Automated analyzer and automated analyzer

Abstract

To provide an analysis device and method, which enable automated preparation of mixed blood plasma obtained by mixing blood plasma under test and normal blood plasma at a given mixing ratio.SOLUTION: An automatic analysis device comprises a measurement unit configured to irradiate blood plasma under test added with a reagent, normal blood plasma, and / or mixed blood plasma with light from a light source to measure agglutination time based on resultant scattered light and / or transmitted light, a control unit, and a display unit for displaying a display screen, where the display unit displays amounts of the normal blood plasma and the blood plasma under test required for the measurement.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] The present invention relates to an automated analyzer for performing qualitative and quantitative analysis of biological samples such as blood and urine, and more particularly to an automated analyzer and automated analyzer method suitable for blood coagulation and hemostasis testing. [Background technology]

[0002] Blood coagulation tests are performed for purposes such as understanding the pathology of the blood coagulation and fibrinolytic system, diagnosing DIC (disseminated intravascular coagulation), confirming the effectiveness of thrombosis treatment, and diagnosing hemophilia. In particular, blood coagulation time measurement involves mixing the sample with reagents and measuring the time it takes for a fibrin clot to form (hereinafter referred to as blood coagulation time). If there are congenital or acquired abnormalities, the blood coagulation time will be prolonged.

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

[0004] One method for differentiating the cause of prolonged blood clotting time is the cross-mixing test (also called a 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 APTT prolongation, but it may also be performed on other parameters such as PT (prothrombin time), dPT (diluted PT), dAPTT (diluted APTT), KCT (kaolin clotting time), and dRVVT (diluted Russell's snake venom time). Incidentally, although APTT is a major test that can be performed at most facilities that conduct blood coagulation tests, it is currently not performed frequently. When 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 treatment of serious diseases such as hemophilia. The reason for this situation is that the preparation and incubation of specimens are complicated, and the interpretation of the results is not clear, requiring skilled laboratory technicians.

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

[0006] [Patent Document 1] WO2009 / 153964 publication [Overview of the project] [Problems that the invention aims to solve]

[0007] However, Patent Document 1 does not disclose an automated method for mixing test plasma and normal plasma. When prepared manually, the process can become complicated, and variations in the accuracy of the mixing ratio of the resulting plasma mixture may occur depending on the skill level of the operator.

[0008] Therefore, the present invention aims to provide an automated analyzer and an automated analysis method that enable the automation of the preparation of mixed plasma obtained by mixing test plasma and normal plasma in a predetermined mixing ratio.

Means for Solving the Problems

[0009] To solve the above problems, the automatic analyzer of the present invention irradiates light from a light source onto a test plasma, a normal plasma, and / or a mixed plasma to which a reagent has been added, and measures the coagulation time based on the obtained scattered light and / or transmitted light, and includes a control unit and a display unit that displays a display screen. The display unit displays the required amounts of the normal plasma and the test plasma required for the measurement.

[0010] Further, the automatic analysis method of the present invention is an automatic analysis method using an automatic analyzer having at least a measurement unit, a control unit, and a display unit. The measurement unit irradiates light from a light source onto a test plasma, a normal plasma, and / or a mixed plasma to which a reagent has been added, measures the coagulation time based on the obtained scattered light and / or transmitted light, and the display unit displays the required amounts of the normal plasma and the test plasma required for the measurement.

Effects of the Invention

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

[0012] Problems, configurations, and effects other than those described above will be clarified by the description of the following embodiments.

Brief Description of the Drawings

[0013] [Figure 1] It is an overall schematic configuration diagram of the automatic analyzer of Example 1 according to an embodiment of the present invention. [Figure 2] It is a schematic diagram of a cross-mixing test. [Figure 3] It is a flowchart showing the processing flow of the automatic analyzer shown in FIG. 1. [Figure 4] It is an example of a display of an operation screen at the time of requesting a cross-mixing test measurement. [Figure 5] It is an example of a display of an operation screen at the time of requesting a cross-mixing test measurement. [Figure 6] This figure shows the state when normal plasma is aspirated using a sample dispensing mechanism. [Figure 7] This figure shows the state of the sample when the sample is aspirationed using the sample dispensing mechanism. [Figure 8] This figure shows the state of normal plasma or test plasma during dispensing by the sample dispensing mechanism. [Figure 9] This figure shows the mixing state of the mixed plasma by the mixing mechanism. [Figure 10] This figure shows the cross-mixing test results obtained using the automated analyzer in Example 1. [Figure 11] This is a schematic diagram of the overall configuration of an automated analyzer according to Example 2, which is another embodiment of the present invention. [Figure 12] Figure 11 is an explanatory diagram illustrating the transport sequence of sample racks in the automated analyzer shown. [Figure 13] Figure 11 illustrates the order in which the sample racks are transported during a cross-mixing test in the automated analyzer shown. [Figure 14] Figure 11 is an explanatory diagram of the sample dispensing position during a cross-mixing test in the automated analyzer shown. [Figure 15] This flowchart shows the processing flow of the automated analyzer according to Example 3, which is another embodiment of the present invention. [Figure 16] This is an example of the operation screen displayed when requesting a cross-mixing test according to Example 3. [Figure 17] This flowchart shows the processing flow of the automated analyzer according to Example 4, which is another embodiment of the present invention. [Figure 18] This is a timing chart showing the operation of the automated analyzer in Example 4. [Figure 19] This flowchart shows the processing flow of the automated analyzer according to Example 5, which is another embodiment of the present invention. [Figure 20] This flowchart shows the processing flow of the automated analyzer according to Example 6, which is another embodiment of the present invention. [Figure 21] This is an example of the operation screen displayed when requesting a cross-mixing test according to Example 6. [Figure 22] This figure shows normal plasma only, test plasma only, and mixed plasma with five different mixing ratios. [Figure 23] This figure shows plasma consisting of normal plasma only, plasma of the test subject only, and mixed plasma with a specific mixing ratio of the three types. [Figure 24] This figure shows normal plasma only, test plasma only, and mixed plasma with a single mixing ratio. [Modes for carrying out the invention]

[0014] In this specification, "test plasma" includes both the plasma of hospitalized or outpatient patients and the plasma of subjects examined during health checkups, etc. Furthermore, in this specification, "normal plasma," "test plasma," and "mixed plasma mixed at various ratios" may also refer collectively to samples used for measuring blood coagulation time. Also, in this specification, "general sample" refers to a sample from a subject.

[0015] Figure 2 is a schematic diagram of the cross-mixing test. Samples are prepared by adding normal plasma to the test plasma and mixing them so that the proportion 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 proportion of normal plasma is plotted and a graph is created. As shown in Figure 2, the horizontal axis is the normal plasma percentage (%), and the vertical axis is APTT (blood clotting time). For example, as shown by the solid line (a) in Figure 2, in the deficiency type, the APTT prolongation is corrected by the addition of normal plasma, showing a downward convex pattern. On the other hand, in the inhibitor type, as shown by the solid line (b) in Figure 2, the APTT prolongation is not easily corrected even when normal plasma is added, showing an upward convex pattern. However, the inhibitor's reaction to factor VIII is time and temperature dependent. Therefore, the reaction immediately after mixing (hereinafter referred to as the immediate reaction) may not show a clear convex shape, but may show an convex shape after incubation at 37°C for a certain period of time (hereinafter referred to as the delayed reaction). Therefore, it is recommended to measure both immediate and delayed reactions in cross-mixing tests. The following describes embodiments of the present invention with reference to the drawings. [Examples]

[0016] Figure 1 is a schematic diagram of the overall configuration of an automated analyzer according to Example 1 of one embodiment of the present invention. Here, the basic flow of blood coagulation testing will be explained using Figure 1, but it is not limited to the following example. The automated 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 storage section 119, and a control section 120.

[0017] The sample dispensing mechanism 101 aspirates the sample contained in the sample container 103, which is placed on the sample disk 102 that rotates clockwise and counterclockwise, and dispenses it into the reaction vessel 104, which is housed in the reaction vessel stock section 111. The sample dispensing mechanism 101 is equipped with a sample dispensing probe 101a at its tip, and performs sample aspiration and dispensing operations through the operation of a sample syringe pump 105 controlled by the control unit 120.

[0018] The reagent dispensing mechanism 106 aspirates reagents contained in reagent containers 108 placed on the reagent disk 107 and dispenses them into reaction vessels 104 located in the reaction vessel stock section 111. The reagent dispensing mechanism 106 is equipped with a reagent dispensing probe 106a at its tip and performs reagent aspiration and dispensing operations through the operation of a reagent syringe pump 110 controlled by the control unit 120. Furthermore, the reagent dispensing mechanism 106 incorporates 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, which is controlled by the control unit 120.

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

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

[0021] The detection unit 116 is not limited to a configuration that receives scattered light from the reaction solution (sample) 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 (sample) in the reaction vessel 104. Alternatively, the detection unit 116 may use both the scattered light detection method and the transmitted light detection method. Furthermore, in addition to the above, the detector 116 may utilize viscosity. The reaction vessel transport mechanism 112 grasps the reaction vessel 104 after measurement is complete and disposes of it in the reaction vessel disposal section 117. Furthermore, to improve processing capacity, the system may be configured to include an incubator 124 without a detector, which is used to warm the sample before adding the measurement starter reagent.

[0022] The analysis items of the sample to be analyzed by the automated analyzer 100 are input from the operation unit 118 to the control unit 120 via the keyboard 118b, which serves as the input unit, or the operation screen displayed on the display unit 118c. Alternatively, the system may be configured to use a GUI (Graphical User Interface) in which the analysis items are input by manipulating the analysis items displayed on the display unit 118c with a mouse 118a or the like.

[0023] In Figure 1, for convenience in showing all components, the reaction vessel stock section 111, sample disk 102, and reagent disk 107 are shown spaced apart. However, in reality, the sample disk 102 and reaction vessel stock section 111 are positioned within the range of the arc-shaped movement trajectory in the horizontal plane of the sample dispensing probe 101a, which constitutes the sample dispensing mechanism 101. Furthermore, the reagent disk 107 and reaction vessel stock section 111 are positioned within the range of the arc-shaped movement trajectory in the horizontal plane of the reagent dispensing probe 106a, which constitutes the reagent dispensing mechanism 106. Therefore, when viewed from above, the sample disk 102, reaction vessel stock section 111, and reagent disk 107 are arranged in a roughly triangular shape.

[0024] Next, the method for requesting a cross-mixing test and preparing the sample in the automated analyzer 100 of this embodiment will be described in detail below. Figure 3 is a flowchart showing the processing flow of the automated analyzer shown in Figure 1, and in particular, it shows the flow of the sample preparation method when requesting a cross-mixing test. First, the automated analyzer 100 receives a request for a cross-mixing test (step S101). There are two methods for receiving requests: receiving them via a network system using a host computer, and receiving cross-mixing test measurement requests entered by an operator via the control unit 118. The following explanation will describe the case where a measurement request is entered via the control screen as an example.

[0025] Figures 4 and 5 show examples of the operation screen displayed on the display unit 108c, which constitutes the operation unit 118, when a cross-mixing test measurement request is made. As shown in Figure 4, the cross-mixing test measurement request screen (operation screen) has an area that displays the type of sample, i.e., whether it is a general sample, an emergency sample, or a control. In Figure 4, it is shown that a cross-mixing measurement request is made for a general sample. The cross-mixing test request screen (operation screen) also has a test item selection / specification area 127. The operator can specify the items to be tested for the cross-mixing test from this operation screen using the test item selection / specification area 127. In the example shown in Figure 4, the item APTT is selected and specified. The operation screen also has an area where the normal plasma percentage can be selected and specified. In the example shown in Figure 4, all seven conditions for the normal plasma percentage—0, 10, 20, 50, 80, 90, and 100%—are set. It should be noted that the normal plasma ratios set here are not limited to the seven conditions shown in Figure 4. For example, it is sufficient to have three or more conditions including 0% and 100%, i.e., test plasma only, normal plasma only, and mixed plasma with at least one mixed ratio. Other mixed ratios can be set arbitrarily.

[0026] As shown in Figure 4, once the measurement items and normal plasma ratio are set, the analysis operation control unit 120a calculates the required normal plasma volume and test plasma volume for measurement, determines the different normal plasma volume and test plasma volume for each condition, and controls the operation of the sample dispensing mechanism 101. At that time, as shown in Figure 5, the required normal plasma volume and test plasma volume are displayed on the display unit 118c to inform the operator. Being able to know the required plasma volume reduces the burden on the operator in calculating the required amount and has the effect of preventing plasma volume shortages during preparation. Here, in Figure 5, the operator specifies the placement positions of normal plasma, test plasma, and empty sample container, but the device may be controlled to specify the placement positions. Also, in Figure 5, the normal plasma placement position is set to "100", the test plasma placement position to "101", and the empty sample container starting position to "102". Here, each position represents the location of the sample container 103 in the sample disk 102, and is not necessarily identified solely by numbers. For example, the location of the sample container 103 may be identified by a combination of letters and numbers. Furthermore, when receiving requests 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 (step S102) in the state shown in Figure 5, the normal plasma volume, the test plasma volume, and the presence or absence of an empty sample container are checked (step S103). Here, an empty sample container is a disposable, resealable container with an individual identification medium. The individual identification medium is used to identify the sample, and for example, a barcode or RFID may be used. The individual identification medium of the test sample includes a sample ID to identify the sample, as well as measurement request information. An arbitrary number is assigned to the individual identification medium attached to the empty sample container and is used to manage the mixed plasma after mixing the normal plasma and the test plasma. The normal plasma volume, the test plasma volume, and the presence or absence of an empty sample container are checked by the liquid level detection function of the sample dispensing mechanism 101, that is, by using the change in electrical characteristics such as capacitance or resistance value that changes when the sample dispensing probe 101a provided at the tip of the sample dispensing mechanism 101 comes into contact with or is close to the liquid surface to detect the liquid level. Alternatively, the system may be configured to capture images using a small camera or similar device (sensors such as CCD, CMOS, or PMT) and calculate the liquid volume from the liquid level. Below, we will explain, as an example, a case in which the liquid level detection function of the sample dispensing mechanism 101 is used and a barcode is used as the individual identification medium.

[0028] As the sample disk 102 rotates clockwise and counterclockwise, the barcode, which is the individual identification medium of the subject sample, is read when the subject sample and empty sample container, placed in the positions specified in Figure 5, pass in front of the reader unit 125. The requested items for the subject sample identified by the read barcode are compared, and the normal plasma ratio created in the placed empty sample container and the original subject sample information are compared with the ID of each mixed plasma. Next, as shown in Figure 6, the sample container 103a, which is filled with normal plasma, is moved to the dispensing position of the sample dispensing mechanism 101, and the amount of normal plasma is confirmed by the liquid level detection function of the sample dispensing probe 101a. Similarly, the sample container 103b, which is 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 sample dispensing probe 101a (Figure 7). Furthermore, for empty sample containers, the liquid level detection function of the sample dispensing probe 101a recognizes that the installed sample container is empty when there is no contact with the liquid surface and contact with the bottom of the sample container (abnormal descent detection).

[0029] Returning to Figure 3, in step S104, if the container placement check reveals that the normal plasma volume, the test plasma volume, or the required number of empty sample containers are not placed in the designated positions, the mixed plasma preparation is stopped and a system alarm is displayed (step S105). This avoids the risk of plasma shortage during measurement or contamination of the sample disk 102 by dispensing further into sample containers that already contain samples (normal plasma, test plasma, or mixed plasma) where no empty sample containers are placed.

[0030] In step S104, if it is confirmed that the required amount of normal plasma and the required amount of test plasma have been prepared and the required number of empty sample containers have been set up, the dispensing of normal plasma into the empty sample containers will begin (step S106). Here, the dispensing operation of normal plasma will be described. The rotation of the sample disk 102, which rotates clockwise and counterclockwise, moves the sample container 103a filled with normal plasma to the dispensing position, and the sample dispensing mechanism 101 aspirates the normal plasma (Figure 6). In the example shown in Figure 6, the sample disk 102 rotates counterclockwise in a step-like manner, and the distance moved in each step corresponds to the pitch between two adjacent sample containers 103. As a result, the barcode attached to the sample container 103 is read by the reader 125 as described above, the sample ID is identified, and then the sample container is positioned directly below the sample dispensing mechanism 101 (sample dispensing position), which is located in front of the reader 125, along the rotation direction of the sample disk 102. In other words, each sample container 103 is always positioned in the dispensing position after the sample ID is identified by the reader 125.

[0031] Next, the sample container 103, which is positioned in the dispensing position by the stepwise rotation of the sample disk 102, is the sample container 103b filled with the test plasma (Figure 7), and therefore does not dispense the normal plasma aspirated from the sample dispensing probe 101a that constitutes the sample dispensing mechanism 101. Subsequently, the sample container positioned in the dispensing position is the empty sample container 103c, which dispenses the normal plasma aspirated into the sample dispensing probe 101a (Figure 8). This operation is repeated to dispense normal plasma into the empty sample containers 103d to 103i. Once the dispensing of normal plasma is complete (step S107), the dispensing of the test plasma is performed (step S108).

[0032] In step S108, the dispensing operation of the test plasma begins with the rotation of the sample disk 102, which first positions the sample container 103b, filled with test plasma, into the dispensing position. The sample dispensing probe 101a of the sample dispensing mechanism 101 then aspirates the test plasma (Figure 7). Subsequently, the rotation of the sample disk 102 positions the sample container 103c, from which normal plasma was dispensed in step S106, into the dispensing position. The sample dispensing probe 101a then dispenses the aspirated test plasma into the sample container 103c (Figure 8). The same procedure is followed to dispense test plasma into sample containers 103d to 103i using the sample dispensing probe 101a. This process is repeated until all the test plasma has been dispensed (step S109). In steps S106 and S108, the amount of normal plasma and test plasma dispensed from the sample dispensing probe 101a, which constitutes the sample dispensing mechanism 101, into each sample container 103c to 103i corresponds, for example, to the normal plasma ratio set on the operation screen shown in Figure 4. Returning to Figure 3, in step S110, as shown in Figure 9, the mixed plasma of normal plasma and test plasma dispensed into the sample container 103c, located directly below the stirring mechanism 126, is stirred by the stirring mechanism 126. Here, the stirring mechanism 126 is performed, for example, by immersing a stirring blade or spatula-shaped rod, provided at its tip, into the mixed plasma in the sample container 103c and rotating it, as shown in Figure 9. Note that the stirring mechanism 126 is not limited to the method of rotating a stirring blade or spatula-shaped rod. For example, it may be configured to stir the mixed plasma in the sample container by irradiating it with ultrasound. Alternatively, the sample disk 102 may be rotated in forward and reverse directions (clockwise and counterclockwise), or the mixed plasma may be stirred by the discharge pressure when dispensing normal plasma or test plasma from the sample dispensing probe 101a to the sample container 103, i.e., the discharge pressure of the sample syringe pump 105.

[0033] Thus, in the automated analyzer 100 of this embodiment, mixed plasma with various normal plasma ratios can be automatically prepared by the sample dispensing mechanism 101 and the stirring mechanism 126 using the operation screen shown in Figure 4 above.

[0034] In Figure 3, the system is configured to dispense normal plasma (step S106) followed by test plasma (step S108). However, it is not limited to this configuration, and it is also possible to dispense normal plasma after dispensing test plasma to prepare mixed plasma. Furthermore, from the viewpoint of preventing contamination between normal plasma and test plasma, the system is configured to dispense normal plasma and test plasma independently, but it is not limited to this configuration. For example, if the sample dispensing mechanism 101 is sufficiently washed and there is no concern about contamination, it is also possible to prepare (create) mixed plasma one by one. In this case, the required amount of normal plasma is dispensed into the empty sample container 103c, followed by the required amount of test plasma. Mixed plasma is prepared sequentially for each empty sample container, such as preparing mixed plasma in sample container 103c, followed by preparing mixed plasma in empty sample container 103d.

[0035] Alternatively, once the two types of samples have been dispensed, or when step S109 in Figure 3 has been completed, the display unit 118c may show a screen indicating that the preparation is complete. The operator may then close and agitate the sample container containing the prepared samples and place it back on the sample disk 102. In this case, there is no need to include the sample agitation mechanism 126, which allows for a smaller device.

[0036] After sample preparation is complete, analysis is performed using the seven mixed plasma samples prepared on 103c to 103i. Measurements performed immediately following sample preparation in this manner are defined as immediate measurements. In step S111 of Figure 3, the barcodes attached to the seven sample containers 103c to 103i, each containing seven mixed plasma samples with different normal plasma ratios, are read by the reader unit 125 to identify the samples containing only normal plasma, only test plasma, and five different mixing ratios, namely 10%, 20%, 50%, 80%, and 90% normal plasma ratios, respectively, 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 vessels 104 located in the reaction vessel stock unit 111. Subsequently, the reaction vessel transport mechanism 112 moves each reaction vessel 104 to the detection unit 113, where 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 sample containers of the seven prepared samples have a function that recognizes the normal plasma ratio and subject sample ID matched in step S103, enabling matching with the measurement results.

[0037] Incidentally, what distinguishes the cross-mixing test from a normal analysis is that multiple (in this case, seven) APTT coagulation times are calculated for a single subject sample, and a single graph is created for diagnosis. For immediate results after the measurement is completed, for example, as shown by the solid line (a) in Figure 10, a graph obtained by plotting the normal plasma ratio of each mixed plasma on the horizontal axis and the APTT coagulation time on the vertical axis is displayed on the operation unit 118c (step S113). The matching of measurement results using individual identification media and the automatic graph creation function prevent input errors by the operator and provide reliable results. At this time, it is preferable to print the results from the printer 123 via the interface 122.

[0038] If a delayed measurement is to be performed immediately after an immediate measurement (step S114), the container of mixed plasma (residual sample) after the immediate measurement is sealed and incubated at 37°C for a certain period of time. Incubation is performed in the incubator 124, but if the device does not have an incubator 124, it is performed outside the device. Here, we will describe the case where the incubator 124 is not provided in the device and incubation is performed outside the device in order to save space and reduce costs. The device counts the incubation time starting from the measurement end time. At this time, the operator can know the end time of incubation from the operation screen by setting the incubation time in advance. Preferably, when the incubation end time approaches, a display indicating the end of incubation is output (step S115). This allows the operator to understand the status of the sample during incubation and to perform the measurement without forgetting. The operator opens the incubated mixed plasma container, places it on the sample disk 102, and presses the measurement start button. When the measurement start button is pressed (step S116), the sample disk 102 rotates, reading the mixed plasma ID placed in the position specified on the operation screen shown in Figure 5. The normal plasma ratio and the subject sample ID, which were matched in step S103, are recognized, the requested items are matched (step S117), and the delayed measurement is performed (step S118). After the measurement is complete, a delayed graph, shown by the solid line (b) in Figure 10, is created (step S119), and the results are compared with the immediate results (step S120). At this time, the immediate and delayed graphs may be combined into one, as shown in Figure 2, or they may be displayed as two separate graphs.

[0039] As described above, according to this embodiment, the preparation of mixed plasma, immediate / delayed analysis, and immediate / delayed result matching are performed automatically, eliminating variations in measurement results due to the operator's skill level and errors such as human error in sample handling, thereby increasing reliability. Furthermore, the burden on the operator is reduced, and results can be obtained more quickly. Furthermore, it is possible to realize an automated analyzer and automated analysis method that can automate the preparation of mixed plasma obtained by mixing test plasma and normal plasma in a predetermined mixing ratio. [Examples]

[0040] Figure 11 is a schematic diagram of the overall configuration of an automated analyzer according to Embodiment 2, which is another embodiment of the present invention. In this embodiment, the automated analyzer comprises 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. In other words, it differs from Embodiment 1 in that it has various transport mechanisms for loading the sample container 103 onto the sample rack 201 and transporting the sample rack 201. Other aspects are the same as in Embodiment 1, and the same reference numerals are used for the same components as in Embodiment 1, and their descriptions are omitted below.

[0041] As shown in Figure 11, the configuration allows for the connection of multiple analysis units 210 along the transport line 204, but in this embodiment, the system is configured to include at least one analysis unit for performing coagulation tests. The basic configuration of the analysis unit 210 for performing coagulation tests and the basic analysis flow are generally the same as in Embodiment 1, but since the sample is supplied via the transport line 204, it does not have a sample disk 102. The following section will describe in detail the sample supply method, which differs significantly from that of Example 1. In the automated analyzer of this embodiment, the transport system of the analysis unit 210, which is arranged along the transport line 204, includes a second reading unit (analysis unit) 211 for verifying analysis request information for the sample, a first rack handling mechanism 212 for receiving the sample rack 201 from the transport line 204, a dispensing line 213 for dispensing the sample from the sample containers in the sample rack 201, which has the function of keeping the sample rack 201 on standby until dispensing begins, a retraction area 214 for retracting the sample rack 201 when preparing mixed plasma for cross-mixing, and a second rack handling mechanism 215 for transporting the sample rack 201 to the return line 205 after sample dispensing.

[0042] First, we will explain the sample supply flow, specifically the order in which sample racks are transported, when performing general analyses, such as those involving calibrators, controls, and general samples, using Figure 12. When an analysis request is received via the operation unit 118, the sample racks 201 lined up in the sample rack supply unit 202 are transferred to the transport line 204, as indicated by arrow (a) in Figure 12. Then, the individual identification media (e.g., barcodes, etc.) 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 number and sample container number are recognized (arrow (b) in Figure 12). Subsequently, if there are sample racks 201 in the dispensing line 213, the samples read by the first reading unit (transport line) 209 are placed in the sample rack waiting unit 206 to await analysis (arrow (c) in Figure 12). When the dispensing of samples in the dispensing line 213 is completed, the waiting sample racks 201 are sent to the analysis unit 210, where the sample rack number and sample container number are recognized by the second reading unit (analysis unit) 211 ((d) in Figure 12). Next, the samples are drawn into the dispensing line 213 via the first rack handling mechanism 212 ((e) in Figure 12), and the samples are dispensed by the sample dispensing mechanism 101. At this time, if there are no sample racks 201 in the dispensing line 213, the samples are transported directly to the dispensing line 213 without being placed in the sample rack waiting section 206.

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

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

[0045] When there are no samples being analyzed in the dispensing line 213 and the sample racks 201 containing the test plasma, normal plasma, and empty sample containers to be analyzed are confirmed, the sample racks containing the test plasma and the sample racks containing the empty sample containers are transported to the analysis unit 210 in that order. The second reading unit (analysis unit) 211 then recognizes the sample rack number and the sample container number (Figure 13 (d)). Subsequently, the samples are sent to the dispensing line 213 (Figure 13 (e)) via the second rack handling mechanism 215, and, as in Example 1 described above, the liquid level detection function and abnormal drop detection function of the sample dispensing mechanism 101 confirm that the required amounts of test plasma and normal plasma are filled, and that the sample containers 103 required for mixed plasma preparation are empty. If the sample plasma volume, normal plasma volume, and empty sample container are not correctly placed, they are returned to the transport line 204 via the first rack handling mechanism 212, then transported to the return line 205 via the second rack handling mechanism 215, and returned to the sample rack storage unit 203. Upon arrival, a system alarm is output, and sample preparation is stopped.

[0046] Meanwhile, the sample rack 201, in which the correct volume of test plasma, normal plasma, and empty sample containers have been confirmed to be installed, is returned to the transport line 204 via the first rack handling mechanism 212, and then transported again to the dispensing line 213 via the second rack handling mechanism 215. The test plasma from the transported sample rack 201 is aspirated and then dispensed into the empty sample container. At this time, if the empty sample container is located in another sample rack, the sample rack is placed in the retraction area 214 provided on the dispensing line 213, and the sample dispensing mechanism 101 rotates in an arc shape in the horizontal plane to dispense into the empty sample container (Figure 14). By repeating the same operation, mixed plasma is prepared by dispensing the test plasma and normal plasma. At this time, it is desirable that the stirring mechanism 126 shown in Example 1 be positioned so as to be accessible on the dispensing line 213, and that the mixed plasma can be mixed.

[0047] The sample rack containing the prepared samples 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 (Figure 13 (g)). Subsequently, the sample rack 201 containing the prepared samples is drawn into the sample rack waiting section 206 (Figure 13 (h)) via the waiting section handling mechanism 207 and awaits analysis. Here, if the analysis section 210 does not have a stirring mechanism 126 as shown in Figure 11, it is sent to the return line 205 via the second rack handling mechanism 215 (Figure 13 (g)) and returned to the sample rack storage section 203 (Figure 13 (g)). The operator retrieves the prepared samples from the returned sample racks, stirs them, and then places them back in the rack supply section 202 to perform analysis of any item (e.g., APTT) (immediate measurement). The analysis method is the same as in Example 1, so the explanation is omitted.

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

[0049] According to this embodiment, in addition to the effects of Example 1, immediate and delayed measurements can be easily performed by controlling the transport direction of the sample rack. [Examples]

[0050] Figure 15 is a flowchart showing the processing flow of an automated analyzer according to Example 3, which is another embodiment of the present invention. In this embodiment, the configuration of the automated analyzer itself may be either that of Example 1 or Example 2 described above. The difference from Examples 1 and 2 is that instead of preparing the sample to be measured (creating mixed plasma) in a sample container, normal plasma and test plasma are directly dispensed into the reaction vessel to prepare the sample to be measured. In other words, in this embodiment, since the measurement is performed by adding reagents after directly dispensing normal plasma and test plasma into the reaction vessel, there is less sample loss compared to the method described in Examples 1 and 2 above, where normal plasma and test plasma are mixed in a separate container to create mixed plasma, and then redispensed into the reaction vessel at the time of measurement.

[0051] As shown in Figure 15, first, the automated analyzer receives a request for a cross-mixing test via the control unit 118 (step S301). Subsequently, the process is the same as in Example 1 and Example 2 described above, up to the point where the press of the "Start" button shown in Figure 5 is recognized (step S302).

[0052] As shown in Figure 16, in the cross-mixing measurement request screen of this embodiment, the operator specifies the normal plasma ratio setting and the selection of analysis items using the test item selection / specification area 127, similar to Embodiment 1. Here, as shown in Figure 16, in this embodiment, in addition to the subject ID, the operation screen is provided with areas for inputting the normal plasma ID and the position of the tested plasma / normal plasma. When the "Start" button is pressed, if an individual identification medium such as a barcode is attached to the tested plasma / normal plasma, the sample ID of the tested plasma / normal plasma passing in front of the reading unit 125 is recognized by the rotation of the sample disk 102. If reading the sample ID fails, or if no individual identification medium is attached, recognition is possible by manually entering the sample ID and position of the tested plasma / normal plasma in the fields on the operation screen in Figure 16. Furthermore, when receiving requests from a network system using a host computer, analysis can be performed without setting the measurement items or measurement conditions.

[0053] When the start button is pressed (step S302), the sample dispensing mechanism 101 aspirates normal plasma placed on the sample disk 102 and dispenses it into the reaction vessel 104 (step S303). Subsequently, the test plasma is aspirated and dispensed into the reaction vessel 104 (step S304). Here, we have shown a procedure for dispensing normal plasma followed by the test plasma, but the order of steps S303 and S304 may be reversed. Alternatively, the test plasma may be aspirated after the normal plasma has been aspirated and then discharged into the reaction vessel 104 together without discharging into the reaction vessel 104.

[0054] If the measurement is an immediate-type measurement (step S305), the reaction vessel transport mechanism 112 grasps the reaction vessel and moves it to the detection unit 113 (step S306). Then, the reagent dispensing mechanism 106 dispenses the reagent (step S307) and performs detection (step S308), and this is repeated until all samples with the normal plasma ratio set on the operation screen shown in Figure 16 have been measured (S309). After the measurement is complete, a graph of the immediate-type measurement results is created (step S310).

[0055] Furthermore, 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 start time of heating is stored. The preparation of all mixed plasma with the normal plasma ratio set on the operation screen shown in Figure 16 (step S312) is repeated, and all mixed plasma is incubated. When the heating is finished (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 automated analyzer, the risk of outputting incorrect results 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 in progress. More preferably, the system has a function that allows the incubation time to be set flexibly. Subsequently, reagent dispensing (step S315) and detection (step S316) are performed using the reagent dispensing mechanism 106. This process is repeated until all prepared samples have been measured (step S317), and after the measurement is complete, a graph of the delayed measurement results is created (step S318).

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

[0057] Thus, according to this embodiment, by directly dispensing normal plasma and test plasma into the reaction vessel 104, and performing the preparation, incubation, measurement, and output of the measurement results of the mixed plasma fully automatically, it is possible to provide highly reliable results that do not depend on the operator's skill level. Furthermore, the burden on the test subject can be reduced by decreasing the amount of sample used for preparation. Furthermore, since this embodiment allows for direct input of the positions of sample containers filled with normal plasma and test plasma, it can be applied even to facilities that do not use a sample ID management function. [Examples]

[0058] Figure 17 shows the processing flow of the automated analyzer of Example 4, which is another embodiment of the present invention. While Examples 1 to 3 have described the method of performing the cross-mixing test, the automated analyzer is not only used to perform the cross-mixing test, but is also normally used for tests aimed at understanding the pathological state of the coagulation and fibrinolysis system, diagnosing DIC (disseminated intravascular coagulation), and confirming the effectiveness of thrombosis treatment. In other words, when the mixed plasma for the cross-mixing test has finished incubation and is ready for delayed analysis, if there is a backlog of regular analysis requests, it may not be possible to analyze the mixed plasma for the cross-mixing test immediately. Therefore, the automated analyzer according to this embodiment differs from Examples 1 to 3 in that it has a function that allows the priority of tests to be selected according to the classification of the sample.

[0059] The automated analyzer described in this embodiment has a function that allows it to be analyzed with priority over regular samples in order to meet the speed required in clinical testing, such as when testing blood coagulation ability before surgery or when reporting test results to outpatients on the same day. Here, these samples requiring speed are collectively defined as emergency samples, and are characterized by being able to be analyzed with priority over general samples. On the other hand, for mixed plasma for cross-mixing tests, since the incubation time is managed, there is a demand to measure immediately after a certain incubation period is completed. Therefore, Figure 17 illustrates a process in which priority can be selected according to the operator's needs for each sample classification, and the measurement order is determined according to the priority. Figure 17 illustrates an example where the priority is set to "Emergency Sample Measurement > Delayed Cross-Mixing Test > General Sample Measurement," but the priority setting is not limited to this form.

[0060] When the incubation of the mixed plasma prepared for delayed cross-mixing is complete (step S401), if the device is not in standby mode, follow the flow below (step S402). Determine whether there are any requests for emergency samples among the planned items (step S403). If there are no requests for emergency samples, proceed to step S406 and reschedule to perform the delayed cross-mixing test with priority over requests for general samples (step S406). However, if an analysis of an emergency sample is requested, the analysis will be performed in the order of emergency sample, cross-mixing test, and general sample. During the analysis of the emergency sample, the mixed plasma for cross-mixing will be temporarily placed on standby in incubator 124 (step S404). Once the analysis of the emergency sample is complete (step S405), reschedule to perform the delayed cross-mixing test with priority over requests for general samples (step S406). At this point, when the incubation of the mixed plasma prepared for delayed cross-mixing is complete (step S401), if the instrument is in standby mode, the above 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). Next, reagents are dispensed into the prepared mixed plasma (step S408), and detection is performed (step S409). Steps S407 to S409 are repeated until all analyses of the mixed plasma prepared for delayed cross-mixing are completed. Once the analysis of the mixed plasma is complete (step S410), the results of the cross-mixing test are calculated and output (step S411).

[0061] Subsequently, if there are still requests for general samples (step S412), the general samples are analyzed (step S413), and once the analysis of the general samples is complete (step S414), the automated analyzer enters standby mode (step S415).

[0062] Figure 18 is a timing chart showing the operation of the automated analyzer shown in Figure 17. As shown in Figure 18, when the automated analyzer itself is in standby mode and receives a request to measure a general sample, the automated analyzer becomes operational for measuring the general sample. At this time, if a request to measure an emergency sample is received, as mentioned above, the processing of the emergency sample has the highest priority, followed by the delayed measurement of the cross-mixing test sample (mixed plasma), and the measurement of general samples has the lowest priority. Therefore, the processing of the emergency sample is prioritized. After the processing of the emergency sample is completed, if the incubation time for the mixed plasma for the cross-mixing test ends while general sample processing is in progress, the processing of general samples is temporarily interrupted and the delayed measurement is started. If a request to measure an emergency sample is received while the delayed measurement is being performed, even if the priority of the emergency sample processing is set high, the emergency sample processing will remain on standby until the delayed measurement is completed, and the analysis of the emergency sample will be performed after the cross-mixing test is completed.

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

[0064] Figure 19 is a flowchart showing the processing flow of an automated analyzer according to Example 5, which is another embodiment of the present invention. This embodiment differs from Examples 1 to 4 described above 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 in Examples 1 to 4, so its explanation will be omitted below. In a cross-mixing test, for example, seven measurement values ​​are treated as a set of results, so it is necessary to secure reagents from the same lot (preferably the same bottle) for each set of measurements. In particular, when the measurement item is APTT, calibration is not performed, so variations in measurement results are likely to occur if reagents from different lots are used. Furthermore, even with the same lot, variations are likely to occur between reagents in reagent containers (reagent bottles) that have been stored in the instrument for a while and reagents in newly opened reagent containers (reagent bottles). Therefore, in the automated analyzer of this embodiment, when an analysis request for a cross-mixing test is confirmed, it is important to secure reagents that can perform at least one set of measurements. As shown in Figure 19, when an immediate analysis request is received (step S501), the control unit 120 checks the required number of tests (number of prepared mixed plasmas) and the remaining amount of reagents. That is, it determines whether the relationship "number of mixed plasma samples ≤ number of remaining reagent tests" exists (step S502). If the result of the judgment in step S502 is "No," that is, if the number of mixed plasma samples exceeds the number of remaining reagent tests, the process proceeds to step S504 and an alarm is displayed on the display unit 118c. If the result of the judgment in step S502 is that the number of mixed plasma samples is less than or equal to the number of remaining reagent tests, the process proceeds to step S503 and the cross-mixing test is performed (analysis is performed).

[0065] Furthermore, if multiple reagent bottles for the same item are installed, the control unit 120 controls the system to ensure that analysis is not performed across bottles in at least one set of measurements. For example, if bottle 1 has "3 tests" remaining, bottle 2 has "100 tests" remaining, and a cross-mixing test is requested for 7 points (7 conditions), then "number of mixed plasma samples (7 bottles) ≥ number of reagent tests remaining in bottle 1" will be met, so the analysis in bottle 1 is canceled and compared with the number of tests remaining in bottle 2. If it is bottle 2, then "number of mixed plasma samples (7 bottles) ≤ number of reagent tests remaining in bottle 2" will be met, so the cross-mixing test (analysis) is performed. Also, if there are no reagent bottles available for analysis, a system alarm is output and the start of the analysis is canceled (step S504).

[0066] According to this embodiment, it is possible to perform analysis using reagents from the same bottle for a set of cross-mixing tests without running out of reagents during the analysis. Furthermore, this allows for the provision of highly reliable results. [Examples]

[0067] Figure 20 is a flowchart showing the processing flow of the automated analyzer in Example 6, which is another embodiment of the present invention. In this embodiment, the method of preparing the mixed plasma differs from that of Examples 1 to 5 described above. Furthermore, the configuration of the automated analyzer and the general flow of coagulation testing are the same as in Example 1 or Example 2, so redundant explanations will be omitted below. Regarding the sample preparation method, explanations will be simplified as much as possible for points that are the same as in Example 1.

[0068] In the above-described Examples 1 and 2, as shown in Figure 5, the required normal plasma volume and test plasma volume are displayed on the display unit 118c to inform the operator, thereby avoiding the risk of sample shortage during the process. However, if the normal plasma volume and / or test plasma volume are insufficient due to operator error, sample shortage will occur during preparation, and the sample being prepared will be wasted. Therefore, the automated analyzer in this embodiment enables effective measurement without wasting samples, even if the normal plasma and / or test plasma that should be prepared as described above are insufficient.

[0069] As shown in Figure 20, when the automated analyzer receives a request for a cross-mixing test (step S601) and the measurement items and normal plasma ratio are set, the analysis operation control unit 120a performs the following process. That is, the analysis operation control unit 120a calculates the normal plasma volume and test plasma volume required for measurement, determines the different normal plasma volume and test plasma volume for each condition, and controls the operation of the sample dispensing mechanism 101. Next, when the "Start" button on the operation screen shown in Figure 5 is pressed, the analysis operation control unit 120a recognizes that the "Start" button has been pressed (step S602). Subsequently, it checks for the presence or absence of an empty sample container (step S603). The method for checking for the presence or absence of an empty sample container is the same as the process in step S103 of Figure 3 (Example 1). In step S604, it is determined whether the number of empty sample containers obtained by executing step S603 is N (where N is a natural number) or greater. 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 Figure 5. If the determination shows 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 determination shows that empty sample containers are placed in the predetermined positions, the process proceeds to step S606, where the plasma volume is checked using the liquid level detection function of the sample dispensing mechanism 101.

[0070] Incidentally, a minimum of 3 measurement points is recommended for the cross-mixing test. In other words, the cross-mixing test can be performed with 3 or more points. Figure 21 shows an example of the operation screen display when requesting a cross-mixing test in this embodiment. As shown in Figure 21, the cross-mixing test measurement request screen has an area where the priority of the normal plasma ratio can be selected. In the example shown in Figure 21, it is possible to input in three stages in order of priority, from highest to lowest. That is, the priority set in the priority setting area is in the relationship of "priority 1 > priority 2 > priority 3". Also, it shows a state where priority 1 is set for normal plasma ratios of 0%, 50%, and 100%, priority 2 is set for normal plasma ratios of 10% and 20%, and priority 3 is set for normal plasma ratios of 80% and 90%. These set priorities are stored in the memory unit 119. In addition, FIGS. 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 under 7 conditions of normal plasma ratios of 0, 10, 20, 50, 80, 90, and 100% and performing a crossmixing test, 700 μL or more of normal plasma and test plasma are each required. Here, even if either one or both are less than the required amount, a method for obtaining valid analysis results with a small plasma volume will be described.

[0071] Here, returning to FIG. 20, in step S607, it is determined whether the normal plasma volume is X N or more, and whether the test plasma volume is Y N or more. Here, X N is 700 μL in the example shown in FIG. 22, and Y N is also 700 μL. As a result of the determination, if either one or both of "normal plasma volume ≧ X N " and "test plasma volume ≧ Y N " do not satisfy the conditions, that is, if the plasma volume 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 priorities set for each normal plasma ratio stored in the storage unit 119 are referred to, the conditions corresponding to priority 3 are excluded, and recalculation of the plasma volume is executed. In step S609, it is determined whether "normal plasma volume ≧ (X N -X P3 )" and "test plasma volume ≧ (Y N -Y P3 )" are satisfied. Here, the normal plasma volume (X N -X P3 ) when measuring under the condition excluding priority 3 is 360 μL, and the test plasma volume (Y N -Y P3 ) when measuring under the condition excluding priority 3 is 640 μL (FIG. 23). As a result of the determination, "normal plasma volume ≧ (X N -X P3 )" and "test plasma volume ≧ (Y N -Y P3If either or both of the above conditions are not met, proceed to step S610. On the other hand, if the determination shows that the above conditions are met, proceed 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 with priority 2 and priority 3 are excluded. Here, the normal plasma volume of 300 μL and the test plasma volume of 300 μL are obtained as the recalculated plasma volumes (Figure 24). Next, proceed to step S611, "Normal plasma volume ≥ (X N -X P3 -X P2 )" and "Test Plasma volume ≧(Y N -Y P3 -Y P2 It determines whether the condition ")" is met. Based on the result of the determination, the normal plasma volume ≥(X N -X P3 -X P2 )" and "Test plasma volume ≥ (Y N -Y P3 -Y P2 )" If either or both conditions are not met, the process proceeds to step S612, a system alarm is output to the display unit 118c, and the preparation of the mixed plasma is stopped. On the other hand, if the judgment result shows that the above conditions are met, the process proceeds to step S613.

[0073] In step S613, the analysis operation control unit 120a controls the sample dispensing mechanism 101 and the reagent dispensing mechanism 106 to start dispensing normal plasma and test plasma. The dispensing of normal plasma and test plasma is the same as in Example 1 described above, so the explanation is omitted here. Once all of the normal plasma and test plasma has been dispensed (step S614), the analysis operation control unit 120a controls the stirring mechanism 126 to stir the mixed plasma (step S615). After stirring the mixed plasma, the analysis is performed. Figure 20 illustrates an example where priority levels are set to three, but this is not the only option; priority levels can be set arbitrarily.

[0074] According to this embodiment, in addition to the effects of Examples 1 and 2 described above, it is possible to obtain effective cross-mixing measurement results even when the amount of normal plasma and / or test plasma required for measurement corresponding to the initially set normal plasma ratio is insufficient.

[0075] It should be noted that the present invention is not limited to the embodiments described above, and various modifications are included. For example, the embodiments described above are described in detail to make the present invention easier to understand, and are not necessarily limited to those having all the configurations described. Furthermore, it is possible to replace parts of the configuration of one embodiment with the configuration of another embodiment, and it is also possible to add configurations from other embodiments to the configuration of one embodiment. In addition, it is possible to add, delete, or replace parts of the configuration of each embodiment with configurations from other embodiments. [Explanation of Symbols]

[0076] 100...Automatic analyzer, 101...Sample dispensing mechanism, 101a...Sample dispensing probe, 102...Sample disc, 103...Sample container, 104...Reaction vessel, 105...Sample syringe pump, 106...Reagent dispensing mechanism, 106a...Reagent dispensing probe, 107...Reagent disc, 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 Unit, 120a...Analysis Operation Control Unit, 120b...Calculation Unit, 121...A / D Converter, 122...Interface, 123...Printer, 124...Incubator, 125...Reading Unit, 126...Agitation Mechanism, 127...Inspection Item Selection / Specification Area, 201...Sample Rack, 202...Sample Rack Supply Unit, 203...Sample Rack Storage Unit, 204...Transport Line 205...Return line, 206...Sample rack waiting area, 207...Waiting area handling mechanism, 208...Rack return mechanism, 209...First reading unit (transport line), 210...Analysis unit, 211...Second reading unit (analysis unit), 212...First rack handling mechanism, 213...Dispensing line, 214...Evacuation area, 215...Second rack handling mechanism

Claims

1. A measuring unit that irradiates a mixture of test plasma (to which reagents have been added) and normal plasma with light from a light source and measures the coagulation time based on the resulting scattered and / or transmitted light, Control unit and It comprises a display unit that displays a screen, The display unit is an automated analyzer that displays, on the same screen, the required amounts of normal plasma and test plasma for measurement, as well as the placement positions of the normal plasma and test plasma.

2. In the automated analyzer described in claim 1, The control unit is an automated analyzer that calculates the required amounts of normal plasma and test plasma based on the requested test items and normal plasma ratio.

3. In the automated analyzer described in claim 1, The aforementioned installation location is the automatic analyzer specified by the control unit.

4. In the automated analyzer described in claim 1, The aforementioned installation location is an automated analyzer input by the user.

5. In the automated analyzer described in claim 1, The measurement unit is an automated analyzer that measures not only the immediate-type solidification time but also the delayed-type solidification time.

6. An automated analysis method using an automated analyzer having at least a measuring unit, a control unit, and a display unit, The measurement unit irradiates a mixture of test plasma to which reagents have been added and normal plasma with light from a light source, and measures the coagulation time based on the scattered and / or transmitted light obtained. The display unit is an automated analysis method that displays, on the same screen, the required amounts of normal plasma and test plasma for measurement, and the placement locations of the normal plasma and test plasma.

Images