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Timestamp: 2014-03-17 11:24:00
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Matched Legal Cases: ['Application No. 2007201377', 'Application No. 2009202200', 'application No. 2007201377', 'application No. 2008221593', 'application No. 2009200097', 'application No. 2011201199', 'application No. 2008221593', 'application No. 2582643', 'application No. 2582643', 'application No. 2639776', 'Application No. 2648625', 'Application No. 200910134602', 'application No. 07251388', 'Application No. 07251388', 'Application No. 07', 'Application No. 08', 'Application No. 10', 'Application No. 10', 'Application No. 2011', 'Application No. 2009']

Patent US20090184004 - System and method for measuring an analyte in a sample - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsMethods of determining a corrected analyte concentration in view of some error source are provided herein. The methods can be utilized for the determination of various analytes and/or various sources of error. In one example, the method can be configured to determine a corrected glucose concentration...http://www.google.com/patents/US20090184004?utm_source=gb-gplus-sharePatent US20090184004 - System and method for measuring an analyte in a sampleAdvanced Patent SearchPublication numberUS20090184004 A1Publication typeApplicationApplication numberUS 12/349,017Publication dateJul 23, 2009Filing dateJan 6, 2009Priority dateJan 17, 2008Also published asCA2648625A1, CN101598702A, CN101598702B, CN103293214A, EP2098857A2, EP2098857A3, EP2508876A1, EP2508877A1, EP2511698A1, US8603768, US20130068633, US20130098763Publication number12349017, 349017, US 2009/0184004 A1, US 2009/184004 A1, US 20090184004 A1, US 20090184004A1, US 2009184004 A1, US 2009184004A1, US-A1-20090184004, US-A1-2009184004, US2009/0184004A1, US2009/184004A1, US20090184004 A1, US20090184004A1, US2009184004 A1, US2009184004A1InventorsRonald C. Chatelier, Alastair M. Hodges, Santhanagopalan NandagopalanOriginal AssigneeLifescan, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (99), Non-Patent Citations (50), Referenced by (16), Classifications (11), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetSystem and method for measuring an analyte in a sampleUS 20090184004 A1Abstract Methods of determining a corrected analyte concentration in view of some error source are provided herein. The methods can be utilized for the determination of various analytes and/or various sources of error. In one example, the method can be configured to determine a corrected glucose concentration in view of an extreme level of hematocrit found within the sample. In other embodiments, methods are provided for identifying various system errors and/or defects. For example, such errors can include partial-fill or double-fill situations, high track resistance, and/or sample leakage. Systems are also provided for determining a corrected analyte concentration and/or detecting some system error.
G 2 = G 1  ( 1 + Corr 100 ) if the initial glucose concentration G1 is greater than a glucose threshold.
RELATED APPLICATIONS This application claims priority pursuant to 35 U.S.C. � 119 to U.S. Provisional Patent Application Ser. No. 61/021,713, entitled �System and Method For Measuring An Analyte In A Sample,� filed on Jan. 17, 2008, the entirety of this application being incorporated herein by reference thereto.
FIELD The present disclosure relates to methods and systems for determining analyte concentration of a sample.
BACKGROUND Analyte detection in physiological fluids, e.g. blood or blood derived products, is of ever increasing importance to today's society. Analyte detection assays find use in a variety of applications, including clinical laboratory testing, home testing, etc., where the results of such testing play a prominent role in diagnosis and management of a variety of disease conditions. Analytes of interest include glucose for diabetes management, cholesterol, and the like. In response to this growing importance of analyte detection, a variety of analyte detection protocols and devices for both clinical and home use have been developed.
SUMMARY OF THE INVENTION Various aspects of a method of calculating a corrected analyte concentration of a sample are provided. That is, the methods typically include making an initial analyte determination, determining a correction factor based on various system measurements and/or parameters, and modifying the initial analyte concentration based on the correction factor thereby overcoming some source of error. For example, the analyte can be glucose and the error source can be an increased hematocrit level which if not accounted for could result in an incorrect reading. Other methods account for various system errors such as double-dosing events, maximum current check, minimum current check, high resistance track, and/or leakage. While the methods provided below are focused on the detection of glucose, various other protocols are within the spirit and scope of the disclosure. For example, the method can be utilized for the detection or measurement of lactate, cholesterol, hemoglobin or total antioxidants.
G 2 = G 1  ( 1 + Corr 100 ) . As will be apparent to those skilled in the art, any number and magnitude of test voltages can be supplied to the sample at any number or pattern of time intervals. For example, in one embodiment, the second test voltage V2 can be applied immediately after the first test voltage V1. Also, the first test voltage V1 can have a first polarity and the second test voltage V2 has a second polarity wherein the first polarity is opposite in magnitude or sign to the second polarity. As indicated, the first and second test voltage can be of virtually any amount capable of providing the desired effect. For example, in one embodiment, the first test voltage V1 can range from about −100 mV to about −600 mV with respect to the second electrode, and the second test voltage V2 can range from about +100 mV to about +600 mV with respect to the second electrode. Additionally, the method can further include applying a third test voltage V3 for a third time interval T3 between the first electrode and the second electrode where the absolute magnitude of the resulting test current is substantially less than the absolute magnitude of the resulting test current for the second test voltage V2. The third test voltage can be applied before the first test voltage V1 or at any other time interval (e.g., after the second test voltage) as desired. Additionally, various arrangement and/or configurations of electrodes are included herein. For example, in an exemplary embodiment, the first electrode and the second electrode can have an opposing face arrangement. Additionally, a reagent layer can be disposed on the first electrode.
G 2 = G 1  ( 1 + Corr 100 ) . In one embodiment, the method can also include applying a third test voltage V3 for a third time interval T3 between the first electrode and the second electrode where the absolute magnitude of the resulting test current is substantially less than the absolute magnitude of the resulting test current for the second test voltage V2. In such an embodiment, the third test voltage V3 can be applied before the first test voltage V1. In such an embodiment, the third test voltage V3 is of a magnitude that results in a test current that is substantially less than the absolute magnitude of the resulting test current for the second test voltage V2 to minimize interference with the currents that are measured during the application of V1 and V2. The smaller current flowing during the application of V3 means a smaller amount of redox species is electrochemically reacted at the electrodes so less disruption of the concentration profiles of the redox species in the electrochemical cell will be caused by the application of V3.
ratio = i 1 i 1 - i 2 , where i1 is the first test current and i2 is the second test current. In use, the method can include a step of providing an error message indicating a defective test strip if the ratio is greater than a first predetermined threshold (e.g., about 1.2).
log  ( i 1 i 2 ) log  ( i 3 i 4 ) , where i1 is the first test current, i2 is the second test current, i3 is the third test current, and i4 is the fourth test current. In use, the method can further include a step of providing an error message indicating a defective test strip if the third ratio is less than a predetermined threshold (e.g., about 1, about 0.95, etc.).
The formulation can be applied at some desired rate (e.g., about 570 μL/min) using a 13 gauge needle poised about 150 μm above a palladium web moving at about 10 n/min. Before coating the palladium web with the enzyme formulation, the web can be coated with 2-mercaptoethane sulfonic acid (MESA). A spacer having a desired thickness (e.g., about 95 μm) with a channel cut therein having some desired width (e.g., a width of about 1.2 mm) can be laminated to the reagent layer and the palladium web at some desired temperature (e.g., about 70� C.). A MESA-coated gold web can be laminated to the other side of the spacer. The spacer can be made from a polymer substrate such as polyester coated on both sides with a thermoplastic adhesive such as Vitel, which is a linear saturated copolyester resin having a relatively high molecular weight. Release liners can optionally be laminated on top of the adhesive layer on each side of the spacer to protect the adhesive until lamination. The resulting laminate can be cut such that the fill path of the sample-receiving chamber is about 3.5 mm long, thus giving a total volume of about 0.4 μL.
In one embodiment, the test meter 100 can perform a glucose test by applying a plurality of test voltages for prescribed intervals, as shown in FIG. 6. The plurality of test voltages may include a first test voltage V1 for a first time interval T1, a second test voltage V2 for a second time interval T2, and a third test voltage V3 for a third time interval T3. A glucose test time interval TG represents an amount of time to perform the glucose test (but not necessarily all the calculations associated with the glucose test). The glucose test time interval TG can range from about 1 second to about 15 seconds or longer and more preferably from about 1 second to about 5 seconds. The plurality of test current values measured during the first, second, and third time intervals may be performed at a frequency ranging from about 1 measurement per nanosecond to about one measurement per 100 milliseconds. While an embodiment using three test voltages in a serial manner is described, one skilled in the art will appreciate that the glucose test can include different numbers of open-circuit and test voltages. For example, as an alternative embodiment, the glucose test could include an open-circuit for a first time interval, a second test voltage for a second time interval, and a third test voltage for a third time interval. One skilled in the art will appreciate that names �first,� �second,� and �third� are chosen for convenience and do not necessarily reflect the order in which the test voltages are applied. For instance, an embodiment can have a potential waveform where the third test voltage can be applied before the application of the first and second test voltage.
G 1 = ( i 2 i 3 ) p � ( a � i 1 - z ) Eq .  1 In Equation 1, i1 is a first test current value, i2 is a second test current value, and i3 is a third test current value, and the terms p, z, and a are empirically derived calibration constants. All test current values (i.e., i1, i2, and i3) in Equation 1 use the absolute value of the current. The first test current value i1 and the second test current value i2 can each be defined by an average or summation of one or more predetermined test current values that occur during the third time interval T3. The third test current value i3 can be defined by an average or summation of one or more predetermined test current values that occur during the second time interval T2. One skilled in the art will appreciate that names �first,� �second,� and �third� are chosen for convenience and do not necessarily reflect the order in which the current values are calculated.
i 1 = i 2  { i pc - 2  i pb + i ss i pc + i ss } Eq .  2 A calculation of the steady-state current iss can be based on a mathematical model, an extrapolation, an average at a predetermined time interval, or a combination thereof. One example of a method for calculating iss can be found in U.S. Pat. No. 6,413,410 and U.S. Pat. No. 5,942,102, the entirety of these patents being incorporated herein by reference.
G 1 = ( i 2 i 3 ) p � ( a � i 2 � { i pc - 2  i pb + i ss i pc + i ss } - z ) Eq .  3 In addition to endogenous interferents, extreme hematocrit levels under certain circumstances can affect the accuracy of a glucose measurement. Thus, Equation 3 can be further modified to provide a corrected glucose concentration G2 that is accurate even if the sample has an extreme hematocrit level (e.g., about 10% or about 70%).
Analyte Detection at Extreme Hematocrit Levels: Methods and systems of accurately measuring glucose concentrations in extreme hematocrit samples are provided herein. For example, FIG. 8 is a flow diagram depicting a method 2000 for calculating an accurate glucose concentration that accounts for blood samples having an extreme hematocrit level. A user can initiate a test by applying a sample to the test strip, as shown in step 2001. A first test voltage V1 can be applied for a first time interval T1, as shown in step 2002. The resulting test current is then measured for the first time interval T1, as shown in step 2004. After the first time interval T1, the second test voltage V2 is applied for a second time interval T2, as shown in step 2006. The resulting test current is then measured for the second time interval T2, as shown in step 2008. After the second time interval T2, the third test voltage V3 is applied for a third time interval T3, as shown in step 2010. The resulting test current is then measured for the third time interval T3, as shown in step 2012.
G 2 = G 1  ( 1 + Corr 100 ) Eq .  10 After the corrected glucose concentration G2 is calculated in either step 2038 or step 2040, it is outputted as a glucose reading in step 2042.
Identifying System Errors: Various embodiments of a method for identifying system errors, which may include user errors when performing a test, test meter errors, and defective test strips, are also provided. For example, FIG. 11 is a flow diagram depicting an exemplary embodiment of a method 1000 of identifying system errors in performing an analyte measurement. As shown, a user can initiate a test by applying a sample to a test strip, as shown in step 1002. After the sample has been dosed, the test meter applies a first test voltage V1 for a first time interval T1, as shown in step 1004 a. A resulting test current is then measured for the first time interval T1, as shown in step 1005 a. During the first time interval T1, the test meter performs a double dose check 1006 a, and a maximum current check 1012 a. If either the double dose check 1006 a or maximum current check 1012 a fails, then the test meter will display an error message, as shown in step 1028. If the double dose check 1006 a and maximum current check 1012 a both pass, then the test meter can apply a second test voltage V2 for a second time interval T2, as shown in step 1004 b. A resulting test current is measured for the second time interval T2, as shown in step 1005 b. During the application of the second test voltage V2, the test meter performs a double dose check 1006 b, a maximum current check 1012 b, and a minimum current check 1014 b. If one of the checks 1006 b, 1012 b, or 1014 b fail, then the test meter will display an error message, as shown in step 1028. If all of the checks 1006 b, 1012 b, and 1014 b pass, then the test meter will apply a third test voltage V3, as shown in step 1004 c. A resulting test current is measured for the third time interval T3, as shown in step 1005 c. During the application of the third test voltage V3, the test meter performs a double dose check 1006 c, maximum current check 1012 c, a minimum current check 1014 c, a high resistance check 1022 c, and a sample leakage check 1024 c. If all of the checks 1006 c, 1012 c, 1014 c, 1022 c, and 1024 c pass, then the test meter will display a glucose concentration, as shown in step 1026. If one of the checks 1006 c, 1012 c, 1014 c, 1022 c, and 1024 c fails, then the test meter will display an error message, as shown in step 1028.
Double-Dosing Events A double dose occurs when a user applies an insufficient volume of blood to a sample-receiving chamber and then applies a subsequent bolus of blood to further fill the sample-receiving chamber. An insufficient volume of blood expressed on a user's fingertip or a shaky finger can cause the occurrence of a double-dosing event. The currently disclosed system and method can be configured to identify such double-fill events. For example, FIG. 12 shows a test current transient where a double-dosing event occurs during the second test time interval T2 thereby causing a spike to be observed (see solid line). When there is no double-dosing event, the test current transient does not have a peak (see dotted line of FIG. 12).
Maximum Current Check As referred to in steps 1012 a, 1012 b, and 1012 c of FIG. 11, a maximum current check can be used to identify a test meter error or a test strip defect. An example of a test meter error occurs when the blood is detected late after it is dosed. An example of a defective test strip occurs when the first and second electrodes are shorted together. FIG. 13 shows a test current transient where the test meter did not immediately detect the dosing of blood into the test strip (see solid line). In such a scenario, a late start will generate a significant amount of ferrocyanide before the second test voltage V2 is applied causing a relatively large test current value to be observed. In contrast, when the test meter properly initiates the test voltage waveform once blood is applied, the test current values for the second time interval are much smaller, as illustrated by the dotted line in FIG. 13.
Minimum Current Check: As referred to in steps 1014 b and 1014 c of FIG. 11, a minimum current check can be used to identify various potential issues, such as, for example, a false start of a glucose test, an improper time shift by a test meter, and a premature test strip removal. A false start can occur when the test meter initiates a glucose test even though no sample has been applied to the test strip. Examples of situations that can cause a test meter to inadvertently initiate a test are an electrostatic discharge event (ESD) or a temporary short between first and second electrodes. Such events can cause a relatively large current to be observed for a least a short moment in time that initiates a test even though no liquid sample has been introduced into the test strip.
High Resistance Track: As referred to in step 1022 c of FIG. 11, a high resistance track can be detected on a test strip that can result in an inaccurate glucose reading. A high resistance track can occur on a test strip that has an insulating scratch or a fouled electrode surface. For the situation in which the electrode layers are made from a sputtered gold film or sputtered palladium film, scratches can easily occur during the handling and manufacture of the test strip. For example, a scratch that runs from one lateral edge 56 to another lateral edge 58 on first electrode layer 66 can cause an increased resistance between the first contact pads 67 and the first electrode 66. Sputtered metal films tend to be very thin (e.g., about 10 nm to about 50 nm) making them prone to scratches during the handling and manufacture of the test strip. In addition, sputtered metal films can be fouled by exposure to volatile compounds such as, for example, hydrocarbons. This exposure causes an insulating film to form on the surface of the electrode, which increases the resistance. Another scenario that can cause a high resistance track is when the sputtered metal film is too thin (e.g., less than about 10 nm). Yet another scenario that can cause a high resistance track is when the test meter connectors do not form a sufficiently conductive contact to the test strip contact pads. For example, the presence of dried blood on the test meter connectors can prevent sufficiently conductive contact to the test strip contact pads.
R 1 = i 1 i 1 - i 2 Eq .  14 If the first ratio R1 is greater than a predetermined threshold, then the test meter may output an error message due to the test strip having a high resistance track. The predetermined threshold may be about 1.2. It is significant that the first test current i1 is about a maximum current value because it is the most sensitive to resistance variations according to Eq. 13. If a first test current i1 is measured at a time that was closer to the minimum current value, then Equation 14 would be less sensitive for determining whether a high resistance track was present. It is advantageous to have relatively low variation in the first ratio R1 when testing low resistance test strips. The relatively low variation decreases the likelihood of mistakenly identifying a high resistance track test strip. As determined and described herein, the variation of first ratio R1 values for test strips having a low resistance track is about four times lower when a first test current value i1 was defined as a current value immediately after the application of the third test voltage V3, as opposed to being a sum of current values during the third time interval T3. When there is a high variation in first ratio R1 values for low resistance test strips, the probability of mistakenly identifying a high resistance track increases.
Leakage As previously referred to in step 1024 c in FIG. 11, a leakage can be detected on a test strip when the spacer 60 does not form a sufficiently strong liquid impermeable seal with the first electrode layer 66. A leakage occurs when liquid seeps in between the spacer 60 and the first electrode 66 and/or the second electrode 64. FIG. 4B shows a reagent layer 72 that is immediately adjacent to the walls of the spacer 60. However, in another embodiment (not shown) where leakage is more likely to occur, the reagent layer 72 can have an area larger than the cutout area 68 that causes a portion of the reagent layer 72 to be in between the spacer 60 and the first electrode layer 66. Under certain circumstances, interposing a portion of the reagent layer 72 in between the spacer 60 and the first electrode layer 66 can prevent the formation of a liquid impermeable seal. As a result, a leakage can occur which creates an effectively larger area on either the first electrode 66, which in turn, can cause an inaccurate glucose reading. An asymmetry in the area between the first electrode 66 and the second electrode 64 can distort the test current transient where an extra hump appears during the third time interval T3, as illustrated in FIG. 16.
FIG. 16 shows test current transients during a third time interval T3 for three different types of test strip lots where test strip lot 1 (squares) has a leakage of liquid between the spacer and the first electrode. Test strip lot 1 was constructed using a dryer setting that did not sufficiently dry the reagent layer and also was laminated with a pressure setting that was not sufficient to form a liquid impermeable seal to the electrodes. Normally, the reagent layer is sufficiently dried so that an adhesive portion of the spacer 60 can intermingle with the reagent layer and still forms a liquid impermeable seal to the first electrode layer 66. In addition, sufficient pressure must be applied so that the adhesive portion of the spacer 60 can form the liquid impermeable seal to the first electrode layer 66. The test strip lot 2 was prepared similarly to test strip lot 1 except that they were stored at about 37� Celsius for about two weeks. The storage of the test strip lot 2 caused the adhesive bond to anneal creating a liquid impermeable seal to the electrodes. Test strip lot 3 was constructed using a dryer setting that was sufficient to dry the reagent layer and also was laminated with a pressure setting sufficient to form a liquid impermeable seal. Both test strip lots 2 and 3 (triangles and circles respectively) show a more rapid decay in the test current magnitude with time compared to test strip 1 (squares), as illustrated in FIG. 16.
R 4 = log  ( i 1 i 2 ) log  ( i 3 i 4 ) Eq .  15 In one embodiment, the first test current i1 and the second test i2 current may be about the two largest current values occurring during the third time interval T3. The fourth test current i4 may be a smallest current value occurring during the third time interval T3. The third test current i3 may be selected at a third test time so that a difference between the fourth test time and a third test time is greater than a difference between a second test time and a first test time. In one illustrative embodiment, the first test current, the second test current, the third test current, and the fourth test current may be measured at about 4.1 seconds, about 4.2 seconds, about 4.5 seconds, and about 5 seconds, respectively.
R 5 = log  ( i 1 i 3 ) log  ( i 3 i 4 ) Eq .  16 One skilled in the art will appreciate further features and advantages of the present disclosure based on the above-described embodiments. Accordingly, the present disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.
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