Abstract:
The present invention is to present a biological sample analyzer, comprising: a characteristic information obtainer for obtaining characteristic information representing a characteristic of a component contained in a biological sample of a patient; a processor; and a memory storing software instructions adapted to enable the processor to perform operations comprising: (a) analyzing the characteristic information based on a first condition for analyzing a biological sample of a patient who does not have a predetermined attribution; and (b) analyzing the characteristic information based on a second condition for analyzing a biological sample of a patient who has the predetermined attribution.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority under 35 U.S.C. §119 to Japanese Patent Application No. JP2008-088828 filed Mar. 28, 2008, the entire content of which is hereby incorporated by reference. 
       FIELD OF THE INVENTION 
       [0002]    The present invention relates to a biological sample analyzer and computer program product for analyzing biological samples such as blood, urine and the like from a human patient. 
       BACKGROUND 
       [0003]    Conventional sample analyzers for analyzing biological sample such as blood and urine are disclosed, for example, in U.S. Pat. No. 6,391,263 and Japanese Laid-Open Patent Publication No. 2003-083960. 
         [0004]    A sample analyzer which allows the analysis condition to be modified according to animal species is disclosed in U.S. Pat. No. 6,391,263. 
         [0005]    A blood analyzer which measures blood after diluting the blood with a reagent to increase the amount, and thereafter performs a calculation process to correct for the additional amount, when it is difficult to collect a sufficient amount of blood as in the case of a child, and when analyzing a sample which has an abnormally number of blood cells, is disclosed in Japanese Laid-Open Patent Publication No. 2003-083960. 
         [0006]    Since sample attributes vary widely depending on the animal species when samples are collected from animals other than humans, analyzers have been developed which execute sample analysis after changing the analysis condition according the animal species as in the previously mentioned case of U.S. Pat. No. 6,391,263. 
         [0007]    Because sample attributes do not vary much according to the patient when samples are collected from humans, there is no need to change the analysis condition depending on the sample. However, ever greater analysis precision has come to be required by analyzers over the years, and conventional analyzers may not meet such requirements. 
         [0008]    For example, the blood analyzer disclosed in Japanese Laid-Open Patent Publication No. 2003-083960 performs measurements of blood which may be of insufficient quantity such as blood collected from a child under conditions which correspond to the attributes of adult human blood after having increased the quantity of the blood by diluting the blood more than usual, and cannot perform such measurements under condition which correspond to the attributes of child humans. Therefore, it is difficult to perform precision analysis in accordance with a full range of human attributes using the blood analyzer disclosed in Japanese Laid-Open Patent Publication No. 2003-083960. 
       SUMMARY OF THE INVENTION 
       [0009]    A first aspect of the present invention is a biological sample analyzer, comprising: a characteristic information obtainer for obtaining characteristic information representing a characteristic of a component contained in a biological sample of a patient; a processor; and a memory storing software instructions adapted to enable the processor to perform operations comprising: (a) analyzing the characteristic information based on a first condition for analyzing a biological sample of a patient who does not have a predetermined attribution; and (b) analyzing the characteristic information based on a second condition for analyzing a biological sample of a patient who has the predetermined attribution. 
         [0010]    A second aspect of the present invention is a biological sample analyzer, comprising: a characteristic information obtainer which obtains characteristic information representing a characteristic of a component contained in a biological sample of a patient based on a first obtaining condition when the patient does not have a predetermined attribution, and obtains characteristic information representing the characteristic of the component contained in the biological sample of the patient based on a second obtaining condition when the patient has the predetermined attribution; and a processing section for executing an operation to analyze the characteristic information obtained by the characteristic information obtainer. 
         [0011]    A third aspect of the present invention is a computer program product for enabling a computer to control a biological sample analyzer, comprising: a computer readable medium, and software instructions, on the computer readable medium, for enabling the computer to perform predetermined operations comprising: (a) controlling the biological sample analyzer so as to obtain characteristic information representing a characteristic of a component contained in a biological sample of a patient; (b) analyzing the characteristic information based on a first condition for analyzing a biological sample of a patient who does not have a predetermined attribution; and (c) analyzing the characteristic information based on a second condition for analyzing a biological sample of a patient who has the predetermined attribution. 
         [0012]    A fourth aspect of the present invention is a computer program product for enabling a computer to control a biological sample analyzer, comprising: a computer readable medium, and software instructions, on the computer readable medium, for enabling the computer to perform predetermined operations comprising: (a) controlling the biological sample analyzer so as to obtain characteristic information representing a characteristic of a component contained in a biological sample of a patient based on a first obtaining condition corresponding to a patient who does not have a predetermined attribution; (b) controlling the biological sample analyzer so as to obtain characteristic information representing the characteristic of the component contained in the biological sample of the patient based on a second obtaining condition corresponding to a patient who has the predetermined attribution; and (c) analyzing the characteristic information obtained in at least one of the operation (a) and the operation (b). 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1  is a perspective view schematically showing the structure of the biological sample analyzer of a first embodiment of the present invention; 
           [0014]      FIG. 2  is a block diagram showing the structure of the measuring device of the biological sample analyzer of the first embodiment of the present invention; 
           [0015]      FIG. 3  is a block diagram schematically illustrating the structure of the sample preparing section of the first embodiment of the present invention; 
           [0016]      FIG. 4  is a block diagram schematically illustrating the structure of the detecting section and the analog processing section of the first embodiment of the present invention; 
           [0017]      FIG. 5  is a block diagram showing the structure of the operation display device of the biological sample analyzer of the first embodiment of the present invention; 
           [0018]      FIG. 6  shows an example of the data structure of the age information storage section; 
           [0019]      FIG. 7  shows an example of a scattergram produced by the leukocyte classification measurement (DIFF measurement); 
           [0020]      FIG. 8  shows an example of the relationship between sampling values and lymphocyte distribution region in the scattergram produced by the DIFF measurement; 
           [0021]      FIG. 9  is a flow chart showing the CPU processing sequences of the operation display device and controller of the control board of the measuring device of the first embodiment of the present invention; 
           [0022]      FIG. 10  is a flow chart showing the child blood analysis processing sequence of the CPU of the operation display device of the first embodiment of the present invention; 
           [0023]      FIG. 11  shows an example of a measurement data operation processing result; 
           [0024]      FIG. 12  is a flow chart showing the CPU reanalysis processing sequence of the operation display device of the first embodiment of the present invention; and 
           [0025]      FIG. 13  is a flow chart showing the CPU processing sequences of the operation display device and controller of the control board of the measuring device of a second embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0026]    A blood analyzer for analyzing blood is specifically described hereinafter as an example of the biological sample analyzer of the present embodiment based on the drawings. The analysis process thus is a blood cell classification process, and the analysis data are generated as classification data. Note that the blood analyzer of the present embodiment is configured to analyze blood of human beings. 
       First Embodiment  
       [0027]      FIG. 1  is a perspective view schematically showing the structure of the first embodiment of the biological sample analyzer of the present invention; As shown in  FIG. 1 , the biological sample analyzer of the first embodiment is configured by a measuring device  1 , and an operation and display device  2  which is connected to the measuring device  1  so as to be capable of data communication therewith. 
         [0028]    The measuring device  1  and the operation and display device  2  are connected via a communication line which is not shown in the drawing. The operation and display device  2  controls the operation of the measuring device  1 , processes the measurement data output from the measuring device  1 , and obtains analysis results through data communication with the measuring device  1 . The measuring device  1  and the operation and display device  2  may also be connected over a network, or may be configured as a single integrated device so as to send and receive data by interprocess communication and the like. 
         [0029]    The measuring device  1  detects characteristics information of the leukocytes, reticulocytes, and platelets in the blood using flow cytometry, and transmits the detection data as measurement data to the operation and display device  2 . Flow cytometry is a measurement method which forms a sample flow that includes a measurement sample, detects light such as forward scattered light, side scattered light, and side fluorescent light that is emitted by the particles (blood cells) in the measurement sample when the measurement sample is irradiated by laser light to detect the particles (blood cells) in the measurement sample. 
         [0030]      FIG. 2  is a block diagram showing the structure of the measuring device  1  of the biological sample analyzer of the first embodiment of the present invention. The measuring device  1  is provided with a device mechanism  4 , detecting section  5  for executing the measurement of a measurement sample, an analog processing section  6  for processing the output of the detecting section  5 , display and operation section  7 , and control board  9  for controlling the operation of the various hardware. 
         [0031]    The control board  9  is provided with a controller  91  which has a control processor and a memory for the operation of the control processor, twelve-bit A/D converter  92  for converting the signals output from the analog processing section  6  to digital signals. And an operation section  93  for storing the digital signals output from the A/D converter  92  and executing a process for selecting data to be output top the controller  91 . The controller  91  is connected to the display and operation section  7  through a bus  94   a  and an interface  95   b,  connected to the device mechanism  4  through the bus  94   a  and an interface  95   a,  and connected to the operation and display device  2  through a bus  94   b  and an interface  95   c.  The operation section  93  outputs the operation results to the controller  91  through an interface  95   d  and the bus  94   a.  The controller  91  also transmits the operation results (measurement data) to the operation and display device  2 . 
         [0032]    The device mechanism  4  is provided with a sample preparing section  41  for preparing a measurement sample from blood and reagent. The sample preparing section  41  prepares leukocyte measurement samples, reticulocyte measurement samples, and platelet measurement samples. 
         [0033]      FIG. 3  is a block diagram schematically illustrating the structure of the sample preparing section  41  of the first embodiment of the present invention. The sample preparing section  41  is provided with a collection tube  41   a  to be filled with a predetermined amount of blood, sampling valve  41   b  for aspirating the blood, and a reaction chamber  41   c.    
         [0034]    The sampling valve  41   b  is configured to be capable of determining the amount of blood within the collection tube  41   a  aspirated by an aspirating pipette which is not shown in the drawing. The reaction chamber  41   c  is connected to the sampling valve  41   b,  and is configured to be capable of mixing a predetermined reagent and staining solution with the fixed amount of blood determined by the sampling valve  41   b.  The reaction chamber  41   c  is also connected to the detecting section  5 , and is configured so that a measurement sample prepared by mixing the predetermined reagent and staining solution in the reaction chamber  41   c  inflows to the detecting section  5 . 
         [0035]    The sample preparing section  41  can thus prepare a measurement sample in which the leukocytes are stained and the erythrocytes are hemolyzed as the leukocyte measurement sample. The sample preparing section  41  can also prepare a measurement sample in which the reticulocytes are stained as a reticulocyte measurement sample, and prepare a measurement sample in which the platelets are stained as a platelet measurement sample. The prepared measurement sample is supplied together with a sheath fluid to a sheath flow cell of the detecting section  5  which will be described later. 
         [0036]      FIG. 4  is a block diagram schematically showing the structure of the detecting section  5  and the analog processing section  6  of the first embodiment of the present invention. As shown in  FIG. 4 , the detecting section  5  is provided with a light-emitting part  501  for emitting laser light, irradiating lens unit  502 , sheath flow cell  503  for irradiating by laser light, collective lens  504  disposed on a line extending in the direction of advancement of the light from the light-emitting part  50 , pinhole  505  and PD (photodiode)  506  (a beam stopper which is not shown in the drawing is disposed between the sheath flow cell  503  and the collective lens  504 ), collective lens  507  which is disposed in a direction which intersects the direction of the light emitted from the light-emitting part  501 , dichroic mirror  508 , optical filter  509 , pinhole  510  and APD (avalanche photodiode)  511 , and PD (photodiode)  512  which is disposed on the dichroic mirror  508  side. 
         [0037]    The light-emitting part  501  is provided to irradiate light on a sample flow which contains a measurement sample passing through the interior of the sheath flow cell  503 . The irradiating lens unit  502  is provided to render the light emitted from the light-emitting part  501  into parallel rays. The PD  506  is provided to receive the forward scattered light emitted from the sheath flow cell  503  Note that information relating to the size of the particles (blood cells) in the measurement sample can be obtained from the forward scattered light emitted from the sheath flow cell  503 . 
         [0038]    The dichroic mirror  508  is provided to separate the side scattered light and the side fluorescent light emitted from the sheath flow cell  503 . Specifically, the dichroic mirror  508  is provided to direct the side scattered light emitted from the sheath flow cell  503  to the PD  512 , and to direct the side fluorescent light emitted from the sheath flow cell  503  to the APD  511 . The PD  512  is also provided to receive the side scattered light. Internal information relating to the size and the like of the nucleus of the particles (blood cells) within the measurement sample can be obtained from the side scattered light emitted from the sheath flow cell  503 . 
         [0039]    The APD  511  is also provided to receive the side fluorescent light. When light irradiates a fluorescent substance such as a stained blood cell, light is emitted which has a longer wavelength that that of the irradiating light. The intensity of the fluorescence increases as the degree of staining increases. Therefore, characteristic information related to the degree of staining of the blood cell can be obtained by measuring the intensity of the side fluorescent light emitted from the sheath flow cell  503 . It is therefore possible to perform other measurements in addition to classifying leukocytes by the difference in the side fluorescent light intensity. PD  506 , PD  512 , and APD  511  convert the optical signals of the respectively received light to electrical signals, and the converted electrical signals are then amplified by amplifiers  61 ,  62 , and  63  and the amplified signals are transmitted to the control board  9 . 
         [0040]    In the first embodiment, the light-emitting part  501  emits light with an output of 3.4 mW during the leukocyte classification measurement (hereinafter referred to as “DIFF measurement”). The light-emitting part  501  also emits light with an output of 6 mW during the reticulocyte measurement (hereinafter referred to as “RET measurement”). The light-emitting part also emits light at an output of 10 mW during platelet measurement (hereinafter referred to as “PLT measurement”). 
         [0041]      FIG. 5  is a block diagram showing the structure of the operation and display device  2  of the biological sample analyzer of the first embodiment of the present invention. As shown in  FIG. 5 , the operation and display device  2  is configured by a CPU (central processing unit)  21 , RAM  22 , memory device  23 , input device  24 , display device  25 , output device  26 , communication interface  27 , and an internal bus  28  which is connected to the previously described hardware. The CPU  21  is connected to each piece of previously mentioned hardware of the operation and display device  2  through the internal bus  28 , and controls the operation of the aforesaid hardware and executes various software functions according to a computer program  231  which is stored in the memory device  23 . RAM  22  is configured of a volatile memory such as an SRAM, SDRAM or the like, and stores load modules during the execution of the computer program  231  as well as temporary data generated during the execution of the computer program  231 . 
         [0042]    The memory device  23  is configured by an internal fixed type memory device (hard disk) or the like. The memory device  23  is also provided with a patient information memory device  232  which stores information relating to patients and including the age information of the patient (subject) associated with identification information which can be obtained by reading a barcode label.  FIG. 6  shows an example of the data structure of the patient information memory device  232 . As shown in  FIG. 6 , the patient information memory device  232  stores subject ID which is the identification information that identifies the subject, sex information of the subject, age information of the subject, disease information relating the content of the disease, and treatment information which identifies the treatment, and all of which is associated with a sample ID which is which is the identification information obtained by reading a barcode label. Note that the patient information memory device  232  is not limited to being provided in the memory device  23  insofar as the patient information may also be prestored on an external computer and obtained by querying the external computer through the communication interface  27 . 
         [0043]    The communication interface  27  is connected to the internal bus  28 , and is capable of sending and receiving data when connected to the measuring device  1  through a communication line. That is, the communication interface  27  sends information instructing the start of a measurement and the like to the measuring device  1 , and receives measurement data. 
         [0044]    The input device  24  is a data input medium such as a keyboard and mouse or the like. The display device  25  is a display device such as a CRT monitor, LCD or the like, and graphically displays the analysis results. The output device  26  is a printing device such as a laser printer, inkjet printer or the like. 
         [0045]    In the measuring device  1  and operation and display device  2  of the biological sample analyzer having the structure described above, a scattergram such as that shown in  FIG. 7  is prepared and displayed on the display device  25  when adult blood is measured and the leukocytes contained in the blood have been classified as lymphocytes, monocytes, neutrophils, basophils, and eosinophils.  FIG. 7  shows an example of a scattergram produced by the leukocyte classification measurement (DIFF measurement). In  FIG. 7 , the vertical axis represents the side fluorescent light intensity, and the horizontal axis represents the side scattered light intensity, respectively. The method of classifying leukocytes used by the biological sample analyzer of the first embodiment is described below. 
         [0046]    In the biological sample analyzer of the first embodiment, a lymphocyte distribution region  101  in which lymphocytes are assumed to be distributed, a monocyte distribution region  102  in which monocytes are assumed to be distributed, an eosinphil distribution region  103  in which eosinophils are assumed to be distributed, a neutrophil distribution region  104  in which neutrophils are assumed to be distributed, and a basophil distribution region in which basophils are assumed to be distributed are predetermined based on previous statistical values of adult blood, as shown in  FIG. 7 . After integer sequence information has been sampled based on the measurement data, the degree of belonging of blood cells to each distribution region is then calculated for the lymphocyte distribution region  101 , monocyte distribution region  102 , eosinophil distribution region  103 , neutrophil distribution region  104 , and basophil distribution region  105 , and each blood cell is classified into a specific type of blood cell according to the calculated degree of belonging. The numbers of lymphocytes, monocytes and the like can then be determined by counting the classified blood cells. This leukocyte classification method is described in detail in U.S. Pat. No. 5,555,196. Note that the computer program for executing this leukocyte classification method, and the data used in the execution of this computer program are prestored in the memory device  23 . 
         [0047]    The present inventors acknowledge that the blood cells contained in child blood have lower stainability than blood cell contained in adult blood. It is therefore clear that the sampling values will be distributed somewhat lower in each region of the original distributions shown in  FIG. 7  in measurement data obtained by measuring child blood.  FIG. 8  shows an example of the relationship between sampling values and the lymphocyte distribution region  101  of a scattergram prepared for a DIFF measurement. 
         [0048]    As shown in  FIG. 8 , the sampling values are clustered on the margin of the lymphocyte distribution region  101  in the case of measurement data of adult blood. However, when the measurement data are for a child blood rather than adult blood, both the fluorescent light intensity and the scattered light intensity are lower values when measured since the child blood has a lower stainability than does adult blood. The sampling values therefore cluster near the edge of the region  111  which is below the lymphocyte distribution region  101 . 
         [0049]    When the distribution trend from the scattergram is entirely shifted below the assumed region as described above, the measurement data can be determined to be data from child blood, and it can be understood that the region  111  in which the sampling values cluster must be shifted in the direction of the arrow  112  to improve the accuracy of the classification process. A means is disclosed below for shifting the measurement data of child blood in order to realize a classification process which has better accuracy using the same blood cell classification method as when classifying leukocytes based on adult blood, even when the measurement data are data from child blood. 
         [0050]      FIG. 9  is a flow chart showing the processing sequence of the CPU  21  of the operation and display device  2  and the controller  91  of the control board  9  of the measuring device  1  of the first embodiment of the present invention. The controller  91  of the measuring device  1  executes initialization (step S 914 ) and an operations check of the each part of the measuring device  1  when the starting of the measuring device  1  is detected. The CPU  21  of the operation and display device  2  also executes initialization (program initialization) (step S 901 ), and displays a menu screen on the display device  25  (step S 902 ) when the starting of the operation and display device  2  is detected. The selection of the DIFF measurement, RET measurement, and CBC measurement (complete blood cell count measurement) can be input, and the measurement start instruction, and shutdown instruction and the like can be input from the menu screen. The case wherein the DIFF measurement has been selected on the menu screen in the first embodiment is described below. 
         [0051]    The CPU  21  of the operation and display device  2  determines whether or not a measurement start instruction has been received (step S 903 ); when the determination of the CPU  21  is that a measurement start instruction has not been received (step S 903 : NO), the CPU  21  skips the subsequent steps S 904  through S 909 . When the CPU  21  has determined that a measurement start instruction has been received (step S 903 : YES), the CPU  21  transmits instruction information specifying to start a measurement to the measuring device  1  (step S 904 ). The controller  91  of the measuring device  1  determines whether or not instruction information specifying to start a measurement has been received (step S 915 ); when the controller  91  has determined that a instruction information specifying to start a measurement has been received (step S 915 : YES), the controller  91  has the barcode reader (not shown in the drawing) read the barcode label (not shown in the drawing) adhered to the container which contains the blood to obtain the blood identification information (sample ID) (step S 916 ). When the controller  91  has determined that instruction information specifying to start a measurement has not been received (step S 915 : NO), the controller  91  skips steps  916  through S 920 . 
         [0052]    The controller  91  transmits the obtained identification information (sample ID) to the operation and display device  2  (step S 917 ), and the CPU  21  of the operation and display device  2  determines whether or not the identification information (sample ID) has been received (step S 905 ). When the CPU  21  determines that the identification information (sample ID) has not been received (step S 905 : NO), the CPU  21  enters a reception standby state. When the CPU  21  determines that the identification information (sample ID) has been received (step S 905 : YES), the CPU  21  obtains the patient information by querying the patient information memory device  232  of the memory device  23  (step S 906 ), and transmits the patient information to the measuring device  1  (step S 907 ). 
         [0053]    The controller  91  of the measuring device  1  then determines whether or not the patient information has been received (step S 918 ); when the controller  91  determines that the patient information has not been received (step S 918 : NO), the controller  91  enters a reception standby state. When the controller determines that the patient information has been received (step S 918 : YES), the controller  91  controls the sample preparing section  41  so as to prepare a measurement sample, and thereafter starts the measurement of a measurement sample (step S 919 ). Specifically, the DIFF measurement is executed, and the electrical signals corresponding to the intensity of the received side scattered light and side fluorescent light are transmitted to the control board  9  via the detecting section  5  and the analog processing section  6 . The A/D converter  92  of the control board  9  converts the obtained analog signals to 12-bit digital signals, and the operation section  93  subjects the digital signals output from the A/D converter  92  to predetermined processing, and transmits the signals to the controller  91 . The controller  91  transmits the received 12-bit integer sequence information as measurement data to the operation and display device  2  (step S 920 ). 
         [0054]    The CPU  21  of the operation and display device  2  determines whether or not the measurement data have been received (step S 908 ); when the CPU  21  determines that the measurement data have been received (step S 908 : YES), the CPU  21  executes an analysis process based on the received measurement data (step S 909 ). When the CPU  21  determines that the measurement data have not been received (step S 908 : NO), the CPU  21  enters a reception standby state. 
         [0055]      FIG. 10  is a flow chart showing the sequence of the analysis process executed in step S 909  of  FIG. 9  by the CPU  21  of the operation and display device  2  of the first embodiment of the present invention. In  FIG. 10 , the CPU  21  of the operation and display device  2  generates a first classification data by compressing the measurement data (12-bit integer sequence information) obtained from the measuring device  1  to 8-bit integer sequence information and stores the first classification data in the memory device  23  (step S 1001 ), and generates a second classification data which is 8-bit integer sequence information with data values that are larger than the data values of the first classification data generated in step S 1001  and stores the second classification data in the memory device  23  (step S 1002 ). The first classification data are data which are used when analysis is based on adult blood, and the second classification data are data which are used when analysis is performed based on child blood. That is, the obtained integer sequence information of the child blood must be slightly elevated in order to classify the blood cells within the blood using the same blood cell classification method as adult blood because child blood cells have a lower stainability than does adult blood. 
         [0056]    Specifically, the CPU  21  compresses the 12-bit integer sequence information obtained from the measuring device  1  directly to 8-bit integer sequence data when generating the first classification data, and after multiplying the 12-bit integer sequence information 1.2 times, then compresses the integer part to 8-bit integer sequence data when generating the second classification data. By multiplying the 12-bit integer sequence information 1.2 times and thereafter compressing the 8-bit data to generate the second classification data for child blood in this way, a proportion which maintains the continuity of the integer sequence values can be increased compared to when the first classification data of adult blood is simply multiplied 1.2 times to generate the second classification data. 
         [0057]      FIG. 11  shows an example of a measurement data operation processing result. That is, when the measurement data are integer values which are consecutively 9 through 13, “11” is deleted when these integer values are simply multiplied 1.2 times, so that the values are no longer consecutive integer values, as shown in  FIG. 11 . Thus, there is concern that an accurate count result cannot be obtained when classifying a plurality of types of particles. 
         [0058]    In the first embodiment, the measurement data is obtained as integer sequence information which has a larger number of bits (12-bits) than the number of bits (8-bits) used in the classification process, and the measurement data are multiplied 1.2 times to generate a second classification data of child blood by compressing the integer part of the multiplied data to 8-bit integer sequence information. The classification process is then executed on the generated second classification data. A proportion which maintains the continuity of the integer values can be increased thereby. That is, since the 12-bit integer sequence information is multiplied 1.2/16 times when generating the second classification data for child blood compared to multiplying the 12-bit integer sequence information 1/16 times when generating the first classification data for adult blood, the range of the measurement data which are the same integer values when multiplied 1.2/16 times is broadened, thus making errors difficult to occur. 
         [0059]    For example, consider the case when the number of each element (X 1 , X 2 ) (where X 1 , X 2 =0, 1, 2 . . . ) is designated F in two-dimensional distribution data DN which has N×N (N being a natural number) individual elements, and the two-dimensional distribution data Dn are compressed to two-dimensional distribution data Dm which has M×M (M being a natural number) individual elements. Furthermore, M&lt;N obtains. 
         [0060]    Each element (X 1 , X 2 ) in the two-dimensional distribution data which has N×N individual elements corresponds to the elements (U 1 , U 2 ) (where U 1 , U 2 =0, 1, 2, . . . ) shown in equation (1) in the distribution data Dm. In equation (1), Int(x) is a function which represents the integer part of the argument x. This is equivalent, for example, to the process of compressing 12-bit measurement data to 8-bits. 
         [0000]      ( U 1, U 2)=(Int( X 1( M/N ),Int( X 2( M/N )   (1) 
         [0061]    Next, when the two-dimensional distribution data DL which has L(L individual elements in a partial region within the two-dimensional distribution data Dm are converted to two-dimensional distribution data which has M(M individual elements (L&lt;M&lt;N), the elements (X 1 , X 2 ) (where X 1 , X 2 =0, 1, 2, . . . , N(L/M) in the distribution data Dn corresponds to the elements (V 1 , V 2 ) (where V 1 , V 2 =0, 1, 2, . . . , M) in the distribution data Dm 1 , as shown in equation (2). This is equivalent to a process which shifts up the 8-bit data. 
         [0000]      ( V 1, V 2)=(Int( X 1( M 2/( N ( L ),Int( X 2( M 2/( N ( L )   (2) 
         [0062]    That is, the number of elements of the distribution data Dm 1  can be calculated and converted to smooth distribution data by initially converting (expanding) the two-dimensional distribution data DL which have an L(L element partial region to two-dimensional distribution data which have N(N elements, and then converting to two-dimensional distribution data which have M(M elements. 
         [0063]    Returning to  FIG. 10 , the CPU  21  of the operation and display device  2  executes the leukocyte classification process based on the generated first classification data (step S 1003 ), counts the number of classified lymphocytes, monocytes, eosinophils, neutrophils, and basophils (step S 1004 ), and stores the count results in the memory device  23  (step S 1005 ). The CPU  21  also generates a scattergram such as that shown in  FIG. 7 , displays the count results and the scattergram on the display device  25  as leukocyte classification results (step S 1006 ), and the process returns to step S 910  of  FIG. 9 . The user can visually confirm the scattergram displayed on the display device  25 , for example by confirming whether or not the sampling values are distributed below the pre-assumed distribution region. When the sampling values are distributed below the pre-assumed distribution region, the user then determines that an analysis failure has occurred because the analyzed blood is child blood, and inputs an execution instruction to execute a reanalysis process based on child blood. 
         [0064]    Returning to  FIG. 9 , the CPU  21  of the operation and display device  2  determines whether or not a reanalysis execution instruction has been received from the user (step S 910 ); when a reanalysis execution instruction has been received (step S 910 : YES), the CPU  21  executes the reanalysis process (step S 911 ). Specifically, a “reanalysis” button is provided on the toolbar of the screen which displays the classification results on the display device  25 , and the CPU  21  receives the reanalysis instruction when the “reanalysis” button is selected by the user. 
         [0065]      FIG. 12  is a flow chart showing the sequence of the reanalysis process executed in step S 911  of  FIG. 9  by the CPU  21  of the operation and display device  2  of the first embodiment of the present invention. In  FIG. 12 , the CPU  21  of the operation and display device  2  determines whether or not to execute the reanalysis based on child blood (step S 1201 ). In the operation and display device  2 , not only can a reanalysis instruction be issued to reanalyze classification results obtained based on adult blood to obtain classification results based on child blood, a reanalysis instruction can also be issued to reanalyze classification results obtained based on child blood to obtain classification results base don adult blood. Thus, the CPU  21  reads the second classification data from the memory device  23  (step S 1202 ) when the CPU  21  determines whether or not to execute reanalysis based on child blood in step S 1201 , that is, determines whether or not a reanalysis instruction specifying reanalysis of classification results obtained based on adult blood so as to obtain classification results based on child blood has been received from the user and the CPU  21  has determined to execute reanalysis based on child blood (step S 1201 : YES). 
         [0066]    When the CPU  21  has determined to not execute reanalysis based on child blood (step S 1201 : NO), the CPU  21  reads the first classification data from the memory device  23  (step S 1203 ). The CPU  21  executes the classification process based on the read first classification data or second classification data (step S 1204 ), and counts the numbers of classified lymphocytes, monocytes, eosinophils, neutrophils, and basophils. The CPU  21  stores the count results in the memory device  23  (step S 1206 ), displays the classification results on the display device  25  (step S 1207 ), and the process returns to step S 912 . 
         [0067]    Note that “Child” in this case may mean a newborn, infant, or toddler. The user of the biological sample analyzer of this embodiment may optionally set the sample analyzer, for example, so that a patient admitted to a pediatric department or obstetrics and gynecology department is designated as a “child,” or a child who is a preschooler may be designated as a “child,” rather than a patient less than a predetermined age. The manufacturer who fabricates the biological sample analyzer may also set the range of the “child.” 
         [0068]    Returning to  FIG. 9 , the CPU  21  of the operation and display device  2  determines whether or not a shutdown instruction has been received (step S 912 ); when the CPU  21  has determined that a shutdown instruction has not been received (step S 912 : NO), the CPU  21  returns the process to step S 903 , and the previously described process is repeated. When the CPU  21  has determined that a shutdown instruction has been received (step S 912 : YES), the CPU  21  transmits shutdown instruction information to the measuring device  1  (step S 913 ). 
         [0069]    The controller  91  of the measuring device  1  determines whether or not shutdown instruction information has been received (step S 921 ); when the controller  91  has determined that shutdown instruction information has not been received (step S 921 : NO), the controller  91  returns the process to step S 915  and the previously described process is repeated. When the controller  91  has determined that shutdown instruction information has been received (step S 921 : YES), the controller  91  executes shutdown (step S 922 ) and the process ends. 
         [0070]    According to the first embodiment described above, high precision analysis results can be obtained by changing the classification data of “child blood” and “adult blood”. 
         [0071]    According to the first embodiment, it is possible to save time and a great deal of the expense required to develop various analysis programs because analysis processing can be executed using a shared common analysis program even when the ages of the patients differ. 
         [0072]    Note that although a first classification data for adult blood and a second classification data for child blood are generated and stored in a memory device  23  before a user specifies re-analysis in the embodiment described above, the second classification data for child blood need not be generated until the user specifies re-analysis on the basis of child blood and then generating the second classification data at the time such specification has been made. In this case, the operation processing load on the device can be reduced since the second classification data are only generated when specified. 
         [0073]    Although the classification process is executed for child blood when an instruction specifying the execution of a reclassification process for child blood has been issued by the user after the classification process for adult blood has been executed in the above embodiment, the present invention is not limited to this sequence. For example, the classification process for child blood may also be executed when it has been determined that the blood is child blood based on the age information stored in the patient information memory part  232 . 
         [0074]    Although the analysis process for adult blood and the analysis process for child blood are executed by respectively generating a first classification data for adult blood and second classification data for child blood then performing a classification process based on the first classification data and performing a classification process based on the second classification data, the present invention is not limited to this sequence. The first classification data for adult blood and the second classification data for child blood may also be identical, then the first classification data may be processed using an adult blood cell classification method in the case of adult blood, and the second classification data may be processed using a child blood classification method in the case of child blood. For example, when classifying white blood cells, the previously mentioned lymphocyte distribution region, the monocyte distribution region and the like (refer to  FIG. 7 ) may be set to different regions when performing the analysis process for child blood and when performing the analysis process for adult blood. 
         [0075]    Although white blood cells are analyzed using the second classification data for child blood when a re-analysis instruction is issued from the user and the classification results are subsequently displayed in the first embodiment, the present invention is not limited to this arrangement. A classification process based on the first classification data for adult blood and a classification process based on the second classification data for child blood may both be executed before a re-analysis instruction is issued by the user. Furthermore, the classification results based on adult blood and the classification results based on child blood may be prestored in the memory device so that the classification results based on child blood can be displayed when an instruction to display the classification results based on child blood has been issued by the user. 
       Second Embodiment  
       [0076]    The biological sample analyzer of a second embodiment of the present invention is described in detail below based on the drawings. Structures of the biological sample analyzer of the second embodiment of the present invention which are identical to the first embodiment are designated by like reference numbers and detailed description thereof is omitted. The second embodiment differs from the first embodiment in that the patient age information is obtained before starting the blood sample measurements, and whether or not the measurement sample is adult blood or child blood is determined based on the age information and thereafter the measurement data are obtained in accordance with the corresponding measurement condition. 
         [0077]      FIG. 13  is a flow chart showing the processing sequence of the CPU  21  of the operation display device  2  and the controller  91  of the control board  9  of the measuring device  1  of the second embodiment of the present invention. The controller  91  of the measuring device  1  executes initialization (step S 1313 ) and an operations check of the each part of the measuring device  1  when the starting of the measuring device  1  is detected. The CPU  21  of the operation display device  2  also executes initialization (program initialization) (step S 1301 ), and displays a menu screen on the display device (step S 1302 ) when the starting of the operation display device  2  is detected. The selection of the DIFF measurement, RET measurement, and CBC measurement can be input, and the measurement start instruction, and shutdown instruction and the like can be input from the menu screen. The case wherein the DIFF measurement has been selected on the menu screen in the second embodiment is described below. 
         [0078]    The CPU  21  of the operation display device  2  determines whether or not a measurement start instruction has been received (step S 1303 ); when the determination of the CPU  21  is that a measurement start instruction has not been received (step S 1303 : NO), the CPU  21  skips the subsequent steps S 1304  through S 1310 . When the CPU  21  has determined that a measurement start instruction has been received (step S 1303 : YES), the CPU  21  transmits instruction information specifying to start a measurement to the measuring device  1  (step S 1304 ). The controller  91  of the measuring device  1  determines whether or not instruction information specifying to start a measurement has been received (step S 1314 ); when the controller  91  has determined that instruction information specifying to start a measurement has been received (step S 1314 : YES), the controller  91  has the barcode reader (not shown in the drawing) read the barcode label (not shown in the drawing) adhered to the container which contains the blood to obtain the blood identification information (sample ID) (step S 1315 ). When the controller  91  has determined that instruction information specifying to start a measurement has not been received (step S 1314 :NO), the controller  91  skips steps S 1315  through S 1321 . 
         [0079]    The controller  91  transmits the obtained identification information (sample ID) to the operation display device  2  (step S 1316 ), and the CPU  21  of the operation display device  2  determines whether or not the identification information (sample ID) has been received (step S 1305 ). When the CPU  21  determines that the identification information (sample ID) has not been received (step S 1305 : NO), the CPU  21  enters a reception standby state. When the CPU  21  determines that the identification information (sample ID) has been received (step S 1305 : YES), the CPU  21  obtains the patient information which includes the patient age information by querying the patient information memory section  232  of the memory device  23  (step S 1306 ). 
         [0080]    The CPU  21  transmits the obtained patient information to the measuring device  1  (step S 1307 ), and the controller  91  of the measuring device  1  determines whether or not the patient information has been received (step S 1317 ). When the controller  91  determines that the patient information has not been received (step S 1317 : NO), the controller  91  enters the reception standby state. When the controller  91  determines that the patient information has been received (step S 1317 : YES), the controller  91  then determines whether or not the measurement object blood is child blood based on the received patient information (step S 1318 ). Specifically, the measurement object blood is determined to be child blood if the patient age is a predetermined age, for example, an age of less than 1 year. 
         [0081]    When the controller  91  determines that the measurement object blood is child blood (step S 1318 : YES), the controller  91  starts the measurement of the blood using the measurement condition for child blood (step S 1319 ). Specifically, when performing the measurement for child blood, the controller  91  controls the sample preparing section  41  so as to prepare a measurement sample, and thereafter sets the operating voltage of the PD  512  and APD  511  of the detecting section  5  to 290 V, and detects the side scattered light and side fluorescent light from the blood cells in the measurement sample. Specifically, the electrical signals corresponding to the intensity of the received side scattered light and side fluorescent light are transmitted to the control board  9  via the detecting section  5  and the analog processing section  6 . The A/D converter  92  of the control board  9  converts the obtained analog signals to 12-bit digital signals, and the operation section  93  performs predetermined processing to the digital signals output from the A/D converter  92 , and transmits the signals to the controller  91 . 
         [0082]    On the other hand, when the controller  91  determines that the measurement object blood is not child blood (step S 1318 : NO), the controller  91  starts the measurement of the blood using the measurement condition for adult blood (step S 1320 ). Specifically, the controller  91  controls the sample preparing section  41  so as to prepare a measurement sample, and thereafter sets the operating voltage of the PD  512  and APD  511  of the detecting section  5  to 280 V, and detects the side scattered light and side fluorescent light from the blood cells in the measurement sample. The subsequent measurement sequence is identical to that for child blood and is therefore not described in detail. Thus, the operating voltage is set at 290 V for the PD  512  and APD  511  of the detecting section  5  when measuring child blood compared to setting the operating voltage at 280 V for the PD  512  and APD  511  of the detecting section  5  when measuring adult blood, so that the same fluorescent intensity can be obtained when measuring child blood which contains blood cells which are difficult to stain as when measuring adult blood. Analysis results can therefore be obtained with excellent precision by the analysis process which is described below, even without performing the child blood analysis process. 
         [0083]    Note that the amount of the staining solution used when preparing the measurement sample may be changed depending on whether adult blood measurement is performed or child blood measurement is performed. For example, 25 μl if staining solution may be used to prepare child blood measurement samples, whereas 20 μl of staining solution may be used to prepare adult blood measurement samples. Thus, fluorescent light of the same intensity as adult blood can be obtained from the blood cells contained in child blood. 
         [0084]    When preparing a child blood measurement sample, the amount of hemolytic agent added to the blood may also be greater than when preparing an adult blood measurement sample And the hemolysis time may be increased to facilitate adequate hemolysis and staining of the blood cells contained in child blood by the staining solution. The staining time may also be increased to adequately stain the blood cells in child blood. 
         [0085]    The illumination intensity of the light from the light source  501  may also be higher when measuring child blood than when measuring adult blood, and the electric signals subjected to photoelectric conversion by the PD  51  and APD  511  may be amplified by an increased amplification factor in the amplifiers  62  and  63 . 
         [0086]    The controller  91  transmits the received 12-bit integer sequence information as measurement data to the operation display device  2  (step S 1321 ). The CPU  21  of the operation display device  2  determines whether or not measurement data have been received (step S 1308 ); when the CPU  21  determines that measurement data have not been received (step S 1308 : NO), the CPU  21  enters the reception standby state. When the CPU  21  determines that the measurement data have been received (step S 1308 : YES), the CPU  21  executes the analysis process on the received measurement data (step S 1309 ), and displays the analysis results on the display device  25  (step S 1310 ). 
         [0087]    The CPU  21  determines whether or not a shutdown instruction has been received (step S 1311 ); when the CPU  21  determines that a shutdown instruction has not been received (step S 1311 : NO), the CPU  21  returns the process to step S 1303  and the process described above is repeated. When the CPU  21  has determined that a shutdown instruction has been received (step S 1311 : YES), the CPU  21  transmits shutdown instruction information to the measuring device  1  (step S 1312 ). 
         [0088]    The controller  91  of the measuring device  1  determines whether or not shutdown instruction information has been received (step S 1322 ); when the controller  91  has determined that shutdown instruction information has not been received (step S 1322 : NO), the controller  91  returns the process to step S 1314  and the previously described process is repeated. When the controller  91  has determined that shutdown instruction information has been received (step S 1322 : YES), the controller  91  executes shutdown (step S 1323 ) and the process ends. 
         [0089]    Note that although the controller  91  of the measuring device  1  determines whether or not a sample is child blood based on the patient information received from the operation display device  2  in the second embodiment, the CPU  21  of the operation display device  2  may also determine whether or not a sample is child blood based on the patient information stored in the patient information memory part  232  and may transmit the determination result to the measuring device  1 . 
         [0090]    Whether or not a sample is child blood is not limited to being determined based on the age information stored in the patient information memory part  232  of the operation display device  2 , inasmuch as the determination may also be made by a comprehensive determination which includes other information. Furthermore, a configuration may pre-provide a memory part for storing the age information in the measuring device  1 , and the patient age information of a patient can be input by a user and stored in the memory part in the display and operation unit  7  so that the determination can be made based on the age information stored in the memory part. 
         [0091]    A screen for setting a child blood mode which performs measurements of measurement object blood under condition used for child blood, or an adult blood mode which performs measurements under condition used for adult blood, may be displayed on the display device  25  of the operation display device  2  or on the display and operation section  7  of the measuring device  1 , so that the measurement of the blood is performed in a user-set mode. 
         [0092]    According to the second embodiment described above, characteristic information of blood cells in blood can be respectively obtained under measurement condition suited for adults when a patient is an adult and under measurement condition suited for children when the patient is a child by changing the measurement condition of the sample blood based on whether the patient is adult or child. Therefore, influences caused by differences in the degree of staining of the blood cells can be suppressed, and high precision analysis results can be obtained. 
         [0093]    Note that although a blood analyzer which analyzes blood cells contained in blood which is used as a sample is described by way of example in the above first and second embodiments, the present invention is not limited to these examples inasmuch as the same effect may be expected when the present invention is applied to a biological sample analyzer which analyzes samples which contain biological particles such as cells in urine. Although the analysis results are displayed by the display device  25  of the operation display device  2  in the first and second embodiments described above, the present invention is not specifically limited to this example inasmuch as the results may also be displayed on a display device of another computer connected to a network. 
         [0094]    Although the patient age information is associated with a sample ID in the patient information memory part  232  in the first and second embodiment described above, the present invention is not limited to this arrangement inasmuch as, for example, information which indicates a patient is newborn, infant, toddler or the like may also be prestored in the patient information memory section  232 . 
         [0095]    Although the first classification data and second classification data are generated by obtaining 12-bit integer sequence information as measurement data from the measuring device  1  and compressing the 12-bit integer sequence information to 8-bit integer sequence information in the first and second embodiments described above, the present invention is not limited to this configuration. For example, 16-bit integer sequence information may also be obtained from the measuring device  1  and used to generate  10 -bit classification data. Moreover, the measurement data and classification data need not necessarily be integer sequence information. 
         [0096]    In the first and second embodiments described above, the 12-bit integer sequence information obtained from the measuring device  1  is directly compressed to 8-bit integer sequence information when generating the first classification data for adult blood, and the 12-bit integer sequence information is multiplied by 1.2 and thereafter the integer sequence information is compressed to 8-bit integer sequence information when generating the second classification data for child blood; however, the present invention is not limited to this configuration. The 8-bit integer sequence information may be obtained as measurement data from the measuring device  1  and the 8-bit integer sequence information obtained from the measuring device  1  may be directly used when performing the classification process for blood cells in adult blood, and the 8-bit integer sequence information obtained from the measuring device  1  may be multiplied by 1.2 to obtain integer sequence information to be used when performing the classification process for blood cells in child blood. 
         [0097]    In the embodiments described above, the conditions of the analysis process and the measurement process are determined based on whether a patient is adult or child; however, the present invention is not limited to this configuration. The conditions of the analysis process and the measurement process may also be determined based on whether a patient has a predetermined attribute. For example, the determination may be made based on whether a patient has a predetermined disease, or may be made based on whether a patient has been administered a predetermined medication. Such attribute information is desirably associated with the sample ID and prestored in the patient information memory part  232 .