Abstract:
The clinical laboratory test apparatus includes: an analyzing unit for analyzing a specimen; a reception part for receiving specimen information before analysis of the specimen; a discrimination part for discriminating whether or not a specimen is suited for analysis based on the specimen information; and a control part for controlling the analyzing unit based on the discrimination result obtained by the discrimination part.

Description:
This application claims priority under 35 U.S.C. §119 to Japanese Patent Application No. 2003-337273 filed Sep. 29, 2003, the entire content of which is hereby incorporated by reference. 
     FIELD OF THE INVENTION 
     The present invention relates to a clinical laboratory test apparatus and clinical laboratory test system capable of recognizing beforehand whether or not an accurate assay result can be obtained before the specimen is analyzed. 
     BACKGROUND 
     An immunoassay method is known which corrects the amount (assay value) of antibody or antigen in blood obtained by immunoassay of a whole blood specimen based on a hematocrit value obtained from a blood analyzer, so as to obtain the amount of antibody or antigen (corrected value) in the serum or plasma (refer to Japanese Laid-Open Patent Publication No. 10-48214). 
     In this method, when the specimen has an abnormally low hematocrit value, a problem arises inasmuch as an accurate correction value (amount of antibody or antigen in the serum or plasma of the specimen) cannot be obtained. 
     SUMMARY 
     In view of the above information, an object of the present invention is to provide a clinical laboratory test apparatus and clinical laboratory test system capable of recognizing that a specimen is unsuitable for assay before the assay of the specimen for which an accurate assay result cannot be obtained. 
     The clinical laboratory test apparatus of a first aspect of the present invention includes: (a) an analyzing unit for analyzing a specimen; (b) a reception means for receiving specimen information before analysis of the specimen; (c) a discrimination means for discriminating whether or not a specimen is suited for analysis based on the specimen information; and (d) a control means for controlling the analyzing unit based on the discrimination result obtained by the discrimination means. 
     The clinical laboratory test system of a second aspect of the present invention includes: (a) a first specimen analyzing part for analyzing a specimen; (b) a second analyzing part for analyzing a specimen; and (c) an information transmission means for transmitting specimen information obtained by the first specimen analyzing part to the second specimen analyzing part; wherein the second specimen analyzing part is provided with an analyzing unit for analyzing a specimen; a discrimination means for discriminating whether or not a specimen is suited for analysis before the specimen is examined based on specimen information transmitted by the information transmission means; and a control means for controlling the analyzing unit based on the discrimination result of the discrimination means. 
     The clinical laboratory test system of a third aspect of the present invention includes: (a) a first specimen analyzing part for analyzing specimens; (b) a second analyzing part for analyzing specimens; and (c) an information transmission means for transmitting specimen information between the first specimen analyzing part and the second specimen analyzing part; wherein the information transmission means comprises a discrimination means for discriminating whether or not a specimen is suited for analysis by the second specimen analyzing part based on the analysis information obtained when the specimen was analyzed by the first specimen analyzing part; and the discrimination result of the discrimination means is transmitted to the second specimen analyzing part; and wherein the second specimen analyzing part comprises an analyzing unit for analyzing specimen; and a control means for controlling the analyzing unit based on the discrimination result transmitted from the information transmitting means. 
     The clinical laboratory test system of a fourth aspect of the present invention includes: (a) a transport part for transporting containers accommodating specimens; (b) a first specimen analyzing part comprising a first analyzing unit for analyzing specimens accommodated in the containers transported by the transport unit; (c) a second specimen analyzing part comprising a second analyzing unit for analyzing specimens accommodated in the containers transported by the transporting part which have been analyzed by the first specimen analyzing part; and (d) a control means for controlling the transport part, first specimen analyzing part, and second specimen analyzing part; wherein the control means discriminates whether or not a specimen is suited for analyzing by the second specimen analyzing part based on the analysis information obtained when the first specimen analyzing part analyzed the specimen. 
     The specimen clinical laboratory test method of a fifth aspect of the present invention includes: the steps of receiving specimen information before analysis of a specimen; discriminating whether or not a specimen is suited for analysis based on the specimen information; and determining whether or not to automatically execute analysis of a specimen will be based on the discrimination result. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  an exterior view of a first embodiment of the system; 
         FIG. 2  is a structural diagram of a blood analyzer; 
         FIG. 3  is a structural diagram of a whole blood immunoassay apparatus; 
         FIG. 4  is a perspective view of a rack; 
         FIG. 5  is a table for anomaly determination; 
         FIG. 6  is an illustration representing the message output flow; 
         FIG. 7  is an illustration of a message; 
         FIG. 8  is an illustration of a message; 
         FIG. 9  is an exterior view of a second embodiment of the system; 
         FIG. 10  is an illustration showing the message output flow; 
         FIG. 11  is an external view of a third embodiment of the system; 
         FIG. 12  is a structural diagram of a server computer; 
         FIG. 13  is an illustration showing the message output flow; 
         FIG. 14  is a structural diagram of a fourth embodiment of the system 
         FIG. 15  is a table showing the discrimination results; 
         FIG. 16  is an immunosample container accommodating an immunoreagent; and 
         FIG. 17  shows the memory structure of the control part of the whole blood immunoassay apparatus. 
     
    
    
     DETAILED DESCRIPTION 
     The embodiments of the present invention are described hereinafter with reference to the drawings. In the following embodiments, a whole blood immunoassay apparatus is described in the examples as an example of the clinical laboratory test apparatus of the present invention. 
     First Embodiment 
       FIG. 1  is an external view showing a first embodiment of the system including a whole blood immunoassay apparatus. The system connects a blood analyzer  1  and whole blood immunoassay apparatus  2  via a communication cable  24  so as to allow communication. The communication cable  24  is an RS232C serial cable. 
     As shown in  FIG. 1 , the blood analyzer  1  includes a rack supply unit  13  for supplying one by one a plurality of racks  27  holding sample containers  26 , barcode reader  14  for reading the barcode of the sample container  26 , sample mixing/suctioning apparatus  15  for mixing and suctioning blood samples of the sample container  26 , sample analyzer  11  for analyzing suctioned blood samples, and display/operation unit  12  for inputting analysis conditions and outputting assay results. The display/operation unit  12  is a touch panel-type display capable of display and operation (input). 
     As shown in  FIG. 2 , the sample analyzer  11  of the blood analyzer  1  includes a control unit  101 , sample quantification unit  102 , sample preparation unit  103 , and sample assay unit  104 . The control unit  101  includes a microcomputer provided with RAM, ROM, memory such as a hard disk or the like, and CPU; and a communication controller for sending and receiving data. 
     The sample quantification unit  102  measures the blood sample mixed and suctioned by the sample mixing/suctioning device  15  from the sample container  26 . The sample quantification unit  102  may be formed of three ceramic disks. A flow path through which a blood sample flows may be formed by three ceramic disks, such that the center disk is rotated between the outer two stationary disks, and a suctioned blood sample is quantified by remaining within the center disk flow path the inlet and outlet of which is blocked. 
     The sample preparation unit  103  includes an erythrocyte sample preparation unit  111  for diluting a blood sample and preparing a sample for erythrocyte/platelet assay, leukocyte sample preparation unit  112  for subjecting a blood sample to hemolysis and preparing a sample for leukocyte assay, and an HGB sample preparation unit  113  for subjecting a blood sample to hemolysis and preparing a sample for HGB (hemoglobin) assay. 
     The sample assay unit  104  includes an erythrocyte sample assay unit  121  for obtaining a measurement signal by measuring the electrical resistance when a prepared erythrocyte/platelet assay sample passes through an orifice (pore), leukocyte assay unit  122  for obtaining a measurement signal by optically measuring a prepared leukocyte sample using a flow cytometer, and an HGB sample assay unit  123  for obtaining a measurement signal by measuring the light absorption of a prepared HGB sample. 
     The control unit  101  receives the analysis conditions from the display/operation unit  12  and the output signals from the barcode reader  14 , and controls the rack supply unit  13 , sample mixing/suctioning device  15 , sample quantification unit  102 , sample preparation unit  103 , and sample assay unit  104 . 
     The control unit  101  receives the measurement signal from the sample preparation unit  104 , and calculates the number of erythrocytes contained in the sample, the number and particle size of the leukocytes and platelets, concentration of the hemoglobin (HGB), hematocrit value, mean volume of the erythrocytes (MCV) and the like. 
     As shown in  FIG. 1 , the whole blood immunoassay apparatus  2  includes a rack supply unit  23  for supplying one by one a plurality of racks  27  holding sample containers  26 , barcode reader  24  for reading the barcode of the sample container  26 , sample mixing/suctioning device  25  for mixing and suctioning blood samples of the sample container  26 , immunosample analyzer  21  for analyzing suctioned blood samples, and display/operation unit  22  for inputting analysis conditions and outputting assay results. The display/operation unit  22  is a touch panel-type display capable of display and operation (input). 
     As shown in  FIG. 3 , the immunosample analyzer  21  of the whole blood immunoassay apparatus  2  includes a control unit  201 , immunosample quantification unit  202 , immunoreagent quantification unit  203 , immunosample preparation unit  204 , immunosample assay unit  205 , and immunoreagent feeder unit  207 . The control unit  201  includes a microcomputer provided with RAM, ROM, memory such as a hard disk or the like, and CPU; and a communication controller for sending and receiving data. 
     The immunosample quantification unit  202  measures the blood sample mixed and suctioned by the sample mixing/suctioning device  25  from the sample container  26 . The immunosample quantification unit  202  measures the blood sample via a dispenser unit such as a dispenser pipette or the like. The immunoreagent quantification unit  203  measures the immunoreagent via a dispenser unit such as a pipette or the like from the reagent containers  17  and  18  (refer to  FIG. 16 ) held by the reagent feeder  207 . 
     The immunosample preparation unit  204  mixes a measured quantity of blood sample (whole blood sample) and immunoreagent to prepare the immunoassay sample. As shown in  FIG. 16 , the immunoreagent includes the reagent container  16  accommodating a dilution fluid for diluting blood samples, the reagent container  17  for accommodating buffer solution for maintaining the prepared immunoassay sample at a constant pH, and immunoreagent container  18  for accommodating latex reagent sensitized to antigen or antibody. 
     The immunosample assay unit  205  analyzes the prepared immunoassay sample via a counting immunoassay. The counting immunoassay is an analysis method wherein a latex reagent sensitized for an antibody or antigen is reacted with an antigen or antibody in the sample, the agglutinated particles are discriminated by flow cytometry, and counted. 
     The control unit  201  receives the output signals of the barcode reader  23  and the analysis conditions of the display/operation unit  22 , and controls the rack supply unit  23 , sample mixing/suctioning device  25 , immunosample quantification unit  202 , immunoreagent quantification unit  203 , immunosample preparation unit  204 , and immunosample assay unit  205 . 
     Furthermore, the control unit  201  receives the assay signals from the sample assay unit  205 , and calculates the values of cancer markers and infection markers and the like contained in the sample. Cancer markers and infection markers are calculated as antigen concentration or antibody concentration. Then, correction is performed based on the hematocrit received from the blood analyzer  1  to convert to serum or plasma antigen concentration or antibody concentration. 
     The control unit  101  of the blood analyzer  1  and the control unit  201  of the whole blood immunoassay apparatus  2  are connected via a communication cable  24 , such that assay results obtained by the blood analyzer  1  are transmitted by a communication controller of the control unit  101  from the control unit  101  to the control unit  201  of the whole blood immunoassay apparatus  2  through the communication cable  24 . The assay result of the blood analyzer  1  transmitted to the whole blood immunoassay apparatus  2  includes erythrocyte count, hematocrit, mean erythrocyte volume, and platelet count. 
     As shown in  FIG. 4 , each rack  27  is shaped to hold test tubes upright so as to accommodate  10  test tubes  26 . The test tube  26  is a container shaped like a test tube with a closed bottom and an open top end which is covered by a cap, and is capable of internally accommodating blood as a sample, and a barcode label  28  is adhered to the outer surface of the container. The barcode label  28  includes an ID number and the like as information identifying the blood sample (specimen). 
     The operation of the clinical laboratory test system is described below. 
     A rack  27  which holds sample containers  26  is loaded in the rack supply unit  13  of the blood analyzer  1 . When an assay instruction is input from the display/operation unit  12 , the rack  27  on the rack supply unit  13  is moved to the interior. The rack  27  which has been moved to the interior is transversely fed to the left, and the barcode label  28  adhered to the sample container  26  is read by the barcode reader  14 . Subsequently, after sample mixing by the sample mixing/suctioning unit  15 , the blood sample is suctioned from the sample container  26  by a suction needle. The suctioned blood sample is measured by the sample quantification unit  102 , and after the blood sample is subjected to dilution or hemolysis by the sample preparation unit  103 , the sample is assayed by the sample assay unit  104 . The assay signal obtained by the assay is transmitted to the control unit  101 , and after analysis is stored in the memory of the control unit  101  as ID number and assay data. Furthermore, by setting automatic transmission of the assay data, the control unit  101  sends the assay data to the control unit  201  of the whole blood immunoassay apparatus  2  through the communication cable  24  via the communication controller of the control unit  101  at the same time as the assay result is output to the display/operation unit  12 . 
     The assay data transmitted to the whole blood immunoassay apparatus  2  includes erythrocyte count, hematocrit, mean erythrocyte volume (MCV) platelet count (PLT) and the like. 
     The control unit  201  of the whole blood immunoassay apparatus  2  which received the assay data stores the ID number and assay data in the memory of the control unit  201 . The assay data stored in the memory stores the erythrocyte count, hematocrit, platelet count, and MCV corresponding to ID number, as shown in  FIG. 17 . Furthermore, an anomaly determination table for determining whether or not the specimen can be subjected to whole blood immunoassay by the whole blood immunoassay apparatus  2  is stored beforehand in the memory of the control unit  201 , as shown in  FIG. 5 . The anomaly determination table shown in  FIG. 5  shows a threshold  302  corresponding to assay item  301 , anomaly determination equation  303  representing when the threshold is exceeded or not met, and anomaly value  304  for when the anomaly determination equation applies. 
     The assay operation of the whole blood immunoassay apparatus  2  executed by the control unit  201  is described below using the flow chart of  FIG. 6 . The sample container  26  which has been assayed by the blood analyzer  1  is set in the rack supply unit  23  of the whole blood immunoassay apparatus  2 . The barcode label  28  of the placed sample container  26  is read by the barcode reader  24 , and the ID number is transmitted to the control unit  201  (steps S 1  and S 2 ). The control unit  201  retrieves the assay data of the same ID number receives from the blood analyzer  1  from the memory of the control unit  201  (refer to  FIG. 17 ) (step S 3 ). Then it is determined whether or not the ID number of the retrieved result matches the ID number (step S 4 ). When the ID numbers do not match, the routine returns to the step of reading the barcode label  28  of the next sample container  26  (step S 1 ). When the ID numbers match, the assay data of that ID number are read from the memory of the control unit  201  (step S 5 ). A determination is made as to whether or not the read assay data contains anomaly value by referring to the anomaly determination table (refer to  FIG. 5 ) within the memory of the control unit  201 . 
     When an anomaly value is not determined, the blood sample in the sample container  26  corresponding to the assay data is determined to be suitable for whole blood assay, and the blood sample in the sample container  26  is assayed (step S 8 ). A fixed quantity of the blood sample is suctioned from the sample container  26  by the immunosample quantification unit  202 , and a fixed quantity of reagent is suctioned by the immunoreagent quantification unit  203 . The suctioned blood sample and reagent are transported to the immunosample preparation unit  204 , to prepare the whole blood immunoassay sample. The prepared whole blood immunoassay sample is transported to the immunosample assay unit  205  and assayed. In the control unit  201 , correction is performed based on the hematocrit transmitted from the blood analyzer  1  to convert the assay data to antigen concentration or antibody concentration of the serum or plasma. The assay result is output to the display/operation unit  22 . 
     When an anomaly value is determined, the blood sample in the sample container  26  corresponding to the assay data is determined to be unsuited for whole blood immunoassay, and the display screen (message) shown in  FIG. 7  is output to the display-operation unit  22  (step S 9 ). This display screen shows an example of high level PLT specimen (high level platelet specimen). The assay technician promptly performs the following measures when the specimen is determined to be unsuitable based on this display screen. Specifically the specimen is centrifuged and the plasma is subjected to immunoassay, and a blood collection order is again output and the serum of the new specimen is subjected to immunoassay. 
     Furthermore, there may be times during the whole blood immunoassay when an assay is needed on an emergency basis even though assay data reliability is low. For example, when the hematocrit value is high, MCV (mean erythrocyte volume) value is high, or the MCV value is low, the display screen (message) shown in  FIG. 8  is output to the display/operation unit  22 , and the assay technician determines whether or not to perform an assay. In the state in which the display screen shown in  FIG. 8  is displayed on the display/operation unit  22 , the operation of the whole blood immunoassay apparatus  2  is stopped, and unless the technician performs an operation, the apparatus cannot proceed to the next operation. When the user pushes the OK button on the display screen shown in  FIG. 8 , the whole blood immunoassay of the specimen begins. When the user presses the cancel button, the whole blood immunoassay of the specimen is not performed, and a determination is made as to whether or not whole blood immunoassay is possible for the next specimen. 
     In the immunoassay of the infection items, serum is typically used as the assay sample, however, a problem arises inasmuch as approximately 30 min is required to obtain the whole blood or serum. Furthermore, in the whole blood immunoassay apparatus, a problem arises inasmuch as suitable assay data may not be obtained from the specimen. 
     In the first embodiment, a determination is made as to whether or not a specimen is suitable for assay in the whole blood immunoassay apparatus  2  before the specimen is assayed based on assay data of the specimen (whole blood) obtained by the blood analyzer  1 . In this way the operator can rapidly determine to perform an immunoassay using the whole blood immunoassay apparatus, or perform an immunoassay using serum. 
     In the first embodiment, the display/operation units  12  and  22  are touch panel type displays capable of both display and operation (input), however, in another embodiment the structures may be separated into input units and output units. A keyboard, mouse, ten-key pad, and touch-key pad and the like may be used as input devices, and display devices such as CRT, LCD and the like, printing devices such as printers and the like, and sound output devices may be used as output devices. 
     Furthermore, in the first embodiment, the leukocyte assay unit  122  is constructed so as to obtain an assay signal by optical measurement using a flow cytometer, however, the leukocyte assay unit  122  may be constructed so as to obtain an assay signal by measuring electrical resistance when the leukocyte sample passes through an orifice (pore). 
     Although the immunosample assay unit  205  is constructed so as to perform analysis by a counting immunoassay of a prepared immunoassay sample in the first embodiment, the immunosample assay unit  205  may be constructed so as to perform analysis by the change in light absorption or change in scattered light by exposing to light an immunoassay sample containing agglutinated particles produced by antigen/antibody reaction. 
     Although the control unit  201  performs correction based on the hematocrit transmitted from the blood analyzer  1  to convert the assay data to antigen concentration or antibody concentration in serum or plasma in the first embodiment, the control unit  201  also may perform correction by the erythrocyte count measured by the immunosample assay unit  205  to convert the assay data to the antigen concentration or antibody concentration in the serum or plasma. 
     Second Embodiment 
       FIG. 9  is an exterior view showing a second embodiment of the system including a whole blood immunoassay apparatus. In  FIG. 9 , descriptions of the parts corresponding to parts in  FIG. 1  are omitted and such parts are given similar reference numbers. This system includes a blood analyzer  1  connected to a network interface  507 , and a whole blood immunoassay apparatus  2  connected to a network interface  508 , which are connected to a server computer  501  over a network such as the internet. 
     As shown in  FIG. 10 , the server  501  includes a CPU  502  for reading programs and performing processes, ROM  503  in which is stored beforehand the control sequence of the CPU  502 , RAM  504  which is used by the CPU  502  when performing processing, memory device  505  which is a recording medium for supplying program code, and network interface  506  used when connecting to the network. The network interface is a general purpose TCI/IP interface (transmission control protocol/internet protocol). 
     The structures of the blood analyzer  1  and whole blood immunoassay apparatus  2  are identical to those shown in  FIGS. 2 and 3  and further descriptions are omitted. 
     The operation of the clinical laboratory test system is described below. 
     When a rack  27  is placed in the rack supply unit  13  of the blood analyzer  1 , the barcode of the sample container  26  is read by the barcode reader  14 , the blood sample in the sample container  26  is analyzed, and the ID number and assay data are saved to the memory of the control unit  101 . Since automatic transmission of the assay data is set, when the control unit  101  transmits the ID number and assay data from the memory to the server computer  501  over the network via the network interface  507 , the CPU  502  stores the ID number and assay data in the memory device  505 . The assay data stored in the memory device  505  are erythrocyte count, hematocrit, platelet count, and MCV corresponding to the ID number identical to that stored in the memory of the control unit  201 , as shown in  FIG. 17 . 
     The assay operation of the whole blood immunoassay apparatus  2  executed by the control unit  201  is described below using the flow chart of  FIG. 11 . When the rack  27  is placed in the rack supply unit  23 , the barcode label  28  of the sample container  26  is read by the barcode reader  24 , and information including the ID number is transmitted to the control unit  201  (steps S 1  and S 2 ). The control unit  201  of the whole blood immunoassay apparatus  2  inquires to the server computer  501  for the ID number (step S 3 ). The CPU  502  of the server computer  501  retrieves the assay data of the same ID number received from the blood analyzer  21  from the memory device  505  (step S 4 ). A determination is made as to whether or not there are assay data which match the ID number (step S 5 ). When there are no assay data matching the ID number, the CPU  502  of the server computer transmits the determination result to the control unit  201  of the whole blood immunoassay apparatus  2  over the network interface  506 , and control unit  201  issues instructions to read the barcode label  28  of the next sample container  26  (step  1 ). When there are assay data with matching ID number, the CPU  502  of the server computer transmits the ID number and assay data from the memory device  505  to the control unit  201  of the whole blood immunoassay apparatus  2 , and the control unit  201  acquires the assay data having that ID number, and stores the assay data in the control unit  201  (step S 6 ). The control unit  201  compares the anomaly determination table (refer to  FIG. 5 ) and the assay data stored in the memory of the control unit  201 , and determines whether or not there is an anomaly value (step S 7 , S 8 ). 
     When it is determined that there is no anomaly value, the blood sample in the sample container  26  corresponding to the assay data is determined to be suitable for whole blood assay, and the blood sample in the sample container  26  is assayed (step S 9 ). A fixed quantity of the blood sample is suctioned from the sample container  26  by the immunosample quantification unit  202 , and a fixed quantity of reagent is suctioned from the immunoreagent quantification unit  203 . The suctioned blood sample and reagent are transported to the immunosample preparation unit  204 , and the whole blood immunosample is prepared. The prepared whole blood immunoassay sample is transported to the sample assay unit  205  and assayed. In the control unit  201 , correction is performed based on the hematocrit transmitted from the blood analyzer  1  to convert the assay data to antigen concentration or antibody concentration in the serum or plasma. The assay result is output to the display/operation unit  22 . 
     When it is determined there is an anomaly value, it is determined that the blood sample in the sample container  26  corresponding to the assay data is unsuited for whole blood immunoassay, and the display screen shown (message) in  FIG. 7  is output to the display/operation unit  22  (step S 10 ). This display screen shows an example of a high level PLT specimen (high level platelet specimen). 
     In the second embodiment, the blood analyzer  1  and whole blood immunoassay apparatus  2  are connected to the server computer  501  over a network, however, the blood analyzer  1  and whole blood immunoassay apparatus  2  also may be connected directly over a network. In this case, the network represents a communication line such as the internet, intranet, inthernet and the like. 
     Although the blood analyzer  1  and whole blood immunoassay apparatus  2  are respectively connected to a network through network interfaces  507  and  508  in the second embodiment, the control unit  101  of the blood analyzer  1  and the control unit  201  of the whole blood immunoassay apparatus  2  also may incorporate network interfaces. 
     In this way information can be transmitted between devices in different locations by connecting the blood analyzer  1  and whole blood immunoassay apparatus  2  through a network, and it is possible for the whole blood immunoassay apparatus  2  to determine whether or not a target specimen is suitable for whole blood immunoassay based on the assay data of the blood analyzer  1 . 
     Third Embodiment 
       FIG. 12  is an exterior view of the third embodiment of the system including a whole blood immunoassay apparatus. In  FIG. 12 , descriptions of the parts corresponding to parts in  FIG. 1  are omitted and such parts are given similar reference numbers. This system includes a blood analyzer  1  connected to a host computer  401 , and a whole blood immunoassay apparatus  2  connected to the host computer  401  by communication cables  415  and  416 , respectively. 
     As shown in  FIG. 12 , the host computer  401  includes control unit  412  provided with a memory for storing specimen assay data transmitted from the blood analyzer  1 , CRT  411  for displaying assay data and the determination result as to whether or not whole blood immunoassay is possible, and keyboard  413  for inputting assay conditions and assay data. The control unit  401  includes a microcomputer provided with RAM, ROM, memory such as a hard disk or the like, and CPU; and a communication controller for sending and receiving data. 
     The structures of the blood analyzer  1  and whole blood immunoassay apparatus  2  are identical to those shown in  FIGS. 2 and 3  and further descriptions are omitted. 
     The operation of this specimen laboratory test system is described below. 
     When the rack  27  is placed in the rack supply unit  13  of the blood analyzer  1 , the barcode  28  of the sample container  26  is read by the barcode reader  14 , the blood sample in the sample container  26  is analyzed, and the ID number and assay data are saved in the memory of the control unit  101 . Since automatic transmission of the assay data is set, when the control unit  101  transmits the ID number and assay data from the memory to the host computer  401  over the communication cable  415  via the communication controller of the control unit  101 , the control unit  412  stores the ID number and assay data in the memory of the control unit  412 . The assay data stored in the control unit  412  are erythrocyte count, hematocrit, platelet count, and MCV corresponding to the ID number identical to that stored in the memory of the control unit  201 , as shown in  FIG. 17 . 
     The assay operation of the whole blood immunoassay apparatus  2  executed by the control unit  201  is described below using the flow chart of  FIG. 13 . When the rack  27  is placed in the rack supply unit  23 , the barcode label  28  of the sample container  26  is read by the barcode reader  24 , and the ID number is transmitted to the control unit  201  (steps S 1  and S 2 ). The control unit  201  of the whole blood immunoassay apparatus  2  inquires to the host computer  401  for the ID number (step S 3 ). The control unit  412  of the host computer retrieves the assay data of the same ID number received from the blood analyzer  21  from the memory of the control unit  412  (step S 4 ). A determination is made as to whether or not there are assay data which match the ID number (step S 5 ). When there are no assay data matching the ID number, the control unit  412  of the host computer transmits the determination result to the control unit  201  of the whole blood immunoassay apparatus  2  via the communication controller of the control unit  412 , and control unit  201  issues instructions to read the barcode label  28  of the next sample container  26  (step  1 ). When there are assay data with matching ID number, the communication controller of the control unit  412  of the host computer transmits the result to the control unit  201  of the whole blood immunoassay apparatus  2 , and the control unit  201  acquires the assay data having that ID number, and stores the assay data in the memory of the control unit  201  (step S 6 ). The control unit  201  compares the anomaly determination table (refer to  FIG. 5 ) and the assay data stored in the memory of the control unit  201 , and determines whether or not there is an anomaly value (step S 7 , S 8 ). 
     When it is determined that there is no anomaly value, the specimen in the sample container  26  corresponding to the assay data is determined to be suitable for whole blood assay, and the blood sample in the sample container  26  is assayed (step S 9 ). A fixed quantity of the blood sample is suctioned from the sample container  26  by the immunosample quantification unit  202 , and a fixed quantity of reagent is suctioned from the immunoreagent quantification unit  203 . The suctioned blood sample and reagent are transported to the immunosample preparation unit  204 , and the whole blood immunosample is prepared. The prepared whole blood immunoassay sample is transported to the sample assay unit  205  and assayed. In the control unit  201 , correction is performed based on the hematocrit transmitted from the blood analyzer  1  to convert the assay data to antigen concentration or antibody concentration in the serum or plasma. The assay result is output to the display/operation unit  22 . 
     When it is determined there is an anomaly value, it is determined that the blood sample in the sample container  26  corresponding to the assay data is unsuited for whole blood immunoassay, and the display screen (message) shown in  FIG. 7  is output to the display/operation unit  22  (step S 10 ). This display screen shows an example of a high level PLT specimen (high level platelet specimen). 
     Although the blood analyzer  1  and host computer  401 , and the whole blood immunoassay apparatus  2  and the host computer  401  are respectively connected via communication cables  415  and  416  in the third embodiment, they also may be connected over a network instead of communication cables. For example, the network may be a communication line such as the internet, intranet, inthernet or the like. Furthermore, assay data of the blood analyzer  1  also may be input to the host computer  401  from the keyboard  413 . 
     Furthermore, in the third embodiment, the host computer  401  is constructed so as to transmit assay data assayed by the blood analyzer  1  to the whole blood immunoassay apparatus  2 , however, the host computer  401  may receive assay data assayed by the blood analyzer  1 , and determine whether or not the assay data is suited for whole blood immunoassay, and thereafter transmit the determination result to the whole blood immunoassay apparatus  2 . Furthermore, the host computer  401  may receive assay data from the blood analyzer  1 , determine whether or not the sample is suited for whole blood immunoassay, and thereafter output a display screen (message) as to whether or not the sample is suited for whole blood immunoassay to the CRT  411  of the host computer  401 . 
     In this way assay data from the blood analyzer  1  accumulates in the host computer  401  by having the host computer  401  disposed between the blood analyzer  1  and the whole blood immunoassay apparatus  2 , such that assay data or determination results as to whether or not a sample is suited for whole blood immunoassay based on the assay data can be transmitted from the host computer  401  to the whole blood immunoassay apparatus  2 . With such a structure, it is possible to manage many clinical laboratory test apparatuses. 
     Fourth Embodiment 
       FIG. 14  is a structural diagram showing a fourth embodiment of a system including a whole blood immunoassay apparatus. 
     A blood analyzer  3  and whole blood immunoassay apparatus  4  are disposed in the center of this clinical laboratory test system; a rack feed unit  8  for transporting one by one a plurality of racks  27  holding sample containers  26  is provided on the right side, and a rack collection unit  9  for collecting the racks  27  is provided on the left side. A rack feed unit  10  for transversely feeding one by one the racks  27  from the rack feed unit  8  to the rack collection unit  9  is provided between the units  8  and  9 . 
     The blood analyzer  3  includes a barcode reader  31  for reading the barcode label  28  of the sample container  26 , sample mixing device  32  for mixing the blood sample in the sample container  26 , suction device  33  for suctioning a mixed blood sample from the sample container  26 , sample quantification unit  302  for measuring the suctioned blood sample, sample preparation unit  303  for preparing a measured blood sample, and assay unit  304  for assaying the measured blood sample. 
     The sample preparation unit  303  has the same construction as the sample preparation unit  103  of  FIG. 2 , and includes an erythrocyte sample preparation unit for diluting a blood sample and preparing a sample for erythrocyte/platelet assay, leukocyte sample preparation unit for subjecting a blood sample to hemolysis and preparing a sample for leukocyte assay, and an HGB sample preparation unit for subjecting a blood sample to hemolysis and preparing a sample for HGB (hemoglobin) assay. Since these structures are identical to those in  FIG. 2 , detailed descriptions are omitted. [ 0086 ] The whole blood immunoassay apparatus  4  includes a barcode reader  41  for reading the barcode label  28  of the sample container  26 , sample mixing device  42  for mixing the blood sample in the sample container  26 , suction device  43  for suctioning the mixed blood sample from the sample container  26 , immunosample quantification unit  402  for measuring the suctioned blood sample, immunoreagent quantification unit  403  for measuring the immunoassay reagent, immunosample preparation unit  404  for preparing an analysis sample from the measured blood sample and reagent, and immunosample assay unit  405  for assaying the prepared sample. Since the immunosample quantification unit  402 , immunoreagent quantification unit  403 , immunosample preparation unit  404 , and immunosample assay unit  405  have the same construction as shown in  FIG. 3 , detailed descriptions are omitted. 
     The control unit  5  receives the output signals from the barcode readers  31  and  41  and the input unit  6  for inputting analysis conditions, and controls the rack supply unit  8 , rack feed unit  10 , rack collection unit  9 , blood analyzer  3 , and whole blood immunoassay apparatus  4 . The control unit  5  includes a microcomputer provided with RAM, ROM, memory such as a hard disk or the like, and CPU; and a communication controller for sending and receiving data. 
     Furthermore, the input unit  4  includes a keyboard and mouse. The output unit  7  is a CRT. The rack feed unit  10  is a unit for transverse feeding formed by a lever for rotational movement provided on the bottom surface of the transport path for transporting the specimen rack, the lever being inserted into a concavity formed in the bottom surface of the specimen rack. 
     The operation of the clinical laboratory test system is described below. 
     As shown in  FIG. 14 , when the a plurality of racks  27  holding sample containers  26  are arrayed in vertical rows on the rack feed unit  8 , all the racks  27  are lined up and advance in the direction indicated by the arrow C, and thereafter, the lead rack  27  is transversely fed to the rack feed unit  10 . 
     The rack  27  transported by the rack feed unit  10  is stopped when the lead sample container  26  is at a position opposite the barcode reader  31 . When the barcode reader  31  reads the barcode label  28  of the lead sample container  26 , the sample container  26  again transversely transported and stopped directly below the sample mixing device  32  of the blood analyzer  3 . 
     Then, when the blood sample in the lead sample container  26  is mixed by the sample mixing device  32 , the rack  27  is moved only a predetermined distance (array pitch of the sample containers  26 ), and the blood sample from the sample container  26  which is completely mixed is suctioned by the sample suction device  33 . 
     The suctioned blood sample is measured by the sample quantification unit  302 , an assay sample is prepared by the sample preparation unit  303 , and the prepared assay sample is assayed by the sample assay unit  304 . During the suction operation of the sample suction device  33 , the sample mixing device  32  mixes the sample of the next sample container  26 . 
     The rack  27  intermittently transports the sample containers  26  one by one, and the barcode labels  28  of the sample containers  26  are sequentially read by the barcode reader  41  of the whole blood immunoassay apparatus  4 . After temporarily storing the ID number and assay data of the blood analyzer  3  in the memory of the control unit  5 , the control unit  5  compares the assay data and anomaly determination table (refer to  FIG. 5 ), determines whether or not the sample is suited for whole blood immunoassay, and stores the ID number and determination result in the memory of the control unit  5 . 
     When the barcode label  28  of the sample container  26  is read by the barcode reader  41  of the whole blood immunoassay apparatus  4 , the control unit  5  retrieves the determination result stored in the memory of the control unit  5  based on the ID number, and determines whether or not the blood sample in the sample container  26  is suited for whole blood immunoassay. 
     When the blood sample in the sample container  26  is determined to be suitable for whole blood immunoassay, the control unit  5  controls the rack feed unit  10 , and stops the relevant sample container  26  directly below the sample mixing device  42  of the whole blood immunoassay apparatus  4 . Then, after the sample container  26  has been mixed by the sample mixing device  42 , the rack  27  is moved only a predetermined distance, and the blood sample is suctioned from the thoroughly mixed sample container  26  by the sample suction device  43 . The suctioned blood sample is measured by the immunosample quantification unit  402  and mixed with a reagent measured by the immunoassay reagent quantification unit  403 ; and after the assay sample is prepared by the immunosample preparation unit  404 , the sample is assayed by the immunosample assay unit  405 . In the control unit  5 , correction is performed based on the hematocrit stored in the blood analyzer  3  to convert the assay data to antigen concentration or antibody concentration in serum or plasma. 
     When the blood sample in the container  26  is determined to be unsuited for whole blood immunoassay, the control unit  5  controls the feed unit  10  and the relevant sample container  26  passes through the sample mixing device  42  and sample suction device  43  of the whole blood immunoassay device  4 . 
     Furthermore, the control unit  5  outputs to the output unit  7  the result of the determination as to whether or not the sample is suitable for whole blood immunoassay based on the assay data obtained from the blood analyzer  3  as the table shown in  FIG. 15 . 
     When all blood samples suited for whole blood immunoassay have been suctioned from the  10  containers (all sample containers held in one rack  27 ), the rack  27  is transported in the arrow D direction and collected in the arrow E direction in the rack collection unit  9 . When the a rack requiring assay is present on the rack feed unit  8 , the rack  27  is transported from the rack feed unit  8  to the rack feed unit  10 , and the previously described processing is repeated on the blood samples of each sample container  26  in the rack  27 . 
     In this way in the clinical laboratory test system described above, simply by placing the rack in the system, a determination is made as to whether or not the specimen in the rack is suited for whole blood immunoassay, and at the same time the specimens which are suited for assay can be automatically subjected to whole blood immunoassay and the determination results of specimens which are unsuited for whole blood immunoassay can be displayed. Therefore, until immunoassays of all specimens are completed, an operator need not be constantly in attendance of the system. 
     In the fourth embodiment, the control unit  5  performs correction based on the hematocrit transmitted from the blood analyzer  3  to convert the assay data to antigen concentration or antibody concentration in serum or plasma; however, the control unit  5  also may perform correction by erythrocyte count assayed by the immunosample assay unit  205  to convert the assay data to antigen concentration or antibody concentration in serum or plasma. 
     Although the in each of the first through fourth embodiments the whole blood immunoassay apparatus is connected so as to allow communication with a blood analyzer, the whole blood immunoassay apparatus need not necessarily be capable of communication with the blood analyzer inasmuch as assay data obtained by a blood analyzer may be input to the whole blood immunoassay apparatus by an operator. Furthermore, assay data of the blood analyzer may be output on a barcode label, and the assay data may be read from the barcode label adhered to the specimen container by a barcode reader, and input to the whole blood immunoassay apparatus. In this case, the barcode label is desirably a two-dimensional barcode capable of storing a large quantity of information. 
     In the above embodiments, specimens may be blood or urine normally collected from humans or other animals. 
     Although the specimen laboratory test apparatus is a whole blood immunoassay apparatus in the above embodiments, other specimen laboratory test apparatus, such as blood coagulation assay apparatus, biochemical analyzer, urine qualitative analyzer, urine sedimentation analyzer and the like, may be used. 
     Although whether or not a specimen is suited for whole blood immunoassay is determined by the whole blood immunoassay apparatus based on assay data from a blood analyzer in the above embodiments, the determination as to whether or not a specimen is suited for whole blood immunoassay also may be based on attribute information of the patient, including medical history, patient comments, specimen comments and the like.