0.284 
               
               
                 A104 
                 0.378 
                 2344 
                 2732 
                 3369 
                 388 
                 1025 
                 0.378 
                 0.378 
               
               
                 A105 
                 0.292 
                 2427 
                 2750 
                 3532 
                 323 
                 1105 
                 0.292 
                 0.292 
               
               
                 A107 
                 0.217 
                 2140 
                 2305 
                 2902 
                 165 
                 762 
                 0.217 
                 0.217 
               
               
                 A108 
                 0.364 
                 1876 
                 2034 
                 2311 
                 158 
                 435 
                 0.364 
                 0.364 
               
               
                 A109 
                 0.421 
                 1900 
                 2206 
                 2627 
                 306 
                 727 
                 0.421 
                 0.421 
               
               
                 A110 
                 0.310 
                 2621 
                 3048 
                 4001 
                 427 
                 1380 
                 0.310 
                 0.310 
               
               
                 A111 
                 0.393 
                 2064 
                 2409 
                 2942 
                 345 
                 878 
                 0.393 
                 0.393 
               
               
                 A112 
                 0.190 
                 2000 
                 2165 
                 2868 
                 165 
                 868 
                 0.190 
                 0.190 
               
               
                 A113 
                 0.283 
                 1699 
                 1872 
                 2310 
                 173 
                 611 
                 0.283 
                 0.283 
               
               
                 A114 
                 0.429 
                 1838 
                 2101 
                 2452 
                 263 
                 614 
                 0.429 
                 0.429 
               
               
                 A115 
                 0.297 
                 2091 
                 2281 
                 2731 
                 190 
                 640 
                 0.297 
                 0.297 
               
               
                 A116 
                 0.321 
                 1571 
                 1707 
                 1994 
                 136 
                 423 
                 0.321 
                 0.321 
               
               
                 A117 
                 0.275 
                 1691 
                 1874 
                 2356 
                 183 
                 665 
                 0.275 
                 0.275 
               
               
                 A118 
                 0.267 
                 1835 
                 1969 
                 2338 
                 134 
                 503 
                 0.267 
                 0.267 
               
               
                 A119 
                 0.260 
                 2118 
                 2320 
                 2895 
                 202 
                 777 
                 0.260 
                 0.260 
               
               
                 A120 
                 0.265 
                 1833 
                 1960 
                 2313 
                 127 
                 480 
                 0.265 
                 0.265 
               
               
                 A121 
                 0.308 
                 1825 
                 1992 
                 2368 
                 167 
                 543 
                 0.308 
                 0.308 
               
               
                 A122 
                 0.397 
                 1674 
                 1931 
                 2322 
                 257 
                 648 
                 0.397 
                 0.397 
               
               
                 A123 
                 0.320 
                 1669 
                 1824 
                 2153 
                 155 
                 484 
                 0.320 
                 0.320 
               
               
                 A124 
                 0.360 
                 1627 
                 1766 
                 2013 
                 139 
                 386 
                 0.360 
                 0.360 
               
               
                 A125 
                 0.181 
                 1485 
                 1591 
                 2072 
                 106 
                 587 
                 0.181 
                 0.181 
               
               
                 A126 
                 0.591 
                 2476 
                 2969 
                 3310 
                 493 
                 834 
                 0.591 
                 0.591 
               
               
                 A127 
                 0.160 
                 1935 
                 2040 
                 2591 
                 105 
                 656 
                 0.160 
                 0.160 
               
               
                 A128 
                 0.220 
                 2485 
                 2627 
                 3132 
                 142 
                 647 
                 0.220 
                 0.220 
               
               
                 A129 
                 0.255 
                 3083 
                 3385 
                 4268 
                 302 
                 1185 
                 0.255 
                 0.255 
               
               
                 A130 
                 0.254 
                 3137 
                 3330 
                 3896 
                 193 
                 759 
                 0.254 
                 0.254 
               
               
                 A131 
                 0.364 
                 1729 
                 1930 
                 2282 
                 201 
                 553 
                 0.364 
                 0.364 
               
               
                 A132 
                 0.364 
                 2288 
                 2601 
                 3149 
                 313 
                 861 
                 0.364 
                 0.364 
               
               
                 A133 
                 0.400 
                 2132 
                 2531 
                 3130 
                 399 
                 998 
                 0.400 
                 0.400 
               
               
                 A134 
                 0.500 
                 3654 
                 4285 
                 4916 
                 631 
                 1262 
                 0.500 
                 0.500 
               
               
                 A135 
                 0.341 
                 1511 
                 1652 
                 1924 
                 141 
                 413 
                 0.341 
                 0.341 
               
               
                 A136 
                 0.197 
                 2697 
                 2874 
                 3596 
                 177 
                 899 
                 0.197 
                 0.197 
               
               
                 A137 
                 0.420 
                 1797 
                 1980 
                 2233 
                 183 
                 436 
                 0.420 
                 0.420 
               
               
                 A138 
                 0.315 
                 1931 
                 2137 
                 2585 
                 206 
                 654 
                 0.315 
                 0.315 
               
               
                 A139 
                 0.227 
                 1905 
                 2069 
                 2629 
                 164 
                 724 
                 0.227 
                 0.227 
               
               
                 A140 
                 0.294 
                 1483 
                 1623 
                 1959 
                 140 
                 476 
                 0.294 
                 0.294 
               
               
                 A141 
                 0.315 
                 1872 
                 2044 
                 2418 
                 172 
                 546 
                 0.315 
                 0.315 
               
               
                 A142 
                 0.435 
                 2390 
                 2573 
                 2811 
                 183 
                 421 
                 0.435 
                 0.435 
               
               
                 A143 
                 0.515 
                 2047 
                 2421 
                 2773 
                 374 
                 726 
                 0.515 
                 0.515 
               
               
                 A144 
                 0.235 
                 2017 
                 2143 
                 2553 
                 126 
                 536 
                 0.235 
                 0.235 
               
               
                 A145 
                 0.246 
                 1492 
                 1602 
                 1939 
                 110 
                 447 
                 0.246 
                 0.246 
               
               
                 A146 
                 0.222 
                 1899 
                 2068 
                 2660 
                 169 
                 761 
                 0.222 
                 0.222 
               
               
                 A147 
                 0.288 
                 1608 
                 1738 
                 2059 
                 130 
                 451 
                 0.288 
                 0.288 
               
               
                 A148 
                 0.191 
                 1967 
                 2090 
                 2610 
                 123 
                 643 
                 0.191 
                 0.191 
               
               
                 A149 
                 0.328 
                 1581 
                 1718 
                 1999 
                 137 
                 418 
                 0.328 
                 0.328 
               
               
                 A150 
                 0.247 
                 1558 
                 1690 
                 2092 
                 132 
                 534 
                 0.247 
                 0.247 
               
               
                 A151 
                 0.289 
                 2177 
                 2402 
                 2954 
                 225 
                 777 
                 0.289 
                 0.289 
               
               
                 A152 
                 0.324 
                 1876 
                 2006 
                 2278 
                 130 
                 402 
                 0.324 
                 0.324 
               
               
                 A153 
                 0.232 
                 1713 
                 1859 
                 2343 
                 146 
                 630 
                 0.232 
                 0.232 
               
               
                 A154 
                 0.262 
                 1887 
                 2053 
                 2520 
                 166 
                 633 
                 0.262 
                 0.262 
               
               
                 A155 
                 0.368 
                 2906 
                 3327 
                 4049 
                 421 
                 1143 
                 0.368 
                 0.368 
               
               
                 A156 
                 0.207 
                 2191 
                 2291 
                 2674 
                 100 
                 483 
                 0.207 
                 0.207 
               
               
                 A157 
                 0.385 
                 1886 
                 2065 
                 2351 
                 179 
                 465 
                 0.385 
                 0.385 
               
               
                 A158 
                 0.235 
                 2424 
                 2551 
                 2964 
                 127 
                 540 
                 0.235 
                 0.235 
               
               
                 A159 
                 0.290 
                 2678 
                 2973 
                 3694 
                 295 
                 1016 
                 0.290 
                 0.290 
               
               
                 A160 
                 0.435 
                 2160 
                 2489 
                 2915 
                 329 
                 755 
                 0.435 
                 0.435 
               
               
                 A161 
                 0.159 
                 1674 
                 1762 
                 2227 
                 88 
                 553 
                 0.159 
                 0.159 
               
               
                 A162 
                 0.232 
                 3480 
                 3835 
                 5011 
                 355 
                 1531 
                 0.232 
                 0.232 
               
               
                 A163 
                 0.238 
                 2505 
                 2697 
                 3311 
                 192 
                 806 
                 0.238 
                 0.238 
               
               
                 A164 
                 0.250 
                 2535 
                 2718 
                 3267 
                 183 
                 732 
                 0.250 
                 0.250 
               
               
                 A165 
                 0.197 
                 2072 
                 2189 
                 2665 
                 117 
                 593 
                 0.197 
                 0.197 
               
               
                 A166 
                 0.288 
                 1883 
                 2051 
                 2467 
                 168 
                 584 
                 0.288 
                 0.288 
               
               
                 A167 
                 0.214 
                 2228 
                 2321 
                 2662 
                 93 
                 434 
                 0.214 
                 0.214 
               
               
                 A168 
                 0.415 
                 2366 
                 2847 
                 3525 
                 481 
                 1159 
                 0.415 
                 0.415 
               
               
                 A169 
                 0.136 
                 2543 
                 2661 
                 3412 
                 118 
                 869 
                 0.136 
                 0.136 
               
               
                 A170 
                 0.351 
                 1456 
                 1589 
                 1835 
                 133 
                 379 
                 0.351 
                 0.351 
               
               
                 A171 
                 0.400 
                 2463 
                 2761 
                 3208 
                 298 
                 745 
                 0.400 
                 0.400 
               
               
                 A172 
                 0.200 
                 1944 
                 2070 
                 2574 
                 126 
                 630 
                 0.200 
                 0.200 
               
               
                 A173 
                 0.263 
                 1505 
                 1600 
                 1866 
                 95 
                 361 
                 0.263 
                 0.263 
               
               
                 A174 
                 0.254 
                 1687 
                 1816 
                 2194 
                 129 
                 507 
                 0.254 
                 0.254 
               
               
                 A175 
                 0.383 
                 1681 
                 1821 
                 2047 
                 140 
                 366 
                 0.383 
                 0.383 
               
               
                 A176 
                 0.245 
                 2344 
                 2544 
                 3159 
                 200 
                 815 
                 0.245 
                 0.245 
               
               
                 A177 
                 0.344 
                 1596 
                 1733 
                 1995 
                 137 
                 399 
                 0.344 
                 0.344 
               
               
                 A178 
                 0.262 
                 2019 
                 2183 
                 2644 
                 164 
                 625 
                 0.262 
                 0.262 
               
               
                 A179 
                 0.222 
                 2056 
                 2181 
                 2619 
                 125 
                 563 
                 0.222 
                 0.222 
               
               
                 A180 
                 0.375 
                 1891 
                 2096 
                 2438 
                 205 
                 547 
                 0.375 
                 0.375 
               
               
                 A181 
                 0.413 
                 2575 
                 2959 
                 3505 
                 384 
                 930 
                 0.413 
                 0.413 
               
               
                 A182 
                 0.204 
                 1828 
                 1930 
                 2328 
                 102 
                 500 
                 0.204 
                 0.204 
               
               
                 A183 
                 0.364 
                 1523 
                 1644 
                 1856 
                 121 
                 333 
                 0.364 
                 0.364 
               
               
                 A184 
                 0.214 
                 2049 
                 2187 
                 2693 
                 138 
                 644 
                 0.214 
                 0.214 
               
               
                 A185 
                 0.236 
                 2417 
                 2606 
                 3217 
                 189 
                 800 
                 0.236 
                 0.236 
               
               
                 A186 
                 0.455 
                 2223 
                 2909 
                 3729 
                 686 
                 1506 
                 0.455 
                 0.455 
               
               
                 A187 
                 0.234 
                 1654 
                 1755 
                 2086 
                 101 
                 432 
                 0.234 
                 0.234 
               
               
                 A188 
                 0.311 
                 2229 
                 2460 
                 2972 
                 231 
                 743 
                 0.311 
                 0.311 
               
               
                 A189 
                 0.392 
                 2320 
                 2588 
                 3003 
                 268 
                 683 
                 0.392 
                 0.392 
               
               
                 A190 
                 0.300 
                 2473 
                 2670 
                 3130 
                 197 
                 657 
                 0.300 
                 0.300 
               
               
                 A191 
                 0.276 
                 1782 
                 1907 
                 2235 
                 125 
                 453 
                 0.276 
                 0.276 
               
               
                 A192 
                 0.258 
                 2127 
                 2255 
                 2623 
                 128 
                 496 
                 0.258 
                 0.258 
               
               
                 A193 
                 0.214 
                 1788 
                 1920 
                 2404 
                 132 
                 616 
                 0.214 
                 0.214 
               
               
                 A194 
                 0.313 
                 1930 
                 2107 
                 2496 
                 177 
                 566 
                 0.313 
                 0.313 
               
               
                 A195 
                 0.235 
                 1581 
                 1710 
                 2129 
                 129 
                 548 
                 0.235 
                 0.235 
               
               
                 A196 
                 0.244 
                 1821 
                 1958 
                 2381 
                 137 
                 560 
                 0.244 
                 0.244 
               
               
                 A197 
                 0.203 
                 1743 
                 1835 
                 2196 
                 92 
                 453 
                 0.203 
                 0.203 
               
               
                 A198 
                 0.400 
                 1696 
                 1912 
                 2236 
                 216 
                 540 
                 0.400 
                 0.400 
               
               
                 A199 
                 0.417 
                 1498 
                 1665 
                 1899 
                 167 
                 401 
                 0.417 
                 0.417 
               
               
                 A200 
                 0.281 
                 1441 
                 1554 
                 1843 
                 113 
                 402 
                 0.281 
                 0.281 
               
               
                 A201 
                 0.273 
                 2036 
                 2205 
                 2656 
                 169 
                 620 
                 0.273 
                 0.273 
               
               
                 A202 
                 0.345 
                 1898 
                 2080 
                 2426 
                 182 
                 528 
                 0.345 
                 0.345 
               
               
                 A203 
                 0.244 
                 1768 
                 1880 
                 2226 
                 112 
                 458 
                 0.244 
                 0.244 
               
               
                 A204 
                 0.385 
                 1642 
                 1820 
                 2105 
                 178 
                 463 
                 0.385 
                 0.385 
               
               
                 A205 
                 0.256 
                 1851 
                 1983 
                 2367 
                 132 
                 516 
                 0.256 
                 0.256 
               
               
                 A207 
                 0.190 
                 2173 
                 2299 
                 2835 
                 126 
                 662 
                 0.190 
                 0.190 
               
               
                 A208 
                 0.333 
                 2277 
                 2531 
                 3039 
                 254 
                 762 
                 0.333 
                 0.333 
               
               
                 A209 
                 0.372 
                 1721 
                 1937 
                 2302 
                 216 
                 581 
                 0.372 
                 0.372 
               
               
                 A210 
                 0.278 
                 1907 
                 2066 
                 2479 
                 159 
                 572 
                 0.278 
                 0.278 
               
               
                 A211 
                 0.240 
                 2153 
                 2306 
                 2791 
                 153 
                 638 
                 0.240 
                 0.240 
               
               
                 A212 
                 0.421 
                 2143 
                 2458 
                 2891 
                 315 
                 748 
                 0.421 
                 0.421 
               
               
                 A213 
                 0.264 
                 2057 
                 2332 
                 3099 
                 275 
                 1042 
                 0.264 
                 0.264 
               
               
                 A214 
                 0.300 
                 2116 
                 2363 
                 2939 
                 247 
                 823 
                 0.300 
                 0.300 
               
               
                 A215 
                 0.255 
                 1982 
                 2118 
                 2515 
                 136 
                 533 
                 0.255 
                 0.255 
               
               
                 A216 
                 0.273 
                 2799 
                 3061 
                 3760 
                 262 
                 961 
                 0.273 
                 0.273 
               
               
                 A217 
                 0.244 
                 2021 
                 2237 
                 2906 
                 216 
                 885 
                 0.244 
                 0.244 
               
               
                 A218 
                 0.293 
                 2319 
                 2571 
                 3179 
                 252 
                 860 
                 0.293 
                 0.293 
               
               
                 A219 
                 0.393 
                 2098 
                 2309 
                 2635 
                 211 
                 537 
                 0.393 
                 0.393 
               
               
                 A220 
                 0.302 
                 1803 
                 1943 
                 2266 
                 140 
                 463 
                 0.302 
                 0.302 
               
               
                 A222 
                 0.310 
                 1705 
                 1876 
                 2256 
                 171 
                 551 
                 0.310 
                 0.310 
               
               
                 A223 
                 0.310 
                 1593 
                 1732 
                 2041 
                 139 
                 448 
                 0.310 
                 0.310 
               
               
                 A224 
                 0.357 
                 1649 
                 1811 
                 2103 
                 162 
                 454 
                 0.357 
                 0.357 
               
               
                 A225 
                 0.368 
                 1655 
                 1824 
                 2114 
                 169 
                 459 
                 0.368 
                 0.368 
               
               
                   
               
             
          
         
       
     
         [0116]    Comparative Results of nATFt&#39;s and nATFz&#39;s 
         [0117]    Results between patients in two different geographic locations (i.e., two different hospitals) were compared for correlation with each other. This comparison is expressed in Table 4 below, and includes a comparison of INR values calculated by the WHO method for each respective location, with GInr representing one location for these traditionally WHO determined values, and MInr representing values based on data obtained at the other location. The values identified as ATFz and ATFt, such as, GATFt and MATFt, and GATFz and MATFz, represent anticoagulant therapy factors derived from the expressions (1) through (9) above. 
         [0118]    The ATFa represents an anticoagulation therapy factor derived from our method and apparatus for the expression ATFa=XR (2-nFTR)  wherein a maximum acceleration point is obtained, and nFTR=IUX/IUT, where IUX is the change in optical density from a time prior to the MAP time (t &lt;MAP  which is t MAP  minus some time from MAP) to the optical density at a time after the MAP time (t &gt;MAP  which is t MAP  plus some time from MAP); and wherein IUT=the change in optical density at the time t 1  to the optical density measured at time t EOT , where time t EOT  is the end of the test (EOT). The (IUX) represents the fibrinogen (FBG) for MAP (−a number of seconds) to MAP (+a number of seconds) (that is the fibrinogen (FBG) converted from t &lt;MAP  to t &gt;MAP  on  FIG. 2 ) The (IUT) represents fibrinogen converted from c 1  to c EOT  (that is the fibrinogen converted from t 1  to t EOT , see  FIG. 2 ). The XR for the ATFa expression is XR=TX/MNTX, which is the ratio of time to map (TX) by the mean normal time to map of 20 presumed “normal” patients. 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 4 
               
             
             
               
                   
               
               
                 COMPARATIVE RESULTS FOR ATFt and ATFz 
               
             
          
           
               
                   
                   
                   
                   
                   
                 Std. 
                   
                   
               
               
                 Comparison 
                 n 
                 r 
                 m 
                 b 
                 Error 
                 Ng 
                 Lassen 
               
               
                   
               
             
          
           
               
                 GInr vs. 
                 129 
                 0.996 
                 0.891 
                 0.148 
                 0.082 
                 6/129 = 
                 delta &lt;= 0.4 5@96.1% 
               
               
                 GATFa 
                   
                   
                   
                   
                   
                 4.7% 
                 delta &lt;= 0.7 2@98.4% 
               
               
                   
                   
                   
                   
                   
                   
                 mismatches 
               
               
                 GInr vs. 
                 129 
                 0.975 
                 1.014 
                 −0.016 
                 0.215 
                 15/129 = 
                 delta &lt;= 0.4 9@93% 
               
               
                 GATFz 
                   
                   
                   
                   
                   
                 11.6% 
                 delta &lt;= 0.7 3@97.7% 
               
               
                   
                   
                   
                   
                   
                   
                 mismatches 
               
               
                 GInr vs. 
                 129 
                 0.971 
                 0.895 
                 0.332 
                 0.232 
                 26/129 = 
                 delta &lt;= 0.4 18@86.0% 
               
               
                 GATFt 
                   
                   
                   
                   
                   
                 20.2% 
                 delta &lt;= 0.7 2@98.4% 
               
               
                   
                   
                   
                   
                   
                   
                 mismatches 
               
               
                 MInr vs. 
                 129 
                 0.996 
                 0.943 
                 0.082 
                 0.094 
                 18/129 = 
                 delta &lt;= 0.4 15@88.4% 
               
               
                 MATFa 
                   
                   
                   
                   
                   
                 14.0% 
                 delta &lt;= 0.7 5@96.1% 
               
               
                   
                   
                   
                   
                   
                   
                 mismatches 
               
               
                 MInr vs. 
                 129 
                 0.985 
                 0.993 
                 −0.058 
                 0.177 
                 2/129 = 
                 delta &lt;= 0.4 0@100% 
               
               
                 MATFz 
                   
                   
                   
                   
                   
                 1.6% 
                 delta &lt;= 0.7 0@100% 
               
               
                   
                   
                   
                   
                   
                   
                 mismatches 
               
               
                 MInr vs. 
                 129 
                 0.981 
                 0.851 
                 0.420 
                 0.200 
                 8/129 = 
                 delta &lt;= 0.4 6@95.3 
               
               
                 MATFt 
                   
                   
                   
                   
                   
                 6.2% 
                 delta &lt;= 0.7 2@98.4% 
               
               
                   
                   
                   
                   
                   
                   
                 mismatches 
               
               
                   
               
             
          
         
       
     
         [0119]    A comparison of combined location data is shown in Table 5, below. The sample size was 217. 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 5 
               
             
             
               
                   
               
               
                 STATISTICAL SUMMARY OF MHTL DATA 
               
             
          
           
               
                 Com- 
                   
                   
                   
                   
                 Std. 
                   
                   
               
               
                 parison 
                 n 
                 r 
                 m 
                 b 
                 Error 
                 Ng 
                 Lassen 
               
               
                   
               
               
                 Inr vs 
                 217 
                 0.984 
                 1.006 
                 0.011 
                 0.215 
                 30/217 = 
                 delta &lt;= 0.4 
               
               
                 ATFa 
                   
                   
                   
                   
                   
                 13.8% 
                 16@92.6% 
               
               
                   
                   
                   
                   
                   
                   
                 mismatches 
                 delta &lt;= 0.7 
               
               
                   
                   
                   
                   
                   
                   
                   
                 1@99.5% 
               
               
                 Inr vs. 
                 217 
                 0.984 
                 1.002 
                 0.120 
                 0.214 
                 26/217 = 
                 delta &lt;= 0.4 
               
               
                 ATFz 
                   
                   
                   
                   
                   
                 12.0% 
                 18@91.7% 
               
               
                   
                   
                   
                   
                   
                   
                 mismatched 
                 delta &lt;= 0.7 
               
               
                   
                   
                   
                   
                   
                   
                   
                 3@98.6% 
               
               
                 Inr vs. 
                 217 
                 0.984 
                 0.900 
                 0.482 
                 1.218 
                 45/217 = 
                 delta &lt;= 0.4 
               
               
                 ATFt 
                   
                   
                   
                   
                   
                 20.7% 
                 43@80.2% 
               
               
                   
                   
                   
                   
                   
                   
                 mismatches 
                 delta &lt;= 0.7 
               
               
                   
                   
                   
                   
                   
                   
                   
                 6@97.2% 
               
               
                   
               
             
          
         
       
     
         [0120]    Comparative results were also calculated for the ATFt which includes the lag phase fibrinogen, in accordance with the IULz, using the expression (5.1) for the TEOT value. Table 6 below provides the values for the ATFz, ATFt, and the ATFt2 (which is obtained from expression 5.1 using the IULz). 
         [0000]    
       
         
               
               
               
               
               
               
             
           
               
                   
                 TABLE 6 
               
               
                   
                   
               
               
                   
                 ID 
                 INR 
                 INRz 
                 ATFt 
                 ATFt2 
               
               
                   
                   
               
             
             
               
                   
                 A001 
                 3.1 
                 2.9 
                 2.4 
                 2.6 
               
               
                   
                 A002 
                 3.3 
                 2.9 
                 2.4 
                 2.6 
               
               
                   
                 A003 
                 3.3 
                 2.9 
                 2.4 
                 2.6 
               
               
                   
                 A004 
                 2.1 
                 2.3 
                 1.8 
                 2.0 
               
               
                   
                 A005 
                 2.9 
                 2.6 
                 2.1 
                 2.3 
               
               
                   
                 A007 
                 2.1 
                 2.0 
                 1.5 
                 1.6 
               
               
                   
                 A008 
                 2.8 
                 2.8 
                 2.3 
                 2.5 
               
               
                   
                 A009 
                 3.4 
                 3.1 
                 2.6 
                 2.8 
               
               
                   
                 A010 
                 1.9 
                 1.8 
                 1.3 
                 1.5 
               
               
                   
                 A011 
                 2.1 
                 1.9 
                 1.5 
                 1.6 
               
               
                   
                 A012 
                 3.2 
                 2.8 
                 2.3 
                 2.5 
               
               
                   
                 A013 
                 3.5 
                 3.3 
                 2.8 
                 3.0 
               
               
                   
                 A014 
                 1.8 
                 1.7 
                 1.3 
                 1.4 
               
               
                   
                 A015 
                 1.9 
                 1.8 
                 1.3 
                 1.5 
               
               
                   
                 A016 
                 3.2 
                 2.9 
                 2.4 
                 2.6 
               
               
                   
                 A017 
                 1.8 
                 1.9 
                 1.4 
                 1.6 
               
               
                   
                 A018 
                 2.2 
                 2.1 
                 1.7 
                 1.8 
               
               
                   
                 A019 
                 1.8 
                 1.9 
                 1.5 
                 1.6 
               
               
                   
                 A020 
                 3.5 
                 3.4 
                 2.9 
                 3.2 
               
               
                   
                 A021 
                 2.8 
                 2.7 
                 2.2 
                 2.4 
               
               
                   
                 A022 
                 2.2 
                 2.2 
                 1.7 
                 1.9 
               
               
                   
                 A023 
                 3.2 
                 2.9 
                 2.3 
                 2.5 
               
               
                   
                 A024 
                 3.7 
                 3.5 
                 2.9 
                 3.1 
               
               
                   
                 A025 
                 1.8 
                 1.7 
                 1.2 
                 1.4 
               
               
                   
                 A026 
                 1.6 
                 1.6 
                 1.2 
                 1.4 
               
               
                   
                 A027 
                 1.5 
                 1.5 
                 1.1 
                 1.3 
               
               
                   
                 A028 
                 1.9 
                 2.0 
                 1.5 
                 1.7 
               
               
                   
                 A029 
                 2.1 
                 2.1 
                 1.6 
                 1.8 
               
               
                   
                 A030 
                 2.6 
                 2.6 
                 2.1 
                 2.3 
               
               
                   
                 A031 
                 2.7 
                 2.5 
                 2.1 
                 2.3 
               
               
                   
                 A032 
                 4.1 
                 3.8 
                 3.1 
                 3.3 
               
               
                   
                 A033 
                 2.9 
                 2.9 
                 2.4 
                 2.6 
               
               
                   
                 A034 
                 2.2 
                 2.2 
                 1.7 
                 1.9 
               
               
                   
                 A035 
                 4.9 
                 4.7 
                 4.3 
                 4.7 
               
               
                   
                 A036 
                 3.2 
                 2.9 
                 2.4 
                 2.6 
               
               
                   
                 A037 
                 2.5 
                 2.7 
                 2.1 
                 2.4 
               
               
                   
                 A038 
                 1.6 
                 1.6 
                 1.1 
                 1.2 
               
               
                   
                 A039 
                 1.4 
                 1.6 
                 1.1 
                 1.3 
               
               
                   
                 A040 
                 2.4 
                 2.4 
                 1.9 
                 2.1 
               
               
                   
                 A041 
                 2.3 
                 2.4 
                 2.0 
                 2.2 
               
               
                   
                 A042 
                 4.1 
                 3.8 
                 3.3 
                 3.6 
               
               
                   
                 A044 
                 4.2 
                 3.7 
                 3.2 
                 3.4 
               
               
                   
                 A045 
                 2.7 
                 2.8 
                 2.3 
                 2.5 
               
               
                   
                 A047 
                 2.8 
                 2.8 
                 2.3 
                 2.5 
               
               
                   
                 A048 
                 3.9 
                 3.6 
                 3.1 
                 3.3 
               
               
                   
                 A049 
                 2.6 
                 2.4 
                 1.9 
                 2.1 
               
               
                   
                 A050 
                 2.8 
                 2.8 
                 2.3 
                 2.5 
               
               
                   
                 A051 
                 1.9 
                 1.9 
                 1.4 
                 1.6 
               
               
                   
                 A052 
                 2.8 
                 2.6 
                 2.0 
                 2.2 
               
               
                   
                 A053 
                 3.0 
                 2.8 
                 2.2 
                 2.4 
               
               
                   
                 A054 
                 2.1 
                 2.0 
                 1.5 
                 1.7 
               
               
                   
                 A055 
                 5.6 
                 5.4 
                 5.3 
                 5.6 
               
               
                   
                 A056 
                 3.6 
                 3.7 
                 3.1 
                 3.4 
               
               
                   
                 A057 
                 2.8 
                 2.6 
                 2.0 
                 2.2 
               
               
                   
                 A058 
                 8.5 
                 8.7 
                 8.6 
                 9.1 
               
               
                   
                 A059 
                 2.9 
                 2.6 
                 2.1 
                 2.3 
               
               
                   
                 A060 
                 3.5 
                 3.0 
                 2.4 
                 2.6 
               
               
                   
                 A061 
                 2.4 
                 2.5 
                 2.0 
                 2.1 
               
               
                   
                 A062 
                 7.0 
                 7.2 
                 6.8 
                 7.3 
               
               
                   
                 A063 
                 3.0 
                 3.0 
                 2.5 
                 2.7 
               
               
                   
                 A064 
                 2.2 
                 2.2 
                 1.7 
                 1.9 
               
               
                   
                 A065 
                 2.6 
                 2.8 
                 2.4 
                 2.6 
               
               
                   
                 A066 
                 2.0 
                 1.9 
                 1.4 
                 1.6 
               
               
                   
                 A067 
                 1.8 
                 1.8 
                 1.4 
                 1.6 
               
               
                   
                 A068 
                 2.6 
                 2.4 
                 1.9 
                 2.1 
               
               
                   
                 A069 
                 2.4 
                 2.2 
                 1.6 
                 1.8 
               
               
                   
                 A070 
                 2.4 
                 2.3 
                 1.7 
                 1.9 
               
               
                   
                 A071 
                 1.9 
                 2.0 
                 1.5 
                 1.7 
               
               
                   
                 A072 
                 1.8 
                 1.9 
                 1.5 
                 1.6 
               
               
                   
                 A073 
                 1.5 
                 1.7 
                 1.3 
                 1.4 
               
               
                   
                 A074 
                 1.7 
                 1.8 
                 1.3 
                 1.5 
               
               
                   
                 A075 
                 1.6 
                 1.4 
                 1.0 
                 1.1 
               
               
                   
                 A076 
                 1.4 
                 1.6 
                 1.2 
                 1.3 
               
               
                   
                 A077 
                 4.5 
                 4.6 
                 4.1 
                 4.4 
               
               
                   
                 A078 
                 2.2 
                 2.1 
                 1.6 
                 1.8 
               
               
                   
                 A080 
                 7.3 
                 7.4 
                 7.3 
                 7.6 
               
               
                   
                 A081 
                 3.8 
                 4.2 
                 3.5 
                 3.8 
               
               
                   
                 A082 
                 1.6 
                 1.7 
                 1.3 
                 1.5 
               
               
                   
                 A083 
                 1.6 
                 1.6 
                 1.1 
                 1.3 
               
               
                   
                 A084 
                 6.7 
                 6.7 
                 6.3 
                 6.6 
               
               
                   
                 A085 
                 3.3 
                 3.4 
                 3.1 
                 3.3 
               
               
                   
                 A086 
                 2.8 
                 2.7 
                 2.2 
                 2.4 
               
               
                   
                 A087 
                 1.8 
                 1.9 
                 1.5 
                 1.6 
               
               
                   
                 A088 
                 1.7 
                 1.9 
                 1.4 
                 1.6 
               
               
                   
                 A089 
                 2.3 
                 2.1 
                 1.6 
                 1.7 
               
               
                   
                 A090 
                 6.3 
                 6.6 
                 6.3 
                 6.7 
               
               
                   
                 A091 
                 7.6 
                 8.1 
                 7.6 
                 8.1 
               
               
                   
                 A092 
                 1.9 
                 2.3 
                 1.8 
                 2.0 
               
               
                   
                 A093 
                 4.9 
                 4.3 
                 4.0 
                 4.2 
               
               
                   
                 A094 
                 3.2 
                 3.3 
                 2.7 
                 2.9 
               
               
                   
                 A095 
                 1.5 
                 1.6 
                 1.2 
                 1.4 
               
               
                   
                 A096 
                 2.3 
                 1.9 
                 1.4 
                 1.6 
               
               
                   
                 A097 
                 1.3 
                 1.3 
                 0.9 
                 1.0 
               
               
                   
                 A098 
                 1.4 
                 1.5 
                 1.1 
                 1.2 
               
               
                   
                 A099 
                 1.8 
                 1.7 
                 1.3 
                 1.4 
               
               
                   
                 A100 
                 1.4 
                 1.6 
                 1.2 
                 1.3 
               
               
                   
                 A101 
                 2.7 
                 2.7 
                 2.2 
                 2.4 
               
               
                   
                 A102 
                 3.8 
                 3.6 
                 3.0 
                 3.2 
               
               
                   
                 A103 
                 2.0 
                 2.2 
                 1.8 
                 1.9 
               
               
                   
                 A104 
                 3.2 
                 3.3 
                 2.9 
                 3.2 
               
               
                   
                 A105 
                 3.7 
                 3.6 
                 3.2 
                 3.4 
               
               
                   
                 A107 
                 2.9 
                 2.8 
                 2.3 
                 2.5 
               
               
                   
                 A108 
                 2.1 
                 2.1 
                 1.6 
                 1.8 
               
               
                   
                 A109 
                 2.2 
                 2.3 
                 1.8 
                 2.0 
               
               
                   
                 A110 
                 3.9 
                 4.2 
                 3.9 
                 4.1 
               
               
                   
                 A111 
                 2.5 
                 2.7 
                 2.2 
                 2.4 
               
               
                   
                 A112 
                 2.5 
                 2.5 
                 2.1 
                 2.3 
               
               
                   
                 A113 
                 1.9 
                 1.9 
                 1.4 
                 1.6 
               
               
                   
                 A114 
                 2.1 
                 2.1 
                 1.7 
                 1.8 
               
               
                   
                 A115 
                 2.4 
                 2.6 
                 2.1 
                 2.3 
               
               
                   
                 A116 
                 1.7 
                 1.6 
                 1.2 
                 1.3 
               
               
                   
                 A117 
                 1.6 
                 1.9 
                 1.5 
                 1.6 
               
               
                   
                 A118 
                 2.1 
                 2.1 
                 1.6 
                 1.7 
               
               
                   
                 A119 
                 3.0 
                 2.7 
                 2.3 
                 2.4 
               
               
                   
                 A120 
                 2.1 
                 2.0 
                 1.6 
                 1.7 
               
               
                   
                 A121 
                 2.2 
                 2.1 
                 1.6 
                 1.7 
               
               
                   
                 A122 
                 1.7 
                 1.9 
                 1.4 
                 1.6 
               
               
                   
                 A123 
                 1.8 
                 1.8 
                 1.3 
                 1.5 
               
               
                   
                 A124 
                 1.8 
                 1.7 
                 1.2 
                 1.3 
               
               
                   
                 A125 
                 1.4 
                 1.4 
                 1.1 
                 1.3 
               
               
                   
                 A126 
                 3.7 
                 3.2 
                 3.0 
                 3.3 
               
               
                   
                 A127 
                 2.4 
                 2.3 
                 1.8 
                 2.0 
               
               
                   
                 A128 
                 3.8 
                 3.5 
                 2.9 
                 3.1 
               
               
                   
                 A129 
                 5.3 
                 5.3 
                 4.8 
                 5.3 
               
               
                   
                 A130 
                 4.7 
                 5.2 
                 4.5 
                 4.9 
               
               
                   
                 A131 
                 1.7 
                 1.9 
                 1.5 
                 1.6 
               
               
                   
                 A132 
                 2.8 
                 3.1 
                 2.7 
                 2.9 
               
               
                   
                 A133 
                 2.6 
                 2.9 
                 2.5 
                 2.7 
               
               
                   
                 A134 
                 6.6 
                 6.0 
                 6.6 
                 7.1 
               
               
                   
                 A135 
                 1.5 
                 1.5 
                 1.1 
                 1.2 
               
               
                   
                 A136 
                 4.3 
                 4.2 
                 3.6 
                 3.8 
               
               
                   
                 A137 
                 1.9 
                 1.9 
                 1.5 
                 1.6 
               
               
                   
                 A138 
                 2.0 
                 2.3 
                 1.8 
                 2.0 
               
               
                   
                 A139 
                 2.1 
                 2.3 
                 1.8 
                 2.0 
               
               
                   
                 A140 
                 1.3 
                 1.5 
                 1.1 
                 1.2 
               
               
                   
                 A141 
                 2.2 
                 2.1 
                 1.7 
                 1.8 
               
               
                   
                 A142 
                 3.4 
                 2.9 
                 2.5 
                 2.7 
               
               
                   
                 A143 
                 2.5 
                 2.5 
                 2.1 
                 2.3 
               
               
                   
                 A144 
                 2.5 
                 2.4 
                 1.9 
                 2.1 
               
               
                   
                 A145 
                 1.4 
                 1.4 
                 1.1 
                 1.2 
               
               
                   
                 A146 
                 2.3 
                 2.3 
                 1.9 
                 2.0 
               
               
                   
                 A147 
                 1.7 
                 1.6 
                 1.2 
                 1.4 
               
               
                   
                 A148 
                 2.3 
                 2.4 
                 1.9 
                 2.1 
               
               
                   
                 A149 
                 1.6 
                 1.6 
                 1.2 
                 1.3 
               
               
                   
                 A150 
                 1.6 
                 1.6 
                 1.2 
                 1.3 
               
               
                   
                 A151 
                 2.8 
                 2.9 
                 2.4 
                 2.6 
               
               
                   
                 A152 
                 2.2 
                 2.1 
                 1.6 
                 1.7 
               
               
                   
                 A153 
                 1.8 
                 1.9 
                 1.5 
                 1.6 
               
               
                   
                 A154 
                 2.2 
                 2.2 
                 1.7 
                 1.9 
               
               
                   
                 A155 
                 4.8 
                 4.6 
                 4.3 
                 4.7 
               
               
                   
                 A156 
                 2.9 
                 2.8 
                 2.2 
                 2.4 
               
               
                   
                 A157 
                 2.1 
                 2.1 
                 1.6 
                 1.8 
               
               
                   
                 A158 
                 3.6 
                 3.3 
                 2.6 
                 2.8 
               
               
                   
                 A159 
                 3.9 
                 4.1 
                 3.6 
                 3.9 
               
               
                   
                 A160 
                 2.7 
                 2.8 
                 2.3 
                 2.5 
               
               
                   
                 A161 
                 1.7 
                 1.8 
                 1.4 
                 1.5 
               
               
                   
                 A162 
                 6.6 
                 6.8 
                 6.4 
                 6.9 
               
               
                   
                 A163 
                 3.9 
                 3.6 
                 3.1 
                 3.3 
               
               
                   
                 A164 
                 4.0 
                 3.6 
                 3.0 
                 3.3 
               
               
                   
                 A165 
                 2.7 
                 2.6 
                 2.0 
                 2.2 
               
               
                   
                 A166 
                 2.2 
                 2.2 
                 1.7 
                 1.9 
               
               
                   
                 A167 
                 2.9 
                 2.8 
                 2.2 
                 2.4 
               
               
                   
                 A168 
                 3.6 
                 3.5 
                 3.1 
                 3.3 
               
               
                   
                 A169 
                 4.1 
                 3.8 
                 3.2 
                 3.4 
               
               
                   
                 A170 
                 1.4 
                 1.4 
                 1.0 
                 1.1 
               
               
                   
                 A171 
                 3.4 
                 3.3 
                 2.9 
                 3.1 
               
               
                   
                 A172 
                 2.5 
                 2.3 
                 1.8 
                 2.0 
               
               
                   
                 A173 
                 1.6 
                 1.4 
                 1.0 
                 1.1 
               
               
                   
                 A174 
                 1.8 
                 1.8 
                 1.4 
                 1.5 
               
               
                   
                 A175 
                 1.8 
                 1.7 
                 1.3 
                 1.4 
               
               
                   
                 A176 
                 3.4 
                 3.3 
                 2.7 
                 2.9 
               
               
                   
                 A177 
                 1.7 
                 1.6 
                 1.2 
                 1.3 
               
               
                   
                 A178 
                 2.3 
                 2.5 
                 2.0 
                 2.1 
               
               
                   
                 A179 
                 2.6 
                 2.5 
                 2.0 
                 2.2 
               
               
                   
                 A180 
                 2.3 
                 2.2 
                 1.7 
                 1.9 
               
               
                   
                 A181 
                 3.5 
                 3.7 
                 3.3 
                 3.6 
               
               
                   
                 A182 
                 2.1 
                 2.0 
                 1.6 
                 1.7 
               
               
                   
                 A183 
                 1.5 
                 1.5 
                 1.0 
                 1.2 
               
               
                   
                 A184 
                 2.6 
                 2.5 
                 2.0 
                 2.2 
               
               
                   
                 A185 
                 3.3 
                 3.4 
                 2.9 
                 3.1 
               
               
                   
                 A186 
                 3.1 
                 3.5 
                 3.1 
                 3.3 
               
               
                   
                 A187 
                 1.8 
                 1.7 
                 1.3 
                 1.4 
               
               
                   
                 A188 
                 3.1 
                 2.9 
                 2.4 
                 2.6 
               
               
                   
                 A189 
                 3.0 
                 3.0 
                 2.6 
                 2.8 
               
               
                   
                 A190 
                 3.6 
                 3.4 
                 2.8 
                 3.1 
               
               
                   
                 A191 
                 2.0 
                 1.9 
                 1.5 
                 1.6 
               
               
                   
                 A192 
                 2.7 
                 2.6 
                 2.1 
                 2.3 
               
               
                   
                 A193 
                 2.1 
                 2.0 
                 1.6 
                 1.7 
               
               
                   
                 A194 
                 2.2 
                 2.3 
                 1.8 
                 2.0 
               
               
                   
                 A195 
                 1.4 
                 1.6 
                 1.2 
                 1.4 
               
               
                   
                 A196 
                 2.0 
                 2.1 
                 1.6 
                 1.8 
               
               
                   
                 A197 
                 1.8 
                 1.9 
                 1.4 
                 1.5 
               
               
                   
                 A198 
                 2.0 
                 1.9 
                 1.4 
                 1.5 
               
               
                   
                 A199 
                 1.5 
                 1.5 
                 1.0 
                 1.2 
               
               
                   
                 A200 
                 1.4 
                 1.4 
                 1.0 
                 1.1 
               
               
                   
                 A201 
                 2.6 
                 2.5 
                 2.0 
                 2.2 
               
               
                   
                 A202 
                 2.5 
                 2.2 
                 1.7 
                 1.9 
               
               
                   
                 A203 
                 2.0 
                 1.9 
                 1.4 
                 1.6 
               
               
                   
                 A204 
                 1.8 
                 1.7 
                 1.3 
                 1.4 
               
               
                   
                 A205 
                 1.9 
                 2.1 
                 1.6 
                 1.8 
               
               
                   
                 A207 
                 2.7 
                 2.8 
                 2.3 
                 2.5 
               
               
                   
                 A208 
                 3.0 
                 3.0 
                 2.5 
                 2.8 
               
               
                   
                 A209 
                 1.9 
                 1.9 
                 1.5 
                 1.6 
               
               
                   
                 A210 
                 2.4 
                 2.2 
                 1.7 
                 1.9 
               
               
                   
                 A211 
                 2.9 
                 2.7 
                 2.2 
                 2.4 
               
               
                   
                 A212 
                 2.8 
                 2.7 
                 2.3 
                 2.5 
               
               
                   
                 A213 
                 2.7 
                 2.8 
                 2.3 
                 2.5 
               
               
                   
                 A214 
                 2.8 
                 2.8 
                 2.3 
                 2.5 
               
               
                   
                 A215 
                 2.5 
                 2.3 
                 1.8 
                 2.0 
               
               
                   
                 A216 
                 4.1 
                 4.4 
                 3.9 
                 4.2 
               
               
                   
                 A217 
                 2.3 
                 2.6 
                 2.2 
                 2.3 
               
               
                   
                 A218 
                 2.9 
                 3.2 
                 2.7 
                 3.0 
               
               
                   
                 A219 
                 2.7 
                 2.5 
                 2.0 
                 2.2 
               
               
                   
                 A220 
                 2.0 
                 2.0 
                 1.5 
                 1.7 
               
               
                   
                 A222 
                 2.0 
                 1.9 
                 1.4 
                 1.6 
               
               
                   
                 A223 
                 1.7 
                 1.6 
                 1.2 
                 1.4 
               
               
                   
                 A224 
                 1.6 
                 1.7 
                 1.3 
                 1.4 
               
               
                   
                 A225 
                 1.8 
                 1.7 
                 1.3 
                 1.4 
               
               
                   
                   
               
             
          
         
       
     
         [0121]    Table 7 represents a comparison of the data from Table 6. 
         [0000]    
       
         
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
           
               
                   
                 TABLE 7 
               
               
                   
                   
               
               
                   
                 “r” 
                 “m” 
                 “b” 
                 StdErr 
                 StdDev 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                 INR 
                 INRz 
                 0.988 
                 0.988 
                 0.059 
                 0.190 
                 1.201 
               
               
                 vs 
                 ATFt 
                 0.984 
                 0.966 
                 0.568 
                 0.215 
                 1.238 
               
               
                   
                 ATFt2 
                 0.983 
                 0.913 
                 0.504 
                 0.219 
                 1.257 
               
               
                 ATFt 
                 ATFt2 
                 1.000 
                 0.946 
                 −0.068 
                 0.022 
                 1.264 
               
               
                 vs 
               
               
                   
               
             
          
         
       
     
         [0122]    Table 8 provides comparative data for the anticoagulant therapy factors, similar to Table 2, but using the ATFt2 method from expressions (4) and (5.1) for corresponding GINRt2 and MINRt2 values. 
         [0000]    
       
         
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 8 
               
               
                   
               
               
                 ID 
                 AINR 
                 GINR 
                 GINRa 
                 GINRz 
                 GINRt2 
                 MINR 
                 MINRa 
                 MINRz 
                 MINRt2 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 U0800 
                 2.0 
                 2.0 
                 2.0 
                 2.0 
                 1.7 
                 2.1 
                 2.1 
                 2.2 
                 2.1 
               
               
                 U7440 
                 2.6 
                 3.0 
                 3.0 
                 2.9 
                 2.9 
                 3.0 
                 3.0 
                 2.8 
                 3.4 
               
               
                 U7443 
                 2.0 
                 2.0 
                 2.0 
                 2.0 
                 1.8 
                 2.1 
                 2.2 
                 2.1 
                 1.8 
               
               
                 U7458 
                 1.4 
                 1.4 
                 1.4 
                 1.4 
                 1.2 
                 1.4 
                 1.4 
                 1.3 
                 1.3 
               
               
                 U7465 
                 9.7 
                 7.4 
                 8.1 
                 6.6 
                 7.9 
                 7.1 
                 7.5 
                 8.1 
                 7.8 
               
               
                 U7469 
                 1.1 
                 1.1 
                 1.1 
                 1.1 
                 0.9 
                 1.2 
                 1.1 
                 1.1 
                 1.0 
               
               
                 U7470 
                 3.2 
                 3.4 
                 3.6 
                 3.4 
                 3.2 
                 3.6 
                 3.7 
                 3.8 
                 3.8 
               
               
                 U8080 
                 3.1 
                 3.6 
                 3.6 
                 3.3 
                 3.6 
                 3.3 
                 3.3 
                 3.5 
                 3.4 
               
               
                 U8087 
                 1.9 
                 1.9 
                 1.9 
                 1.8 
                 1.6 
                 1.9 
                 1.9 
                 1.9 
                 1.7 
               
               
                 U8092 
                 1.7 
                 1.7 
                 1.8 
                 1.7 
                 1.6 
                 1.9 
                 1.9 
                 1.9 
                 1.6 
               
               
                 U3050 
                 2.7 
                 2.8 
                 3.1 
                 2.6 
                 2.2 
                 2.3 
                 2.3 
                 2.3 
                 2.0 
               
               
                 U3077 
                 1.3 
                 1.4 
                 1.4 
                 1.4 
                 1.1 
                 1.3 
                 1.3 
                 1.3 
                 1.2 
               
               
                 U3083 
                 1.6 
                 1.6 
                 1.6 
                 1.6 
                 1.3 
                 1.6 
                 1.7 
                 1.6 
                 1.4 
               
               
                 U8210 
                 2.6 
                 2.9 
                 3.0 
                 2.8 
                 2.7 
                 2.7 
                 2.8 
                 2.8 
                 2.6 
               
               
                 U8221 
                 3.2 
                 3.7 
                 4.0 
                 3.7 
                 3.4 
                 3.5 
                 3.5 
                 3.3 
                 3.6 
               
               
                 U3408 
                 1.1 
                 1.2 
                 1.2 
                 1.2 
                 0.9 
                 1.1 
                 1.0 
                 1.0 
                 0.9 
               
               
                 U3453 
                 1.1 
                 1.2 
                 1.2 
                 1.2 
                 1.0 
                 1.2 
                 1.2 
                 1.2 
                 1.0 
               
               
                 U3457 
                 2.2 
                 2.3 
                 2.4 
                 2.2 
                 1.9 
                 2.1 
                 2.3 
                 2.2 
                 1.8 
               
               
                 U3395 
                 2.7 
                 3.2 
                 3.5 
                 3.2 
                 2.7 
                 2.8 
                 2.9 
                 2.5 
                 2.3 
               
               
                 U3398 
                 1.5 
                 1.7 
                 1.8 
                 1.8 
                 1.5 
                 1.6 
                 1.6 
                 1.6 
                 1.5 
               
               
                 U3456 
                 1.1 
                 1.0 
                 1.0 
                 1.0 
                 0.8 
                 1.0 
                 1.0 
                 1.0 
                 0.9 
               
               
                 U3459 
                 2.9 
                 2.6 
                 2.8 
                 2.6 
                 2.2 
                 2.4 
                 2.5 
                 2.5 
                 2.0 
               
               
                 U0415 
                 0.9 
                 0.9 
                 0.9 
                 0.9 
                 0.8 
                 0.9 
                 1.0 
                 1.0 
                 0.8 
               
               
                 U0432 
                 1.8 
                 1.5 
                 1.5 
                 1.5 
                 1.3 
                 1.4 
                 1.4 
                 1.4 
                 1.3 
               
               
                 U0436 
                 2.4 
                 2.4 
                 2.6 
                 2.3 
                 2.1 
                 2.4 
                 2.4 
                 2.4 
                 2.2 
               
               
                 U0438 
                 3.9 
                 3.7 
                 4.2 
                 3.7 
                 3.2 
                 3.8 
                 4.2 
                 3.9 
                 3.6 
               
               
                 U0439 
                 2.3 
                 2.2 
                 2.3 
                 2.1 
                 1.8 
                 2.3 
                 2.3 
                 2.2 
                 2.0 
               
               
                 U0440 
                 5.8 
                 4.8 
                 5.4 
                 5.2 
                 4.4 
                 4.6 
                 4.8 
                 4.3 
                 5.2 
               
               
                 U0441 
                 4.5 
                 4.9 
                 5.6 
                 6.0 
                 5.0 
                 4.4 
                 4.7 
                 4.7 
                 5.4 
               
               
                 U0442 
                 1.8 
                 1.7 
                 1.8 
                 1.7 
                 1.5 
                 1.8 
                 1.8 
                 1.8 
                 1.6 
               
               
                 U3724 
                 2.7 
                 2.4 
                 2.5 
                 2.4 
                 2.0 
                 2.6 
                 2.7 
                 2.6 
                 2.3 
               
               
                 U0849 
                 2.4 
                 2.3 
                 2.4 
                 2.1 
                 1.8 
                 2.3 
                 2.4 
                 2.2 
                 2.0 
               
               
                 U0860 
                 1.0 
                 1.0 
                 1.0 
                 1.0 
                 0.8 
                 1.0 
                 1.0 
                 1.0 
                 0.9 
               
               
                 U0861 
                 2.8 
                 2.9 
                 3.0 
                 2.8 
                 2.6 
                 3.0 
                 3.0 
                 2.9 
                 3.0 
               
               
                 U0863 
                 1.7 
                 1.7 
                 1.7 
                 1.7 
                 1.7 
                 1.7 
                 1.8 
                 1.8 
                 1.8 
               
               
                 U0875 
                 2.2 
                 2.0 
                 2.2 
                 2.1 
                 1.6 
                 2.0 
                 2.0 
                 2.0 
                 1.7 
               
               
                 U0843 
                 1.4 
                 1.4 
                 1.4 
                 1.4 
                 1.2 
                 1.4 
                 1.5 
                 1.5 
                 1.3 
               
               
                 U0848 
                 1.3 
                 1.4 
                 1.4 
                 1.4 
                 1.2 
                 1.3 
                 1.4 
                 1.4 
                 1.2 
               
               
                 U0855 
                 1.3 
                 1.3 
                 1.3 
                 1.3 
                 1.2 
                 1.2 
                 1.2 
                 1.2 
                 1.3 
               
               
                 U0867 
                 3.2 
                 2.9 
                 3.2 
                 2.8 
                 2.5 
                 3.0 
                 3.1 
                 3.0 
                 2.9 
               
               
                 U1201 
                 1.9 
                 1.9 
                 2.0 
                 1.9 
                 1.7 
                 1.8 
                 1.8 
                 1.9 
                 1.8 
               
               
                 U1202 
                 1.3 
                 1.3 
                 1.3 
                 1.3 
                 1.2 
                 1.4 
                 1.4 
                 1.4 
                 1.2 
               
               
                 U1205 
                 1.6 
                 1.8 
                 1.9 
                 1.8 
                 1.6 
                 1.9 
                 1.9 
                 1.8 
                 1.7 
               
               
                 U1207 
                 1.9 
                 1.9 
                 2.0 
                 1.8 
                 1.5 
                 1.9 
                 1.9 
                 1.7 
                 1.7 
               
               
                 U1230 
                 1.3 
                 1.4 
                 1.5 
                 1.4 
                 1.3 
                 1.4 
                 1.5 
                 1.5 
                 1.5 
               
               
                 U1198 
                 2.2 
                 2.1 
                 2.2 
                 2.1 
                 1.9 
                 2.0 
                 2.0 
                 2.0 
                 2.3 
               
               
                 U1199 
                 2.8 
                 3.3 
                 3.6 
                 3.1 
                 2.8 
                 3.2 
                 3.2 
                 2.8 
                 3.3 
               
               
                 U1218 
                 3.0 
                 2.6 
                 2.9 
                 2.9 
                 2.7 
                 2.8 
                 3.1 
                 3.1 
                 3.2 
               
               
                 U1225 
                 2.2 
                 2.3 
                 2.3 
                 2.1 
                 1.9 
                 2.6 
                 2.4 
                 2.2 
                 2.2 
               
               
                 U1575 
                 1.4 
                 1.3 
                 1.3 
                 1.3 
                 1.4 
                 1.4 
                 1.4 
                 1.4 
                 1.4 
               
               
                 U1579 
                 1.5 
                 1.7 
                 1.7 
                 1.7 
                 1.5 
                 1.8 
                 1.8 
                 1.7 
                 1.5 
               
               
                 U1649 
                 0.9 
                 0.8 
                 0.8 
                 0.8 
                 0.8 
                 0.9 
                 0.9 
                 0.9 
                 0.8 
               
               
                 U1576 
                 2.2 
                 2.1 
                 2.1 
                 2.1 
                 2.1 
                 2.3 
                 2.3 
                 2.3 
                 2.2 
               
               
                 U1581 
                 1.7 
                 1.7 
                 1.7 
                 1.8 
                 1.9 
                 1.7 
                 1.8 
                 1.8 
                 1.7 
               
               
                 U1599 
                 2.0 
                 1.7 
                 1.8 
                 1.8 
                 2.0 
                 2.0 
                 2.1 
                 2.1 
                 2.0 
               
               
                 U1600 
                 3.5 
                 3.2 
                 3.4 
                 3.4 
                 3.7 
                 3.9 
                 4.2 
                 3.5 
                 3.7 
               
               
                 U4471 
                 1.5 
                 1.6 
                 1.7 
                 1.6 
                 1.5 
                 1.7 
                 1.7 
                 1.7 
                 1.7 
               
               
                 U4757 
                 2.0 
                 2.1 
                 2.1 
                 2.0 
                 1.8 
                 2.0 
                 2.0 
                 2.1 
                 2.0 
               
               
                 U4767 
                 2.6 
                 2.4 
                 2.5 
                 2.6 
                 2.0 
                 2.6 
                 2.6 
                 2.5 
                 2.3 
               
               
                 U4772 
                 2.5 
                 2.7 
                 2.8 
                 2.5 
                 2.6 
                 2.8 
                 2.8 
                 2.9 
                 2.5 
               
               
                 U4801 
                 1.3 
                 1.4 
                 1.4 
                 1.4 
                 1.2 
                 1.5 
                 1.5 
                 1.4 
                 1.2 
               
               
                 U4737 
                 2.9 
                 2.6 
                 2.8 
                 2.7 
                 2.3 
                 2.7 
                 2.9 
                 2.8 
                 2.5 
               
               
                 U4752 
                 1.4 
                 1.5 
                 1.6 
                 1.5 
                 1.3 
                 1.5 
                 1.5 
                 1.5 
                 1.4 
               
               
                 U5133 
                 0.9 
                 0.9 
                 0.9 
                 0.9 
                 0.7 
                 1.0 
                 1.0 
                 1.0 
                 0.8 
               
               
                 U5173 
                 1.1 
                 1.2 
                 1.2 
                 1.2 
                 1.1 
                 1.2 
                 1.2 
                 1.2 
                 1.0 
               
               
                 U5175 
                 1.7 
                 1.8 
                 1.9 
                 1.8 
                 1.7 
                 1.9 
                 1.9 
                 1.9 
                 1.7 
               
               
                 U5178 
                 2.3 
                 2.2 
                 2.3 
                 2.1 
                 1.9 
                 2.6 
                 2.9 
                 2.8 
                 2.0 
               
               
                 U5183 
                 2.9 
                 2.6 
                 2.8 
                 2.6 
                 2.3 
                 3.6 
                 3.9 
                 3.7 
                 3.0 
               
               
                 U5158 
                 5.5 
                 5.1 
                 5.9 
                 5.7 
                 5.8 
                 6.0 
                 6.6 
                 7.1 
                 7.0 
               
               
                 U5169 
                 2.6 
                 2.9 
                 3.2 
                 3.2 
                 3.2 
                 3.2 
                 3.4 
                 3.6 
                 3.7 
               
               
                 U5190 
                 2.8 
                 2.7 
                 2.8 
                 2.9 
                 2.8 
                 3.2 
                 3.4 
                 3.5 
                 3.2 
               
               
                 U5193 
                 3.1 
                 3.0 
                 3.1 
                 3.0 
                 2.9 
                 3.6 
                 3.7 
                 3.7 
                 3.4 
               
               
                 U5589 
                 1.6 
                 1.8 
                 1.9 
                 1.8 
                 1.6 
                 1.9 
                 2.0 
                 1.8 
                 1.5 
               
               
                 U5592 
                 1.1 
                 1.2 
                 1.2 
                 1.2 
                 1.1 
                 1.4 
                 1.3 
                 1.3 
                 1.4 
               
               
                 U5593 
                 1.7 
                 1.8 
                 1.9 
                 1.8 
                 1.6 
                 1.8 
                 1.9 
                 1.8 
                 1.7 
               
               
                 U5565 
                 2.7 
                 3.2 
                 3.3 
                 3.3 
                 3.1 
                 3.5 
                 3.5 
                 3.6 
                 3.5 
               
               
                 U5591 
                 2.0 
                 2.2 
                 2.3 
                 2.3 
                 2.1 
                 2.3 
                 2.3 
                 2.1 
                 2.3 
               
               
                 U5594 
                 2.3 
                 2.6 
                 2.8 
                 2.8 
                 2.8 
                 2.8 
                 2.8 
                 3.0 
                 3.0 
               
               
                 U5597 
                 3.3 
                 3.3 
                 3.6 
                 3.6 
                 3.1 
                 4.1 
                 4.0 
                 4.3 
                 4.0 
               
               
                 U5993 
                 1.0 
                 0.9 
                 0.9 
                 0.9 
                 0.8 
                 1.0 
                 1.0 
                 1.0 
                 0.8 
               
               
                 U6017 
                 1.0 
                 0.9 
                 1.0 
                 1.0 
                 0.8 
                 0.9 
                 0.9 
                 0.9 
                 0.8 
               
               
                 U6056 
                 1.0 
                 1.0 
                 1.0 
                 1.0 
                 0.9 
                 1.0 
                 1.0 
                 1.0 
                 0.9 
               
               
                 U5992 
                 1.4 
                 1.4 
                 1.4 
                 1.4 
                 1.3 
                 1.3 
                 1.4 
                 1.4 
                 1.3 
               
               
                 U6047 
                 2.3 
                 2.3 
                 2.4 
                 2.3 
                 2.0 
                 2.2 
                 2.3 
                 2.3 
                 2.2 
               
               
                 U6060 
                 1.9 
                 2.1 
                 2.2 
                 2.2 
                 2.0 
                 2.3 
                 2.0 
                 2.0 
                 2.1 
               
               
                 U6065 
                 3.1 
                 2.8 
                 2.9 
                 2.8 
                 2.7 
                 3.0 
                 3.1 
                 2.9 
                 2.8 
               
               
                 U6928 
                 1.2 
                 1.2 
                 1.2 
                 1.2 
                 1.2 
                 1.2 
                 1.2 
                 1.2 
                 1.1 
               
               
                 U6929 
                 1.2 
                 1.2 
                 1.2 
                 1.2 
                 1.1 
                 1.2 
                 1.2 
                 1.2 
                 1.0 
               
               
                 U6951 
                 1.5 
                 1.5 
                 1.5 
                 1.5 
                 1.5 
                 1.6 
                 1.7 
                 1.6 
                 1.4 
               
               
                 U6977 
                 1.3 
                 1.3 
                 1.3 
                 1.3 
                 1.2 
                 1.3 
                 1.4 
                 1.4 
                 1.1 
               
               
                 U6936 
                 2.4 
                 2.5 
                 2.4 
                 2.6 
                 3.2 
                 2.6 
                 2.6 
                 2.7 
                 2.6 
               
               
                 U6938 
                 2.1 
                 2.1 
                 2.1 
                 2.2 
                 2.3 
                 2.3 
                 2.3 
                 2.3 
                 2.3 
               
               
                 U6972 
                 2.4 
                 2.4 
                 2.5 
                 2.4 
                 2.5 
                 2.8 
                 2.8 
                 2.8 
                 2.5 
               
               
                 U6987 
                 5.1 
                 4.5 
                 4.4 
                 5.0 
                 5.5 
                 5.7 
                 5.4 
                 5.7 
                 7.0 
               
               
                 U7316 
                 1.2 
                 1.1 
                 1.1 
                 1.1 
                 1.1 
                 1.3 
                 1.3 
                 1.3 
                 1.1 
               
               
                 U7321 
                 1.5 
                 1.4 
                 1.4 
                 1.4 
                 1.5 
                 1.6 
                 1.6 
                 1.6 
                 1.5 
               
               
                 U7324 
                 1.3 
                 1.2 
                 1.3 
                 1.2 
                 1.2 
                 1.4 
                 1.4 
                 1.4 
                 1.2 
               
               
                 U7317 
                 2.0 
                 1.6 
                 1.7 
                 1.7 
                 1.6 
                 1.9 
                 1.9 
                 1.8 
                 1.6 
               
               
                 U7318 
                 2.8 
                 2.7 
                 2.9 
                 2.9 
                 2.6 
                 3.3 
                 3.4 
                 3.3 
                 2.7 
               
               
                 U7320 
                 2.0 
                 1.9 
                 1.9 
                 1.9 
                 2.2 
                 2.0 
                 2.1 
                 2.1 
                 2.2 
               
               
                 U7322 
                 1.8 
                 1.7 
                 1.7 
                 1.7 
                 1.5 
                 1.7 
                 1.8 
                 1.7 
                 1.4 
               
               
                 U7708 
                 1.6 
                 1.6 
                 1.6 
                 1.6 
                 1.6 
                 1.7 
                 1.7 
                 1.7 
                 1.7 
               
               
                 U7713 
                 1.4 
                 1.6 
                 1.6 
                 1.6 
                 1.5 
                 1.6 
                 1.6 
                 1.6 
                 1.5 
               
               
                 U7727 
                 1.7 
                 1.7 
                 1.7 
                 1.8 
                 1.7 
                 1.9 
                 1.9 
                 1.9 
                 1.9 
               
               
                 U7794 
                 1.9 
                 1.8 
                 1.9 
                 1.8 
                 1.6 
                 1.7 
                 1.8 
                 1.7 
                 1.6 
               
               
                 U7707 
                 2.2 
                 2.2 
                 2.3 
                 2.3 
                 2.3 
                 2.3 
                 2.3 
                 2.3 
                 2.2 
               
               
                 U7710 
                 2.3 
                 2.5 
                 2.6 
                 2.7 
                 2.8 
                 2.7 
                 2.9 
                 3.0 
                 3.0 
               
               
                 U7724 
                 2.4 
                 2.4 
                 2.5 
                 2.6 
                 2.7 
                 2.7 
                 2.7 
                 2.8 
                 2.9 
               
               
                 U7738 
                 2.4 
                 2.3 
                 2.4 
                 2.5 
                 2.2 
                 2.4 
                 2.5 
                 2.6 
                 2.3 
               
               
                 U8559 
                 1.6 
                 1.4 
                 1.4 
                 1.4 
                 1.3 
                 1.6 
                 1.7 
                 1.6 
                 1.3 
               
               
                 U8570 
                 1.2 
                 1.2 
                 1.2 
                 1.2 
                 1.3 
                 1.2 
                 1.2 
                 1.2 
                 1.3 
               
               
                 U8575 
                 0.9 
                 0.8 
                 0.8 
                 0.8 
                 0.8 
                 0.9 
                 0.9 
                 0.9 
                 0.8 
               
               
                 U8555 
                 2.6 
                 2.4 
                 2.5 
                 2.6 
                 2.6 
                 2.9 
                 3.1 
                 3.0 
                 2.6 
               
               
                 U8558 
                 2.3 
                 2.2 
                 2.3 
                 2.3 
                 2.2 
                 2.3 
                 2.3 
                 2.4 
                 2.4 
               
               
                 U8563 
                 2.2 
                 2.3 
                 2.3 
                 2.4 
                 2.3 
                 2.4 
                 2.4 
                 2.5 
                 2.5 
               
               
                 U9031 
                 2.1 
                 2.4 
                 2.3 
                 2.3 
                 2.5 
                 2.6 
                 2.4 
                 2.3 
                 2.4 
               
               
                 U9032 
                 1.7 
                 1.7 
                 1.7 
                 1.7 
                 1.6 
                 1.9 
                 1.9 
                 1.7 
                 1.5 
               
               
                 U9040 
                 1.4 
                 1.4 
                 1.4 
                 1.4 
                 1.2 
                 1.4 
                 1.4 
                 1.3 
                 1.1 
               
               
                 U9034 
                 3.0 
                 2.9 
                 2.8 
                 3.0 
                 4.0 
                 3.4 
                 3.4 
                 3.5 
                 3.8 
               
               
                 U9039 
                 2.7 
                 3.0 
                 3.2 
                 3.1 
                 3.1 
                 3.2 
                 3.2 
                 3.2 
                 3.3 
               
               
                 U9049 
                 3.5 
                 3.3 
                 3.5 
                 3.5 
                 3.5 
                 3.6 
                 3.8 
                 3.6 
                 3.7 
               
               
                 U9055 
                 2.4 
                 2.1 
                 2.1 
                 2.2 
                 2.1 
                 2.4 
                 2.4 
                 2.4 
                 2.1 
               
               
                 U0048 
                 1.8 
                 1.8 
                 1.8 
                 1.8 
                 1.7 
                 1.9 
                 2.0 
                 2.0 
                 1.8 
               
               
                 U0050 
                 1.8 
                 1.7 
                 1.8 
                 1.8 
                 1.7 
                 1.9 
                 2.0 
                 2.0 
                 1.7 
               
               
                 U0056 
                 1.6 
                 1.5 
                 1.5 
                 1.5 
                 1.4 
                 1.8 
                 1.8 
                 1.7 
                 1.5 
               
               
                 U0047 
                 2.1 
                 1.7 
                 1.8 
                 1.8 
                 1.6 
                 2.0 
                 2.1 
                 2.0 
                 1.7 
               
               
                 U0058 
                 3.2 
                 2.8 
                 2.9 
                 3.0 
                 3.0 
                 3.3 
                 3.4 
                 3.2 
                 3.3 
               
               
                 U0060 
                 2.2 
                 2.1 
                 2.1 
                 2.2 
                 2.1 
                 2.2 
                 2.2 
                 2.2 
                 2.3 
               
               
                 U0062 
                 2.8 
                 2.6 
                 2.7 
                 2.8 
                 2.7 
                 3.0 
                 3.2 
                 3.2 
                 2.9 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 9 
               
             
             
               
                   
               
               
                 COMPARATIVE RESULTS 
               
             
          
           
               
                 Comparison 
                   
                   
                   
                   
                   
                   
                   
               
               
                 on 
                 n 
                 r 
                 m 
                 b 
                 Std. Error 
                 Ng 
                 Lassen 
               
               
                   
               
             
          
           
               
                 GInr vs 
                 129 
                 0.997 
                 0.879 
                 0.163 
                 0.079 
                 7/129 = 
                 Delta &lt;= 0.4|5 @ 96.1% 
               
               
                 GATFa 
                   
                   
                   
                   
                   
                 5.4% 
                 Delta &lt;= 0.7|2 @ 98.4% 
               
               
                 GInr vs 
                 129 
                 0.986 
                 0.948 
                 0.078 
                 0.162 
                 3/129 = 
                 Delta &lt;= 0.4|4 @ 96.9% 
               
               
                 GATFz 
                   
                   
                   
                   
                   
                 2.3% 
                 Delta &lt;= 0.7|2 @ 98.4% 
               
               
                 GInr vs 
                 129 
                 0.974 
                 0.935 
                 0.413 
                 0.221 
                 20/129 = 
                 Delta &lt;= 0.4|16 @ 87.6% 
               
               
                 GATFt2 
                   
                   
                   
                   
                   
                 15.5% 
                 Delta &lt;= 0.7|4 @ 96.9% 
               
               
                 MInr vs 
                 129 
                 0.996 
                 0.921 
                 0.122 
                 0.092 
                 9/129 = 
                 Delta &lt;= 0.4|2 @ 98.4% 
               
               
                 MATFa 
                   
                   
                   
                   
                   
                 7.0% 
                 Delta &lt;= 0.7|0 @ 100.0% 
               
               
                 MInr vs 
                 129 
                 0.989 
                 0.908 
                 0.190 
                 0.155 
                 7/129 = 
                 Delta &lt;= 0.4|4 @ 96.9% 
               
               
                 MATFz 
                   
                   
                   
                   
                   
                 5.4% 
                 Delta &lt;= 0.7|2 @ 98.4% 
               
               
                 MInr vs 
                 129 
                 0.983 
                 0.893 
                 0.491 
                 0.193 
                 8/129 = 
                 Delta &lt;= 0.4|13 @ 89.9% 
               
               
                 MATFt2 
                   
                   
                   
                   
                   
                 6.2% 
                 Delta &lt;= 0.7|4 @ 96.9% 
               
               
                   
               
             
          
         
       
     
         [0123]    Table 9 provides comparative data for the ATFa, ATFz and ATFt2 and INR values calculated by the WHO method for each respective location, with GInr representing one location for these traditionally WHO determined values, and MInr representing values based on data obtained at the other location. The values identified as ATFz and ATFt2, such as, GATFt2 and MATFt2, and GATFz and MATFz, represent anticoagulant therapy factors derived from the expressions (1) through (9) above, inclusive of expressions (5.1) and (8.1). 
         [0124]    Further comparative results are provided in Table 10 to illustrate the effect of prothrombin time (PT) on INR values. Table 10 provides a comparison based on data from Table 3, and provides INR values for PT&#39;s of PT=PT (under the heading “INR”), PT=PT+0.5 (under the heading “+0.5”), PT=PT+1.0 (under the heading “+1.0”), PT=PT+1.5 (under the heading “+1.5”), and PT=+2.0 (under the heading “+2.0”). The new anticoagulation therapy factor (ATFt2) was compared with the WHO method for determining ATF. The WHO method utilizes the mean prothrombin time of 20 presumed normal patients. The thromboplastin reagents list MNPT “expected ranges” listed in the accompanying thromboplastin-reagent (Tp) brochures. These brochures acknowledge that MNPT differences are inevitable because of variations in the 20 “normal donor” populations. Geometric, rather than arithmetic mean calculation limits MNPT variation somewhat, but simulated 0.5 second incremented increases over a total 2.5 second range, show ever-increasing INR differences notably at higher INR levels. To exemplify this, Table 10 shows these changes with Thromboplastin C Plus (which has a manufacturer&#39;s reported ISI=1.74 and MNPT=9.89 seconds) in POTENS+. 
         [0000]    
       
         
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                   
                 TABLE 10 
               
               
                   
                   
               
               
                   
                 ID 
                 PT 
                 INR 
                 +0.5 
                 +1.0 
                 +1.5 
                 +2.0 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 WEC 
                 9.8 
                 1.0 
                 0.9 
                 0.8 
                 0.8 
                 0.7 
               
               
                   
                 A095 
                 12.5 
                 1.5 
                 1.4 
                 1.3 
                 1.2 
                 1.1 
               
               
                   
                 A191 
                 14.8 
                 2.0 
                 1.9 
                 1.7 
                 1.6 
                 1.5 
               
               
                   
                 A112 
                 16.9 
                 2.5 
                 2.3 
                 2.2 
                 2.0 
                 1.8 
               
               
                   
                 A208 
                 18.6 
                 3.0 
                 2.8 
                 2.5 
                 2.3 
                 2.2 
               
               
                   
                 A020 
                 20.3 
                 3.5 
                 3.2 
                 3.0 
                 2.7 
                 2.5 
               
               
                   
                 A164 
                 21.9 
                 4.0 
                 3.7 
                 3.4 
                 3.1 
                 2.9 
               
               
                   
                 A093 
                 24.5 
                 4.9 
                 4.5 
                 4.1 
                 3.8 
                 3.5 
               
               
                   
                 A055 
                 26.5 
                 5.6 
                 5.1 
                 4.7 
                 4.4 
                 4.0 
               
               
                   
                 A090 
                 28.5 
                 6.3 
                 5.8 
                 5.3 
                 4.9 
                 4.6 
               
               
                   
                 R091 
                 32.2 
                 7.8 
                 7.2 
                 6.6 
                 6.1 
                 5.7 
               
               
                   
                 A058 
                 33.8 
                 8.5 
                 7.8 
                 7.2 
                 6.6 
                 6.2 
               
               
                   
                   
               
             
          
         
       
     
         [0125]    Since the in-house determined MNPT would continue with that Tp lot, intralaboratory results would be relatively unaffected. However, between laboratory INR agreements, or interlab results, are compromised. As a denominator, considering the expression used to derive the MNPT, such as expression (B), above, MNPT is, of course, less problematic for INRs than the exponent, ISI. Comparative results, showing interlab results, are provided in Table 11. ATFt is seen to be numerically equal to WHO/INRs determined in both analytical instruments, namely, the MDA-Electra 9000C and the POTENS+. Identical computer bits derived in POTENS+ from the absorbances creating the thrombin-fibrinogen-fibrin clotting curve are used for the POTENS+WHO/INR and ATFt (NO ISI, NO MNPT) determinations. MNPT is, of course, still necessary for the WHO method. For ATFt, Zero Order Kinetics Line&#39;s slope is extended in both directions to intersect with the Tp-plasma baseline and the absorbance at total fibrin formation. The sum of this interval and the time from the Tp injection to the beginning of Zero Order Kinetics (T 2 S) is Value 1. Value 2 is T 2 S/100e. “e” is the Natural Logarithm, base 2.71828. ATFt=(Value 1)*(Value 2), in accordance with expression (4) herein (and the expression (8.1) for ATFt2). 
         [0126]    Table 11 provides statistical comparisons for results obtained using two POTENS+coagulometers (one designated as GINR and another designated as MINR), and using a Bio Merieux MDA-180 coagulometer (designated as AINR). The POTENS+, WHO/INRs, INR z s, and ATFts and the MDA-180 (AINR) WHO/INRs are compared. Statistical data and Bland-Altman plot data demonstrate that the new anticoagulant therapy factor ATFt may replace WHO/INR and provide results which are within the parameters of traditional therapeutic or reference ranges. 
         [0000]    
       
         
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
             
           
               
                   
                 TABLE 11 
               
               
                   
                   
               
               
                   
                   
                 “r” 
                 “m” 
                 “b” 
                 StdErr 
                 StdDev 
                 mY 
                 mX 
                 My/mX 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                 AINR 
                 GINR 
                 0.937 
                 0.872 
                 0.290 
                 0.388 
                 1.148 
                 2.169 
                 2.155 
                 1.007 
               
               
                 vs 
                 GATFz 
                 0.941 
                 1.119 
                 −0.208 
                 0.378 
                 1.022 
                 2.169 
                 2.124 
                 1.021 
               
               
                   
                 GATFt2 
                 0.951 
                 1.003 
                 0.146 
                 0.343 
                 1.081 
                 2.169 
                 2.016 
                 1.076 
               
               
                   
                 MINR 
                 0.950 
                 1.018 
                 −0.126 
                 0.349 
                 1.070 
                 2.169 
                 2.253 
                 0.963 
               
               
                   
                 MATFz 
                 0.943 
                 1.020 
                 −0.040 
                 0.371 
                 1.065 
                 2.169 
                 2.167 
                 1.001 
               
               
                   
                 MATFt2 
                 0.937 
                 0.872 
                 0.290 
                 0.388 
                 1.148 
                 2.169 
                 2.155 
                 1.007 
               
               
                 MINR 
                 GINR 
                 0.971 
                 1.036 
                 0.039 
                 0.247 
                 1.001 
                 2.253 
                 2.136 
                 1.055 
               
               
                 vs 
               
               
                 MINRz 
                 GINRz 
                 0.984 
                 1.082 
                 −0.132 
                 0.186 
                 0.978 
                 2.167 
                 2.124 
                 1.020 
               
               
                 vs 
               
               
                 MINRt2 
                 GINRt2 
                 0.979 
                 1.110 
                 −0.083 
                 0.242 
                 1.123 
                 2.155 
                 2.016 
                 1.069 
               
               
                 vs 
               
               
                   
               
             
          
         
       
     
         [0127]    The linear regression analysis expression y=mx+b, when solved for the slope, m, is expressed as (y−b)/x. This is biased, so the expression is y/x is when b is equal to zero. The comparison in Table 11, above, provides comparative data for mean y (mY) and mean x (mX) values, including the slope mY/mX. The use of mY/mX is used to provide comparative results. 
         [0128]    In another embodiment, an article may be provided to derive an anticoagulant therapy factor (ATF). The article may comprise stored instructions on a storage media which can be read and processed with a processor. For example, the computer may be provided with a stored set of instructions, or chip, which is programmed to determine a new ATF for the spectral data obtained from the coagulation activity of a sample. For example, the computer chip may be preprogrammed with a set of instructions for cooperating with the output of a photodetection device, such as, the device shown and described in  FIG. 1 , which provides electrical data to said computer processor and/or storage device as a function of the optical density for a sample being analyzed. The chip may be employed in, or used with, an apparatus having input means and storage means for storing data. The set of instructions on the chip includes instructions for carrying out the steps of determining one or more anticoagulant therapy factors based on the expressions (1) through (9), inclusive of expressions (5.1) and (8.1). 
         [0129]    According to alternate embodiments, methods for determining an anticoagulant therapy factor are provided to derive an INR. The customary classical INR (also referred to herein as INR m ) has been the laboratory standard of care for monitoring oral anticoagulant therapies, such as, for example, coumarin therapy, for 25 years. However, the classical INR (INRm) which is discussed in the background, above, is cumbersome, and suffers from exponential inaccuracies. According to an alternate embodiment, the exponent-derived INR m  (that is, the manufacturer&#39;s INR) may be supplantable by carrying out a clotting reaction and recording absorbance values over time intervals. The alternate INR (INRn) may be determined by computing the representative area of a trapezoid formed within the clotting curve absorbance, as determined by the absorbance values for the clotting reaction of a patient sample. According to preferred embodiments, the trapezoidal area is provided to approximate area under the clotting curve. According to this embodiment, the ISI and MNPT are eliminated. The sample of a person&#39;s blood or blood component is obtained and reacted with the coagulant, such as thromboplastin C, and the corresponding time and absorbance values for the clotting reaction of the sample are recorded. 
         [0130]    The INRn may be used to determine and regulate treatment for a patient, including administration of anticoagulant therapy, and other blood therapy applications. According to one embodiment of the method, obtaining values for an area in connection with a blood clotting analysis is used to derive a corresponding INR value (INRn) (e.g., a value that may be used as the INR value is used). For example, according to a preferred embodiment, an Area T, which may be made up of two sides S1 and S2, an upper base S3 and a lower base S4, may be derived to generate an INR value, INRn. An INRn value may be derived from clotting curve data, wherein one or more locations along the clotting curve may be used to determine values corresponding to a designated area, as in accordance with preferred embodiments, may be represented by a trapezoidal area, such as that area represented by Area T. According to a preferred embodiment, the area is a two dimensional planar location, and, for example, may comprise a designated area located in a quadrant of an ordinate and abscissa corresponding with clotting curve time and absorbance values. The clotting curve and absorbance values, preferably, may be obtained with the use of a photodetection apparatus, and a computer that records the electrical output of the detection components. For example, a linear-output photo-optical coagulometer may be used to obtain optically responsive signal data from the sample, as the clotting reaction takes place. This reaction and absorbance data collection may be conducted as described herein in conjunction with the use of a coagulometer, such as the instrument illustrated in  FIG. 1 , or other suitable absorbance measuring device. Preferred devices are described herein and may be configured with the instructions to provide the INRn. 
         [0131]    As illustrated in connection with  FIG. 6 , a clotting curve is shown. An Area T is identified in the first quadrant where the clotting curve of a coagulation reaction is illustrated. The Area T derivation may be used to derive a corresponding INRn value for the patient sample that generated the information represented by the clotting curve. The INRn values obtained by the method and apparatus are useful in determining the treatment course for an individual, based on the INRn value. 
         [0132]    According to a preferred embodiment, the INRn may be expressed with the following formulae: 
         [0000]      INRn=(Area  T )*MUL  (10) 
         [0133]    The MUL is a multiplier that is based on two relationships that are addressed by the multiplier. MUL relates the sampling rate of the instrument and the pixel parity of the x-y axis. The instrument used to measure the optical changes in the sample generates values, and preferably, the values, or signals are taken at a particular frequency. For example, a preferred sampling rate for the clotting curve reaction of a patient blood or blood component sample may be a number of optical absorbance values in a particular time interval. A preferred rate, for example, may be 100 optical absorbance values (or samples) per second, expressed 100/second. The sample rate preferably is used to derive a multiplier component, MUL. Also used to derive the multiplier component is the parity value, which is a multiplier utilized to create x-y pixel parity for the clotting curve information (that is shown expressed on the clotting curve graph, see  FIG. 6 ). According to the example illustrated, the sampling rate used was 100 values per second. The pixel parity multiplier was 0.535. The multiplier, according to this example, is 0.535 (pixel parity value)/100 (the number of samples reflected in a second). The multiplier, or MUL, according to a preferred embodiment, was 0.00535. 
         [0134]    In order to derive the INRn, the clotting curve is considered, and the theoretical or hypothetical zero order kinetic line, or line L as it is referred to and appears on the Figures, provides an (x,y) coordinate of (TEOT, 0), where the time value at which the clotting reaction, if theorized from the slope or line taken between the point where the maximum acceleration of the conversion rate of fibrinogen transformation begins (T2S) and the end of the maximum conversion (which is the last highest delta value of conversion rate), which is T2 or Tmap. The value, TEOT, is a time value, and generally, for example, may be expressed in seconds. As illustrated, the right side S2, may be designated to correspond with the line formed between the point (t1, c1) and TEOT. According to an alternate embodiment, the slope of the line L may corresponds with the slope of the side S2 of trapezoidal Area T. For example, according to some embodiments, the line L may form the side S2 of the trapezoid whose area is illustrated as Area T. 
         [0135]    As shown in the preferred embodiments illustrated in  FIGS. 6 and 7 , a segment of the line from TEOT and the point on the clotting curve T1, forms the trapezoid side S2. 
         [0136]    With the multiplier MUL, the INRn may be derived according to the following expression: 
         [0000]      INRn=(( T 1+TEOT)/2)*0.00535 *T 2  (11) 
         [0137]    As illustrated in  FIG. 7 , the lower base, S4, of the trapezoid TP, is the time value of the theoretical or hypothetical end of the coagulation test, TEOT. The time value component TEOT includes the time value of T2 plus the time value (Tiut) to convert the remainder of the fibrinogen in the sample that is considered to provide active optical activity (by the theoretical time value of the end of the test, TEOT). Both the Teot and TSot are values that are determined from the absorbance readings for a sample in a coagulation reaction. Dividing the difference in Instrument Units (RU)@ T2S to IU@ T2 (which is IUX) by the time it takes this conversion T2S to T2 (which may be represented by the time interval, Tiux) gives the maximum transformation rate for a specific sample. Using this specific test rate (UX/Tiux), it is determined how long it would take to convert the fibrinogen from T2S to T3 (end of test) and add this value to T2S. This gives the TEot. Another value listed in the data Table 14 is the TSot which is the hypothetical start of test. The TSot is similar to the TEot, the hypothetical end of test. (The TEot, according to some embodiments, also may be referred to herein as a theoretical end of test.) The time that it takes to convert the IU@T1 to IU@T2S (which may be expressed as the difference between T1 and T2S (the value Tcon)) may be determined using the same rate of change. The TSot is determined by subtracting the time (Tcon) from T2S to give the TSot. The TSot may come before or after T1 and the TEot will always come before T3. 
         [0138]    Referring again to  FIG. 7 , an upper base, S3, is indicated to correspond with the time of the start of the clot formation when the coagulation reaction is carried out. The start time of the clotting is represented by the time, T1, as shown in  FIG. 6 . With the upper and lower bases, S3 and S4, respectively, being ascertained through the clotting reaction times, they may be averaged (e.g., divided by 2). The S3, S4 average may be used to derive a trapezoidal area, such as, for example, Area T, represented by the clotting absorbance signal data. The altitude S1 (or height) of the trapezoidal area, Area T, is derived by the value of the point of time (T1) where the beginning of the conversion of fibrinogen to fibrin for the patient sample is determined. That point is represented as time value T1 on  FIGS. 6 and 7 . The height component of the trapezoid represented by Area T is designated to correspond with the side S1. The height component is assigned the value T1*MUL (T1 multiplied by the multiplier). 
         [0139]    The INRn may be determined for a patient sample by determining (i) when the clot formation begins, which is represented by the time value T1, (ii) when the clotting commences a maximum conversion rate (of conversion of fibrinogen to fibrin in the patient sample), which is represented by the time value T2, and (iii) the end of the maximum conversion rate, represented by the time value T3 (the end of the maximum conversion rate). Therefore, according to embodiments of the present method and apparatus, a new INR determination that, through the transformation of information (e.g., signals corresponding to optical activity of a clotting reaction), may be derived by (i) determining the start of the clotting when a reagent (such as, for example, thromboplastin C) is reacted with a blood or blood component sample of a person (by determining the length of time from the introduction of the reagent and sample to the time clotting begins, which is T1), (ii) determining the start of the maximum acceleration rate of conversion for the clotting reaction that began at time T1) which is represented by the time T2, and (ii) determining the value of the end of the maximum conversion rate for the clotting reaction, which is represented by the value T3. 
         [0140]    The present method and apparatus may be used to derive an INR, IRn, which does not utilize exponential components, and therefore, is not subject to exponential inaccuracies that have previously been experienced in connection with traditional INR determinations. The INRn value may be used to monitor a patient&#39;s blood or blood components for administration of oral anticoagulant therapy, such as, for example, coumarin, and other treatment agents, including those discussed herein. The present method and apparatus preferably, according to a preferred embodiment, where INRn is derived (and may be used for treatment administration of anticoagulant therapy). 
         [0141]    The clotting curve illustrates a representation of absorbance values for a clotting reaction where substantially optically clear fibrinogen converts to turbid fibrin, hence reducing the absorbance unit values, as indicated on the abscissa. The point of intersection of the line L with the x-axis, or the time axis, preferably, may be derived using the value T2S and adding to that time value, the time required to convert additional fibrinogen in the sample, which is the time value corresponding with the absorbance value IUT (in instrument units). The TEOT value may be derived from the intercept that the slope of the line L defined by T2S and T2 makes with the x-axis. However, as described herein, the x axis would, in theory, be where y=0, and accordingly, since some signal may be detected (and hence not zero), the trapezoidal lower base S4 ( FIGS. 6 and 7 ) may be represented along y=Ceot, between times T0 and TEot. According to a preferred embodiment, the TEOT value may be derived by the following determination: 
         [0000]      TEOT=T2S+(ZTM/IUX*IUT)  (12) 
         [0000]    where ZTM is the time (in seconds) to convert the fibrinogen corresponding to the time interval between T2S and T2, or in other words, the time to convert the IUX absorbance value (the IUX being the difference between instrument units (or IU) at T2S (IU@T2S) and instrument units at T2 (IU@T2)). The IUT value is the difference between instrument units (or IU) at T2S (IU@T2S) and instrument units at T3 (IU@T3). 
         [0142]    A method was carried out using the Dade Behring Thromboplastin C Plus (Dade TPC+) as the reagent. The number of patient samples that were reacted and used to obtain the following data was 218. The WHO INR (the World Health Organization INR is the average of INR values from five different thromboplastins. The INRm is the manufacturer&#39;s INR. INRz is the INR that is derived using the exponent (2-FTR) instead of the ISI (as described herein (see formulae (1), (2), (3), (3.1), above). INRn (uses no ISI and no MNPT values for its determination) and is the calculation for the INR in accordance with the alternate embodiment described herein and represented by the formula INRn=((T1+TEOT)/2)*0.00535*T2, which is formula (II), above. 
         [0143]    Coagulation reactions were carried out for a number of individuals, using the blood samples from the individuals, prepared as indicated herein in connection with clotting reactions, where a clotting reagent is added to the blood sample, and preferably a blood plasma sample. The absorbance values (measured in instrument units) were obtained for the sample throughout the coagulation reaction using a linear-output photo-optical coagulometer, POTENS+. The clotting agent used was thromboplastin reagent (Tp) which was injected into citrated human blood plasma. The clotting curve absorbance values were tracked as optically-clear fibrinogen (Fg) (also referred to as FBG herein) converts into turbid fibrin. The table below provides the values of the absorbance and time data that was obtained. By extending the slope L derived by the slope of the curve where the maximum conversion rate of fibrinogen occurs, a trapezoid is formed whose area may be derived and used to provide a value, INRn, which is essentially equal to the traditionally obtained INR values. 
         [0000]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 12 
               
             
             
               
                   
               
               
                 Comparative Summary 
               
             
          
           
               
                 INR WHO 
                   
                   
                   
                   
               
               
                 (INRw) 
                 NG 
                 LASSEN Agreement 
                 Poller 
                 Highest 
               
             
          
           
               
                 Versus 
                 Discordant 
                 &lt;=0.4 
                 &lt;=0.7 
                 Diff &gt;10% 
                 Percent 
               
               
                   
               
             
          
           
               
                 vs. INR M   
                 13.8% 
                 85.3% 
                 95.9% 
                  9/218 
                 4.1% 
                 18.3% 
               
               
                 vs. INR Z   
                 10.1% 
                 89.4% 
                 96.3% 
                  7/218 
                 3.2% 
                 15.2% 
               
               
                 vs. INR N   
                 9.2% 
                 88.5% 
                 96.3% 
                 12/218 
                 5.5% 
                 14.8% 
               
               
                   
               
             
          
         
       
     
         [0144]    Table 12 provides comparative data for INRn, INRz and INRn values compared with INR values calculated by the INR WHO method (which is also represented as INRw). The INR obtained using the WHO method (INRw) was compared with each of the alternate INR determinations, including INRm (using the manufacturer&#39;s INR), INRz, using the expressions of the above formulae (1), (2), (3), (3.1), as discussed herein, and INRn, using the expressions of the above formulae (10), (11), (12). 
         [0145]    Further details of the comparative data are provided in Table 13 to illustrate values for each of the INR WHO comparisons. 
         [0000]                                                                                                                    TABLE 13               COMPARATIVE SUMMARY DETAILS       using DADE TPC+ Thromboplastin                   WHO INR vs INRm Specimens       Using NG algorithm       Number of mismatches 30/218 = 13.8%                        Range   &lt;2.0   13(13, 0)/79   16.5%           Range    2.0 to 3.0   12(10, 2)/91   13.2%           Range   &gt;3.0 to 4.5    5(4, 1)/37   13.5%           Range   &gt;4.5    0(0, 0)/11   0.0%                        Lassen values       Samples: 218 delta &lt;= 0.4 32@85.3% delta &lt;= 0.7 9@95.9%                    WHO INR vs INRz Specimens       Using NG algorithm       Number of mismatches 22/218 = 10.1%                        Range   &lt;2.0   11(11, 0)/79   13.9%           Range    2.0 to 3.0    5(4, 1)/91   5.5%           Range   &gt;3.0 to 4.5    5(2, 3)/37   13.5%           Range   &gt;4.5    1(0, 1)/11   9.1%                        LASSEN values       Samples: 218 delta &lt;= 0.4 23@89.4% delta &lt;= 0.7 8@96.3%                    INRw vs. INRn Specimens       Using NG algorithm       Number of mismatches 20/218 = 9.2%                        Range   &lt;2.0    1(1, 0)/79   1.3%           Range    2.0 to 3.0   13(4, 9)/91   14.3%           Range   &gt;3.0 to 4.5    6(4, 2)/37   16.2%           Range   &gt;4.5    0(0, 0)/11   0.0%                        LASSEN values       Samples: 218 delta &lt;= 0.4 25@88.5% delta &lt;= 0.7 8@96.3%                    
The sample data upon which the above data summaries were based, is provided in Table 14. Table 14 provides corresponding data for a coagulation study. In Tables 14 and 15, the following references are used, and may be further identified by reference to  FIG. 8 :
       ID—Sample ID   T0—Time of thromboplastin reagent injection   T1—Start of the clot formation   T2S—Start of maximum conversion rate   T2—End of maximum conversion rate. (Last highest delta value of conversion rate.)   T3—(T 4 −T 2s )   T4—Hypothetical End Of Test (HEOT)   IU—Instrument unit   IUT—Delta IU between IU@T2S and IU@T3   IUX—Delta IU between IU@T2S and IU@T2   IUA—Altitude component value of the trapezoidal area (in instrument units) (c1—ceot)   IUL—Length component value of the trapezoidal area (in instrument units)   ZTM—Time in seconds to convert the IUX (T2−T2S)   TEOT—Hypothetical End Of Test. (Time at T2S plus the time to convert IUT.)   TSot—Hypothetical Start Of Test   Fg—Fibrinogen concentration of the blood sample (in g/l)   c1—Absorbance value (in instrument units) at time of the start of the clot formation (T1)   cT2S —Absorbance value (in instrument units) at the time of the start of maximum conversion rate (T2S)   c2—Absorbance value (in instrument units) at time of the end of maximum conversion rate   (T2). (Last highest delta value of conversion rate.)   ceot—Absorbance value (in instrument units) at time TEOT         
         [0000]    
       
         
               
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 14 
               
               
                   
               
               
                 ID 
                 WHO 
                 INRm 
                 INRz 
                 INRn 
                 T1 
                 T2S 
                 T2 
                 T3 
                 TSot 
                 TEot 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 A001 
                 3.00 
                 3.08 
                 2.55 
                 2.38 
                 18.89 
                 22.04 
                 23.89 
                 49.55 
                 19.66 
                 29.44 
               
               
                 A002 
                 2.88 
                 3.32 
                 2.56 
                 2.19 
                 19.71 
                 23.00 
                 24.42 
                 37.75 
                 20.87 
                 27.61 
               
               
                 A003 
                 2.78 
                 3.33 
                 2.55 
                 2.41 
                 19.75 
                 23.10 
                 25.48 
                 37.55 
                 20.94 
                 28.51 
               
               
                 A004 
                 2.08 
                 2.03 
                 2.03 
                 1.66 
                 14.85 
                 19.66 
                 21.62 
                 37.55 
                 16.89 
                 24.96 
               
               
                 A005 
                 2.30 
                 2.87 
                 2.31 
                 2.04 
                 18.11 
                 21.69 
                 23.83 
                 37.55 
                 19.36 
                 26.75 
               
               
                 A007 
                 1.85 
                 2.03 
                 1.78 
                 1.45 
                 14.86 
                 18.19 
                 20.18 
                 33.95 
                 15.87 
                 22.83 
               
               
                 A008 
                 2.83 
                 2.62 
                 2.42 
                 2.17 
                 17.22 
                 21.59 
                 23.63 
                 41.95 
                 18.97 
                 28.20 
               
               
                 A009 
                 2.70 
                 3.38 
                 2.65 
                 2.47 
                 19.91 
                 23.91 
                 26.43 
                 37.87 
                 21.39 
                 29.31 
               
               
                 A010 
                 1.65 
                 1.88 
                 1.61 
                 1.24 
                 14.22 
                 17.16 
                 19.27 
                 30.15 
                 14.73 
                 21.38 
               
               
                 A011 
                 1.83 
                 2.09 
                 1.71 
                 1.34 
                 15.10 
                 17.90 
                 19.32 
                 33.75 
                 15.57 
                 22.26 
               
               
                 A012 
                 2.68 
                 3.17 
                 2.47 
                 2.03 
                 19.21 
                 22.40 
                 23.94 
                 36.95 
                 19.78 
                 27.33 
               
               
                 A013 
                 3.30 
                 3.44 
                 2.92 
                 2.86 
                 20.13 
                 24.09 
                 26.68 
                 50.15 
                 21.60 
                 31.76 
               
               
                 A014 
                 1.60 
                 1.78 
                 1.55 
                 1.12 
                 13.76 
                 17.01 
                 18.35 
                 30.15 
                 14.78 
                 20.43 
               
               
                 A015 
                 1.70 
                 1.88 
                 1.60 
                 1.20 
                 14.23 
                 17.15 
                 18.96 
                 28.30 
                 14.74 
                 21.17 
               
               
                 A016 
                 2.73 
                 3.02 
                 2.53 
                 2.14 
                 18.68 
                 22.33 
                 23.35 
                 45.75 
                 19.91 
                 27.94 
               
               
                 A017 
                 1.70 
                 1.78 
                 1.63 
                 1.24 
                 13.76 
                 17.29 
                 18.86 
                 31.35 
                 14.82 
                 21.66 
               
               
                 A018 
                 2.18 
                 2.17 
                 1.91 
                 1.60 
                 15.44 
                 18.77 
                 21.23 
                 34.55 
                 16.09 
                 24.36 
               
               
                 A019 
                 1.85 
                 1.82 
                 1.71 
                 1.41 
                 13.97 
                 17.58 
                 19.30 
                 36.75 
                 15.29 
                 22.74 
               
               
                 A020 
                 3.80 
                 3.52 
                 2.93 
                 2.75 
                 20.40 
                 25.35 
                 28.02 
                 42.75 
                 22.47 
                 31.31 
               
               
                 A021 
                 2.63 
                 2.83 
                 2.39 
                 2.08 
                 17.98 
                 21.51 
                 23.37 
                 37.35 
                 18.91 
                 27.65 
               
               
                 A022 
                 2.08 
                 2.18 
                 1.92 
                 1.59 
                 15.46 
                 19.01 
                 20.55 
                 36.75 
                 16.65 
                 24.14 
               
               
                 A023 
                 3.20 
                 3.11 
                 2.55 
                 2.20 
                 18.98 
                 22.51 
                 23.92 
                 43.35 
                 20.09 
                 28.15 
               
               
                 A024 
                 3.03 
                 3.39 
                 3.05 
                 2.81 
                 19.94 
                 25.22 
                 27.22 
                 45.28 
                 22.66 
                 31.44 
               
               
                 A025 
                 1.73 
                 1.84 
                 1.51 
                 1.06 
                 14.03 
                 16.98 
                 18.01 
                 27.40 
                 15.09 
                 19.73 
               
               
                 A026 
                 1.45 
                 1.60 
                 1.45 
                 1.11 
                 12.94 
                 15.96 
                 17.58 
                 31.69 
                 13.53 
                 20.52 
               
               
                 A027 
                 1.45 
                 1.48 
                 1.36 
                 1.05 
                 12.41 
                 15.34 
                 16.91 
                 33.35 
                 13.12 
                 19.77 
               
               
                 A028 
                 1.90 
                 1.93 
                 1.73 
                 1.41 
                 14.41 
                 17.80 
                 19.22 
                 39.15 
                 15.38 
                 22.98 
               
               
                 A029 
                 2.20 
                 2.06 
                 1.85 
                 1.59 
                 14.99 
                 18.36 
                 20.31 
                 40.55 
                 16.07 
                 23.96 
               
               
                 A030 
                 2.50 
                 2.61 
                 2.25 
                 2.05 
                 17.17 
                 20.52 
                 22.08 
                 48.75 
                 18.18 
                 27.54 
               
               
                 A031 
                 2.43 
                 2.75 
                 2.25 
                 1.95 
                 17.69 
                 21.07 
                 23.20 
                 35.84 
                 18.55 
                 26.49 
               
               
                 A032 
                 3.63 
                 3.83 
                 3.33 
                 2.88 
                 21.40 
                 25.84 
                 26.78 
                 48.15 
                 23.33 
                 32.26 
               
               
                 A033 
                 2.65 
                 2.94 
                 2.52 
                 2.22 
                 18.39 
                 22.44 
                 24.46 
                 41.95 
                 19.79 
                 28.37 
               
               
                 A034 
                 2.08 
                 2.24 
                 1.96 
                 1.69 
                 15.71 
                 19.14 
                 20.89 
                 38.95 
                 16.92 
                 24.62 
               
               
                 A035 
                 4.00 
                 4.87 
                 3.71 
                 4.36 
                 24.58 
                 29.96 
                 34.33 
                 47.75 
                 27.15 
                 38.08 
               
               
                 A036 
                 2.98 
                 3.19 
                 2.51 
                 2.47 
                 19.26 
                 21.94 
                 24.50 
                 43.55 
                 19.89 
                 29.11 
               
               
                 A037 
                 2.20 
                 2.50 
                 2.32 
                 1.97 
                 16.73 
                 21.61 
                 23.71 
                 36.95 
                 18.96 
                 26.80 
               
               
                 A038 
                 1.45 
                 1.57 
                 1.35 
                 0.99 
                 12.82 
                 15.48 
                 16.81 
                 29.69 
                 13.15 
                 19.36 
               
               
                 A039 
                 1.50 
                 1.46 
                 1.39 
                 0.99 
                 12.27 
                 15.70 
                 17.37 
                 28.67 
                 13.27 
                 19.34 
               
               
                 A040 
                 2.28 
                 2.39 
                 2.06 
                 1.79 
                 16.33 
                 19.59 
                 21.24 
                 39.75 
                 17.17 
                 25.75 
               
               
                 A041 
                 2.18 
                 2.30 
                 2.14 
                 1.88 
                 15.95 
                 19.93 
                 21.44 
                 45.15 
                 17.29 
                 26.82 
               
               
                 A042 
                 3.40 
                 4.07 
                 3.36 
                 3.15 
                 22.16 
                 26.65 
                 29.21 
                 49.35 
                 23.45 
                 33.90 
               
               
                 A044 
                 3.38 
                 4.31 
                 3.31 
                 2.90 
                 22.90 
                 26.85 
                 28.41 
                 41.15 
                 24.38 
                 31.92 
               
               
                 A045 
                 2.60 
                 2.70 
                 2.44 
                 2.26 
                 17.52 
                 21.56 
                 24.20 
                 45.75 
                 18.92 
                 28.64 
               
               
                 A047 
                 2.45 
                 2.81 
                 2.46 
                 2.24 
                 17.90 
                 21.99 
                 24.21 
                 41.55 
                 19.51 
                 28.26 
               
               
                 A048 
                 3.38 
                 3.82 
                 3.13 
                 3.15 
                 21.35 
                 25.34 
                 28.49 
                 46.15 
                 22.61 
                 33.32 
               
               
                 A049 
                 2.28 
                 2.68 
                 2.15 
                 1.99 
                 17.42 
                 20.04 
                 22.56 
                 39.55 
                 17.88 
                 26.34 
               
               
                 A050 
                 2.70 
                 2.80 
                 2.49 
                 2.17 
                 17.86 
                 22.06 
                 24.08 
                 40.75 
                 19.20 
                 28.46 
               
               
                 A051 
                 1.88 
                 1.91 
                 1.64 
                 1.32 
                 14.35 
                 17.45 
                 18.41 
                 35.55 
                 15.19 
                 22.32 
               
               
                 A052 
                 2.55 
                 2.82 
                 2.31 
                 2.05 
                 17.94 
                 20.98 
                 22.93 
                 40.35 
                 18.50 
                 27.36 
               
               
                 A053 
                 2.88 
                 3.06 
                 2.48 
                 2.09 
                 18.82 
                 22.39 
                 24.07 
                 38.75 
                 19.78 
                 27.62 
               
               
                 A054 
                 1.90 
                 2.07 
                 1.78 
                 1.48 
                 15.04 
                 18.09 
                 20.21 
                 33.15 
                 15.84 
                 22.99 
               
               
                 A055 
                 6.58 
                 5.56 
                 4.81 
                 5.66 
                 26.51 
                 31.27 
                 36.08 
                 70.15 
                 28.32 
                 45.39 
               
               
                 A056 
                 3.48 
                 3.58 
                 3.19 
                 3.09 
                 20.60 
                 25.34 
                 27.68 
                 53.15 
                 22.73 
                 33.17 
               
               
                 A057 
                 2.58 
                 2.85 
                 2.23 
                 1.87 
                 18.05 
                 21.05 
                 22.66 
                 35.15 
                 18.72 
                 25.88 
               
               
                 A058 
                 7.40 
                 8.47 
                 7.73 
                 8.65 
                 33.76 
                 41.78 
                 45.33 
                 79.97 
                 37.98 
                 55.47 
               
               
                 A059 
                 2.25 
                 2.93 
                 2.27 
                 1.99 
                 18.34 
                 21.38 
                 23.74 
                 34.15 
                 18.82 
                 26.69 
               
               
                 A060 
                 2.43 
                 3.15 
                 2.54 
                 2.21 
                 19.12 
                 23.19 
                 25.32 
                 36.55 
                 20.59 
                 28.16 
               
               
                 A061 
                 2.25 
                 2.49 
                 2.17 
                 1.97 
                 16.70 
                 20.05 
                 22.25 
                 38.35 
                 17.68 
                 26.82 
               
               
                 A062 
                 6.35 
                 6.20 
                 6.43 
                 6.80 
                 28.21 
                 37.32 
                 40.28 
                 78.95 
                 33.62 
                 49.72 
               
               
                 A063 
                 2.65 
                 3.04 
                 2.63 
                 2.61 
                 18.75 
                 22.31 
                 25.84 
                 42.15 
                 19.59 
                 30.73 
               
               
                 A064 
                 2.05 
                 2.21 
                 1.92 
                 1.55 
                 15.59 
                 19.19 
                 21.08 
                 32.55 
                 16.76 
                 23.78 
               
               
                 A065 
                 2.28 
                 2.65 
                 2.47 
                 2.22 
                 17.32 
                 22.25 
                 24.96 
                 39.75 
                 19.39 
                 28.42 
               
               
                 A066 
                 1.83 
                 1.99 
                 1.67 
                 1.24 
                 14.69 
                 17.83 
                 19.19 
                 30.15 
                 15.50 
                 21.52 
               
               
                 A067 
                 1.78 
                 1.75 
                 1.62 
                 1.30 
                 13.63 
                 17.02 
                 18.52 
                 36.75 
                 14.49 
                 22.31 
               
               
                 A068 
                 2.68 
                 2.65 
                 2.13 
                 1.90 
                 17.30 
                 19.97 
                 21.86 
                 37.35 
                 17.76 
                 26.11 
               
               
                 A069 
                 2.10 
                 2.41 
                 1.92 
                 1.41 
                 16.41 
                 19.35 
                 20.15 
                 31.95 
                 16.95 
                 23.19 
               
               
                 A070 
                 1.65 
                 2.38 
                 1.97 
                 1.58 
                 16.29 
                 19.40 
                 20.80 
                 37.55 
                 16.92 
                 24.25 
               
               
                 A071 
                 1.73 
                 1.89 
                 1.73 
                 1.44 
                 14.25 
                 17.63 
                 19.53 
                 39.50 
                 15.23 
                 23.03 
               
               
                 A072 
                 1.60 
                 1.82 
                 1.69 
                 1.45 
                 13.97 
                 17.27 
                 18.98 
                 43.55 
                 14.80 
                 23.54 
               
               
                 A073 
                 1.48 
                 1.49 
                 1.50 
                 1.21 
                 12.46 
                 16.14 
                 17.82 
                 37.75 
                 13.77 
                 21.33 
               
               
                 A074 
                 1.65 
                 1.71 
                 1.59 
                 1.26 
                 13.44 
                 16.86 
                 19.03 
                 33.35 
                 14.56 
                 21.33 
               
               
                 A075 
                 1.58 
                 1.57 
                 1.21 
                 0.75 
                 12.80 
                 14.89 
                 15.87 
                 23.28 
                 13.18 
                 16.85 
               
               
                 A076 
                 1.45 
                 1.44 
                 1.37 
                 1.11 
                 12.18 
                 15.39 
                 16.78 
                 37.55 
                 13.01 
                 20.65 
               
               
                 A077 
                 4.63 
                 4.64 
                 4.03 
                 4.26 
                 23.88 
                 28.45 
                 31.55 
                 64.71 
                 25.61 
                 39.30 
               
               
                 A078 
                 2.05 
                 2.16 
                 1.88 
                 1.64 
                 15.41 
                 18.55 
                 20.89 
                 35.71 
                 16.35 
                 24.06 
               
               
                 A080 
                 6.13 
                 7.35 
                 6.42 
                 8.00 
                 31.12 
                 35.48 
                 40.50 
                 86.95 
                 32.86 
                 55.56 
               
               
                 A081 
                 3.55 
                 3.76 
                 3.63 
                 3.30 
                 21.18 
                 26.98 
                 28.55 
                 57.95 
                 23.84 
                 35.22 
               
               
                 A082 
                 1.53 
                 1.54 
                 1.55 
                 1.29 
                 12.69 
                 16.24 
                 18.15 
                 43.55 
                 13.76 
                 22.16 
               
               
                 A083 
                 1.60 
                 1.60 
                 1.38 
                 0.98 
                 12.97 
                 15.82 
                 16.98 
                 28.23 
                 13.50 
                 19.41 
               
               
                 A084 
                 6.98 
                 6.67 
                 5.72 
                 6.91 
                 29.43 
                 33.64 
                 38.19 
                 76.55 
                 30.96 
                 51.04 
               
               
                 A085 
                 3.10 
                 3.27 
                 3.01 
                 3.29 
                 19.55 
                 24.14 
                 29.21 
                 48.15 
                 21.22 
                 34.28 
               
               
                 A086 
                 2.45 
                 2.85 
                 2.35 
                 2.11 
                 18.07 
                 21.11 
                 22.84 
                 46.95 
                 18.57 
                 27.93 
               
               
                 A087 
                 1.93 
                 1.84 
                 1.69 
                 1.40 
                 14.06 
                 17.40 
                 19.24 
                 37.00 
                 15.03 
                 22.74 
               
               
                 A088 
                 1.78 
                 1.71 
                 1.64 
                 1.35 
                 13.44 
                 17.15 
                 18.79 
                 37.95 
                 14.80 
                 22.43 
               
               
                 A089 
                 2.18 
                 2.28 
                 1.83 
                 1.44 
                 15.90 
                 18.76 
                 20.00 
                 33.95 
                 16.62 
                 22.82 
               
               
                 A090 
                 5.93 
                 6.31 
                 5.59 
                 6.68 
                 28.51 
                 33.63 
                 38.36 
                 84.35 
                 30.64 
                 49.81 
               
               
                 A091 
                 8.23 
                 7.68 
                 6.96 
                 7.83 
                 31.91 
                 38.95 
                 42.75 
                 74.75 
                 35.15 
                 53.48 
               
               
                 A092 
                 2.00 
                 1.91 
                 2.03 
                 1.81 
                 14.36 
                 19.10 
                 21.48 
                 50.15 
                 16.41 
                 26.06 
               
               
                 A093 
                 4.30 
                 4.86 
                 3.81 
                 4.26 
                 24.53 
                 28.21 
                 31.94 
                 53.15 
                 25.81 
                 38.07 
               
               
                 A094 
                 2.53 
                 3.17 
                 2.94 
                 2.41 
                 19.18 
                 24.61 
                 25.77 
                 42.95 
                 22.06 
                 29.60 
               
               
                 A095 
                 1.43 
                 1.50 
                 1.43 
                 1.15 
                 12.48 
                 15.73 
                 17.24 
                 37.76 
                 13.36 
                 20.91 
               
               
                 A096 
                 1.80 
                 2.12 
                 1.69 
                 1.29 
                 15.22 
                 17.85 
                 19.14 
                 30.95 
                 15.59 
                 21.88 
               
               
                 A097 
                 1.40 
                 1.32 
                 1.11 
                 0.76 
                 11.59 
                 13.74 
                 14.88 
                 27.05 
                 11.21 
                 17.41 
               
               
                 A098 
                 1.45 
                 1.40 
                 1.32 
                 1.04 
                 11.98 
                 14.78 
                 16.59 
                 34.95 
                 12.54 
                 19.69 
               
               
                 A099 
                 1.53 
                 1.81 
                 1.52 
                 1.17 
                 13.93 
                 16.63 
                 18.24 
                 30.15 
                 14.48 
                 20.60 
               
               
                 A100 
                 1.40 
                 1.41 
                 1.40 
                 1.18 
                 12.06 
                 15.39 
                 17.01 
                 39.15 
                 13.23 
                 21.06 
               
               
                 A101 
                 2.45 
                 2.76 
                 2.39 
                 2.26 
                 17.71 
                 21.22 
                 24.16 
                 42.97 
                 18.67 
                 28.47 
               
               
                 A102 
                 3.83 
                 3.79 
                 3.13 
                 2.90 
                 21.28 
                 24.77 
                 25.93 
                 56.17 
                 22.32 
                 32.50 
               
               
                 A103 
                 2.15 
                 2.03 
                 1.94 
                 1.74 
                 14.84 
                 18.67 
                 20.63 
                 45.75 
                 16.35 
                 25.35 
               
               
                 A104 
                 3.10 
                 3.21 
                 2.96 
                 3.01 
                 19.32 
                 23.44 
                 27.32 
                 50.53 
                 20.39 
                 33.69 
               
               
                 A105 
                 3.85 
                 3.69 
                 3.15 
                 3.34 
                 20.93 
                 24.28 
                 26.92 
                 63.15 
                 22.14 
                 35.01 
               
               
                 A107 
                 2.53 
                 2.84 
                 2.42 
                 2.36 
                 18.01 
                 21.27 
                 23.85 
                 50.16 
                 19.06 
                 28.89 
               
               
                 A108 
                 1.95 
                 2.08 
                 1.85 
                 1.55 
                 15.06 
                 18.37 
                 20.98 
                 32.12 
                 15.76 
                 23.83 
               
               
                 A109 
                 2.28 
                 2.27 
                 2.06 
                 1.85 
                 15.86 
                 19.19 
                 22.04 
                 38.31 
                 16.53 
                 26.22 
               
               
                 A110 
                 3.83 
                 3.91 
                 3.72 
                 4.05 
                 21.65 
                 26.20 
                 29.96 
                 67.75 
                 23.26 
                 39.93 
               
               
                 A111 
                 2.90 
                 2.52 
                 2.39 
                 2.35 
                 16.84 
                 20.64 
                 24.09 
                 45.11 
                 18.13 
                 29.42 
               
               
                 A112 
                 2.30 
                 2.39 
                 2.22 
                 2.13 
                 16.33 
                 20.00 
                 22.03 
                 56.41 
                 17.63 
                 28.46 
               
               
                 A113 
                 1.80 
                 1.87 
                 1.65 
                 1.41 
                 14.17 
                 16.98 
                 18.78 
                 38.35 
                 14.73 
                 22.94 
               
               
                 A114 
                 1.90 
                 2.10 
                 1.87 
                 1.65 
                 15.13 
                 18.38 
                 20.51 
                 43.35 
                 16.14 
                 24.34 
               
               
                 A115 
                 2.10 
                 2.38 
                 2.30 
                 2.03 
                 16.26 
                 20.91 
                 22.84 
                 47.35 
                 18.27 
                 27.41 
               
               
                 A116 
                 1.78 
                 1.73 
                 1.40 
                 1.07 
                 13.53 
                 15.66 
                 17.28 
                 29.70 
                 13.64 
                 19.58 
               
               
                 A117 
                 1.65 
                 1.62 
                 1.65 
                 1.45 
                 13.04 
                 16.91 
                 18.76 
                 49.15 
                 14.58 
                 23.34 
               
               
                 A118 
                 1.98 
                 2.18 
                 1.80 
                 1.46 
                 15.46 
                 18.36 
                 19.65 
                 35.35 
                 16.10 
                 23.20 
               
               
                 A119 
                 2.65 
                 2.98 
                 2.43 
                 2.32 
                 18.53 
                 21.29 
                 23.20 
                 48.14 
                 19.06 
                 29.09 
               
               
                 A120 
                 1.85 
                 2.11 
                 1.79 
                 1.48 
                 15.18 
                 18.33 
                 19.61 
                 34.35 
                 16.20 
                 23.17 
               
               
                 A121 
                 2.05 
                 2.21 
                 1.82 
                 1.58 
                 15.60 
                 18.24 
                 20.28 
                 36.04 
                 16.20 
                 23.54 
               
               
                 A122 
                 1.55 
                 1.76 
                 1.64 
                 1.42 
                 13.70 
                 16.76 
                 18.82 
                 42.35 
                 14.50 
                 22.94 
               
               
                 A123 
                 1.70 
                 1.81 
                 1.55 
                 1.25 
                 13.91 
                 16.51 
                 18.38 
                 31.51 
                 14.27 
                 21.37 
               
               
                 A124 
                 1.63 
                 1.80 
                 1.46 
                 1.08 
                 13.85 
                 16.27 
                 17.67 
                 29.01 
                 13.94 
                 20.16 
               
               
                 A125 
                 1.50 
                 1.39 
                 1.26 
                 1.04 
                 11.93 
                 14.86 
                 15.88 
                 37.95 
                 12.41 
                 20.50 
               
               
                 A126 
                 3.25 
                 3.70 
                 2.97 
                 3.02 
                 20.99 
                 25.08 
                 28.61 
                 41.35 
                 22.26 
                 32.49 
               
               
                 A127 
                 2.20 
                 2.38 
                 2.05 
                 1.83 
                 16.28 
                 19.39 
                 20.92 
                 51.15 
                 16.81 
                 26.47 
               
               
                 A128 
                 3.38 
                 3.89 
                 3.06 
                 2.64 
                 21.58 
                 24.88 
                 26.01 
                 47.86 
                 22.48 
                 30.67 
               
               
                 A129 
                 4.35 
                 5.25 
                 4.67 
                 4.77 
                 25.65 
                 30.83 
                 33.84 
                 60.80 
                 27.13 
                 42.64 
               
               
                 A130 
                 4.05 
                 4.66 
                 4.55 
                 4.16 
                 23.94 
                 31.39 
                 33.06 
                 58.52 
                 28.41 
                 38.43 
               
               
                 A131 
                 1.63 
                 1.72 
                 1.68 
                 1.42 
                 13.49 
                 17.05 
                 19.42 
                 34.86 
                 14.68 
                 22.81 
               
               
                 A132 
                 2.43 
                 2.65 
                 2.75 
                 2.62 
                 17.33 
                 22.89 
                 26.55 
                 47.95 
                 19.39 
                 31.64 
               
               
                 A133 
                 2.65 
                 2.64 
                 2.56 
                 2.63 
                 17.27 
                 21.32 
                 25.37 
                 48.11 
                 18.85 
                 31.00 
               
               
                 A134 
                 6.33 
                 6.48 
                 6.27 
                 6.27 
                 28.95 
                 36.89 
                 39.54 
                 62.23 
                 32.81 
                 48.31 
               
               
                 A135 
                 1.40 
                 1.49 
                 1.32 
                 0.97 
                 12.42 
                 15.07 
                 16.62 
                 30.63 
                 12.59 
                 19.31 
               
               
                 A136 
                 4.38 
                 4.33 
                 3.63 
                 3.63 
                 22.96 
                 26.93 
                 29.17 
                 62.05 
                 24.27 
                 36.17 
               
               
                 A137 
                 1.58 
                 1.96 
                 1.73 
                 1.33 
                 14.56 
                 18.09 
                 19.56 
                 35.32 
                 15.80 
                 22.09 
               
               
                 A138 
                 2.18 
                 1.99 
                 2.04 
                 1.74 
                 14.69 
                 19.49 
                 21.15 
                 46.15 
                 16.78 
                 25.69 
               
               
                 A139 
                 2.05 
                 2.12 
                 1.97 
                 1.78 
                 15.24 
                 19.05 
                 20.42 
                 48.75 
                 16.77 
                 25.90 
               
               
                 A140 
                 1.35 
                 1.34 
                 1.28 
                 1.01 
                 11.72 
                 14.83 
                 16.21 
                 38.35 
                 12.55 
                 19.52 
               
               
                 A141 
                 2.05 
                 2.22 
                 1.87 
                 1.52 
                 15.65 
                 18.77 
                 20.00 
                 34.32 
                 16.40 
                 23.78 
               
               
                 A142 
                 3.10 
                 3.36 
                 2.60 
                 2.24 
                 19.86 
                 23.90 
                 25.80 
                 37.58 
                 21.43 
                 28.27 
               
               
                 A143 
                 2.08 
                 2.56 
                 2.23 
                 2.08 
                 16.97 
                 20.55 
                 23.80 
                 37.75 
                 17.91 
                 27.25 
               
               
                 A144 
                 2.20 
                 2.44 
                 2.12 
                 1.76 
                 16.53 
                 20.17 
                 21.49 
                 41.68 
                 17.76 
                 25.45 
               
               
                 A145 
                 1.28 
                 1.38 
                 1.28 
                 0.99 
                 11.91 
                 14.81 
                 16.17 
                 36.48 
                 12.38 
                 19.53 
               
               
                 A146 
                 2.48 
                 2.26 
                 1.98 
                 1.80 
                 15.81 
                 18.99 
                 20.67 
                 49.55 
                 16.66 
                 25.97 
               
               
                 A147 
                 1.48 
                 1.64 
                 1.45 
                 1.10 
                 13.14 
                 16.08 
                 17.38 
                 34.14 
                 13.57 
                 20.59 
               
               
                 A148 
                 2.18 
                 2.38 
                 2.07 
                 1.79 
                 16.28 
                 19.67 
                 21.10 
                 46.95 
                 17.00 
                 26.15 
               
               
                 A149 
                 1.33 
                 1.52 
                 1.41 
                 1.05 
                 12.57 
                 15.82 
                 17.19 
                 34.20 
                 13.23 
                 20.16 
               
               
                 A150 
                 1.45 
                 1.55 
                 1.40 
                 1.14 
                 12.72 
                 15.57 
                 16.97 
                 39.21 
                 13.27 
                 20.78 
               
               
                 A151 
                 2.83 
                 2.80 
                 2.52 
                 2.42 
                 17.89 
                 21.77 
                 24.31 
                 56.93 
                 19.30 
                 29.60 
               
               
                 A152 
                 1.85 
                 2.19 
                 1.82 
                 1.34 
                 15.50 
                 18.79 
                 20.08 
                 33.19 
                 16.21 
                 22.66 
               
               
                 A153 
                 1.73 
                 1.77 
                 1.64 
                 1.41 
                 13.75 
                 17.14 
                 18.49 
                 46.91 
                 14.70 
                 23.25 
               
               
                 A154 
                 2.30 
                 2.29 
                 1.97 
                 1.75 
                 15.94 
                 18.86 
                 20.90 
                 41.84 
                 16.50 
                 25.41 
               
               
                 A155 
                 4.98 
                 4.80 
                 3.87 
                 4.77 
                 24.37 
                 29.06 
                 35.08 
                 53.55 
                 26.05 
                 40.50 
               
               
                 A156 
                 2.80 
                 2.77 
                 2.40 
                 1.89 
                 17.76 
                 21.91 
                 23.03 
                 40.00 
                 19.35 
                 26.55 
               
               
                 A157 
                 2.03 
                 2.22 
                 1.87 
                 1.52 
                 15.64 
                 18.86 
                 20.65 
                 36.62 
                 16.47 
                 23.51 
               
               
                 A158 
                 3.43 
                 3.64 
                 2.84 
                 2.55 
                 20.79 
                 24.24 
                 25.84 
                 44.53 
                 22.00 
                 29.68 
               
               
                 A159 
                 3.78 
                 3.94 
                 3.60 
                 3.72 
                 21.74 
                 26.43 
                 29.76 
                 61.35 
                 23.28 
                 37.47 
               
               
                 A160 
                 2.58 
                 2.74 
                 2.47 
                 2.40 
                 17.64 
                 21.60 
                 24.95 
                 44.35 
                 18.99 
                 29.29 
               
               
                 A161 
                 1.68 
                 1.66 
                 1.60 
                 1.31 
                 13.24 
                 16.74 
                 18.54 
                 35.95 
                 14.17 
                 22.40 
               
               
                 A162 
                 7.33 
                 6.56 
                 5.90 
                 6.52 
                 29.16 
                 34.82 
                 38.19 
                 74.78 
                 31.45 
                 49.35 
               
               
                 A163 
                 3.90 
                 3.90 
                 3.15 
                 3.04 
                 21.62 
                 25.10 
                 27.09 
                 49.55 
                 22.75 
                 32.70 
               
               
                 A164 
                 3.45 
                 3.79 
                 3.19 
                 2.83 
                 21.28 
                 25.53 
                 26.93 
                 47.44 
                 23.08 
                 31.66 
               
               
                 A165 
                 2.63 
                 2.60 
                 2.25 
                 1.96 
                 17.13 
                 20.69 
                 22.34 
                 43.75 
                 18.17 
                 26.86 
               
               
                 A166 
                 2.05 
                 2.19 
                 1.91 
                 1.62 
                 15.52 
                 18.84 
                 20.12 
                 42.98 
                 16.44 
                 24.60 
               
               
                 A167 
                 2.65 
                 3.00 
                 2.45 
                 1.91 
                 18.61 
                 22.28 
                 23.38 
                 36.00 
                 19.77 
                 26.68 
               
               
                 A168 
                 3.60 
                 3.61 
                 3.03 
                 3.20 
                 20.68 
                 23.69 
                 25.98 
                 51.55 
                 21.61 
                 34.72 
               
               
                 A169 
                 3.78 
                 4.13 
                 3.34 
                 3.14 
                 22.35 
                 25.61 
                 26.64 
                 60.89 
                 23.24 
                 33.75 
               
               
                 A170 
                 1.30 
                 1.37 
                 1.24 
                 0.88 
                 11.84 
                 14.56 
                 16.01 
                 30.00 
                 12.18 
                 18.39 
               
               
                 A171 
                 3.18 
                 3.41 
                 2.94 
                 3.02 
                 20.01 
                 24.48 
                 27.83 
                 47.95 
                 21.97 
                 32.30 
               
               
                 A172 
                 2.58 
                 2.58 
                 1.99 
                 1.71 
                 17.06 
                 19.43 
                 20.73 
                 39.75 
                 17.41 
                 24.63 
               
               
                 A173 
                 1.48 
                 1.51 
                 1.30 
                 0.95 
                 12.55 
                 15.03 
                 16.46 
                 28.97 
                 12.78 
                 18.91 
               
               
                 A174 
                 1.88 
                 1.84 
                 1.60 
                 1.31 
                 14.04 
                 16.86 
                 18.51 
                 36.75 
                 14.60 
                 21.98 
               
               
                 A175 
                 1.60 
                 1.84 
                 1.52 
                 1.13 
                 14.02 
                 16.78 
                 18.20 
                 29.70 
                 14.61 
                 20.37 
               
               
                 A176 
                 3.08 
                 3.33 
                 2.82 
                 2.72 
                 19.75 
                 23.45 
                 25.14 
                 50.35 
                 21.34 
                 30.91 
               
               
                 A177 
                 1.58 
                 1.73 
                 1.42 
                 1.05 
                 13.56 
                 15.96 
                 17.33 
                 31.35 
                 13.59 
                 19.95 
               
               
                 A178 
                 2.53 
                 2.34 
                 2.16 
                 1.89 
                 16.13 
                 20.20 
                 21.83 
                 43.07 
                 17.75 
                 26.41 
               
               
                 A179 
                 2.33 
                 2.51 
                 2.18 
                 1.86 
                 16.78 
                 20.38 
                 22.02 
                 39.95 
                 17.86 
                 26.18 
               
               
                 A180 
                 2.18 
                 2.26 
                 1.88 
                 1.59 
                 15.79 
                 18.80 
                 20.33 
                 36.32 
                 16.66 
                 23.85 
               
               
                 A181 
                 3.68 
                 3.49 
                 3.21 
                 3.44 
                 20.29 
                 25.17 
                 29.85 
                 51.67 
                 21.98 
                 35.38 
               
               
                 A182 
                 2.05 
                 2.10 
                 1.78 
                 1.44 
                 15.15 
                 18.28 
                 19.30 
                 39.14 
                 15.93 
                 23.28 
               
               
                 A183 
                 1.53 
                 1.55 
                 1.30 
                 0.91 
                 12.70 
                 15.24 
                 16.46 
                 28.49 
                 12.95 
                 18.59 
               
               
                 A184 
                 2.48 
                 2.58 
                 2.22 
                 1.96 
                 17.06 
                 20.49 
                 21.89 
                 47.65 
                 18.04 
                 27.02 
               
               
                 A185 
                 3.05 
                 3.28 
                 2.96 
                 2.87 
                 19.59 
                 24.06 
                 26.64 
                 54.15 
                 21.37 
                 32.25 
               
               
                 A186 
                 3.10 
                 3.12 
                 3.09 
                 3.58 
                 19.01 
                 22.19 
                 29.51 
                 65.55 
                 19.65 
                 37.28 
               
               
                 A187 
                 1.75 
                 1.83 
                 1.51 
                 1.18 
                 13.99 
                 16.52 
                 17.86 
                 34.85 
                 14.22 
                 21.02 
               
               
                 A188 
                 2.93 
                 3.12 
                 2.56 
                 2.46 
                 19.01 
                 22.29 
                 24.63 
                 36.67 
                 20.11 
                 29.31 
               
               
                 A189 
                 2.93 
                 2.98 
                 2.68 
                 2.47 
                 18.52 
                 23.20 
                 25.87 
                 44.13 
                 20.26 
                 30.01 
               
               
                 A190 
                 3.25 
                 3.59 
                 3.00 
                 2.75 
                 20.62 
                 24.60 
                 26.72 
                 44.63 
                 21.77 
                 31.67 
               
               
                 A191 
                 2.05 
                 2.04 
                 1.71 
                 1.39 
                 14.91 
                 17.82 
                 19.08 
                 34.18 
                 15.77 
                 22.39 
               
               
                 A192 
                 2.28 
                 2.49 
                 2.25 
                 1.81 
                 16.69 
                 21.28 
                 22.69 
                 39.02 
                 18.88 
                 25.65 
               
               
                 A193 
                 1.95 
                 2.11 
                 1.84 
                 1.64 
                 15.20 
                 17.86 
                 20.52 
                 39.35 
                 15.51 
                 24.43 
               
               
                 A194 
                 2.18 
                 2.27 
                 1.98 
                 1.72 
                 15.83 
                 19.27 
                 21.44 
                 36.83 
                 16.93 
                 24.78 
               
               
                 A195 
                 1.45 
                 1.37 
                 1.46 
                 1.17 
                 11.86 
                 15.76 
                 17.48 
                 34.90 
                 13.23 
                 21.30 
               
               
                 A196 
                 1.95 
                 1.99 
                 1.82 
                 1.56 
                 14.68 
                 18.04 
                 20.23 
                 42.94 
                 15.59 
                 23.97 
               
               
                 A197 
                 1.63 
                 1.78 
                 1.62 
                 1.28 
                 13.76 
                 17.46 
                 18.33 
                 41.41 
                 15.35 
                 21.69 
               
               
                 A198 
                 1.85 
                 1.92 
                 1.66 
                 1.43 
                 14.39 
                 16.92 
                 19.77 
                 31.95 
                 14.88 
                 22.21 
               
               
                 A199 
                 1.40 
                 1.49 
                 1.32 
                 0.94 
                 12.42 
                 15.08 
                 16.68 
                 28.38 
                 12.57 
                 19.08 
               
               
                 A200 
                 1.35 
                 1.38 
                 1.21 
                 0.88 
                 11.92 
                 14.39 
                 15.64 
                 30.32 
                 12.02 
                 18.39 
               
               
                 A201 
                 2.40 
                 2.56 
                 2.19 
                 1.96 
                 16.97 
                 20.37 
                 22.05 
                 42.55 
                 18.13 
                 26.53 
               
               
                 A202 
                 2.20 
                 2.39 
                 1.93 
                 1.59 
                 16.31 
                 18.99 
                 20.82 
                 37.23 
                 16.43 
                 24.30 
               
               
                 A203 
                 1.80 
                 2.07 
                 1.67 
                 1.28 
                 15.04 
                 17.69 
                 18.76 
                 36.37 
                 15.26 
                 22.07 
               
               
                 A204 
                 1.73 
                 1.80 
                 1.50 
                 1.14 
                 13.85 
                 16.41 
                 17.97 
                 30.75 
                 14.07 
                 20.62 
               
               
                 A205 
                 1.85 
                 1.87 
                 1.84 
                 1.46 
                 14.19 
                 18.51 
                 20.05 
                 39.13 
                 15.79 
                 23.60 
               
               
                 A207 
                 2.65 
                 2.75 
                 2.42 
                 2.11 
                 17.69 
                 21.70 
                 23.07 
                 45.74 
                 19.37 
                 27.59 
               
               
                 A208 
                 3.05 
                 3.04 
                 2.63 
                 2.62 
                 18.75 
                 22.27 
                 25.50 
                 45.50 
                 19.80 
                 30.63 
               
               
                 A209 
                 1.70 
                 1.84 
                 1.69 
                 1.44 
                 14.06 
                 17.22 
                 19.31 
                 37.35 
                 15.00 
                 22.84 
               
               
                 A210 
                 2.35 
                 2.37 
                 1.95 
                 1.58 
                 16.23 
                 19.23 
                 20.54 
                 39.33 
                 16.76 
                 24.32 
               
               
                 A211 
                 2.50 
                 2.68 
                 2.40 
                 2.12 
                 17.44 
                 21.54 
                 23.03 
                 47.55 
                 19.14 
                 27.75 
               
               
                 A212 
                 2.88 
                 2.77 
                 2.44 
                 2.18 
                 17.78 
                 21.82 
                 23.45 
                 43.47 
                 19.54 
                 27.85 
               
               
                 A213 
                 2.53 
                 2.74 
                 2.40 
                 2.41 
                 17.65 
                 20.57 
                 23.19 
                 56.75 
                 18.23 
                 30.50 
               
               
                 A214 
                 2.60 
                 2.80 
                 2.44 
                 2.38 
                 17.86 
                 21.07 
                 24.24 
                 44.75 
                 18.53 
                 29.52 
               
               
                 A215 
                 2.40 
                 2.47 
                 2.06 
                 1.70 
                 16.63 
                 19.82 
                 21.16 
                 41.43 
                 17.36 
                 25.07 
               
               
                 A216 
                 4.48 
                 4.13 
                 3.86 
                 3.78 
                 22.33 
                 27.99 
                 30.59 
                 58.40 
                 24.70 
                 37.52 
               
               
                 A217 
                 2.23 
                 2.33 
                 2.26 
                 2.19 
                 16.10 
                 20.21 
                 22.30 
                 63.13 
                 17.82 
                 28.77 
               
               
                 A218 
                 2.95 
                 2.94 
                 2.82 
                 2.70 
                 18.38 
                 23.22 
                 25.69 
                 59.95 
                 20.39 
                 31.65 
               
               
                 A219 
                 2.38 
                 2.71 
                 2.17 
                 2.01 
                 17.55 
                 20.69 
                 23.43 
                 36.97 
                 18.50 
                 26.17 
               
               
                 A220 
                 1.90 
                 2.05 
                 1.74 
                 1.34 
                 14.92 
                 18.06 
                 19.41 
                 34.75 
                 15.57 
                 22.53 
               
               
                 A222 
                 1.83 
                 1.89 
                 1.63 
                 1.36 
                 14.27 
                 17.07 
                 18.81 
                 33.95 
                 14.98 
                 22.12 
               
               
                 A223 
                 1.73 
                 1.74 
                 1.41 
                 1.05 
                 13.60 
                 16.00 
                 17.00 
                 31.79 
                 13.57 
                 20.14 
               
               
                 A224 
                 1.73 
                 1.62 
                 1.52 
                 1.15 
                 13.03 
                 16.52 
                 18.07 
                 31.77 
                 14.04 
                 20.86 
               
               
                 A225 
                 1.68 
                 1.81 
                 1.52 
                 1.18 
                 13.93 
                 16.59 
                 17.97 
                 32.58 
                 14.29 
                 20.96 
               
               
                   
               
             
          
         
       
     
         [0000]                                                                                                                TABLE 15                   Table 15 provides additional data for the coagulation       study of the samples in Table 14.            ID   Fg   c1   ct2s   C2   Ceot   IUL   IUX   IUT   IUA   Ztm                    A001   388   3738   3720   3706   3664   18   14   56   74   1.85       A002   226   3724   3712   3704   3686   12   8   26   38   1.42       A003   213   3740   3730   3719   3705   10   11   25   35   2.38       A004   370   3733   3709   3692   3663   24   17   46   70   1.96       A005   226   3738   3726   3715   3700   12   11   26   38   2.14       A007   244   3740   3726   3714   3698   14   12   28   42   1.99       A008   482   3741   3714   3693   3646   27   21   68   95   2.04       A009   253   3741   3727   3713   3697   14   14   30   44   2.52       A010   240   3742   3727   3714   3701   15   13   26   41   2.11       A011   352   3713   3690   3676   3647   23   14   43   66   1.42       A012   276   3744   3727   3717   3695   17   10   32   49   1.54       A013   496   3739   3715   3690   3641   24   25   74   98   2.59       A014   226   3732   3717   3708   3694   15   9   23   38   1.34       A015   199   3738   3726   3717   3706   12   9   20   32   1.81       A016   340   3741   3722   3714   3678   19   8   44   63   1.02       A017   331   3742   3720   3706   3681   22   14   39   61   1.57       A018   218   3734   3722   3711   3697   12   11   25   37   2.46       A019   472   3744   3716   3695   3653   28   21   63   91   1.72       A020   246   3741   3727   3714   3698   14   13   29   43   2.67       A021   265   3741   3727   3717   3694   14   10   33   47   1.86       A022   387   3740   3717   3702   3667   23   15   50   73   1.54       A023   420   3743   3719   3705   3663   24   14   56   80   1.41       A024   415   3740   3717   3699   3661   23   18   56   79   2.00       A025   171   3743   3732   3726   3716   11   6   16   27   1.03       A026   363   3742   3718   3702   3673   24   16   45   69   1.62       A027   377   3739   3715   3698   3667   24   17   48   72   1.57       A028   463   3742   3713   3696   3651   29   17   62   91   1.42       A029   472   3740   3713   3690   3647   27   23   66   93   1.95       A030   540   3743   3716   3698   3635   27   18   81   108   1.56       A031   236   3728   3715   3704   3687   13   11   28   41   2.13       A032   309   3732   3716   3710   3675   16   6   41   57   0.94       A033   358   3739   3718   3702   3671   21   16   47   68   2.02       A034   349   3740   3721   3706   3674   19   15   47   66   1.75       A035   209   3734   3725   3711   3699   9   14   26   35   4.37       A036   295   3735   3723   3708   3681   12   15   42   54   2.56       A037   372   3740   3716   3697   3669   24   19   47   71   2.10       A038   304   3742   3721   3709   3686   21   12   35   56   1.33       A039   232   3738   3722   3711   3698   16   11   24   40   1.67       A040   404   3742   3720   3705   3664   22   15   56   78   1.65       A041   493   3739   3711   3695   3638   28   16   73   101   1.51       A042   261   3736   3721   3709   3687   15   12   34   49   2.56       A044   301   3741   3722   3710   3683   19   12   39   58   1.56       A045   453   3739   3714   3689   3647   25   25   67   92   2.64       A047   341   3735   3716   3699   3668   19   17   48   67   2.22       A048   270   3733   3720   3705   3682   13   15   38   51   3.15       A049   252   3737   3725   3711   3690   12   14   35   47   2.52       A050   288   3740   3723   3711   3685   17   12   38   55   2.02       A051   514   3738   3705   3691   3634   33   14   71   104   0.96       A052   276   3737   3723   3712   3687   14   11   36   50   1.95       A053   241   3738   3724   3715   3696   14   9   28   42   1.68       A054   294   3733   3716   3700   3679   17   16   37   54   2.12       A055   540   3737   3718   3687   3627   19   31   91   110   4.81       A056   566   3740   3711   3685   3624   29   26   87   116   2.34       A057   232   3723   3710   3701   3683   13   9   27   40   1.61       A058   360   3738   3723   3709   3669   15   14   54   69   3.55       A059   232   3736   3723   3711   3696   13   12   27   40   2.36       A060   197   3730   3719   3710   3698   11   9   21   32   2.13       A061   294   3734   3720   3707   3680   14   13   40   54   2.20       A062   439   3738   3718   3702   3651   20   16   67   87   2.96       A063   237   3738   3728   3715   3697   10   13   31   41   3.53       A064   285   3737   3719   3705   3685   18   14   34   52   1.89       A065   320   3740   3721   3703   3680   19   18   41   60   2.71       A066   186   3738   3726   3719   3707   12   7   19   31   1.36       A067   494   3740   3708   3689   3641   32   19   67   99   1.50       A068   286   3739   3725   3713   3686   14   12   39   53   1.89       A069   223   3734   3719   3714   3695   15   5   24   39   0.80       A070   354   3739   3716   3703   3671   23   13   45   68   1.40       A071   399   3738   3714   3695   3660   24   19   54   78   1.90       A072   463   3738   3712   3694   3646   26   18   66   92   1.71       A073   494   3738   3707   3685   3639   31   22   68   99   1.68       A074   286   3718   3700   3683   3665   18   17   35   53   2.17       A075   114   3741   3734   3730   3726   7   4   8   15   0.98       A076   385   3742   3718   3704   3665   24   14   53   77   1.39       A077   508   3740   3718   3694   3634   22   24   84   106   3.10       A078   296   3740   3724   3707   3684   16   17   40   56   2.34       A080   499   3741   3729   3706   3637   12   23   92   104   5.02       A081   550   3742   3710   3694   3626   32   16   84   116   1.57       A082   431   3742   3716   3696   3654   26   20   62   88   1.91       A083   296   3742   3720   3709   3686   22   11   34   56   1.16       A084   376   3742   3732   3715   3667   10   17   65   75   4.55       A085   342   3742   3727   3701   3675   15   26   52   67   5.07       A086   448   3742   3717   3700   3650   25   17   67   92   1.73       A087   431   3742   3715   3694   3654   27   21   61   88   1.84       A088   512   3737   3704   3681   3630   33   23   74   107   1.64       A089   292   3742   3723   3712   3687   19   11   36   55   1.24       A090   711   3742   3718   3680   3588   24   38   130   154   4.73       A091   393   3741   3724   3707   3659   17   17   65   82   3.80       A092   711   3740   3696   3657   3582   44   39   114   158   2.38       A093   243   3739   3730   3716   3693   9   14   37   46   3.73       A094   322   3741   3719   3709   3676   22   10   43   65   1.16       A095   490   3743   3710   3689   3638   33   21   72   105   1.51       A096   214   3739   3725   3717   3700   14   8   25   39   1.29       A097   256   3741   3721   3712   3692   20   9   29   49   1.14       A098   398   3742   3716   3695   3659   26   21   57   83   1.81       A099   289   3742   3722   3707   3685   20   15   37   57   1.61       A100   536   3741   3709   3685   3625   32   24   84   116   1.62       A101   269   3740   3727   3712   3690   13   15   37   50   2.94       A102   397   3740   3721   3712   3661   19   9   60   79   1.16       A103   495   3741   3715   3693   3640   26   22   75   101   1.96       A104   260   3730   3719   3705   3682   11   14   37   48   3.88       A105   393   3738   3725   3709   3660   13   16   65   78   2.64       A107   402   3740   3722   3701   3660   18   21   62   80   2.58       A108   198   3743   3732   3721   3709   11   11   23   34   2.61       A109   273   3740   3726   3711   3689   14   15   37   51   2.85       A110   499   3737   3719   3696   3635   18   23   84   102   3.76       A111   366   3739   3723   3701   3667   16   22   56   72   3.45       A112   614   3742   3714   3690   3614   28   24   100   128   2.03       A113   371   3737   3717   3701   3664   20   16   53   73   1.80       A114   388   3732   3711   3691   3655   21   20   56   77   2.13       A115   446   3742   3716   3697   3652   26   19   64   90   1.93       A116   230   3742   3727   3715   3698   15   12   29   44   1.62       A117   499   3739   3710   3687   3630   29   23   80   109   1.85       A118   230   3743   3729   3721   3699   14   8   30   44   1.29       A119   308   3742   3728   3716   3679   14   12   49   63   1.91       A120   250   3737   3722   3713   3688   15   9   34   49   1.28       A121   196   3740   3730   3720   3704   10   10   26   36   2.04       A122   404   3736   3713   3692   3650   23   21   63   86   2.06       A123   205   3742   3730   3720   3704   12   10   26   38   1.87       A124   213   3736   3721   3712   3696   15   9   25   40   1.40       A125   541   3719   3683   3668   3600   36   15   83   119   1.02       A126   177   3743   3735   3725   3714   8   10   21   29   3.53       A127   482   3741   3714   3698   3640   27   16   74   101   1.53       A128   300   3740   3723   3715   3682   17   8   41   58   1.13       A129   338   3744   3728   3715   3677   16   13   51   67   3.01       A130   410   3740   3715   3701   3656   25   14   59   84   1.67       A131   258   3738   3724   3710   3690   14   14   34   48   2.37       A132   381   3742   3720   3697   3665   22   23   55   77   3.66       A133   347   3742   3728   3705   3673   14   23   55   69   4.05       A134   376   3743   3723   3710   3667   20   13   56   76   2.65       A135   330   3741   3717   3702   3676   24   15   41   65   1.55       A136   414   3744   3725   3709   3659   19   16   66   85   2.24       A137   381   3739   3711   3693   3662   28   18   49   77   1.47       A138   487   3743   3712   3693   3641   31   19   71   102   1.66       A139   478   3742   3717   3702   3642   25   15   75   100   1.37       A140   482   3743   3710   3690   3642   33   20   68   101   1.38       A141   373   3739   3714   3701   3661   25   13   53   78   1.23       A142   197   3742   3729   3719   3706   13   10   23   36   1.90       A143   239   3739   3726   3710   3693   13   16   33   46   3.25       A144   460   3740   3709   3692   3641   31   17   68   99   1.32       A145   465   3739   3705   3686   3639   34   19   66   100   1.36       A146   347   3736   3718   3705   3664   18   13   54   72   1.68       A147   385   3742   3713   3698   3661   29   15   52   81   1.30       A148   448   3742   3714   3699   3646   28   15   68   96   1.43       A149   427   3744   3710   3692   3653   34   18   57   91   1.37       A150   607   3742   3701   3676   3608   41   25   93   134   1.40       A151   698   3737   3701   3664   3587   36   37   114   150   2.54       A152   293   3738   3716   3705   3683   22   11   33   55   1.29       A153   626   3729   3691   3670   3596   38   21   95   133   1.35       A154   412   3728   3706   3687   3645   22   19   61   83   2.04       A155   365   3739   3724   3694   3667   15   30   57   72   6.02       A156   250   3733   3717   3710   3688   16   7   29   45   1.12       A157   310   3737   3717   3702   3678   20   15   39   59   1.79       A158   263   3737   3723   3713   3689   14   10   34   48   1.60       A159   404   3733   3715   3696   3652   18   19   63   81   3.33       A160   412   3738   3717   3690   3655   21   27   62   83   3.35       A161   331   3740   3720   3706   3676   20   14   44   64   1.80       A162   421   3738   3722   3706   3653   16   16   69   85   3.37       A163   293   3738   3725   3714   3683   13   11   42   55   1.99       A164   267   3734   3720   3712   3685   14   8   35   49   1.40       A165   485   3736   3707   3688   3636   29   19   71   100   1.65       A166   486   3733   3703   3687   3631   30   16   72   102   1.28       A167   235   3734   3718   3711   3690   16   7   28   44   1.10       A168   317   3732   3722   3711   3669   10   11   53   63   2.29       A169   486   3726   3703   3693   3624   23   10   79   102   1.03       A170   304   3740   3717   3703   3680   23   14   37   60   1.45       A171   365   3740   3722   3698   3666   18   24   56   74   3.35       A172   261   3741   3727   3718   3691   14   9   36   50   1.30       A173   304   3740   3718   3704   3680   22   14   38   60   1.43       A174   412   3733   3707   3688   3648   26   19   59   85   1.65       A175   378   3719   3690   3671   3642   29   19   48   77   1.42       A176   337   3739   3724   3712   3671   15   12   53   68   1.69       A177   267   3740   3721   3710   3689   19   11   32   51   1.37       A178   408   3740   3716   3700   3655   24   16   61   85   1.63       A179   329   3738   3718   3705   3672   20   13   46   66   1.64       A180   250   3733   3719   3709   3686   14   10   33   47   1.53       A181   317   3739   3724   3702   3676   15   22   48   63   4.68       A182   354   3739   3716   3706   3667   23   10   49   72   1.02       A183   209   3726   3711   3703   3689   15   8   22   37   1.22       A184   375   3738   3717   3705   3661   21   12   56   77   1.40       A185   458   3736   3712   3689   3639   24   23   73   97   2.58       A186   545   3738   3721   3672   3620   17   49   101   118   7.32       A187   350   3739   3715   3701   3668   24   14   47   71   1.34       A188   300   3731   3717   3702   3672   14   15   45   59   2.34       A189   358   3731   3709   3689   3658   22   20   51   73   2.67       A190   230   3730   3718   3709   3688   12   9   30   42   2.12       A191   234   3738   3725   3717   3696   13   8   29   42   1.26       A192   261   3739   3722   3712   3691   17   10   31   48   1.41       A193   301   3742   3727   3710   3685   15   17   42   57   2.66       A194   257   3735   3721   3708   3688   14   13   33   47   2.17       A195   716   3739   3692   3660   3589   47   32   103   150   1.72       A196   337   3738   3719   3702   3673   19   17   46   65   2.19       A197   502   3739   3705   3691   3637   34   14   68   102   0.87       A198   208   3728   3718   3704   3692   10   14   26   36   2.85       A199   301   3741   3719   3705   3684   22   14   35   57   1.60       A200   274   3737   3718   3708   3686   19   10   32   51   1.25       A201   319   3741   3725   3713   3681   16   12   44   60   1.68       A202   243   3737   3723   3713   3694   14   10   29   43   1.83       A203   364   3740   3715   3704   3670   25   11   45   70   1.07       A204   239   3739   3724   3714   3697   15   10   27   42   1.56       A205   346   3740   3717   3704   3674   23   13   43   66   1.54       A207   319   3728   3711   3701   3668   17   10   43   60   1.37       A208   306   3737   3724   3707   3680   13   17   44   57   3.23       A209   319   3742   3725   3709   3682   17   16   43   60   2.09       A210   283   3740   3723   3714   3688   17   9   35   52   1.31       A211   515   3741   3712   3694   3637   29   18   75   104   1.49       A212   279   3740   3726   3716   3689   14   10   37   51   1.63       A213   448   3741   3724   3705   3652   17   19   72   89   2.62       A214   283   3739   3727   3712   3687   12   15   40   52   3.17       A215   359   3737   3715   3703   3668   22   12   47   69   1.34       A216   389   3741   3722   3707   3667   19   15   55   74   2.60       A217   560   3740   3716   3695   3630   24   21   86   110   2.09       A218   773   3738   3699   3665   3583   39   34   116   155   2.47       A219   238   3741   3729   3714   3699   12   15   30   42   2.74       A220   356   3741   3717   3704   3674   24   13   43   67   1.35       A222   233   3725   3713   3703   3684   12   10   29   41   1.74       A223   257   3741   3724   3717   3695   17   7   29   46   1.00       A224   351   3742   3718   3703   3676   24   15   42   66   1.55       A225   314   3741   3721   3709   3683   20   12   38   58   1.38                    
Though the sample ID&#39;s in Tables 14 and 15 range from A0001 to A225, gaps in sample numbers indicate occurrences where a sample was not able to be tested because they were beyond three standard deviations.
 
         [0000]                                                              TABLE 16                               R 2     mY                                        INRw                       vs   TPC INRm   0.9482   1.0506x               TPC INRz   0.9482   1.0389x               TPC INRn   0.9401   1.048x           INRw           vs   INRm   −0.0908   −0.0186x               INRz   −0.0966   −0.0144x               INRn   0.0327   −0.0065x                        
The linear regression analysis expression y=m×+b, when solved for the slope, m, is expressed as (y−b)/x. This is biased, so the expression is y/x is when b is equal to zero. The comparison in Table 16, above, provides comparative data for mean y (mY) and mean x (mX) values, including the slope mY/mX. The use of the mY/mX is used to provide comparative results. The data in Table 16 is also represented on the Bland-Altman plots shown in  FIGS. 8 ,  9 ,  10  and  11 . The statistical data and plots demonstrate that the INRn may replace prior WHO INR and provide results which are within the parameters of traditional therapeutic or reference ranges.
 
         [0167]    In accordance with one embodiment, the IBM-compatible computer  30  of  FIG. 1  stores and manipulates these digital values corresponding to the clotting curve represented in  FIG. 6  and the related data provided in Tables 14 and 15. According to a preferred embodiment, the computer may be programmed as follows:
       (k) a sample of blood where the plasma is available, such as, for example, a sample of citrated blood, is obtained and placed in an appropriate container, the computer  30 , as well as the recorder  28 , sequentially records voltage values for a few seconds before injection of the reagent (thromboplastin calcium combined). As previously discussed, thromboplastin (tissue factor) is one of the factors in the human body that causes blood to clot. Prothrombin is another. Fibrinogen is yet another. Before injection of the thromboplastin, the output from the A/D converter  26  is relatively constant. When thromboplastin is injected into the plasma sample in the container, a significant and abrupt change occurs in the recorded voltage values of both the computer  30  and the recorder  28 . This abrupt change is recognized by both the recorder  28  and, more importantly, by the computer  30  which uses such recognition to establish T o . The computer  30  may be programmed so as to correlate the digital quantities of the A/D converter  26  to the analog output of the detector means photocell  10  which, in turn, is directly correlatable to the fibrinogen (FBG) concentration g/l of the sample of blood discussed herein and represented by the clotting curve shown in  FIG. 6 ;   (l) the computer  30  may be programmed to look for a digital quantity representative of a critical quantity F1, and when such occurs, record its instant time T 1 . (The time span between T o  and T 1  is the prothromibin time (PT), and has an normal duration of about 12 seconds, but may be greater than 30 seconds);   (m) following the detection of the quantity c 1 , the computer  30  may be programmed to detect for the acceleration of fibrinogen (FBG) to fibrin conversion. The computer  30  is programmed to detect the maximum acceleration quantity c MAP  or c T2  as illustrated in  FIG. 6 , and its corresponding time of occurrence t MAP , which is T2 in  FIG. 6 .   (d) The computer detects a quantity c EOT  occurring at time t EOT . Typically, it is important that the rate of fibrin formation increase for at least 1.5 seconds following the occurrence of (T 1 ); the computer determines a theoretical end of test (TEOT) based on the determination of the zero order kinetic rate. The computer may be programmed to determine the zero order rate, which is expressed as a Line (L) in  FIG. 6 . The TEOT may be determined by the corresponding time value (TEOT) along the line L which corresponds with the quantity CEOT (i.e., that corresponds with the value for T3);   (e) The computer  30  is programmed to ascertain the value for the time to start (T 2 S) which corresponds with the time at which the simulated zero order kinetic rate begins.   (f) Following the detection of the acceleration of fibrinogen conversion to detect the start time T 2 S, the computer  30  is programmed to detect for a deceleration of the fibrinogen conversion, wherein the fibrinogen concentration decreases from a predetermined quantity c MAP  to a predetermined quantity c EOT  having a value which is about equal but less than the first quantity c 1 . The computer is programmed to ascertain a first delta (IUTz), by determining the difference between the quantity c T2S  and the quantity c EOT ; and a second delta (IUXz) by determining the difference between the quantity c T2S  and the quantity c 2  (or c MAP). ; the computer also determines the value ZTM by determining the difference between the time T 2  (which is Tmap) and the time T 2 S;   (g) the computer  30  manipulates the collected data of (a); (b); (c); (d), (e) and (f) above, to determine the new fibrinogen transfer rate (nFTR). The nFTR may be arrived at based on the principle that if a required amount (e.g., 0.05 g/l) of fibrinogen concentration c 1  is first necessary to detect a clot point (t 1 ); then when the fibrinogen concentration (c EOT ) becomes less than the required amount c 1 , which occurs at time (t EOT ), the fibrinogen end point has been reached. More particularly, the required fibrinogen concentration c 1  is the starting point of fibrinogen conversion of the clotting process and the less than required fibrinogen concentration c EOT  is the end point of the fibrinogen conversion of the clotting process.   (h) the duration of the fibrinogen conversion of the clotting process of the present invention is defined by the zero order time period between TEOT and T 2 S and is generally indicated in  FIG. 6  as IUTz. The difference between the corresponding concentrations c T2S  and cT2 is used to define a delta IUXz.       
 
         [0176]    The computer now has the information needed to determine the TEOT, which is expressed by the following formula: 
         [0000]      TEOT= T 2S+(ZTM/IUX*IUT)  (12)       The TEOT is determined and the data collected is manipulated by the computer  30  to determine a new INR, referred to as INRn:         
         [0000]      INRn=(( T   1 +TEot)/2)*0.00535 *T   2   S   (11)       Using the multiplier MUL (which in this example, as discussed herein and according to expression 10 above, preferably is 0.00535).         
         [0179]    The computer  30  may be used to manipulate and derive the quantities of expression (11) to determine a new INR (INRn) utilizing known programming routines and techniques. The data collected by a computer  30  may be used to manipulate and derive INRn of expression (11). Similarly, one skilled in the art, using known mathematical techniques may derive the theoretical end of test TEOT of expression (5), and using the TEOT value in expression (11), in turn, may determine the new INR, INRn of expression (12). In the INRn determination, the determination is based on the patient&#39;s own sample, and does not rely on the determination of normal prothrombin times for the reagent used (e.g., thromboplastin, innovin or the like). With the INRn determination method, no longer does the accuracy of the quantities determined depend, in whole or part, on the number of specimens used, that is, the number of stable (or presumed stable) patients. 
         [0180]    The new anticoagulation therapy value (INRn) does not require an ISI value, as was previously used to determine anticoagulation therapy factors. The new anticoagulation therapy value INRn uses for its ascertainment the values extracted from the clotting curve (see  FIG. 6 ), in particular T 2 S, Tmap, TEOT, c1, c T2S , ct2 and ceot. In determining the new INRn, the ISI is not required, nor is the MNPT, or the need to obtain and calculate the prothrombin times (PT&#39;s) for 20 presumed normal patients. In carrying out coagulation studies, the new anticoagulant therapy factor INRn may replace the INR traditionally used in anticoagulant therapy management (such as INR WHO and INRm). In addition, using the sample from the patient, the computer  30  has knowledge of the values obtained for the fibrinogen reaction, to ascertain the INRn. 
         [0181]    It should now be appreciated that the present invention provides an apparatus and method for obtaining an new anticoagulant therapy value INRn without encountering the complications involved with obtaining the prior art quantities International Normalized Ratio (INR) and International Sensitivity Index (ISI). 
         [0182]    The new International Normalized Ratio (INRn) preferably is a replacement for the International Normalized Ratio (INR) such as that of the WHO or the manufacturers of the clotting reagent that may provide an ISI for use with their particular clotting reagent. Existing medical literature, instrumentation, and methodologies are closely linked to the International Normalized Ratio (INR). The new INRn was compared for correlation with the INR by comparative testing, to INR quantities of INRw and INRm, even with the understanding that the INR determination may have an error of about +/−15%, at a 95% confidence interval, which needs to be taken into account to explain certain inconsistencies. The hereinbefore description of the new INRn does correlate at least as well as, and preferably better than, studies carried out using the traditional methods and determinations involving International Normalized Ratio (INR). For some comparisons, see the table above, and, in particular, Tables 11, 12 and 13. 
         [0183]    While the invention has been described with reference to specific embodiments, the description is illustrative and is not to be construed as limiting the scope of the invention. The sample container used to contain the sample may comprise a vial, or cuvette, including, for example, the sample container disclosed in our U.S. Pat. No. 6,706,536. For example, although described in connection with body fluids of a human, the present invention has applicability to veterinary procedures, as well, where fluids are to be measured or analyzed. Various modifications and changes may occur to those skilled in the art without departing from the spirit and scope of the invention described herein and as defined by the appended claims.

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