Automatic analysis device and automatic analysis method

Abstract

An analytical device and method are provided that enable the automation of the preparation of mixed plasma obtained by mixing test plasma and normal plasma at a predetermined mixing ratio. [Solution] The analytical device of the present invention comprises a sample rack that contains and holds a plurality of sample containers, a transport unit that transports the sample rack, a sample dispensing mechanism that dispenses test plasma and / or normal plasma that is added to correct the clotting time of the test plasma, a measurement unit that irradiates the test plasma, normal plasma and / or mixed plasma to which a reagent has been added with light from a light source and measures the clotting time based on the resulting scattered light and / or transmitted light, and a control unit, wherein the transport unit transports the sample rack that contains sample containers containing the test plasma, sample containers containing the normal plasma, and empty sample containers to an suction position of the sample dispensing mechanism, and the sample dispensing mechanism aspirates the test plasma and / or normal plasma from the sample containers containing the test plasma or the sample containers containing normal plasma, and discharges it into empty sample containers to prepare mixed plasma.

Description

[Technical field]

[0001] The present invention relates to an automatic analyzer that performs qualitative and quantitative analysis of biological samples such as blood and urine, and in particular to an automatic analyzer and an automatic analysis method that are suitable for blood coagulation and hemostasis tests. [Background technology]

[0002] Blood coagulation tests are performed for the purposes of understanding the pathology of the blood coagulation and fibrinolysis system, diagnosing DIC (disseminated intravascular coagulation), confirming the effectiveness of thrombus treatment, diagnosing hemophilia, etc. In particular, blood clotting time measurements involve mixing a sample with a reagent and measuring the time it takes for a fibrin clot to form (hereinafter referred to as blood clotting time), and if there is a congenital or acquired abnormality, the blood clotting time will be prolonged.

[0003] However, simply measuring the blood clotting time does not allow one to distinguish whether the cause is a decrease in activity due to a deficiency of blood clotting factors (deficiency type) or a decrease in activity due to inhibition of the blood clotting reaction by antibodies against components that constitute the blood clotting system or components in the blood clotting time measurement reagent (inhibitor type). On the other hand, in terms of treatment, it is necessary to clarify the cause, since the treatment policy differs depending on whether the cause of the prolonged blood clotting time is deficiency type or inhibitor type.

[0004] A method for identifying the cause of prolonged blood clotting time is the cross-mixing test (also called blood clotting correction test or cross-mixing test) using normal plasma. In the cross-mixing test, normal plasma is added to the test plasma, and the degree of correction of the blood clotting time is graphed and evaluated. The most typical use of the cross-mixing test is to determine the cause of prolongation of APTT, but it can also be performed on other items such as PT (prothrombin time), dPT (diluted PT), dAPTT (diluted APTT), KCT (kaolin clotting time), and dRVVT (diluted Russell's viper venom time). Although APTT is a major item that can be performed in most facilities that perform blood coagulation tests, it is difficult to say that cross-mixing tests are currently performed frequently. If the test cannot be performed in-house and must be outsourced, it takes time to receive the results, which can lead to delays in the detection and initiation of treatment for serious diseases such as hemophilia. The reason for this situation is that the sample preparation and incubation procedures are complicated, and the interpretation of the results is unclear, requiring the tester to be highly skilled.

[0005] In order to solve the above problems, Patent Document 1 has been proposed. In Patent Document 1, the blood coagulation time is measured for each of test plasma only, normal plasma only, and a sample (mixed plasma) in which test plasma and normal plasma are mixed in at least one mixing ratio, and the difference between the area (A) under a line graph obtained by plotting the obtained measured values ​​and the area (B) under a straight line connecting the measured values ​​of test plasma only and normal plasma only is calculated, and the area ratio (AB) / (B) of this difference is compared with a predetermined reference area ratio Y, and whether it is inhibitor type or deficiency type is judged based on the comparison result. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] WO2009 / 153964 publication Summary of the Invention [Problem to be solved by the invention]

[0007] However, Patent Document 1 does not disclose a method for automating the mixing of test plasma and normal plasma. If the mixture is prepared manually, the work may become complicated, and the accuracy of the mixing ratio of the resulting plasma mixture may vary depending on the skill level of the operator.

[0008] Therefore, an object of the present invention is to provide an automatic analyzer and an automatic analysis method that can automate the preparation of a mixed plasma obtained by mixing test plasma and normal plasma in a predetermined mixing ratio. [Means for solving the problem]

[0009] In order to solve the above problems, the automated analyzer of the present invention comprises a sample rack that accommodates and holds a plurality of sample containers, a transport unit that transports the sample rack, a sample dispensing mechanism that dispenses test plasma and / or normal plasma to be added to correct the clotting time of the test plasma, a measurement unit that irradiates the test plasma, normal plasma and / or mixed plasma to which a reagent has been added with light from a light source and measures the clotting time based on the resulting scattered light and / or transmitted light, and a control unit, wherein the transport unit transports a sample rack that accommodates a sample container containing the test plasma, a sample container containing the normal plasma and an empty sample container to an aspirating position of the sample dispensing mechanism, and the sample dispensing mechanism aspirates the test plasma and / or normal plasma from the sample container containing the test plasma or the sample container containing normal plasma, and discharges it into an empty sample container, thereby preparing mixed plasma.

[0010] Furthermore, the automatic analysis method of the present invention is an automatic analysis method using an automatic analyzer including a sample rack that accommodates and holds a plurality of sample containers, a transport unit that transports the sample rack, a sample dispensing mechanism that dispenses test plasma and / or normal plasma to be added to correct the clotting time of the test plasma, a measurement unit that measures the clotting time, and a control unit, wherein the measurement unit irradiates the test plasma, normal plasma and / or mixed plasma to which a reagent has been added with light from a light source and measures the clotting time based on the resulting scattered light and / or transmitted light, the transport unit transports a sample rack that accommodates a sample container containing the test plasma, a sample container containing the normal plasma, and an empty sample container to an aspirating position of the sample dispensing mechanism, and the sample dispensing mechanism aspirates the test plasma and / or normal plasma from the sample container containing the test plasma or the sample container containing normal plasma, and discharges it into an empty sample container, thereby preparing mixed plasma. Effect of the Invention

[0011] According to the present invention, it is possible to provide an automatic analyzer and an automatic analysis method that can automate the preparation of mixed plasma obtained by mixing test plasma and normal plasma in a predetermined mixing ratio.

[0012] Problems, configurations and effects other than those described above will become apparent from the following description of the embodiments. [Brief description of the drawings]

[0013] [Figure 1] 1 is a schematic overall configuration diagram of an automatic analyzer of Example 1 according to an embodiment of the present invention. [Diagram 2] FIG. 1 is a schematic diagram of a cross-mixing test. [Diagram 3] 2 is a flowchart showing a process flow of the automatic analyzer shown in FIG. 1. [Figure 4] 13 is a display example of an operation screen when a cross-mixing test measurement is requested. [Diagram 5] 13 is a display example of an operation screen when a cross-mixing test measurement is requested. [Figure 6] FIG. 13 is a diagram showing the state when normal plasma is aspirated by the sample dispensing mechanism. [Figure 7] FIG. 13 is a diagram showing the state when test plasma is aspirated by the sample dispensing mechanism. [Figure 8] 13A and 13B are diagrams showing the state when normal plasma or test plasma is discharged by the sample dispensing mechanism. [Figure 9] FIG. 13 is a diagram showing the state of agitation of mixed plasma by a stirring mechanism. [Figure 10] FIG. 1 is a diagram showing the results of a cross-mixing test performed by the automatic analyzer of Example 1. [Figure 11] FIG. 11 is a schematic overall configuration diagram of an automatic analyzer according to a second embodiment of the present invention. [Figure 12] 12 is an explanatory diagram of the transport order of the sample rack in the automatic analyzer shown in FIG. 11. [Figure 13] 12 is a diagram for explaining the transport order of the sample rack during a cross-mixing test in the automatic analyzer shown in FIG. 11. [Figure 14] FIG. 12 is an explanatory diagram of a sample dispensing position during a cross-mixing test in the automatic analyzer shown in FIG. 11. [Figure 15]13 is a flowchart showing a process flow of an automatic analyzer according to a third embodiment of the present invention. [Figure 16] 13 is a display example of an operation screen when a cross-mixing test is requested according to the third embodiment. [Figure 17] 13 is a flowchart showing a process flow of an automatic analyzer of Example 4 according to another embodiment of the present invention. [Figure 18] 10 is a timing chart showing the operation of the automatic analyzer of the fourth embodiment. [Figure 19] 13 is a flowchart showing a process flow of an automatic analyzer according to a fifth embodiment of the present invention. [Figure 20] 13 is a flowchart showing a process flow of an automatic analyzer of Example 6 according to another embodiment of the present invention. [Figure 21] 13 is a display example of an operation screen when a cross-mixing test is requested according to the sixth embodiment. [Figure 22] FIG. 1 shows normal plasma only, test plasma only, and mixed plasma with five different mixing ratios. [Figure 23] FIG. 1 shows normal plasma only, test plasma only, and mixed plasma with three different mixing ratios. [Figure 24] FIG. 1 shows normal plasma only, test plasma only, and mixed plasma with one type of mixing ratio. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] In this specification, "test plasma" includes both plasma from hospitalized or outpatient patients and plasma from subjects in health checkups, etc. In addition, in this specification, "normal plasma", "test plasma" and "mixed plasma mixed at various mixing ratios" are sometimes collectively referred to as samples for measuring blood coagulation time. In addition, in this specification, "general sample" refers to a sample from a subject.

[0015] Figure 2 is a schematic diagram of the cross-mixing test. Normal plasma is added to the test plasma, and the samples are prepared by mixing so that the ratio of normal plasma is 0, 10, 20, 50, 80, 90, and 100%, and APTT is measured. The relationship between the measurement result (blood clotting time) and the ratio of normal plasma is plotted and a graph is created. As shown in Figure 2, the horizontal axis is the normal plasma ratio (%) and the vertical axis is APTT (blood clotting time). For example, in the deficiency type, as shown by the solid line (a) in Figure 2, the APTT prolongation is corrected by the addition of normal plasma, and a downward convex pattern is shown. On the other hand, in the inhibitor type, as shown by the solid line (b) in Figure 2, the APTT prolongation is difficult to correct even when normal plasma is added, and an upward convex pattern is shown. However, since the reaction of inhibitors against factor VIII is time- and temperature-dependent, the reaction immediately after mixing (hereinafter referred to as the immediate reaction) may not show a clear upward convex shape, but may show an upward convex shape in the reaction after a certain period of incubation at 37°C (hereinafter referred to as the delayed reaction). Therefore, it is recommended that cross-mixing tests measure both immediate and delayed responses. Hereinafter, an embodiment of the present invention will be described with reference to the drawings. EXAMPLES

[0016] Fig. 1 is a schematic diagram of the overall configuration of an automatic analyzer according to a first embodiment of the present invention. Here, a basic flow of a blood coagulation test will be described with reference to Fig. 1, but the flow is not limited to the following example. The automatic analyzer 100 is generally composed of a sample dispensing mechanism 101, a sample disk 102, a reagent dispensing mechanism 106, a reagent disk 107, a reaction vessel stock section 111, a reaction vessel transport mechanism 112, a detection unit 113, a reaction vessel disposal section 117, an operation section 118, a memory section 119, and a control section 120.

[0017] The specimen dispensing mechanism 101 aspirates specimens contained in specimen containers 103 arranged on a specimen disk 102 that rotates clockwise and counterclockwise, and dispenses the specimens into reaction containers 104 contained in a reaction container stock unit 111. The specimen dispensing mechanism 101 has a specimen dispensing probe 101a at its tip, and executes the aspirating and dispensing operations of the specimen by the operation of a specimen syringe pump 105 controlled by a control unit 120.

[0018] The reagent dispensing mechanism 106 aspirates reagent contained in reagent containers 108 arranged on a reagent disk 107, and dispenses the reagent into reaction containers 104 contained in a reaction container stock unit 111. The reagent dispensing mechanism 106 has a reagent dispensing probe 106a at its tip, and performs the aspirating and dispensing operations of the reagent by the operation of a reagent syringe pump 110 controlled by a control unit 120. The reagent dispensing mechanism 106 also includes a reagent heating mechanism 109. The temperature of the reagent aspirated by the reagent dispensing mechanism 106 is raised to an appropriate temperature (a predetermined temperature) by the reagent heating mechanism 109 controlled by the control unit 120.

[0019] The reaction vessel transport mechanism 112 transports and sets the reaction vessel 104 housed in the reaction vessel stock section 111. The reaction vessel transport mechanism 112 grasps the reaction vessel 104 and rotates it in an arc in a horizontal plane, thereby transporting and setting the reaction vessel 104 from the reaction vessel stock section 111 to the reaction vessel setting section 114 of the detection unit 113.

[0020] The detection unit 113 has at least one or more reaction vessel installation parts 114 for placing the reaction vessel 104. The detection unit 113 measures the light intensity of the specimen in the reaction vessel 104 inserted in the reaction vessel installation part 114. In this embodiment, the case where one detection unit 113 is arranged is shown, but a configuration having multiple detection units 113 may be used. An example of the detection principle in the detection unit 113 will be described below. Light irradiated from the light source 115 is scattered by the reaction solution in the reaction vessel 104. The detection part (light receiving part) 116 is composed of a photodiode and the like. The detection part 116 receives the scattered light scattered by the reaction solution (specimen) in the reaction vessel 104 and performs photoelectric conversion to output a photometric signal indicating the intensity of the received scattered light to the A / D converter 121. The measurement signal of the scattered light A / D converted by the A / D converter 121 is input to the control part 120 via the interface 122. The operation of the detection unit 113 is controlled by the control unit 120. Here, the control unit 120 is composed of an analysis operation control unit 120a and a calculation unit 120b. The analysis operation control unit 120a and the calculation unit 120b are realized by a processor such as a CPU, for example, and perform control and calculation by reading various programs stored in a ROM or storage unit 119 (not shown) and executing the read programs. That is, the analytical operation control unit 120a controls the sample dispensing mechanism 101 and the sample disk 102 to dispense the sample. The analytical operation control unit 120a also controls the reagent dispensing mechanism 106 and the reagent disk 107 to dispense the reagent into the sample in the reaction container 104. Furthermore, the analytical operation control unit 120a controls the operation of the automatic analyzer, such as moving the reaction container 104 and discarding the reaction container 104. The calculation unit 120b performs a measurement process to measure the reaction time of the sample based on a comparison result between a signal value obtained from a measurement value of light intensity that changes over time according to the degree of the mixed reaction between the sample and the reagent and a predetermined judgment threshold value. The calculated clotting time is output to the display unit 118c and stored in the memory unit 119. The clotting time as the calculation result may be printed out to the printer 123 via the interface 122.

[0021] The detection unit 116 is not limited to a configuration that receives scattered light caused by the reaction solution (specimen) in the reaction vessel 104. For example, the detection unit 116 may be configured to detect the intensity of transmitted light that passes through the reaction solution (specimen) in the reaction vessel 104. The detection unit 116 may also use both the scattered light detection method and the transmitted light detection method. Furthermore, in addition to the above, the detector 116 may also use viscosity. The reaction vessel transport mechanism 112 grasps the reaction vessel 104 after the measurement has been completed, and discards it into the reaction vessel discard unit 117 . For the purpose of improving the processing capacity, an incubator 124 without a detector may be provided for warming the sample before the measurement start reagent is added.

[0022] Analysis items of samples to be analyzed by the automatic analyzer 100 are input from the operation unit 118 to the control unit 120 via a keyboard 118b serving as an input unit or an operation screen displayed on a display unit 118c. Note that a GUI (Graphical User Interface) may be used to input analysis items by operating the analysis items displayed on the display unit 118c with a pointer or the like using a mouse 118a.

[0023] 1, for the sake of convenience in showing all the components, the reaction vessel stock unit 111, the sample disk 102, and the reagent disk 107 are depicted as being spaced apart, but in reality, the sample disk 102 and the reaction vessel stock unit 111 are disposed within the range of an arc-shaped movement locus in a horizontal plane of the sample dispensing probe 101a constituting the sample dispensing mechanism 101. The reagent disk 107 and the reaction vessel stock unit 111 are disposed within the range of an arc-shaped movement locus in a horizontal plane of the reagent dispensing probe 106a constituting the reagent dispensing mechanism 106. Therefore, when viewed from above, the sample disk 102, the reaction vessel stock unit 111, and the reagent disk 107 are disposed in a substantially triangular shape.

[0024] Next, a detailed description will be given below of a method for requesting a cross-mixing test and preparing a sample in the automatic analyzer 100 of this embodiment. Fig. 3 is a flow chart showing the process flow of the automatic analyzer shown in Fig. 1, and in particular shows the flow of a sample preparation method when a cross-mixing test is requested. First, the automatic analyzer 100 accepts a request for a cross-mixing test (step S101). There are two methods for accepting the request: receiving the request via a network system using a host computer, and accepting a cross-mixing test measurement request input by an operator making a measurement request from the operation unit 118. The following describes an example in which a measurement request is input via an operation screen.

[0025] 4 and 5 show examples of the operation screen displayed on the display unit 108c constituting the operation unit 118 when a cross-mixing test measurement is requested. As shown in FIG. 4, the cross-mixing test measurement request screen (operation screen) has an area for displaying the type of sample, that is, whether it is a general sample, an emergency sample, or a control. FIG. 4 shows that the cross-mixing measurement is requested for a general sample. The cross-mixing measurement request screen (operation screen) also has a test item selection / designation area 127. The operator can designate the item for which the cross-mixing test is to be performed from this operation screen using the test item selection / designation area 127. The example shown in FIG. 4 shows a state in which the item APTT is selected. The operation screen also has an area in which the normal plasma ratio can be selected. The example shown in FIG. 4 shows a state in which all seven conditions of normal plasma ratios of 0, 10, 20, 50, 80, 90, and 100% are set. Here, the normal plasma ratio to be set is not limited to the seven conditions shown in FIG. 4, but may be, for example, three or more conditions including 0% and 100%, i.e., test plasma only, normal plasma only, and mixed plasma of at least one mixing ratio, and other mixing ratios can be set arbitrarily.

[0026] As shown in FIG. 4, when the measurement item and normal plasma ratio are set, the analysis operation control unit 120a calculates the amount of normal plasma and the amount of test plasma required for the measurement, determines the amount of normal plasma and the amount of test plasma that differ for each condition, and controls the operation of the specimen dispensing mechanism 101. At that time, as shown in FIG. 5, the required amount of normal plasma and the amount of test plasma are displayed on the display unit 118c to inform the operator. The fact that the operator can grasp the required amount of plasma has the effect of reducing the burden on the operator of calculating the required amount and preventing a shortage of plasma amount during preparation. Here, in FIG. 5, the operator specifies the installation positions of normal plasma, test plasma, and empty specimen containers, but the device may be controlled to specify the installation positions. Also, FIG. 5 shows a state in which "100" is set as the installation position of normal plasma, "101" as the installation position of test plasma, and "102" as the start position of the empty specimen container. Here, each position represents the position of the sample container 103 in the sample disk 102 and is not necessarily identified by numbers alone. For example, the position of the sample container 103 may be identified by a combination of letters and numbers. Furthermore, when a request is received from a network system using a host computer, analysis can be performed without setting measurement items or measurement conditions.

[0027] When the "start" button is pressed in the state shown in FIG. 5 (step S102), the amount of normal plasma, the amount of test plasma, and the presence or absence of an empty sample container are confirmed (step S103). Here, the empty sample container is a disposable, stopperable container having an individual identification medium. The individual identification medium is for identifying the sample, and for example, a barcode or RFID is used. The individual identification medium of the subject sample includes measurement request information and the like in addition to the sample ID for identifying the sample. The individual identification medium attached to the empty sample container is assigned an arbitrary number and is used to manage the mixed plasma after mixing the normal plasma and the test plasma. The amount of normal plasma, the amount of test plasma, and the presence or absence of an empty sample container are confirmed by using the liquid level detection function of the sample dispensing mechanism 101, that is, the sample dispensing probe 101a provided at the tip of the sample dispensing mechanism 101 detects the liquid level by utilizing changes in electrical characteristics such as capacitance or resistance value that change when the sample dispensing probe 101a provided at the tip of the sample dispensing mechanism 101 comes into contact with or approaches the liquid level. Alternatively, an image may be captured using a small camera or the like (a sensor such as a CCD, CMOS, or PMT) and the liquid volume may be calculated from the liquid level. In the following, an example will be described in which the liquid level detection function of the specimen dispensing mechanism 101 is used and a barcode is used as the individual identification medium.

[0028] As the specimen disk 102 rotates clockwise and counterclockwise, the barcodes, which are individual identification media of the specimens, are read when the subject specimens and empty specimen containers placed at the positions specified in FIG. 5 pass in front of the reading unit 125. The requested items for the subject specimens specified by the read barcodes are collated, and the normal plasma ratio and original subject specimen information created in the placed empty specimen containers are collated with the ID of each mixed plasma. Next, as shown in FIG. 6, among the specimen containers 103 in the specimen disk 102, the specimen container 103a filled with normal plasma is moved to the dispensing position of the specimen dispensing mechanism 101, and the amount of normal plasma is confirmed by the liquid level detection function of the specimen dispensing probe 101a. Similarly, the specimen container 103b filled with test plasma is moved to the dispensing position, and the amount of test plasma is confirmed by the liquid level detection function of the specimen dispensing probe 101a (FIG. 7). Furthermore, for empty sample containers, the liquid level detection function of the sample dispensing probe 101a recognizes that the placed sample container is empty when it is not in contact with the liquid level but is in contact with the bottom of the sample container (abnormal descent detection).

[0029] 3, in step S104, if the container installation check shows that the amount of normal plasma or the amount of test plasma is less than the required amount, or if the required number of blank sample containers are not installed in the specified positions, the mixed plasma preparation is stopped and a system alarm is displayed (step S105). This makes it possible to avoid a shortage of plasma during measurement, or a risk of contaminating the sample disk 102 by further dispensing a sample (normal plasma, test plasma, or mixed plasma) into a sample container into which a sample has already been dispensed, in a location where no blank sample container is installed.

[0030] If it is confirmed in step S104 that more than the required amount of normal plasma and test plasma have been prepared and the required number of empty specimen containers have been placed, dispensing of normal plasma into the empty specimen containers begins (step S106). Here, the dispensing operation of normal plasma will be described. The specimen disc 102 rotates clockwise and counterclockwise to move the specimen container 103a filled with normal plasma to the dispensing position, and the specimen dispensing mechanism 101 aspirates the normal plasma (FIG. 6). In the example shown in FIG. 6, the specimen disc 102 rotates counterclockwise in steps, and the movement distance in each step corresponds to the pitch of two specimen containers 103 arranged adjacent to each other. As a result, the barcode attached to the specimen container 103 is read by the reading unit 125 as described above, and after the specimen ID is identified, the specimen container 103 is positioned immediately below the specimen dispensing mechanism 101 located forward of the reading unit 125 along the rotation direction of the specimen disc 102 (specimen dispensing position). That is, each specimen container 103 is always positioned at the dispensing position after the specimen ID is identified by the reading unit 125.

[0031] Next, the specimen container 103 positioned at the dispensing position by the stepped rotation of the specimen disk 102 is specimen container 103b filled with test plasma (FIG. 7), and therefore does not discharge normal plasma aspirated by the specimen dispensing probe 101a constituting the specimen dispensing mechanism 101. The specimen container positioned at the dispensing position next is empty specimen container 103c, which discharges normal plasma aspirated into the specimen dispensing probe 101a (FIG. 8). This operation is repeated to dispense normal plasma into empty specimen containers 103d to 103i. When dispensing of normal plasma is completed (step S107), dispensing of test plasma is subsequently performed (step S108).

[0032] In the dispensing operation of the test plasma in step S108, first, the specimen container 103b filled with the test plasma is positioned at the dispensing position by the rotation of the specimen disk 102, and the test plasma is aspirated by the specimen dispensing probe 101a of the specimen dispensing mechanism 101 (FIG. 7). Next, the specimen container positioned at the dispensing position by the rotation of the specimen disk 102 is the specimen container 103c from which normal plasma was discharged in step S106. The specimen dispensing probe 101a discharges the aspirated test plasma into the specimen container 103c (FIG. 8). In a similar procedure, the specimen dispensing probe 101a dispenses the test plasma into the specimen containers 103d to 103i. This is repeated until dispensing of all the test plasma is completed (step S109). In steps S106 and S108, the amount of normal plasma and test plasma discharged from the sample dispensing probe 101a constituting the sample dispensing mechanism 101 into each of the sample containers 103c to 103i corresponds to the normal plasma ratio set, for example, on the operation screen shown in FIG. 4. Returning to FIG. 3, in step S110, as shown in FIG. 9, the mixed plasma of normal plasma and test plasma dispensed into the specimen container 103c positioned directly below the stirring mechanism 126 is stirred by the stirring mechanism 126. Here, the stirring mechanism 126 is implemented, for example, by infiltrating a stirring blade or a spatula-shaped rod provided at the tip into the mixed plasma in the specimen container 103c and rotating it, as shown in FIG. 9. The stirring mechanism 126 is not limited to a method of rotating a stirring blade or a spatula-shaped rod. For example, it may be configured to irradiate ultrasonic waves to the mixed plasma in the specimen container and stir it. Alternatively, it may be configured to rotate the specimen disk 102 forward and backward (clockwise and counterclockwise), or to stir the mixed plasma by the discharge pressure when discharging normal plasma or test plasma from the specimen dispensing probe 101a to the specimen container 103, that is, the discharge pressure of the specimen syringe pump 105.

[0033] In this manner, in the automatic analyzer 100 of this embodiment, mixed plasma having various normal plasma ratios set by the operation screen shown in FIG. 4 described above can be automatically prepared by the specimen dispensing mechanism 101 and the stirring mechanism 126.

[0034] In FIG. 3, the normal plasma is dispensed (step S106) followed by the test plasma (step S108), but the present invention is not limited thereto. The normal plasma may be dispensed after the test plasma is dispensed to prepare the mixed plasma. In addition, the normal plasma and the test plasma are dispensed independently from the viewpoint of preventing contamination of the normal plasma and the test plasma, but the present invention is not limited thereto. For example, when the sample dispensing mechanism 101 is sufficiently washed and there is no risk of contamination, it is also possible to prepare (prepare) the mixed plasma one by one. In this case, the required amount of normal plasma is dispensed into the empty sample container 103c, and then the required amount of test plasma is dispensed. After preparing the mixed plasma in the sample container 103c, the mixed plasma is prepared in the empty sample container 103d, and so on. Thus, the mixed plasma is prepared for each empty sample container in sequence.

[0035] 3, when the two types of specimens have been dispensed, that is, when step S109 has been completed, a preparation completion screen may be displayed on the display unit 118c, and the operator may cap and stir the specimen container containing the prepared specimen, and place it again on the specimen disk 102. In this case, since there is no need to provide the specimen stirring mechanism 126, the device can be made smaller.

[0036] After the sample preparation is completed, the seven mixed plasmas prepared in 103c to 103i are used for analysis. The measurement performed immediately after the sample preparation is defined as an immediate measurement. In step S111 of FIG. 3, the bar codes attached to the seven sample containers 103c to 103i, each containing a different normal plasma ratio mixed plasma, are read by the reading unit 125, and the mixed plasmas with five different mixture ratios, that is, normal plasma only, test plasma only, and normal plasma ratios of 10, 20, 50, 80, and 90%, are identified, and then the process proceeds to step S112. In step S112, the samples contained in each sample container 103c to 103i are dispensed by the sample dispensing mechanism 101 into different reaction containers 104 contained in the reaction container stock unit 111. Thereafter, each reaction vessel 104 is moved to the detection unit 113 by the reaction vessel transport mechanism 112, and the reaction vessel 104 is set in the reaction vessel installation section 114 as described above, and a photometric signal indicating the intensity of scattered light and / or transmitted light is detected. Here, the seven specimen vessels for the prepared specimens have a function of recognizing the normal plasma ratio and subject specimen ID collated in step S103, and enabling collation with the measurement results.

[0037] However, what makes the cross-mixing test different from normal analysis is that multiple (seven in this case) APTT clotting times are calculated for one subject sample, and one graph is created and used for diagnosis. The results after the immediate measurement are displayed on the operation unit 118c (step S113) by plotting the normal plasma ratio of each mixed plasma on the horizontal axis and the APTT clotting time on the vertical axis, as shown by the solid line (a) in FIG. 10. The function of collating the measurement results using the individual identification medium and automatically creating the graph can prevent the operator from inputting the measurement results incorrectly, and provide reliable results. At this time, it is preferable to print the results from the printer 123 via the interface 122.

[0038] When a delayed measurement is to be performed after the immediate measurement (step S114), the container of the mixed plasma (residual sample) after the immediate measurement is capped and incubated at 37° C. for a certain period of time. The incubation is performed in the incubator 124, but in the case of an apparatus that does not have the incubator 124, it is performed outside the apparatus. Here, a case where the incubator 124 is not provided in the apparatus for the purpose of saving space and reducing costs of the apparatus, and incubation is performed outside the apparatus will be described. The apparatus counts the incubation time from the measurement end time as the starting point. At this time, the operator can know the incubation end time from the operation screen by setting the incubation time in advance. Also, preferably, when the incubation end time is approaching, a display notifying the end of incubation is output (step S115). This allows the operator to grasp the status of the sample during incubation and not forget to measure it. The operator opens the mixed plasma after incubation, places it on the specimen disk 102, and presses the measurement start button. When the measurement start button is pressed (step S116), the specimen disk 102 rotates to read the mixed plasma ID placed at the position specified on the operation screen shown in FIG. 5, recognizes the normal plasma ratio and the subject specimen ID checked in step S103, checks the requested items (step S117), and performs delayed measurement (step S118). When the measurement is completed, a delayed graph shown by the solid line (b) in FIG. 10 is created (step S119), and is checked against the immediate result (step S120). At this time, the immediate and delayed graphs may be combined into one as in FIG. 2, or may be divided into two different graphs and displayed.

[0039] As described above, according to this embodiment, the preparation of mixed plasma, the analysis of immediate / delayed types, and the comparison of the immediate / delayed types of results are performed automatically, thereby eliminating variations in measurement results due to the level of proficiency of the operator and errors such as human sample mix-ups, thereby making it possible to increase reliability. In addition, the burden on the operator is reduced, and results can be obtained quickly. Furthermore, it is possible to realize an automatic analyzer and an automatic analysis method that can automate the preparation of a mixed plasma obtained by mixing test plasma and normal plasma in a predetermined mixing ratio. EXAMPLES

[0040] 11 is a schematic diagram of an entire configuration of an automatic analyzer of Example 2 according to another embodiment of the present invention. In this example, the automatic analyzer includes a sample rack 201, a sample rack supply unit 202, a sample rack storage unit 203, a transport line 204 for transporting the sample rack 201 to the analysis unit 210, a return line 205, a rack standby unit 206, a standby unit handling mechanism 207, a rack return mechanism 208, a first reading unit (transport line) 209, and an analysis unit 210. That is, this example differs from Example 1 in that, as a mechanism for mounting the sample container 103, the sample container 103 is mounted on the sample rack 201 and various transport mechanisms for transporting the sample rack 201 are provided. Other points are the same as those of Example 1, and the same components as those of Example 1 are denoted by the same reference numerals and will not be described below.

[0041] 11, a plurality of analysis units 210 can be connected along the transport line 204, but in this embodiment, the configuration includes at least one analysis unit for performing a coagulation test. The basic configuration of the analysis unit 210 for performing a coagulation test and the basic flow of analysis are generally similar to those in embodiment 1, but since the sample is supplied via the transport line 204, the sample disk 102 is not provided. A method of supplying a specimen, which is significantly different from that in Example 1, will be described in detail below. In the automatic analyzer of this embodiment, the transport system of the analysis section 210 arranged along the transport line 204 includes a second reading section (analysis section) 211 for checking analysis request information for samples, a first rack handling mechanism 212 for receiving the sample rack 201 from the transport line 204, a dispensing line 213 for dispensing samples from sample containers in the sample rack 201 and having the function of allowing the sample rack 201 to wait until dispensing begins, an evacuation area 214 for evacuating the sample rack 201 when preparing mixed plasma for cross mixing, and a second rack handling mechanism 215 for transporting the sample rack 201 after sample dispensing to the return line 205.

[0042] First, the flow of sample supply when performing a general analysis, that is, an analysis of calibrators, controls, general samples, etc., that is, the transport order of sample racks, will be described with reference to FIG. When an analysis request is received via the operation unit 118, the sample racks 201 arranged in the sample rack supply unit 202 are transferred to the transport line 204 as shown by the arrow (a) in FIG. 12, and then the individual identification media (e.g., barcodes, etc.) attached to the sample racks 201 and the sample containers accommodated in the sample racks 201 are read by the first reading unit (transport line) 209, and the sample rack numbers and sample container numbers are recognized (arrow (b) in FIG. 12). Thereafter, if there is a sample rack 201 on the dispensing line 213, the sample read by the first reading unit (transport line) 209 is accommodated in the sample rack standby unit 206 and waits for analysis (arrow (c) in FIG. 12). When the dispensing of the samples on the dispensing line 213 is completed, the waiting sample rack 201 is sent to the analysis unit 210, and the sample rack numbers and sample container numbers are recognized by the second reading unit (analysis unit) 211 ((d) in FIG. 12). Next, the sample is drawn into the dispensing line 213 via the first rack handling mechanism 212 (see (e) in FIG. 12), and the sample is dispensed by the sample dispensing mechanism 101. If there is no sample rack 201 in the dispensing line 213 at this time, the sample is transported directly to the dispensing line 213 without being accommodated in the sample rack standby section 206.

[0043] The sample rack 201 containing the sample after dispensing by the sample dispensing mechanism 101 is transported to the return line 205 via the second rack handling mechanism 215 ((f) in FIG. 12), and then transported to the sample rack waiting section 206 via the waiting section handling mechanism 207 ((g) in FIG. 12). Here, the measurement result is awaited, and if it is determined that no retest is required, the sample rack 201 is transferred to the return line 205 via the waiting section handling mechanism 207 ((h) in FIG. 12), and then transported to the sample rack storage section 203 ((i) in FIG. 12).

[0044] FIG. 13 shows the flow of sample supply in sample preparation for a cross-mixing test, that is, the order in which sample racks are transported. When an analysis request is received from the operation unit 118, the sample racks 201 arranged in the sample rack supply unit 202 are transferred to the transport line 204 (arrow (a) in FIG. 13), and the individual identification media (e.g., barcodes) attached to the sample racks 201 and the sample containers contained in the sample racks 201 are read by the first reading unit (transport line) 209, and the sample rack numbers and sample container numbers are recognized ((b) in FIG. 13). When the first reading unit (transport line) 209 confirms a request for a cross-mixing test, the sample racks 201 containing normal plasma, test plasma, and empty sample containers are all collated, and the sample racks are stored in the rack standby unit 206 to wait for analysis until there are no samples being analyzed in the dispensing line 213 (arrow (c) in FIG. 13). At this time, the sample racks containing the test plasma, normal plasma, and empty sample containers may all be stored in the same sample rack, or may be stored across two or more sample racks.

[0045] When there is no sample being analyzed in the dispensing line 213 and the sample rack 201 accommodating the test plasma to be analyzed, normal plasma, and empty sample containers is confirmed, the sample rack accommodating the test plasma to be analyzed and the sample rack accommodating the empty sample container are transported to the analysis section 210 in this order. Then, the second reading section (analysis section) 211 recognizes the sample rack number and the sample container number ((d) in FIG. 13). Next, the sample is sent to the dispensing line 213 ((e) in FIG. 13) via the second rack handling mechanism 215, and as in the first embodiment, the liquid level detection function and abnormal drop detection function of the sample dispensing mechanism 101 confirm that the required amount of test plasma and normal plasma are filled and that the sample container 103 required for preparing the mixed plasma is empty. If the test plasma volume, normal plasma volume, and empty sample containers are not correctly installed, they are temporarily returned to the transport line 204 via the first rack handling mechanism 212, and then transported to the return line 205 via the second rack handling mechanism 215. When they are returned to the sample rack storage section 203, a system alarm is output and sample preparation is halted.

[0046] On the other hand, the sample rack 201, for which it has been confirmed that the test plasma volume, normal plasma volume, and empty sample container are correctly installed, is temporarily returned to the transport line 204 via the first rack handling mechanism 212, and is transported again to the dispensing line 213 via the second rack handling mechanism 215. The test plasma of the transported sample rack 201 is aspirated and subsequently discharged into the empty sample container. At this time, if the empty sample container is stored in another sample rack, the sample rack is placed in the evacuation area 214 provided on the dispensing line 213, and discharged into the empty sample container by the arc-shaped rotation operation in the horizontal plane of the sample dispensing mechanism 101 (FIG. 14). The same operation is repeated to dispense the test plasma and normal plasma, thereby preparing the mixed plasma. At this time, it is preferable that the stirring mechanism 126 shown in the first embodiment is arranged so as to be accessible on the dispensing line 213, and configured to be capable of mixing the mixed plasma.

[0047] The sample rack containing the prepared sample is returned to the transport line 204 via the first rack handling mechanism 212, and sent to the return line 205 via the second rack handling mechanism 215 ((g) in FIG. 13). After that, the sample rack 201 containing the prepared sample is drawn into the sample rack waiting section 206 ((h) in FIG. 13) via the waiting section handling mechanism 207, and waits for analysis. Here, in the case of a structure in which the analysis section 210 does not have a stirring mechanism 126 as shown in FIG. 11, the sample rack is sent to the return line 205 via the second rack handling mechanism 215 ((g) in FIG. 13), and returned to the sample rack storage section 203 ((g) in FIG. 13). The operator collects the prepared sample from the returned sample rack, and after stirring, places it again in the rack supply section 202, and performs an analysis of an arbitrary item (e.g., APTT) (instantaneous measurement). The analysis method is the same as that in the first embodiment, and therefore will not be described.

[0048] After the analysis, the sample is sent to the return line 205 via the second rack handling mechanism 215 ((g) in FIG. 13) and returned to the sample rack storage unit 203 ((g) in FIG. 13). The operator collects the sample returned to the sample rack storage unit 203, incubates it at 37° C. for a certain period of time, and then places it back in the sample rack supply unit 202 for delayed measurement.

[0049] According to this embodiment, in addition to the effects of the first embodiment, it becomes possible to easily perform real-time measurement and delayed measurement by controlling the transport direction of the sample rack. EXAMPLES

[0050] 15 is a flowchart showing a process flow of an automatic analyzer of Example 3 according to another embodiment of the present invention. In this Example, the configuration of the automatic analyzer itself may be any of the configurations of Example 1 or Example 2 described above, and is different from Example 1 and Example 2 in that normal plasma and test plasma are directly dispensed into a reaction vessel to prepare a measurement target specimen instead of preparing a measurement target specimen (preparing a mixed plasma) in a specimen vessel. That is, in this Example, normal plasma and test plasma are directly dispensed into a reaction vessel and then a reagent is added to perform the measurement, so that there is less loss of specimen compared to the method of mixing normal plasma and test plasma in a separate vessel, preparing a mixed plasma, and then re-dispensing it into a reaction vessel at the time of measurement, as in Example 1 and Example 2 described above.

[0051] 15, first, the automatic analyzer accepts a request for a cross-mixing test via the operation unit 118 (step S301). Then, similar to the above-described first and second embodiments, the process is the same as in the first embodiment up to the point where the pressing of the "start" button shown in FIG. 5 is recognized (step S302).

[0052] As shown in FIG. 16, in the cross-mixing measurement request screen of this embodiment, the operator specifies the normal plasma ratio setting and the selection and specification of the analysis item using the test item selection / specification area 127, as in the first embodiment. Here, as shown in FIG. 16, in this embodiment, an area is provided on the operation screen that allows input of the normal plasma ID and the position of the test plasma / normal plasma in addition to the subject ID. When the "start" button is pressed, if an individual identification medium such as a barcode of the test plasma / normal plasma is attached, the specimen ID of the test plasma / normal plasma passing in front of the reading unit 125 is recognized by the rotation of the specimen disk 102. If the specimen ID cannot be read or if an individual identification medium is not attached, it can be recognized by manually inputting it into the specimen ID and position field of the test plasma / normal plasma on the operation screen of FIG. 16. Also, when a request is received from a network system using a host computer, analysis is possible without setting the measurement items and measurement conditions.

[0053] When the start button is pressed (step S302), the specimen dispensing mechanism 101 aspirates normal plasma placed on the specimen disk 102 and dispenses it into the reaction vessel 104 (step S303). Then, the specimen dispensing mechanism 101 aspirates test plasma and dispenses it into the reaction vessel 104 (step S304). In this example, the normal plasma and the test plasma are dispensed in this order, but the order of steps S303 and S304 may be reversed. In addition, after aspirating the normal plasma, the test plasma may be aspirated without being discharged into the reaction container 104, and then both may be discharged into the reaction container 104 together.

[0054] If the measurement is a real-time measurement (step S305), the reaction vessel transport mechanism 112 grasps the reaction vessel and moves it to the detection unit 113 (step S306). After that, the reagent dispensing mechanism 106 dispenses the reagent (step S307) and performs detection (step S308), and repeats this until the measurement of all samples with normal plasma ratios set on the operation screen shown in Fig. 16 is completed (S309). After the measurement is completed, a graph of the real-time measurement results is created (step S310).

[0055] Also, in step S305, if the measurement of the reaction vessel is not an immediate measurement, i.e., a delayed measurement, the reaction vessel 104 is moved to the incubator 124 (step S311), and the heating start time is stored. The preparation of all mixed plasmas with normal plasma ratios set on the operation screen shown in FIG. 16 (step S312) is repeated, and all mixed plasmas are incubated. At the stage where the heating end time is reached (step S313), the reaction vessel transport mechanism 112 grasps the reaction vessel 104 and moves the reaction vessel 104 to the detection unit 113 (step S314). In this embodiment, since the incubation time can be managed within the automatic analyzer, the risk of outputting an erroneous result due to insufficient or excessive incubation time can be reduced. Here, the time is displayed on the operation screen so that it is clear that the incubation of the cross-mixing test is being performed. More preferably, the incubation time has a function of being flexibly set. Thereafter, reagent is dispensed by the reagent dispensing mechanism 106 (step S315), and detection is performed (step S316). This is repeated until measurement of all prepared samples is completed (step S317), and after measurement is completed, a graph of the delayed measurement results is created (step S318).

[0056] Next, in step S319, the graph of the real-time measurement result obtained in step S310 and the graph of the delayed measurement result obtained in step S318 are compared to obtain a final result (step S319).

[0057] Thus, according to this embodiment, normal plasma and test plasma are directly dispensed into the reaction vessel 104, and the preparation of the mixed plasma, incubation, measurement, and output of the measurement results are all performed automatically, making it possible to provide highly reliable results regardless of the operator's level of proficiency. Furthermore, the burden on the subject can be reduced by reducing the amount of specimen used for preparation. In addition, this embodiment is configured to allow the direct input of the positions of sample containers filled with normal plasma and test plasma, and therefore can be applied in facilities that do not use a sample ID management function. EXAMPLES

[0058] FIG. 17 shows a process flow of an automatic analyzer according to Example 4, which is another embodiment of the present invention. Although the method of performing the cross-mixing test has been described in Examples 1 to 3, the automatic analyzer does not only perform the cross-mixing test, but is usually used for tests aimed at grasping the pathology of the coagulation-fibrinolysis system, diagnosing DIC (disseminated intravascular coagulation), and confirming the effect of thrombus treatment. In other words, when the mixed plasma for the cross-mixing test finishes incubation and performs delayed analysis, if there are many regular analysis requests, the mixed plasma for the cross-mixing test cannot necessarily be analyzed immediately. Therefore, the automatic analyzer according to this embodiment is different from Examples 1 to 3 in that it has a function of selecting the priority of the test for each classification of the specimen.

[0059] In the automatic analyzer described in this embodiment, in order to meet the demand for rapidity in the case of testing blood coagulation ability before surgery in clinical testing or in the case of reporting test results to outpatients on the same day, the automatic analyzer has a function of prioritizing analysis over normal samples. Here, these samples that require rapidity are collectively defined as emergency samples, and the analysis can be performed with priority over normal samples. On the other hand, in the case of mixed plasma for cross-mixing testing, since the incubation time is managed, there is a demand to measure immediately after a certain period of incubation is completed. Therefore, a process in which a priority can be selected for each sample classification according to the needs of the operator and the measurement order is determined according to the priority will be described with reference to FIG. 17. In FIG. 17, the priority is set as "urgent sample measurement>delayed cross-mixing test>normal sample measurement" as an example, but the priority setting is not limited to this form.

[0060] When the incubation of the mixed plasma prepared for delayed cross-mixing is completed (step S401), if the device is not in standby, the following flow is followed (step S402). It is determined whether or not there is a request for an urgent sample among the scheduled items (step S403). If there is no request for an urgent sample, the process proceeds to step S406, and rescheduling is performed so that the delayed cross-mixing test is performed in preference to a request for a general sample (step S406). However, if an analysis of an urgent sample is requested, the analysis is performed in the order of the urgent sample, the cross-mixing test, and the general sample, so that the mixed plasma for cross-mixing is temporarily placed on standby in the incubator 124 during the analysis of the urgent sample (step S404). When the analysis of the urgent sample is completed (step S405), rescheduling is performed so that the delayed cross-mixing test is performed in preference to a request for a general sample (step S406). Here, when the incubation of the mixed plasma prepared for delayed cross-mixing is completed (step S401), if the device is in standby, the above-mentioned scheduling is not necessary and the cross-mixing test analysis is started as follows. First, the mixed plasma prepared for delayed cross-mixing is moved from the incubator 124 to the detection unit 113 (step S407). Then, a reagent is dispensed into the prepared mixed plasma (step S408), and detection is performed (step S409). The processes from step S407 to step S409 are repeated until the analysis of all the mixed plasma prepared for delayed cross-mixing is completed. When the analysis of the mixed plasma is completed (step S410), the result of the cross-mixing test is calculated and output (step S411).

[0061] Thereafter, if a request for a general sample remains (step S412), the general sample is analyzed (step S413), and when the analysis of the general sample is completed (step S414), the automated analyzer goes into a standby state (step S415).

[0062] FIG. 18 is a timing chart showing the operation of the automatic analyzer shown in FIG. 17. As shown in FIG. 18, when the automatic analyzer itself is in a standby state and a measurement request for a general sample is received, the automatic analyzer goes into an operating state for measuring the general sample. At this time, if a measurement request for an urgent sample is received, as described above, the measurement processing of the urgent sample has the highest priority, followed by the delayed measurement of the cross-mixing test sample (mixed plasma) and the measurement of the general sample, which are set to the lowest priority. Therefore, the urgent sample processing is prioritized. After the urgent sample processing is completed, when the incubation time of the mixed plasma for the cross-mixing test ends while the general sample processing is being started again, the general sample processing is temporarily interrupted and the delayed measurement is started. If a measurement request for an urgent sample is received during the execution of the delayed measurement, even if the priority of the urgent sample processing is set to be high, the urgent sample processing goes into a standby state until the delayed measurement ends, and the analysis of the urgent sample is performed after the cross-mixing test ends.

[0063] Thus, according to this embodiment, in addition to the effects of embodiments 1 and 2, the operator can set priorities for each sample in advance, such as interrupt processing for general samples and urgent samples, and the automatic analyzer can perform analysis based on the set priorities, thereby reducing human errors such as sample mix-ups and enabling the automatic analyzer to operate efficiently. EXAMPLES

[0064] 19 is a flowchart showing a process flow of an automatic analyzer of Example 5 according to another embodiment of the present invention. This example differs from Examples 1 to 4 in that reagent management is performed based on the number of mixed plasma samples. Note that the configuration other than the reagent management method is the same as Examples 1 to 4, and therefore a description thereof will be omitted below. In the cross-mixing test, for example, seven measured values ​​are treated as one set of results, so it is necessary to secure reagents of the same lot (preferably the same bottle) for one set of measurements. In particular, when the measurement item is APTT, calibration is not performed, so that measurement results tend to vary with reagents of different lots. In addition, even if it is the same lot, there is a tendency for variation to occur between the reagent in a reagent container (reagent bottle) that has been stored in the device for a while and the reagent in a newly opened reagent container (reagent bottle). Therefore, in the automatic analyzer of this embodiment, when an analysis request for a cross-mixing test is confirmed, it is important to secure reagents that can perform one set of measurements at least once. As shown in FIG. 19, when an immediate analysis request is received (step S501), the control unit 120 executes confirmation of the required number of tests (the number of mixed plasmas prepared) and the remaining amount of reagent. That is, it is determined whether or not the relationship of "number of mixed plasma samples≦number of tests remaining reagent" is satisfied (step S502). If the result of the determination in step S502 is "No", that is, if the number of mixed plasma specimens exceeds the number of remaining reagent tests, the process proceeds to step S504, where an alarm is displayed on the display unit 118c. If the result of the determination in step S502 is that the number of mixed plasma specimens is equal to or less than the number of remaining reagent tests, the process proceeds to step S503, where a cross-mixing test is performed (analysis is performed).

[0065] In addition, when multiple reagent bottles of the same item are installed, the control unit 120 controls so that analysis is not performed across bottles in at least one set of measurements. For example, if the number of remaining tests in bottle 1 is "3 tests", the number of remaining tests in bottle 2 is "100 tests", and a cross-mixing test is requested with 7 points (7 conditions), since "the number of mixed plasma samples (7 bottles) ≧ the number of remaining reagent tests in bottle 1", the analysis in bottle 1 is canceled and the number of remaining tests in bottle 2 is compared. In the case of bottle 2, since "the number of mixed plasma samples (7 bottles) ≦ the number of remaining reagent tests in bottle 2", the cross-mixing test (analysis) is performed. In addition, if there is no reagent bottle that can be analyzed, a system alarm is output and the start of analysis is canceled (step S504).

[0066] According to this embodiment, it is possible to perform a set of cross-mixing tests using the same reagent bottle without causing a shortage of reagent during the analysis, and it is possible to provide highly reliable results. EXAMPLES

[0067] Fig. 20 is a flow chart showing the process flow of an automatic analyzer of Example 6 according to another embodiment of the present invention. In this Example, the method of preparing mixed plasma differs from that of Examples 1 to 5 described above. Other than that, the configuration of the automatic analyzer and the general flow of the coagulation test are the same as those of Examples 1 and 2, so that duplicated explanations will be omitted below. Also, with regard to the method of preparing a sample, explanations of the points similar to those of Example 1 will be simplified as much as possible.

[0068] In the above-mentioned first and second embodiments, as shown in Fig. 5, the required amount of normal plasma and the amount of test plasma are displayed on the display unit 118c, and the operator is informed of the amount, thereby avoiding the risk of a shortage of specimens during the preparation. However, in the unlikely event that the amount of normal plasma and / or the amount of test plasma is insufficient due to an operator error, a shortage of specimens occurs during the preparation, and the specimens being prepared are wasted. Therefore, in the automatic analyzer of this embodiment, even if the normal plasma and / or the test plasma to be prepared is insufficient as described above, it is possible to perform effective measurement without wasting specimens.

[0069] 20, when a request for a cross-mixing test is received in the automatic analyzer (step S601) and the measurement items and normal plasma ratio are set, the analytical operation control unit 120a executes the following process. That is, the analytical operation control unit 120a calculates the amount of normal plasma and the amount of test plasma required for the measurement, determines the amount of normal plasma and the amount of test plasma that differ for each condition, and controls the operation of the specimen dispensing mechanism 101. Next, when the "Start" button on the operation screen shown in Fig. 5 is pressed, the analysis operation control unit 120a recognizes the pressing of this "Start" button (step S602). Next, the presence or absence of an empty specimen container is confirmed (step S603). The method of confirming the presence or absence of an empty specimen container is the same as the process of step S103 in Fig. 3 (Example 1). In step S604, it is determined whether the number of empty sample containers obtained by executing step S603 is equal to or greater than N (N is a natural number). Here, N is set to, for example, 7, which is the number of empty sample containers corresponding to the normal plasma ratio set on the operation screen shown in FIG. 5. If the result of the determination is that the required number of empty sample containers are not placed in the predetermined positions, sample preparation is stopped and a system alarm is displayed on the display unit 118c (step S605). On the other hand, if the result of the determination is that an empty sample container is placed in the predetermined position, the process proceeds to step S606, and the plasma volume is checked using the liquid level detection function of the sample dispensing mechanism 101.

[0070] Incidentally, the number of measurements in the cross-mixing test is recommended to be at least three points. In other words, the cross-mixing test can be performed if three points or more are used. FIG. 21 shows an example of the display of the operation screen when the cross-mixing test is requested in this embodiment. As shown in FIG. 21, the cross-mixing test measurement request screen has an area in which the priority of the normal plasma ratio can be selected. In the example shown in FIG. 21, the priority can be input in three stages in descending order of priority. That is, the priorities set in the priority setting area are in the relationship of "priority 1>priority 2>priority 3". In addition, the state in which priority 1 is set to normal plasma ratios of 0%, 50%, and 100%, priority 2 is set to normal plasma ratios of 10% and 20%, and priority 3 is set to normal plasma ratios of 80% and 90% is shown. These set priorities are stored in the memory unit 119. 22 to 24 show the relationship between the normal plasma volume and the test plasma volume corresponding to each normal plasma ratio. As shown in Fig. 22, when preparing 200 μL of mixed plasma for each of the seven conditions of normal plasma ratios of 0, 10, 20, 50, 80, 90, and 100% and conducting a cross-mixing test, 700 μL or more of normal plasma and test plasma are required. Here, a method for obtaining valid analysis results even with a small plasma volume, even if one or both of them does not meet the required volume, will be described.

[0071] Returning to FIG. 20, in step S607, the normal plasma volume is X N Whether the test plasma volume is Y or more N Determine whether or not it is greater than or equal to X N In the example shown in FIG. 22, Y is 700 μL. N Similarly, the normal plasma volume is 700 μL. N " and "Test plasma volume ≧ Y N " does not satisfy the condition, that is, if the amount of plasma is less than the required amount, the process proceeds to step S608. In step S608, in order to change the number of measurement points, the priority set for each normal plasma ratio stored in the memory unit 119 is referenced, the condition corresponding to priority 3 is excluded, and the plasma volume is recalculated. In step S609, if "normal plasma volume ≧ (X N -X P3 )" and "Test plasma volume ≧ (Y N -Y P3 Here, we determine whether the normal plasma volume (X N -X P3 ) is 360 μL, the test plasma volume (Y N -Y P3 ) is 640 μL (Figure 23). The result of the judgment is "Normal plasma volume ≧ (X N -X P3 )" and "Test plasma volume ≧ (Y N -Y P3If either or both of "1" and "2" do not satisfy the condition, the process proceeds to step S610. On the other hand, if the result of the determination is that the above conditions are satisfied, the process proceeds to step S613.

[0072] In step S610, the plasma volume is recalculated when measuring under conditions where only priority 1 is set, i.e., conditions excluding priorities 2 and 3. Here, the normal plasma volume of 300 μL and the test plasma volume of 300 μL are obtained as the recalculated plasma volumes (FIG. 24). Next, proceed to step S611 and determine whether "normal plasma volume ≧ (X N -X P3 -X P2 ) and "Subject Plasma volume ≧(Y N -Y P3 -Y P2 As a result of the judgment, it is judged whether or not the condition "normal plasma volume" is satisfied. ≧(X N -X P3 -X P2 )" and "Test plasma volume ≧ (Y N -Y P3 -Y P2 )" If either or both of the conditions are not met, the process proceeds to step S612, a system alarm is output to the display unit 118c, and preparation of the mixed plasma is stopped. On the other hand, if the result of the determination is that the above conditions are met, the process proceeds to step S613.

[0073] In step S613, the analytical operation control unit 120a controls the specimen dispensing mechanism 101 and the reagent dispensing mechanism 106 to start dispensing normal plasma and test plasma. Note that the dispensing of normal plasma and test plasma is similar to that in the above-mentioned first embodiment, and therefore a description thereof will be omitted here. When dispensing of all normal plasma and test plasma is completed (step S614), the analytical operation control unit 120a controls the stirring mechanism 126 to stir the mixed plasma (step S615). After stirring the mixed plasma, analysis is performed. In FIG. 20, an example has been described in which the priority is set to three levels, but the priority is not limited to this and can be set arbitrarily.

[0074] According to this embodiment, in addition to the effects of the above-mentioned embodiments 1 and 2, it is possible to obtain valid cross-mixing measurement results even when the amount of normal plasma and / or the amount of test plasma required for the measurement corresponding to the initially set normal plasma ratio is not met.

[0075] The present invention is not limited to the above-mentioned embodiment, and various modifications are included. For example, the above-mentioned embodiment has been described in detail to easily explain the present invention, and is not necessarily limited to those having all the configurations described. Also, it is possible to replace a part of the configuration of one embodiment with the configuration of another embodiment, and it is also possible to add the configuration of another embodiment to the configuration of one embodiment. Also, it is possible to add, delete, or replace a part of the configuration of each embodiment with the configuration of another embodiment. [Explanation of symbols]

[0076] 100···Automatic analyzer, 101···Sample dispensing mechanism, 101a···Sample dispensing probe, 102···Sample disk, 103···Sample container, 104···Reaction container, 105···Sample syringe pump, 106···Reagent dispensing mechanism, 106a···Reagent dispensing probe, 107···Reagent disk, 108···Reagent container, 108a···Reagent, 109···Reagent heating mechanism, 11 0···Reagent syringe pump, 111···Reaction vessel stock section, 112···Reaction vessel transport mechanism, 113···Detection unit, 114···Reaction vessel installation section, 115···Light source, 116···Detection section (light receiving section), 117···Reaction vessel disposal section, 118···Operation section, 118a···Mouse, 118b···Keyboard, 118c···Display section, 119···Memory section, 120··· Control section, 120a...analysis operation control section, 120b...calculation section, 121...A / D converter, 122...interface, 123...printer, 124...incubator, 125...reading section, 126...stirring mechanism, 127...test item selection / designation area, 201...sample rack, 202...sample rack supply section, 203...sample rack storage section, 204...transport line, 205... return line, 206... sample rack waiting section, 207... waiting section handling mechanism, 208... rack return mechanism, 209... first reading section (transport line), 210... analysis section, 211... second reading section (analysis section), 212... first rack handling mechanism, 213... dispensing line, 214... evacuation area, 215... second rack handling mechanism

Claims

1. a sample rack that accommodates and holds a plurality of sample containers; a transport unit that transports the sample rack; a specimen dispensing mechanism for dispensing plasma from the specimen container; Irradiating light from a light source onto the test plasma to which the reagent has been added, and onto normal plasma and / or mixed plasma to which the reagent has been added in order to correct the coagulation time of the test plasma; a measuring unit for measuring the coagulation time based on the obtained scattered light and / or transmitted light; A control unit. the transport unit transports a sample rack accommodating a first sample container containing the test plasma, a second sample container containing the normal plasma, and an empty sample container to an aspiration position of the sample dispensing mechanism; the specimen dispensing mechanism aspirates only the test plasma from the first specimen container and dispenses it into the empty specimen container, aspirates only the normal plasma from the second specimen container and dispenses it into another empty specimen container, and aspirates the test plasma and the normal plasma from the first specimen container and the second specimen container and dispenses them into yet another empty specimen container, thereby preparing specimens with different normal plasma ratios in each of the empty specimen containers; The first sample container, the second sample container and the empty sample container are accommodated in one sample rack.

2. a specimen disk that accommodates and holds a plurality of specimen containers; a sample dispensing mechanism for dispensing each of the test plasma and normal plasma added to correct the coagulation time of the test plasma; Irradiating the test plasma, normal plasma and / or mixed plasma to which the reagent has been added with light from a light source; a measuring unit for measuring the coagulation time based on the obtained scattered light and / or transmitted light; A display unit that displays an operation screen; A control unit. The specimen disk rotates to move the specimen container containing the test plasma, the specimen container containing the normal plasma, and an empty specimen container to a suction position of the specimen dispensing mechanism; the specimen dispensing mechanism aspirates the test plasma from a specimen container containing the test plasma and the normal plasma from a specimen container containing the normal plasma, respectively, and discharges the plasma into an empty specimen container to prepare a mixed plasma; The automatic analyzer according to claim 1, wherein the display unit displays a display screen showing the positions on a sample disk where the sample container containing the test plasma, the sample container containing the normal plasma, and an empty sample container should be placed.

3. 3. The automated analyzer of claim 2, The automatic analyzer according to claim 1, wherein the display screen displays the required amounts of the test plasma and the normal plasma.

4. 2. The automated analyzer of claim 1, The control unit is configured to control the sample dispensing mechanism to prepare samples with different normal plasma ratios to be used in the immediate and delayed measurements, to perform the immediate measurement using the samples with different normal plasma ratios, and to use the samples with different normal plasma ratios remaining after the immediate measurement for the delayed measurement, when performing immediate and delayed measurements.

5. 2. The automated analyzer of claim 1, the transport unit includes a dispensing line for dispensing the test plasma and the normal plasma in the sample container held by the sample rack, An automatic analyzer comprising: a mixing mechanism installed so as to be accessible on the dispensing line, the mixing mechanism mixing the mixed plasma prepared in the empty specimen container.

6. 2. The automated analyzer of claim 1, After the mixed plasma is prepared, the sample rack is transported from the aspiration position, When the sample container is transported to the aspirating position again, the sample dispensing mechanism aspirates test plasma, normal plasma and / or mixed plasma from the sample container and dispenses the test plasma, normal plasma and / or mixed plasma into the measurement section.

7. 7. The automatic analyzer according to claim 6, When performing immediate and delayed type measurements, the automatic analyzer is characterized in that the specimen having a different normal plasma ratio remaining after being discharged into the measurement section for the immediate type measurement is used for the delayed type measurement.

8. 1. An automatic analysis method using an automatic analyzer including a sample rack that accommodates and holds a plurality of sample containers, a transport unit that transports the sample rack, a sample dispensing mechanism that dispenses plasma in the sample containers, a measurement unit that measures coagulation time, and a control unit, comprising: the measurement unit irradiates light from a light source onto the test plasma to which a reagent has been added, and onto normal plasma and / or mixed plasma to which the test plasma has been added in order to correct the coagulation time of the test plasma, and measures the coagulation time based on the resulting scattered light and / or transmitted light; the transport unit transports a sample rack accommodating a first sample container containing the test plasma, a second sample container containing the normal plasma, and an empty sample container to an aspiration position of the sample dispensing mechanism; the specimen dispensing mechanism aspirates only the test plasma from the first specimen container and dispenses it into the empty specimen container, aspirates only the normal plasma from the second specimen container and dispenses it into another empty specimen container, and aspirates the test plasma and the normal plasma from the first specimen container and the second specimen container and dispenses them into yet another empty specimen container, thereby preparing specimens with different normal plasma ratios in each of the empty specimen containers; The automatic analysis method according to claim 1, wherein the first sample container, the second sample container and the empty sample container are accommodated in one sample rack.

9. An automatic analysis method using an automatic analyzer including a specimen disk that contains and holds a plurality of specimen containers, a specimen dispensing mechanism that dispenses test plasma and normal plasma that is added to correct the clotting time of the test plasma, a measurement unit that measures the clotting time, a display unit that displays an operation screen, and a control unit, comprising: the measurement unit irradiates the test plasma, normal plasma, and / or mixed plasma to which a reagent has been added with light from a light source, and measures the coagulation time based on the obtained scattered light and / or transmitted light; The specimen disk rotates to move the specimen container containing the test plasma, the specimen container containing the normal plasma, and an empty specimen container to a suction position of the specimen dispensing mechanism; the specimen dispensing mechanism aspirates the test plasma from a specimen container containing the test plasma and the normal plasma from a specimen container containing the normal plasma, respectively, and discharges the plasma into an empty specimen container to prepare a mixed plasma; The automatic analysis method according to claim 1, wherein the display unit displays a display screen showing the positions on the sample disk where the sample container containing the test plasma, the sample container containing the normal plasma, and the empty sample container should be placed.

10. 10. The automated analysis method of claim 9, The automatic analysis method according to claim 1, wherein the display screen displays the required amounts of the test plasma and the normal plasma.

11. 9. The automated analysis method of claim 8, The control unit controls the sample dispensing mechanism to prepare samples with different normal plasma ratios to be used in the immediate and delayed measurements, to perform the immediate measurement using the samples with different normal plasma ratios, and to use the samples with different normal plasma ratios remaining after the immediate measurement for the delayed measurement, when performing immediate and delayed measurements.

12. 9. The automated analysis method of claim 8, After the mixed plasma is prepared, the sample rack is transported from the aspiration position, When the sample container is transported to the aspirating position again, the sample dispensing mechanism aspirates test plasma, normal plasma and / or mixed plasma from the sample container and dispenses the plasma into the measurement section.

13. 13. The automated analysis method of claim 12, An automatic analysis method characterized in that, when performing immediate and delayed type measurements, the sample with a different normal plasma ratio remaining after being discharged into the measurement section for the immediate type measurement is used for the delayed type measurement.

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