Sample analysis method and sample analysis device

Abstract

To provide a specimen analysis method and specimen analysis device capable of maintaining high reliability of operation values obtained from measurement values of multiple measurement items even when object substances of multiple measurement items in specimens decrease over time.SOLUTION: A specimen analysis method for analyzing specimens for multiple measurement items includes the steps of: measuring a first measurement item and a second measurement item based on a measurement order (S103, S105); performing a process related to a time difference between the measurement of the first measurement item and the measurement of the second measurement item (S101, S107, S111); and obtaining an operation value from the measurement value of the first measurement item and the measurement value of the second measurement item (S109).SELECTED DRAWING: Figure 19

Description

[Technical Field]

[0001] The present invention relates to a sample analysis method and a sample analyzer for analyzing a sample for a plurality of measurement items. [Background technology]

[0002] In a sample analyzer, a sample is measured and analyzed for each measurement item. The measured values ​​of each measurement item are referenced, for example, in diagnosis. Furthermore, calculated values ​​calculated from the measured values ​​of multiple measurement items may have clinical significance. For example, the following Non-Patent Document 1 reports that the ratio of the measured values ​​of β-amyloid 40 (Aβ1-40) to the measured values ​​of β-amyloid 42 (Aβ1-42) is effective in diagnosing Alzheimer's disease. [Prior art documents] [Patent documents]

[0003] [Non-Patent Document 1] Suzanne E Schindler, 11 others, “High-precision plasma β-amyloid 42 / 40 predicts current and future brain amyloidosis”, Neurology, August 2019, vol.93 no.17, p. e1647―e1659 Summary of the Invention [Problem to be solved by the invention]

[0004] Among the measurement items measured by sample analyzers, there are some in which the amount of a target substance in a sample decreases over time. For example, the amount of beta-amyloid 40 and beta-amyloid 42 in a blood sample taken from a subject decreases over time. Therefore, depending on the measurement conditions for these measurement items, the reliability of the above ratio may decrease.

[0005] The present invention aims to provide a sample analysis method and sample analysis device that can maintain high reliability of calculated values ​​obtained from the measured values ​​of multiple measurement items, even when the amount of target substance in a sample for multiple measurement items decreases over time. [Means for solving the problem]

[0006] The sample analysis method of the present invention relates to a sample analysis method for analyzing a sample for a plurality of measurement items. The sample analysis method of the present invention includes measuring a first measurement item and a second measurement item based on a measurement order. By doing so, a measurement value of the first measurement item and a measurement value of the second measurement item are obtained. Steps (S103, S105), wherein the substance corresponding to the first measurement item and the substance corresponding to the second measurement item are substances that decrease over time, The first measurement item End timing and measurement of the second measurement item End timing The time difference between To fit the total into the specified time Steps of executing processing (S101, S107, S111, S131, S132); Here, by executing the process for converging, the measurement value of the first measurement item and the measurement value of the second measurement item become measurement values ​​obtained by measurements in which the time difference is converging to a predetermined time, Measurement value of the first measurement item and measurement value of the second measurement item Ratio based on and a step (S109) of acquiring a calculated value from

[0007] According to the sample analysis method of the present invention, the first measurement item is measured. End timing and measurement of the second measurement item End timing The time difference between To fit the total into the specified time Since the processing is performed, the reliability of the calculated value can be maintained at a high level.

[0008] The sample analyzer (1) of the present invention relates to a sample analyzer that analyzes a sample for multiple measurement items. The sample analyzer (1) of the present invention includes a measurement device (2) that measures a sample, and a control unit (101). The control unit (101) measures a first measurement item and a second measurement item based on a measurement order. By doing so, a measurement value of the first measurement item and a measurement value of the second measurement item are obtained. The measuring device (2) is controlled so that wherein the substance corresponding to the first measurement item and the substance corresponding to the second measurement item are substances that decrease over time, Measurement of the first measurement item End timing and measurement of the second measurement item End timing The time difference between To fit the total into the specified time Execute the process, Here, by executing the process for converging, the measurement value of the first measurement item and the measurement value of the second measurement item become measurement values ​​obtained by measurements in which the time difference is converging to a predetermined time, Measurement value of the first measurement item and measurement value of the second measurement item Ratio based on Get the calculated value from

[0009] According to the sample analyzer of the present invention, similarly to the above sample analysis method, the first measurement item is measured. End timing and measurement of the second measurement item End timing The time difference between To fit the total into the specified time Since the processing is performed, highly reliable calculated values ​​can be obtained. [Effects of the Invention]

[0010] According to the present invention, even when the amount of a target substance in a sample for multiple measurement items decreases over time, the reliability of the calculated values ​​obtained from the measured values ​​of these multiple measurement items can be maintained at a high level. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 is a diagram schematically illustrating the configuration of a sample analyzer according to the first embodiment. [Figure 2] FIG. 2 is a block diagram schematically illustrating the configuration of the control device according to the first embodiment. [Figure 3] FIG. 3 is a diagram schematically showing the configuration of a screen displaying a job list according to the first embodiment. [Figure 4] FIG. 4 is a diagram schematically showing the configuration of a screen for setting item sorting according to the first embodiment. [Figure 5] FIG. 5 is a diagram schematically showing the configuration of a screen for setting item sorting according to the first embodiment. [Figure 6] FIG. 6 is a diagram schematically showing the configuration of a screen for setting item sorting according to a modification of the first embodiment. [Figure 7] FIG. 7 is a diagram schematically showing the configuration of a screen for setting item sorting according to a modification of the first embodiment. [Figure 8] FIG. 8 is a diagram schematically showing the configuration of a screen for setting item information according to the first embodiment. [Figure 9] FIG. 9 is a diagram schematically showing the configuration of a screen for additionally setting measurement items according to the first embodiment. [Figure 10]FIG. 10 is a diagram schematically showing the configuration of a screen for additionally setting measurement items according to the first embodiment. [Figure 11] FIG. 11 is a diagram showing a typical configuration of a screen for an operator to register a measurement order. [Figure 12] FIG. 12 is a diagram showing a schematic configuration of a modified example of a screen for an operator to register a measurement order. [Figure 13] FIG. 13 is a diagram schematically showing the configuration of another modified example of the screen for the operator to register a measurement order. [Figure 14] FIG. 14 is a diagram schematically showing the configuration of a screen displaying a post-measurement job list according to the first embodiment. [Figure 15] FIG. 15 is a diagram schematically showing the configuration of a screen displaying a post-measurement job list according to the first embodiment. [Figure 16] FIG. 16 is a diagram schematically showing the configuration of a screen displaying a measurement order list related to retesting according to the first embodiment. [Figure 17] FIG. 17 is a flowchart showing the sample analysis process according to the first embodiment. [Figure 18] FIG. 18 is a diagram schematically illustrating the configuration of a notification screen according to the first embodiment. [Figure 19] FIG. 19 is a flowchart showing pair processing according to the first embodiment. [Figure 20] FIG. 20 is a flowchart showing the process of the check before starting measurement according to the first embodiment. [Figure 21] FIG. 21 is a flowchart showing the measurement process performed for each measurement item according to the first embodiment. [Figure 22] FIG. 22 is a flowchart showing the post-measurement check process according to the first embodiment. [Figure 23] FIG. 23 is a time chart showing measurements of the first measurement item and the second measurement item according to the first embodiment. [Figure 24]FIG. 24 is a flowchart showing a process for stopping measurement in accordance with the environmental temperature according to the first modification of the first embodiment. [Figure 25] FIG. 25 is a flowchart showing an environmental temperature acquisition process according to the second modification of the first embodiment. [Figure 26] FIG. 26 is a flowchart showing post-measurement check processing according to the second modification of the first embodiment. [Figure 27] FIG. 27 is a flowchart showing pair processing according to the third modification of the first embodiment. [Figure 28] FIG. 28 is a flowchart showing the measurement process performed for each measurement item according to the second embodiment. [Figure 29] FIG. 29 is a flowchart showing pair processing according to the second embodiment. [Figure 30] FIG. 30 is a time chart showing measurements of the first measurement item and the second measurement item according to the second embodiment. [Figure 31] FIG. 31 is a diagram schematically showing the configuration of a screen displaying a post-measurement job list according to another modified example. DETAILED DESCRIPTION OF THE INVENTION

[0012] <Embodiment 1> FIG. 1 is a diagram schematically illustrating the configuration of a sample analyzer 1 according to a first embodiment. The sample analyzer 1 analyzes samples for multiple measurement items. As will be described later, there are combinations of measurement items that require measurements to be performed as close together as possible. The sample analyzer 1 performs processing related to the measurement time difference for such combinations of measurement items.

[0013] 1, for convenience, the housing 2a of the measuring device 2 is illustrated in a transparent state, and the internal configuration of the measuring device 2 is shown in a plan view. Also, FIG. 1 shows the left-right and front-rear directions of the measuring device 2 in a plan view.

[0014] The sample analyzer 1 is an immunoanalyzer for testing samples for various items such as hepatitis B, hepatitis C, tumor markers, thyroid hormones, and dementia markers. The sample may be, for example, whole blood, plasma, serum, or cerebrospinal fluid (CSF).

[0015] The sample analyzer 1 includes a measuring device 2 and a control device 3. The measuring device 2 includes a sample transport unit 11, a sample dispensing unit 12, an emergency sample / tip transport unit 13, a pipette tip supply unit 14, a tip detachment unit 15, reagent tables 16 and 17, a primary reaction unit 18, reagent dispensing units 19 and 20, a primary BF separation table 21, a primary BF separation unit 22, a transfer mechanism 23, a secondary reaction unit 24, a reagent dispensing unit 25, a secondary BF separation table 26, a secondary BF separation unit 27, an R4 reagent dispensing unit 28, an R5 reagent dispensing unit 29, a detection unit 30, a disposal hole 31, and a temperature sensor 32.

[0016] In measurements using the measurement device 2, a sample is mixed with R1 reagent (a reagent containing a capture antibody that binds to proteins such as antigens and peptides contained in the sample), and R2 reagent (a reagent containing magnetic particles that bind to the capture antibody) is added to the resulting mixture. The capture antibody and magnetic particles that have bound to the protein are attracted to the magnet of the primary BF separation unit 22, and contaminants that have not been attracted to the magnet are removed by suction, thereby removing the R1 reagent containing the unreacted capture antibody. R3 reagent (a reagent containing a labeled antibody) is added to the sample after processing by the primary BF separation unit 22. The labeled antibody and magnetic particles that have bound to the protein are attracted to the magnet of the secondary BF separation unit 27, and contaminants that have not been attracted to the magnet are removed by suction, thereby removing the R3 reagent containing the unreacted labeled antibody. After the sample has been processed by the secondary BF separation unit 27, R4 reagent (dispersion liquid) and R5 reagent (a luminescent substrate that emits light during the reaction with the labeled antibody) are added, and the amount of luminescence generated by the reaction between the labeled antibody and the luminescent substrate is measured. Through this process, the protein contained in the sample is quantitatively measured. In the measurements of measurement items 1-40 and 1-42 described below, a sample dilution solution is used as the R1 reagent, and antibody-immobilized particles are used as the R2 reagent.

[0017] When starting the measurement of a sample, the operator places a container T containing the sample in a rack R. The rack R is formed with a holder capable of holding multiple containers T. The operator sets the rack R holding the containers T in the sample transport unit 11.

[0018] The sample transport unit 11 transports the rack R set by the operator to the aspirating position of the sample dispensing unit 12. At the aspirating position, the sample dispensing unit 12 sequentially aspirates the samples in the multiple containers T held in the rack R. In the sample analyzer 1, to prevent the samples aspirated and discharged by the sample dispensing unit 12 from mixing with other samples, the disposable pipette tip is replaced each time a sample is aspirated and discharged.

[0019] The urgent specimen / chip transport unit 13 is equipped with a transport rack 13a that can move left and right. The transport rack 13a is formed with a container setting unit 13b and a chip setting unit 13c. The container setting unit 13b holds a container T containing an urgent specimen that needs to be tested in addition to the specimens being transported by the specimen transport unit 11. The container T held in the container setting unit 13b is transported rightward and positioned so as to overlap with the rotational trajectory of the pipette 12c of the specimen dispensing unit 12.

[0020] The pipette tip supply device 14 sets the introduced pipette tips one by one in the tip setting unit 13c. The pipette tip held in the tip setting unit 13c is transported rightward and positioned so as to overlap the rotational path of the pipette 12c of the sample dispensing unit 12. The tip detachment unit 15 is used to detach the pipette tip attached to the sample dispensing unit 12.

[0021] The specimen dispensing unit 12 includes an arm 12a, a shaft 12b, and a pipette 12c. The arm 12a rotates around the shaft 12b and moves up and down. The pipette 12c is attached to the tip of the arm 12a and aspirates and dispenses specimens. A pipette tip transported by a tip installation unit 13c is attached to the bottom end of the pipette 12c. The specimen dispensing unit 12 aspirates specimens from a container T transported by the specimen transport unit 11 and transport rack 13a.

[0022] The reagent tables 16 and 17 are rotatable tables. A reagent container containing an R1 reagent and a reagent container containing an R3 reagent are placed on the reagent table 16. A reagent container containing an R2 reagent is placed on the reagent table 17.

[0023] The first reaction section 18 includes a first reaction table 18a and a container transfer section 18b. A holder 18c for holding a cuvette C is formed on the first reaction table 18a.

[0024] The reagent dispensing unit 19 includes an arm 19a, a shaft 19b, and a pipette 19c. The arm 19a rotates around the shaft 19b and moves up and down. The pipette 19c is attached to the tip of the arm 19a. The reagent dispensing unit 19 aspirates the R1 reagent from a reagent container placed on the reagent table 16 and dispenses the aspirated R1 reagent into an empty cuvette C on the primary reaction unit 18. The specimen dispensing unit 12 dispenses the aspirated specimen into the cuvette C from which the R1 reagent was dispensed. Thereafter, in the primary reaction unit 18, the specimen and R1 reagent in the cuvette C are heated to a predetermined temperature for a predetermined time, thereby carrying out a primary reaction process.

[0025] The reagent dispensing unit 20 has the same configuration as the reagent dispensing unit 19, and includes an arm 20a, a shaft 20b, and a pipette 20c. The reagent dispensing unit 20 aspirates the R2 reagent in a reagent container placed on the reagent table 17, and dispenses the aspirated R2 reagent into the cuvette C on the primary reaction unit 18 from which the specimen and R1 reagent were dispensed.

[0026] The primary reaction unit 18 drives the primary reaction table 18a to rotate and transfer the cuvette C in the holder 18c, stirring the specimen, R1 reagent, and R2 reagent in the cuvette C. Thereafter, the primary reaction unit 18 performs a secondary reaction process in which the specimen, R1 reagent, and R2 reagent in the cuvette C are heated to a predetermined temperature for a predetermined time. This causes the R2 reagent containing magnetic particles in the cuvette C to react with proteins in the specimen. The container transfer unit 18b transfers the cuvette C after processing by the primary reaction unit 18 to the primary BF separation table 21.

[0027] The primary BF separation unit 22 performs a primary BF separation process to remove the R1 reagent containing unreacted capture antibodies from the sample in the cuvette C on the primary BF separation table 21.

[0028] The transfer mechanism 23 includes an arm 23a, a shaft 23b, and a gripper 23c. The arm 23a rotates around the shaft 23b and moves up and down. The gripper 23c is installed at the tip of the arm 23a and is configured to be able to grip the cuvette C. The transfer mechanism 23 transfers the cuvette C on the primary BF separation table 21 that has been processed by the primary BF separation unit 22 to the secondary reaction unit 24.

[0029] The secondary reaction unit 24 has the same configuration as the primary reaction unit 18, and includes a secondary reaction table 24a and a container transfer unit 24b. A holder 24c for holding a cuvette C is formed on the secondary reaction table 24a.

[0030] The reagent dispensing unit 25 has a configuration similar to that of the reagent dispensing unit 19, and includes an arm unit 25a, a shaft 25b, and a pipette 25c. The reagent dispensing unit 25 aspirates the R3 reagent in a reagent container placed on the reagent table 16 and dispenses the aspirated R3 reagent into the cuvette C on the secondary reaction unit 24 into which the specimen, R1 reagent, and R2 reagent were dispensed. Thereafter, in the secondary reaction unit 24, a third reaction process is performed in which the specimen, R1 reagent, R2 reagent, and R3 reagent in the cuvette C are heated to a predetermined temperature for a predetermined time. The container transfer unit 24b of the secondary reaction unit 24 transfers the cuvette C into which the R3 reagent has been dispensed to the secondary BF separation table 26.

[0031] The secondary BF separation unit 27 has a configuration similar to that of the primary BF separation unit 22, and performs a secondary BF separation process to remove R3 reagent containing unreacted labeled antibody from the sample in the cuvette C on the secondary BF separation table 26. The container transfer unit 24b of the secondary reaction unit 24 transfers the cuvette C on the secondary BF separation table 26 that has been processed by the secondary BF separation unit 27 back to the holder 24c of the secondary reaction unit 24.

[0032] The R4 reagent dispensing unit 28 and the R5 reagent dispensing unit 29 supply the R4 reagent and the R5 reagent, respectively, to the cuvette C on the secondary reaction unit 24 by moving the nozzle unit in parallel and up and down.

[0033] The secondary reaction unit 24 drives the secondary reaction table 24a to rotate and transfer the cuvette C in the holder 24c, stirring the specimen and R1 to R5 reagents in the cuvette C. Thereafter, the secondary reaction unit 24 performs a fourth reaction process in which the specimen and R1 to R5 reagents in the cuvette C are heated to a predetermined temperature for a predetermined time. This causes the R3 reagent containing the labeled antibody to react with the protein in the specimen in the cuvette C, and the R5 reagent containing the luminescent substrate to react with the labeled antibody of the R3 reagent.

[0034] The detection unit 30 includes a transfer mechanism 30a that transfers the cuvette C held in the holder 24c of the secondary reaction unit 24 to the detection unit 30. The detection unit 30 detects light generated in the reaction process between the labeled antibody bound to the protein of the sample and the luminescent substrate using a photodetector such as a photomultiplier tube.

[0035] The used cuvette C is discarded into a disposal hole 31 by a transfer mechanism 30 a of the detection unit 30 .

[0036] The temperature sensor 32 is installed inside the housing 2a of the measurement device 2, near the detection unit 30. The temperature sensor 32 is, for example, a thermistor. The temperature sensor 32 detects the temperature inside the housing 2a of the measurement device 2. The temperature detected by the temperature sensor 32 is used to determine whether the environmental temperature inside the measurement device 2 is appropriate for measurement. The installation position of the temperature sensor 32 may be inside the housing 2a, and is not limited to near the detection unit 30.

[0037] FIG. 2 is a block diagram showing a schematic configuration of the control device 3. As shown in FIG.

[0038] The control device 3 includes a control unit 101 , a storage unit 102 , a display unit 103 , an input unit 104 , and a communication unit 105 .

[0039] The control unit 101 is configured, for example, by a processor such as a CPU. The storage unit 102 is configured, for example, by an SSD, HDD, RAM, etc. The display unit 103 is, for example, a liquid crystal display or an organic EL display. The display unit 103 displays various screens in response to signals from the control unit 101. Screens 200, 210, 220, 230, 240, 250, and 260 (described below) are displayed on the display unit 103. The input unit 104 is, for example, a mouse or keyboard. The input unit 104 transmits signals to the control unit 101 in response to user operations. The display unit 103 and the input unit 104 may be integrated into one unit, such as a touch-panel display. The communication unit 105 is, for example, a network card. The control unit 101 controls each unit of the measurement device 2 and receives signals from the measurement device 2 via the communication unit 105.

[0040] The control unit 101 controls each unit of the measurement device 2 via the communication unit 105 so that the operations described with reference to Fig. 1 are performed for each of the multiple measurement items. As a result, the measurement device 2 dispenses the sample in one container T into cuvettes C in the number of measurement items set for that sample. The measurement device 2 dispenses reagents according to the measurement items into the cuvettes C to prepare measurement samples for each measurement item as described above, and detects light emitted from the measurement samples in the detection unit 30. The control unit 101 converts the amount of light detected by the detection unit 30 into a measurement value that is the concentration of the protein to be measured.

[0041] Measurement items that can be set in embodiment 1 include, for example, HBsAg, HBsAb, HBeAg, TSH, FT3, FT4, PSA, AFP, CEA, HBeAb, HBcAb, HCVAb, HIVAb, HTLV-I, TPAb, CA125, CA19-9, TM, TAT, PIC, tPAI-C, FRN, Insulin, HIVAg+Ab, 1-40, 1-42, etc. Furthermore, an operation item that can be set in embodiment 1 includes, for example, AB42 / 40.

[0042] Measurement items 1-40 are items related to amyloid beta 1-40, and measurement items 1-42 are items related to amyloid beta 1-42. Calculation item AB42 / 40 is an item related to the ratio obtained by dividing the measurement value of measurement item 1-42 by the measurement value of measurement item 1-40.

[0043] When a blood sample is collected from a subject, the amyloid beta 1-40 and 1-42 in the collected blood sample decrease over time, although it is known that the decrease rates are approximately equal.

[0044] Therefore, it is preferable that measurements for measurement items 1-40 and 1-42 in the calculation of calculation item AB42 / 40 be performed as close together as possible, for example, at most one hour apart, preferably no more than 30 minutes apart, and more preferably no more than 15 minutes apart. That is, when measurements for measurement items 1-40 and 1-42 are performed close together, the elapsed time after collection from the subject is approximately equal, and therefore the reduction rates of amyloid beta 1-40 and 1-42 in the samples dispensed from a single container T into cuvette C for measurement item 1-40 and cuvette C for measurement item 1-42 are approximately equal. In this case, when calculating the calculated value (ratio) of calculation item AB42 / 40, the reduction rates of the measured value of measurement item 1-42 in the numerator and the measured value of measurement item 1-42 in the denominator are offset. Therefore, by performing measurements for measurement items 1-40 and 1-42 close together, the reliability of the calculated value (ratio) of calculation item AB42 / 40 can be maintained at a high level.

[0045] From this perspective, in embodiment 1, the sample analyzer 1 is controlled so that measurements of measurement items 1-40 and 1-42 are performed at similar times. For example, as described below, processing is performed so that the time difference between the measurement of measurement item 1-40 and the measurement of measurement item 1-42 falls within a predetermined time (e.g., 1 hour, 30 minutes, 15 minutes, etc.). The screens and control of the sample analyzer 1 controlled from the above perspective are described below.

[0046] Furthermore, as a result of careful investigation by the inventors, it was found that the temperature range of the measurement environment in which high reliability of the measurement value for measurement item 1-40 can be maintained is narrower than the temperature range of the measurement environment in which high reliability of the measurement value for measurement item 1-42 can be maintained. From this perspective, in embodiment 1, sample analyzer 1 is controlled so that the temperature range of the measurement environment allowed for measurement item 1-40 is narrower than the temperature range of the measurement environment allowed for measurement item 1-42. For example, as described below, the appropriate temperature range for measurement item 1-40 is set to 24°C or higher and 31°C or lower, and the appropriate temperature range for measurement item 1-42 is set to 14°C or higher and 38°C or lower.

[0047] FIG. 3 is a diagram showing a schematic configuration of a screen 200 that displays a job list and is displayed on the display unit 103. As shown in FIG.

[0048] The screen 200 includes a job list display area 201 , a details display area 202 , a specimen information display area 203 , a subject information display area 204 , and an order registration button 205 .

[0049] The job list display area 201 is an area that displays various information such as measurement orders associated with specimen numbers and measurement values ​​obtained as a result of the measurement. The job list display area 201 includes items such as progress, measurement date and time, and specimen number, as well as multiple measurement items and calculation items. The progress item indicates the status of the job, such as whether the measurement is completed, the measurement values ​​have been approved, or an error has occurred. The specimen number is a number that can individually identify the specimen contained in the container T.

[0050] A check mark is displayed for each measurement item in the job list display area 201 before measurement if measurement of that measurement item is scheduled. The check mark for each measurement item is displayed based on a measurement order previously set for the sample. The measurement order is obtained from a host computer communicatively connected to the control device 3, or manually input by the operator via a screen 240 (FIGS. 11 to 13) for registering an order, which is displayed on the display unit 103 when the operator operates the input unit 104 to select the order registration button 205. Furthermore, after measurement, the measured values, calculated values, etc. of that measurement item are displayed for each measurement item in the job list display area 201.

[0051] The operator can select information (job) corresponding to a line by selecting the line in the job list display area 201 via the input unit 104. In the example shown in Fig. 3, the job with specimen number "0000099274" on the bottom line is selected, and this line is displayed in inverse video.

[0052] The details display area 202 is an area that displays information such as the measured values ​​and calculated values ​​of each measurement item and calculation item of the job selected in the job list display area 201. In the example shown in Fig. 3, the job in the selected row has not yet undergone measurement processing by the measurement device 2, so the details display area 202 is blank.

[0053] The specimen information display area 203 is an area that displays the specimen number, measurement date and time, etc. of the job selected in the job list display area 201. The subject information display area 204 is an area that displays the subject ID, subject name, etc. of the job selected in the job list display area 201.

[0054] FIG. 4 is a diagram showing a schematic configuration of a screen 210 displayed on the display unit 103 for setting item sorting.

[0055] The screen 210 includes a sort list display area 211 , an up button 212 , a down button 213 , an OK button 214 , and a cancel button 215 .

[0056] The sort list display area 211 has blocks 211a arranged corresponding to all measurement items and calculation items that can be measured and analyzed by the sample analyzer 1. The names of the measurement items and calculation items are displayed in the blocks 211a. The arrangement of the multiple blocks 211a indicates the order in which measurements for the multiple measurement items are performed. When measurement for one sample is started, the measurement item indicated by the upper left block 211a is performed first, and the measurement item indicated by the lower right block 211a is performed last. In the example shown in Figure 4, the measurement of the measurement item HBsAg is performed first, and the measurement of measurement item 1-42 is performed last. The screen 210 in Figure 4 shows an example in which the blocks 211a corresponding to measurement items 1-40 and 1-42 are arranged adjacent to each other.

[0057] The operator can select the measurement item corresponding to block 211a by performing an operation to select block 211a via input unit 104. In the example shown in Fig. 4, block 211a of measurement item 1-40 is selected, and this block 211a is displayed in inverse video. When the operator operates move up button 212 while block 211a is selected, the selected block 211a is moved up one measurement order in the sort list display area 211. When the operator operates move down button 213, the selected block 211a is moved down one measurement order in the sort list display area 211.

[0058] As described above, it is preferable that measurements for measurement items 1-40 and 1-42 are performed close to each other. From this perspective, in the first embodiment, when one of the two blocks 211a corresponding to measurement items 1-40 and 1-42 is selected and the operator operates the move up button 212 or the move down button 213, the measurement order of these two blocks 211a (groups 211b) among all measurement items is changed while the measurement order remains adjacent to each other, as shown in Fig. 5.

[0059] As shown in FIG. 6, even if the blocks 211a corresponding to measurement items 1-40 and 1-42 are not arranged adjacent to each other, when one of the two blocks 211a corresponding to measurement items 1-40 and 1-42 is selected and the operator operates the move up button 212 or the move down button 213, the arrangement of these two blocks 211a (groups 211b) is swapped so that the measurement order is adjacent to each other, as shown in FIG. 7, and the measurement order among all measurement items is changed.

[0060] As a result, measurements of measurement items 1-40 and 1-42 are always performed continuously, so that the reliability of the calculated value (ratio) of calculation item AB42 / 40 can be maintained at a high level.

[0061] When the operator operates the OK button 214, the control unit 101 stores the measurement order of the measurement items in the memory unit 102 based on the arrangement order of the blocks 211a set in the sort list display area 211, and closes the screen 210. When the operator operates the cancel button 215, the control unit 101 discards the contents set in the sort list display area 211, and closes the screen 210.

[0062] 4 to 7, block 211a may be moved by performing a drag-and-drop operation on block 211a instead of using move up button 212 and move down button 213. In this case, blocks 211a of measurement items 1-40 and 1-42 are also moved as group 211b.

[0063] FIG. 8 is a diagram showing a typical configuration of a screen 220 displayed on the display unit 103 and used by the administrator to set item information.

[0064] Screen 220 includes an item list display area 221, a basic settings button 222, and an advanced settings button 223. An administrator who performs maintenance on sample analyzer 1 logs in with administrator privileges and then performs a predetermined operation to display screen 220.

[0065] Blocks 221a corresponding to all measurement items that can be measured and analyzed by the sample analyzer 1 are arranged in the item list display area 221. The names of the measurement items and the calculation items are displayed in the blocks 221a. The blocks 221a are arranged in the measurement order set on the screens 210 of Figures 4 to 7.

[0066] The administrator can select the measurement item corresponding to block 221a by selecting block 221a via input unit 104. In the example shown in FIG. 8, block 221a of measurement item 1-40 is selected. When the administrator operates basic settings button 222 with block 221a selected, a screen for setting basic settings for the selected measurement item, such as the item display name, measurement value display range, and measurement value unit, is displayed on display unit 103. When the administrator operates advanced settings button 223 with block 221a selected, a screen for making additional settings for the selected measurement item is displayed on display unit 103. As shown in FIG. 8, when measurement item 1-40 is selected and the advanced settings button 223 is operated, screen 230 for adding remeasurement conditions, as shown in FIG. 9, is displayed on display unit 103.

[0067] FIG. 9 is a diagram showing a schematic configuration of a screen 230 displayed on the display unit 103 for performing additional settings for the measurement items 1-40.

[0068] The screen 230 includes a measurement item display area 231 , a time interval setting area 232 , and a temperature setting area 233 .

[0069] In the measurement item display area 231, the measurement item names "1-40" are displayed so that it is clear that the screen 230 is for setting up measurement items 1-40.

[0070] The time interval setting area 232 includes a check box 232a and pull-down menus 232b and 232c. If the administrator wants to enable the settings in the pull-down menus 232b and 232c, the administrator checks the check box 232a via the input unit 104. This enables the setting of the time interval between the measurement of measurement item 1-40 and the measurement of the measurement item paired with measurement item 1-40.

[0071] Pull-down menu 232b is a menu for selecting a measurement item to be paired with measurement item 1-40. Pull-down menu 232c is a menu for selecting the maximum time interval between the measurement of measurement item 1-40 and the measurement item to be paired with measurement item 1-40. The administrator operates pull-down menu 232b via input unit 104 to select a measurement item to be paired with measurement item 1-40, and operates pull-down menu 232c to select the time interval. In FIG. 9, measurement item 1-42 is selected as the measurement item to be paired with measurement item 1-40, and one hour is selected as the time interval.

[0072] 9, if the time interval setting area 232 is set and the time interval between the measurement of measurement item 1-40 and the measurement of measurement item 1-42 exceeds one hour, the measured values ​​of measurement items 1-40 and 1-42 will both be considered measurement errors, and the calculated value (ratio) of calculation item AB42 / 40 will not be output. In this case, an order to measure measurement items 1-40 and 1-42 again will be automatically created. This prevents unreliable calculated values ​​from being output, and because a new measurement order is set, it automatically provides an opportunity to obtain highly reliable calculated values.

[0073] Temperature setting area 233 includes check box 233a and pull-down menus 233b and 233c. If the administrator wants to enable the settings in pull-down menus 233b and 233c, he or she operates check box 233a via input unit 104 to check the box. This enables the settings of the appropriate temperature ranges for measurement of measurement items 1-40.

[0074] Pull-down menus 233b and 233c are used to set the upper and lower limits of the appropriate temperature range for measurement of measurement items 1-40. The administrator operates pull-down menus 233b and 233c via input unit 104 to set the appropriate temperature range for measurement of measurement items 1-40. In FIG. 9, the appropriate temperature range for measurement of measurement items 1-40 is set to 24°C or higher and 31°C or lower. When measuring measurement items 1-40, the temperature range is important for obtaining appropriate measurement values, so it is preferable to set such a temperature range.

[0075] When the temperature setting field 233 is set as shown in Figure 9, if the temperature during measurement of measurement item 1-40 falls outside the above temperature range, not only is the measurement of measurement item 1-40 canceled, but the measurement of paired measurement item 1-42 is also canceled. As a result, the measured values ​​of measurement items 1-40 and 1-42 are both deemed to be measurement errors, and the calculated value (ratio) of calculation item AB42 / 40 is not output. In this case, too, an order is automatically created to measure measurement items 1-40 and 1-42 again. This prevents unreliable calculated values ​​from being output, and because a new measurement order is set, it automatically provides an opportunity to obtain highly reliable calculated values.

[0076] When the administrator operates OK button 234, if check box 232a is checked, control unit 101 stores the paired measurement items and time intervals set in time interval setting area 232 in memory unit 102, and if check box 233a is checked, control unit 101 stores the temperature range set in temperature setting area 233 in memory unit 102. Thereafter, control unit 101 closes screen 210. When the administrator operates cancel button 235, control unit 101 discards the contents set on screen 230 and closes screen 230.

[0077] In addition, when the detail setting button 223 is operated with the measurement item 1-42 selected in FIG. 8, a screen 230 shown in FIG.

[0078] FIG. 10 is a diagram showing a schematic configuration of a screen 230 displayed on the display unit 103 for performing additional settings for the measurement item 1-42.

[0079] In the measurement item display area 231, the measurement item name "1-42" is displayed so that it is clear that the screen 230 is a setting relating to the measurement item 1-42.

[0080] When the paired measurement items and time intervals are set as shown in Fig. 9, if the paired measurement items are selected as measurement items 1-40 in pull-down menu 232b in Fig. 10, the time interval in pull-down menu 232c in Fig. 10 will automatically change to the time interval set in Fig. 9. Conversely, when the paired measurement items and time intervals are set as shown in Fig. 10, if the paired measurement items are selected as measurement items 1-42 in pull-down menu 232b in Fig. 9, the time interval in pull-down menu 232c in Fig. 9 will change to the time interval set in Fig. 10. In other words, the time intervals for measurement items 1-40 and 1-42 can be set on either screen in Figs. 9 and 10.

[0081] 10, the check box 233a is initially unchecked. This is because there is no need to individually set the temperature range required to ensure the reliability of the measurement value for the measurement item 1-42. Note that the temperature setting area 233 may be omitted from the screen 230 for the measurement item 1-42.

[0082] FIG. 11 is a diagram showing a schematic configuration of a screen 240 displayed on the display unit 103 for the operator to register a measurement order.

[0083] Screen 240 is displayed when the operator operates order registration button 205 on screen 200 in Fig. 3 via input unit 104. Screen 240 includes check boxes 241, an item display area 242, an OK button 243, and a cancel button 244. Check boxes 241 and item display areas 242 are displayed in one-to-one correspondence.

[0084] When the operator operates the input unit 104 to check the check box 241 and presses the OK button 243, the measurement item corresponding to that check box 241 is registered in the measurement order. As for calculation items, once all measurement items required to acquire the calculation item have been registered, they are automatically registered in the measurement order.

[0085] When the operator checks the check box 241 for only one of the measurement items 1-40 and 1-42 and presses the OK button 243, a message prompting the operator to register the other measurement item in the measurement order is displayed on the display unit 103, as shown in Fig. 18, which will be described later. Note that when the operator checks the check box 241 for only one of the measurement items 1-40 and 1-42 and presses the OK button 243, error information indicating that the measurement order could not be registered may be displayed on the display unit 103.

[0086] FIG. 12 is a diagram showing a schematic configuration of a modified example of the screen 240 displayed on the display unit 103 for the operator to register a measurement order.

[0087] Screen 240a for registering a measurement order differs from screen 240 in that calculation item AB42 / 40 is displayed instead of measurement items 1-40 and 1-42. When the operator checks check box 241 for calculation item AB42 / 40 and operates OK button 243, measurement items 1-40 and 1-42, which are the measurement items required to obtain calculation item AB42 / 40, are registered in the measurement order.

[0088] FIG. 13 is a diagram showing a schematic configuration of another modified example of the screen 240 displayed on the display unit 103 and used by the operator to register a measurement order.

[0089] Screen 240b for registering a measurement order differs from screen 240 in that it displays check boxes 245 corresponding to both measurement items 1-40 and 1-42. When the operator checks check boxes 245 and operates OK button 243, measurement items 1-40 and 1-42 are registered in the measurement order.

[0090] FIG. 14 is a diagram showing a schematic configuration of a screen 200 that displays a post-measurement job list, which is displayed on the display unit 103. As shown in FIG.

[0091] The screen 200 in Fig. 14 shows the state in which measurement and analysis have been completed for all jobs set on the screen 200 in Fig. 3. In Fig. 3, if the measurement was performed successfully, the measurement value is displayed instead of the check mark for the measurement item that was checked for each job in the job list display area 201. In addition, the progress and measurement date and time items in the job list display area 201 respectively display the job status and the date and time when the measurement was performed. In the progress section of Fig. 14, various messages are displayed, such as "Reported," which indicates that the measurement values ​​have been output to a host computer or a printer for printing measurement values ​​and the job is complete, "Validated," which indicates that the measurement values ​​have been approved, "Review," which indicates that the measurement values ​​need to be confirmed, and "Error," which indicates that the measurement failed.

[0092] In the example shown in FIG. 14, the selected job at the bottom has failed measurement. Specifically, measurements were performed normally for all measurement items except for measurement items 1-40 and 1-42, and measurement values ​​were acquired. However, for measurement items 1-40 and 1-42, the time interval between measurements exceeded the time interval (1 hour) shown in FIGS. 9 and 10, so the measurement values ​​for measurement items 1-40 and 1-42 are both displayed as "*****.***," indicating a measurement error. Furthermore, the measurement value for calculation item AB42 / 40 is displayed as "-----.---" because it was not calculated. Accordingly, the detailed display area 202 also displays the same measurement values ​​as those in the job list display area 201. The "···" displayed for measurement items such as HBsAb and HBeAg schematically indicates that the acquired measurement values ​​are displayed as numbers.

[0093] As described above, if an appropriate calculated value is not obtained for calculation item AB42 / 40, a measurement order is automatically generated to remeasure measurement items 1-40 and 1-42 for this sample, as shown in FIG.

[0094] FIG. 15 is a diagram showing a schematic configuration of a screen 200 relating to a post-measurement job list displayed on the display unit 103. As shown in FIG.

[0095] In screen 200 of Figure 15, measurement values ​​for measurement items 1-40 and 1-42 were not obtained for the same sample (sample number "0000099274") as the job above, so a measurement order has been generated that includes these two measurement items and calculation items obtained from the measurement values ​​of these two measurement items in order to perform re-measurements (also called "retests") for these two measurement items.

[0096] FIG. 16 is a diagram showing a schematic configuration of a screen 250 that displays a measurement order list related to retesting, which is displayed on the display unit 103.

[0097] The screen 250 includes a measurement order list display area 251 and a delete button 252 .

[0098] The measurement order list display area 251 displays measurement orders related to retesting. The measurement order list display area 251 includes items such as sample number and registration date and time, as well as multiple measurement items and calculation items. The registration date and time is the date and time when the measurement order related to retesting was set. A check mark is displayed for each measurement item and calculation item in the measurement order list display area 251 if a retest of the measurement item is scheduled. By referring to the measurement order list display area 251, the operator can understand what kind of retest measurement order has been generated for which sample, and can smoothly set the rack R holding the container T again in the sample transport unit 11 (see Figure 1) or smoothly set the container T in the container setting unit 13b (see Figure 1).

[0099] The operator can select a measurement order corresponding to a row in the measurement order list display area 251 via the input unit 104. Then, the operator can delete the measurement order corresponding to the row selected in the measurement order list display area 251 by operating the delete button 252 via the input unit 104. This allows the operator to stop the measurement using the target container T when it is determined that the sample has deteriorated significantly.

[0100] Next, the processing performed by the sample analyzer 1 will be described.

[0101] In the following description, two measurement items set to be measured consecutively will be referred to as the first measurement item and the second measurement item. An item that calculates a calculated value based on the measured value of the first measurement item and the measured value of the second measurement item will be simply referred to as the calculation item below. In embodiment 1, the first measurement item is 1-40, the second measurement item is 1-42, and the calculation item is AB42 / 40. Note that the first measurement item may be 1-42, and the second measurement item may be 1-40.

[0102] FIG. 17 is a flowchart showing the sample analysis process.

[0103] 17 is started when, while a measurement order has been registered, an operator sets a rack R holding a container T containing a sample corresponding to the measurement order in the sample transport unit 11 (see FIG. 1), and sets the container T in the container setting unit 13b (see FIG. 1). The process shown in FIG. 17 is performed for each container T.

[0104] When the container T is positioned at the suction position of the sample dispensing unit 12, the control unit 101 of the control device 3 sequentially performs the judgment of step S11 in the measurement order set on the screen 210 of Figures 4 to 7 based on the measurement items set in the measurement order of the target sample.

[0105] In step S11, the control unit 101 determines whether the measurement item to be determined is the first or second measurement item. If the measurement item to be determined is the first or second measurement item, in step S12 the control unit 101 determines whether a measurement item paired with the measurement order for the target specimen is set in the measurement order. That is, in step S12, if the measurement item to be determined is the first measurement item, it determines whether measurement of the second measurement item is scheduled, and if the measurement item to be determined is the second measurement item, it determines whether measurement of the first measurement item is scheduled.

[0106] If the measurement order includes paired measurement items, in step S13, the control unit 101 determines whether the measurement item to be determined is the first of the paired first and second measurement items to be performed first. If the measurement item to be determined is the first measurement item to be performed first, the control unit 101 performs pair processing (step S14) to perform measurements of the first and second measurement items consecutively according to the measurement order set in Figures 4 to 7. On the other hand, if the measurement item to be determined is the second measurement item to be performed later, step S14 is skipped because measurements of the paired measurement item have already been completed. The pair processing will be described later with reference to Figure 19.

[0107] If the control unit 101 determines in step S12 that there are no paired measurement items in the measurement order, in step S15, the control unit 101 displays a notification screen 260 shown in FIG. 18 on the display unit 103. As shown in FIG. 18, the notification screen 260 includes a notification area 261 and buttons 262 and 263 for notifying the operator that no paired measurement items are set in the measurement order for the target specimen. In the example shown in FIG. 18, when the measurement item to be determined is 1-40 and the paired measurement item is 1-42, the notification area 261 indicates that the calculated value of the calculation item AB42 / 40 cannot be obtained because measurement of the paired measurement item 1-42 is not scheduled. If the operator desires to measure the paired measurement item, the operator operates button 262 via the input unit 104. On the other hand, if the operator does not desire to measure the paired measurement item, the operator operates button 263 via the input unit 104.

[0108] In step S16, the control unit 101 determines which button has been operated on the notification screen 260 of Fig. 18. If button 262 has been operated, the control unit 101 adds the measurement item paired with the measurement item to be determined to the measurement order, and proceeds to step S14. On the other hand, if button 263 has been operated, the control unit 101 proceeds to step S17 so that of the two paired measurement items, only the measurement item to be determined is measured.

[0109] If the control unit 101 determines in step S11 that the measurement item to be determined is neither the first nor the second measurement item, it performs single processing in step S17 to measure the measurement item to be determined. In the single processing in step S17, the control unit 101 executes measurement processing (steps S301 to S314: FIG. 21) described below, and displays the acquired measurement value on the display unit 103.

[0110] In step S18, the control unit 101 determines whether or not processing has been completed for all measurement items based on the measurement order for the target specimen (including a retest order, which will be described later). If processing has not been completed for all measurement items, the process returns to step S11, and the measurement items set in the measurement order are subjected to determination in measurement order, and steps S11 to S17 are performed. On the other hand, if processing has been completed for all measurement items, the process of FIG. 17 ends. Thereafter, if there is a subsequent container T, the process of FIG. 17 is performed continuously for the subsequent container T.

[0111] FIG. 19 is a flowchart showing the pair processing in step S14 of FIG.

[0112] In step S101, the control unit 101 performs a pre-measurement check. In the pre-measurement check, when measurements of the first and second measurement items are performed, the control unit 101 determines whether the time difference between the measurement of the first measurement item and the measurement of the second measurement item falls within a predetermined time. If the control unit 101 determines in the pre-measurement check that the time difference does not fall within the predetermined time, it prohibits the start of measurements of both the first measurement item and the second measurement item, as described below.

[0113] FIG. 20 is a flowchart showing the process of the check before starting measurement shown in FIG.

[0114] In step S201, the control unit 101 acquires reagent information to be used in the measurements of the first and second measurement items from the storage unit 102. Reagent information to be used in the measurements of all measurement items performed by the measurement device 2 (such as the expiration date of the reagent, the number of remaining tests of the reagent, and the remaining amount of the reagent) is stored in advance in the storage unit 102. The control unit 101 updates the reagent information stored in the storage unit 102 whenever a reagent container is replaced or the reagent is consumed. Next, in step S202, the control unit 101 acquires the environmental temperature of the measurement from the temperature sensor 32 (see FIG. 1).

[0115] In step S203, the control unit 101 determines whether or not the reagents used for the measurements of the first and second measurement items are within their expiration dates, based on the reagent information acquired in step S201.

[0116] If the reagent is within its expiration date, in step S204, the control unit 101 determines, based on the reagent information acquired in step S201, whether the remaining amount of reagent to be used in the measurements of the first and second measurement items is equal to or greater than the amount required for measurements of both the first and second measurement items. In step S204, if the remaining number of tests for the reagent contained in the target reagent container for each measurement item is one or more, it is determined that the required amount of reagent is present in the target reagent container. Note that, for each measurement item, it may also be determined that the required amount of reagent is present in the target reagent container for each measurement item if the remaining amount of reagent contained in the target reagent container is equal to or greater than the amount required for one measurement.

[0117] If the amount of reagent is more than the required amount, in step S205, the control unit 101 determines whether the measurement environmental temperature acquired in step S202 is within a predetermined temperature range. The predetermined temperature range is the temperature range set in the temperature setting area 233 in FIG. 9.

[0118] If the environmental temperature is within the predetermined temperature range, the control unit 101 permits the start of measurement of the first and second measurement items in step S206. On the other hand, if the determination in any of steps S203 to S205 is NO, the control unit 101 prohibits the start of measurement of the first and second measurement items in step S207. In this way, the pre-measurement check process ends.

[0119] 19, in step S102, the control unit 101 determines whether or not the start of measurement of the first and second measurement items has been permitted in the pre-measurement check process of step S101. If the start of measurement of the first and second measurement items has been permitted, the control unit 101 performs measurements of the first and second measurement items consecutively according to the measurement order set on screen 210 of FIGS. 4 to 7. In the example shown in FIG. 19, the measurement of the first measurement item is performed before the measurement of the second measurement item.

[0120] In step S103, the control unit 101 starts measurement of the first measurement item. As a result, the control unit 101 executes a measurement process (steps S301 to S314: see FIG. 21) described below for the first measurement item in parallel with the pairing process. Subsequently, in step S104, the control unit 101 determines whether measurement of the second measurement item can be started, in other words, whether the timing to start measurement of the second measurement item has arrived, and waits until measurement of the second measurement item can be started. For example, when the measurement process for the first measurement item progresses to a predetermined step (for example, step S303 in FIG. 21), the control unit 101 determines that measurement of the second measurement item can be started. When measurement of the second measurement item can be started, in step S105, the control unit 101 starts measurement of the second measurement item. As a result, the control unit 101 executes a measurement process (steps S301 to S314: see FIG. 21) described below for the second measurement item in parallel with the pairing process.

[0121] FIG. 21 is a flowchart showing the measurement process performed for each measurement item.

[0122] The measurement process shown in Fig. 21 corresponds not only to the measurement of the first measurement item and the measurement of the second measurement item, but also to the measurement of other measurement items (single process in Fig. 17). All steps in Fig. 21 are performed by control unit 101 controlling each part of measurement device 2.

[0123] In step S301, R1 reagent is dispensed into cuvette C set in holder 18c. In step S302, a specimen is dispensed into the cuvette C. In step S303, the primary reaction unit 18 performs a primary reaction process on the specimen and R1 reagent in the cuvette C. In step S304, R2 reagent is dispensed into the cuvette C. In step S305, the primary reaction unit 18 performs a secondary reaction process on the specimen and R1 and R2 reagents in the cuvette C. In step S306, the primary BF separation unit 22 performs a primary BF separation process to remove the R1 reagent containing unreacted capture antibody from the cuvette C.

[0124] In step S307, the R3 reagent is dispensed into the cuvette C. In step S308, the secondary reaction unit 24 performs a tertiary reaction process on the specimen and the R1 to R3 reagents in the cuvette C. In step S309, the secondary BF separation unit 27 performs a secondary BF separation process to remove the R3 reagent containing unreacted labeled antibody from the cuvette C.

[0125] In step S310, R4 reagent and R5 reagent are dispensed into the cuvette C. In step S311, the secondary reaction unit 24 performs a fourth reaction process on the specimen and R1 to R5 reagents in the cuvette C. In step S312, the detection unit 30 performs an optical detection process to detect light generated from the specimen and R1 to R5 reagents in the cuvette C. In step S313, the control unit 101 stores the time when the optical detection process ends in the memory unit 102. Note that step S313 may be performed only in measurements of the first and second measurement items, and not in measurements of other measurement items. Thereafter, in step S314, a process is performed to convert the amount of light detected in step S312 into a measurement value (the concentration of the protein to be measured).

[0126] Returning to FIG. 19 , in step S106, the control unit 101 determines whether it is time to end step S314 for the first and second measurement items, in other words, whether it is time to end the measurements of the first and second measurement items. If it determines that it is time to end the measurements of the first and second measurement items, the control unit 101 performs a post-measurement check process in step S107. In the post-measurement check process, the control unit 101 determines whether the time difference between the measurement of the first measurement item and the measurement of the second measurement item falls within a predetermined time. If the control unit 101 determines that the time difference does not fall within the predetermined time in the post-measurement check process, it prohibits the output of the calculated values ​​of the calculation items based on the measured values ​​of the first and second measurement items, as will be described later.

[0127] FIG. 22 is a flowchart showing the post-measurement check process.

[0128] In step S401, the control unit 101 determines whether there are measurement values ​​for both the first and second measurement items. In embodiment 1, when a post-measurement check process is executed, measurement values ​​for both the first and second measurement items are usually obtained. However, if a sample or reagent dispensing error occurs in either the measurement of the first measurement item or the measurement of the second measurement item, for example, the measurement value for the measurement item where the dispensing error occurred is not obtained. In this way, if a measurement value for at least one of the first and second measurement items is not obtained, the determination in step S401 is NO.

[0129] When there are measurement values ​​for both the first and second measurement items, in step S402, the control unit 101 reads out from the memory unit 102 the detection times stored in step S313 of Figure 21 for the measurements of the first and second measurement items, and calculates the difference between the two detection times as the time difference ΔT1 between the measurement of the first measurement item and the measurement of the second measurement item.

[0130] FIG. 23 is a time chart showing the measurement of the first measurement item and the measurement of the second measurement item.

[0131] If the measurement order of the second measurement item is after the first measurement item, the measurement of the second measurement item is suspended after the measurement of the first measurement item has started until the measurement of the second measurement item can be started. As a result, as shown in Fig. 23, the measurement start timings of the first measurement item and the second measurement item differ from each other, and as a result, the detection times stored in step S313 also differ from each other. The time difference ΔT1 calculated in step S402 of Fig. 22 is the difference between the timing at which optical detection in step S312 for the measurement of the first measurement item ends and the timing at which optical detection in step S312 for the measurement of the second measurement item ends, as shown in Fig. 23.

[0132] 22, in step S403, the control unit 101 determines whether the time difference ΔT1 acquired in step S402 is within a predetermined time. The predetermined time used in the determination in step S403 is the time interval set in the pull-down menu 232c in FIGS.

[0133] In the first embodiment, the first and second measurement items are measured consecutively, and the time difference ΔT1 between the measurements of the first and second measurement items is usually within a predetermined time. However, there are cases where the measurement of the first and second measurement items is temporarily interrupted and then resumed. For example, there are cases where the environmental temperature inside the measurement device 2 exceeds a predetermined range during the measurement of the first measurement item. In this case, the measurement is temporarily interrupted, and the operator takes measures such as lowering the temperature in the room where the sample analyzer 1 is installed. As a result, once the environmental temperature inside the measurement device 2 falls within the predetermined range, the measurement of the first measurement item is resumed. At this time, if the measurement value of the second measurement item has already been obtained before the measurement of the first measurement item, the time difference ΔT1 between the measurements of the first and second measurement items may exceed the predetermined time. In this case, the determination in step S403 is NO.

[0134] If the time difference ΔT1 is within the predetermined time, in step S404, the control unit 101 permits the output of the calculated value of the calculation item based on the measured values ​​of the first and second measurement items. In embodiment 1, the calculated value of the calculation item is the ratio obtained by dividing the measured value of the second measurement item 1-42 by the measured value of the first measurement item 1-40. On the other hand, if the determination in either step S401 or S403 is NO, in step S405, the control unit 101 prohibits the output of the calculated value of the calculation item based on the measured values ​​of the first and second measurement items. This completes the post-measurement check process.

[0135] Returning to FIG. 19, in step S108, control unit 101 determines whether or not output of the calculated value of the calculation item was permitted in step S404 of FIG. 22. If output of the calculated value is permitted, control unit 101 calculates the calculated value of the calculation item in step S109. Thereafter, in step S110, control unit 101 displays the measured values ​​of the first and second measurement items and the calculated values ​​of the calculation items on display unit 103. As a result, for example, on screen 200 displaying the job list in FIG. 14, the measured values ​​of the first and second measurement items and the calculated values ​​of the calculation items are displayed as shown for jobs whose progress is not an error.

[0136] The display of screen 200 in step S110 may be performed automatically after completion of step S109, or may be performed by the operator inputting a display instruction via input unit 104, but from the viewpoint of reducing the burden on the operator, it is preferable that it be performed automatically.

[0137] On the other hand, if the start of measurement is prohibited in step S207 of Fig. 20, or if the output of the calculated value of the calculation item is prohibited in step S405 of Fig. 22, the control unit 101 generates a measurement order for retesting including the first and second measurement items and calculation items in step S111. Then, in step S112, the control unit 101 displays the retesting order on the display unit 103. In steps S111 and S112, a measurement order for retesting of the first and second measurement items and calculation items (measurement items 1-40, 1-42 and calculation item AB42 / 40 in embodiment 1) is generated as shown in Fig. 16, and a screen 250 showing the retesting order is displayed on the display unit 103.

[0138] Furthermore, in step S113, the control unit 101 displays on the display unit 103 in the columns for the measured values ​​of the first and second measurement items and the calculated value of the calculation item that proper measured values ​​were not obtained. Specifically, as shown in the bottom row of the job list display area 201 and in the detailed display area 202 in Fig. 14, "*****.***" indicating a measurement error is displayed in the columns for the measured values ​​of measurement items 1-40 and 1-42 corresponding to the first and second measurement items, and "----.---" indicating that calculation is impossible is displayed in the column for the calculated value of AB42 / 40 corresponding to the calculation item. In this way, the pair processing shown in Fig. 19 is completed.

[0139] The operator can identify the sample to be retested by referring to the retest order displayed in step S112. Then, the operator sets the container T of the target sample in the sample transport unit 11 or the container setting unit 13b. This causes the process of FIG. 17 to be performed again, and measurement processing for the measurement items set in the retest order is performed.

[0140] <Modification 1 of Embodiment 1> In the first embodiment, in the process of checking before starting measurement, it is determined whether the environmental temperature of the measurement is within a predetermined temperature range, but the environmental temperature of the measurement may also be determined during measurement.

[0141] Fig. 24 is a flowchart showing a process for stopping measurement in accordance with the environmental temperature according to Modification 1 of Embodiment 1. In the example shown in Fig. 24, the first measurement item is measurement item 1-40.

[0142] In step S501, the control unit 101 determines whether or not measurement of the first measurement item has started. When measurement of the first measurement item has started, in step S502 the control unit 101 acquires the measurement ambient temperature from the temperature sensor 32 (see FIG. 1). In step S503, the control unit 101 determines whether or not the measurement ambient temperature acquired in step S502 is within a predetermined temperature range. The predetermined temperature range is the temperature range set in the temperature setting area 233 in FIG. 9.

[0143] If the ambient temperature is outside the predetermined temperature range, in step S504, the control unit 101 stops not only the measurement of the first measurement item that is currently being performed, but also the measurement of the second measurement item. In this case, since the measurement values ​​of the first and second measurement items cannot be obtained, the determination in step S401 in Fig. 22 becomes NO, and the output of the calculated values ​​of the calculation items is prohibited.

[0144] On the other hand, if the environmental temperature is within the predetermined temperature range, in step S505, the control unit 101 determines whether or not the measurement of the first measurement item has been completed. If the measurement of the first measurement item has not been completed, the control unit 101 returns the process to step S502 and repeats the processes of steps S502 to S504 at predetermined time intervals. On the other hand, if the measurement of the first measurement item has been completed, the control unit 101 ends the process of FIG. 24.

[0145] In this way, when the ambient temperature is determined during measurement of the first measurement item, the measurement can be quickly stopped if the temperature rises after the start of the first measurement item, thereby reducing the consumption of reagent that was scheduled to be used.

[0146] <Modification 2 of Embodiment 1> In the first modification of the first embodiment, the measurement ambient temperature is determined during measurement, but the ambient temperature obtained during measurement may be stored and the ambient temperature may be determined after measurement.

[0147] Fig. 25 is a flowchart showing the process of acquiring the environmental temperature according to Modification 2 of Embodiment 1. In Fig. 25, steps S503 and S504 are omitted and step S511 is added, compared to Fig. 24. Step S511 will be described below.

[0148] In step S511, control unit 101 updates the maximum and minimum environmental temperatures stored in memory unit 102 based on the environmental temperature acquired in the immediately preceding step S502. For example, if the acquired environmental temperature is higher than the maximum environmental temperature in memory unit 102, the acquired environmental temperature is newly set as the maximum environmental temperature in memory unit 102, and if the acquired environmental temperature is lower than the minimum environmental temperature in memory unit 102, the acquired environmental temperature is newly set as the minimum environmental temperature in memory unit 102. Through the processing in FIG. 25, the maximum and minimum environmental temperatures of the environmental temperatures that change during measurement of the first measurement item are stored in memory unit 102.

[0149] Fig. 26 is a flowchart showing the post-measurement check process according to Modification 2 of Embodiment 1. In Fig. 26, step S411 is added between steps S403 and S404, as compared to Fig. 22. Step S411 will be described below.

[0150] In step S411, the control unit 101 determines whether the maximum and minimum environmental temperatures acquired by the processing of FIG. 25 are within a predetermined temperature range. The predetermined temperature range is the temperature range set in the temperature setting field 233 of FIG. 9. If the maximum and minimum environmental temperatures are within the predetermined temperature range, in step S404, the control unit 101 permits the output of the calculated value of the calculation item based on the measured values ​​of the first and second measurement items. On the other hand, if the determination in any of steps S401, S403, and S411 is NO, in step S405, the control unit 101 prohibits the output of the calculated value of the calculation item based on the measured values ​​of the first and second measurement items.

[0151] <Modification 3 of Embodiment 1> In the first embodiment, a check is performed before the start of measurement in Fig. 19. However, the present invention is not limited to this, and the check does not necessarily have to be performed before the start of measurement.

[0152] 27 is a flowchart showing pair processing according to Modification 3 of Embodiment 1. In FIG. 27, steps S101 and S102 are omitted compared to FIG.

[0153] In the first embodiment or the third modification of the first embodiment, the acceptance of a measurement order in which measurement items 1-40 and 1-42 are consecutive, such as group 211b in FIGS. 5 and 7, may be omitted, and each measurement item may be accepted in any measurement order. Furthermore, the processes of steps S12, S15, and S16 in FIG. 17 may be omitted, and the notification of paired measurement items in FIG. 18 may not be performed. Furthermore, the processes of steps S111 and S112 in FIGS. 19 and 27 may be omitted, and the process of automatically registering measurement items 1-40 and 1-42 in the retest order may not be performed. In this case, the operator displays screens 240, 240a, and 240b (see FIGS. 11 to 13) for registering an order on the display unit 103, and operates the input unit 104 to register the retest order.

[0154] That is, the control unit 101 only needs to perform at least one of the following processes: reception of measurement items so that the interval between the two measurement items in Figures 4 to 7 is within a predetermined range; notification processing in step S15 when the measurement order includes only one of the measurement items; pre-measurement check processing in step S101; post-measurement check processing in step S107; and retest order generation processing in step S111.

[0155] <Embodiment 2> In the first embodiment, the time difference between the measurement of the first measurement item and the measurement of the second measurement item is the difference ΔT1 in the time when the optical detection process of step S312 ends, whereas in the second embodiment, the time difference between the measurement of the first measurement item and the measurement of the second measurement item is the difference ΔT2 in the start time of the measurements.

[0156] Fig. 28 is a flowchart showing measurement processing performed for each measurement item according to embodiment 2. In Fig. 28, step S313 is omitted and step S321 is added before step S301, as compared to Fig. 21. Step S321 will be described below.

[0157] Immediately before step S301 is executed, in step S321, control unit 101 stores the measurement start time in memory unit 102. Note that step S321 may be executed only in measurements of the first and second measurement items, and not in measurements of other measurement items.

[0158] Fig. 29 is a flowchart showing pair processing according to embodiment 2. In Fig. 29, compared to Fig. 19, when a NO result is obtained in step S104, the process proceeds to steps S131 and S132 instead of returning to step S104. Steps S131 and S132 will be described below.

[0159] If the control unit 101 determines in step S104 that the timing to start measurement of the second measurement item has not arrived, the control unit 101 determines in step S131 whether the elapsed time since the start of measurement of the first measurement item has exceeded a predetermined time. The time when measurement of the first measurement item started is stored in the memory unit 102 in step S321 of Fig. 28. The predetermined time used in the determination in step S131 is the time interval set in the pull-down menu 232c in Figs. 9 and 10.

[0160] FIG. 30 is a time chart showing the measurement of the first measurement item and the measurement of the second measurement item.

[0161] If the measurement order of the second measurement item is after the first measurement item, the measurement of the second measurement item is suspended after the measurement of the first measurement item has started until the measurement of the second measurement item can be started. As a result, as shown in Figure 30, the start timing of the measurement of the first measurement item and the second measurement item will be different from each other, and as a result, the start times stored in step S321 will also be different from each other. The time difference ΔT2 determined in step S131 of Figure 29 is the difference between the start timing of the measurement of the first measurement item and the start timing of the measurement of the second measurement item, as shown in Figure 30.

[0162] 29, if the time difference ΔT2 does not exceed the predetermined time, the control unit 101 returns the process to step S104 and determines again whether the timing to start measurement of the second measurement item has arrived. On the other hand, if the time difference ΔT2 exceeds the predetermined time, the control unit 101 stops measurement of the first and second measurement items in step S132, prohibits output of the calculated values ​​of the calculation items, and proceeds to step S111. If measurement of the first and second measurement items is stopped in step S132, the calculated values ​​of the calculation items are not acquired.

[0163] <Effects of Embodiments 1 and 2> As described above, it is preferable that the measurements of the first and second measurement items are performed as close as possible. According to the first and second embodiments, processing is performed regarding the time difference between the measurement of the first measurement item and the measurement of the second measurement item.

[0164] As a process for the time difference between the measurement of the first measurement item and the measurement of the second measurement item, for example, a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time is executed. As a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time, for example, as shown in Figures 4 to 7, Figures 11 to 13, Figures 17, 19, 27, and 29, a process for accepting a measurement order so that the interval between the two measurement items is within a predetermined range, a process for registering a measurement order so that two measurement items are registered, a notification process in step S15 when the measurement order includes only one of the measurement items, a check process before the start of measurement in step S101, a check process after the measurement in step S107, a process for generating a retest order in step S111, and a process for canceling the measurement when a predetermined time has elapsed in steps S131 and S132 are executed.

[0165] Furthermore, as a process for determining the time difference between the measurement of the first measurement item and the measurement of the second measurement item, for example, as shown in step S403 of FIGS. 22 and 26, a process is executed to determine whether the time difference between the measurement of the first measurement item and the measurement of the second measurement item falls within a predetermined time. If the time difference falls within the predetermined time, the calculated value of calculation item AB42 / 40 is output. If the time difference does not fall within the predetermined time, the output of the calculated value of calculation item AB42 / 40 is prohibited. Alternatively, information indicating that the reliability of the calculated value is low may be output together with the calculated value. This allows the reliability of the calculated value of the calculation item obtained from the measured value of the first measurement item and the measured value of the second measurement item to be maintained at a high level.

[0166] According to the first and second embodiments, as a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time, if it is determined in the pre-measurement check process of step S101 in FIGS. 19 and 29 that the time difference between the measurement of the first measurement item and the measurement of the second measurement item does not fall within the predetermined time, the start of the process for measuring the first measurement item and the second measurement item is prohibited in step S207 in FIG. 20. This allows the operator to prepare the measurement environment before the measurement by replacing the reagent or lowering the temperature of the room in which the sample analyzer 1 is installed, and allows the measurement to be started in an environment in which the time difference between the measurement of the first measurement item and the measurement of the second measurement item falls within the predetermined time. Furthermore, it is possible to avoid measuring the first and second measurement items when the time difference exceeds the predetermined time. This reduces reagent consumption and improves processing efficiency.

[0167] According to the first and second embodiments, in step S204 of FIG. 20, it is determined whether the remaining amount of reagent used in the measurements of the first and second measurement items is equal to or greater than the amount necessary for the measurements of both the first and second measurement items. If the measurements of the first and second measurement items are interrupted due to a lack of reagent, the time difference is likely to exceed the predetermined time. Therefore, if it is determined that the remaining amount of reagent used in the first and second measurement items is equal to or greater than the amount necessary for the measurements of both the first and second measurement items, the time difference is likely to fall within the predetermined time by performing measurements of the first and second measurement items. Therefore, it is possible to obtain highly reliable calculation values ​​for the calculation items.

[0168] According to the first and second embodiments, in step S203 of FIG. 20, it is determined whether the reagents used in the measurements of the first and second measurement items are within their expiration dates. If the measurements of the first and second measurement items are interrupted due to the expiration of the reagents, the time difference is likely to exceed the predetermined time. Therefore, if it is determined that the reagents used for the first and second measurement items are within their expiration dates, performing measurements of the first and second measurement items makes it easier to keep the time difference within the predetermined time. Therefore, it is possible to obtain highly reliable calculated values ​​for the calculation items.

[0169] According to the first and second embodiments, in step S205 of FIG. 20, it is determined whether the environmental temperature of the measurement is within a predetermined temperature range. If the environmental temperature of the measurement is not within the temperature range suitable for measurement, the measurement is suspended until the environmental temperature falls within this temperature range. Therefore, if the environmental temperature is not within the predetermined temperature range, the time difference is likely to exceed the predetermined time. Therefore, if it is determined that the environmental temperature is within the predetermined temperature range, by measuring the first and second measurement items, the time difference is likely to fall within the predetermined time. Therefore, it is possible to obtain highly reliable calculation values ​​for the calculation items.

[0170] According to the first and second embodiments, as a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time, the measurement order of the measurement items is accepted so that the measurement interval between the first measurement item and the second measurement item is within a predetermined time. Specifically, as shown in FIGS. 4 to 7, when moving the blocks 211a of the first and second measurement items, the order of the blocks 211a of the first and second measurement items is maintained adjacent to each other, or the blocks 211a of the first or second measurement item are rearranged to be adjacent to each other, and the block 211a of the first or second measurement item is moved. This makes it easier to keep the time difference between the measurement of the first and second measurement items within the predetermined time. Therefore, it is possible to output highly reliable calculated values ​​of the calculation items.

[0171] According to the second embodiment, as a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time, measurements are performed so that the time difference between the measurements of the first and second measurement items is within a predetermined time. This makes it easier to keep the time difference between the measurement of the first measurement item and the measurement of the second measurement item within the predetermined time. Therefore, it is possible to output highly reliable calculation values ​​for the calculation items.

[0172] Specifically, as a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time, after starting one of the first and second measurement items, a determination is made in step S131 of FIG. 29 as to whether a predetermined time has elapsed before starting the other measurement, i.e., whether the start time difference ΔT2 has exceeded a predetermined time. If the predetermined time has elapsed, the other measurement is stopped in step S132. This allows the operator to determine the cause of the elapse of the predetermined time, resolve the problem, and then start the measurement of the first and second measurement items again. This allows for the output of highly reliable calculated values ​​for the calculation items. Furthermore, because the other measurement is stopped when the predetermined time has elapsed, reagent consumption can be reduced.

[0173] According to the first embodiment, as a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time, in step S403 of FIGS. 22 and 26, it is determined whether the time difference between the measurement of the first measurement item and the measurement of the second measurement item is within a predetermined time. If the predetermined time is exceeded, in step S405, the output of the calculated value of the calculation item is prohibited. This allows the operator to understand the cause of the lapse of the predetermined time, resolve the problem, and then restart the measurement of the first and second measurement items. Therefore, it is possible to output a highly reliable calculated value of the calculation item.

[0174] According to the first and second embodiments, as a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time, a measurement order including the first and second measurement items is generated in step S111 of Figures 19, 27, and 29 based on the fact that the time difference between the measurements of the first and second measurement items exceeds the predetermined time. As a result, when a measurement process for measuring the first and second measurement items is performed again based on the newly generated measurement order, there is a possibility that the time difference ΔT1 in this measurement process will fall within the predetermined time. Therefore, it is possible to obtain highly reliable calculated values ​​of the calculation items.

[0175] According to the first and second embodiments, when the time differences ΔT1 and ΔT2 between the measurements of the first and second measurement items fall within a predetermined time, the calculated values ​​of the calculation items are output to the display unit 103 in step S110 of Figures 19, 27, and 29. This allows the output of highly reliable calculated values ​​of the calculation items.

[0176] According to the first and second embodiments, as a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time, if it is determined in step S12 of FIG. 17 that the measurement order includes only one of the first and second measurement items, a process for notifying the user of this fact is executed in step S15. This prevents the time difference from increasing when measuring one of the first and second measurement items and then registering a measurement order including the other measurement item and measuring the other measurement item. Therefore, the time difference between the measurement of the first measurement item and the measurement of the second measurement item can be kept within a predetermined time. Furthermore, if the user forgets to register an order for one of the measurement items, the user can be made aware of the need to obtain the calculated value of the calculation item. Therefore, the calculated value of the calculation item can be appropriately presented to the user.

[0177] <Other change examples> In the first and second embodiments, in the description of Figures 17 to 30, the first measurement item was one of amyloid beta 1-40 and amyloid beta 1-42, and the second measurement item was the other of amyloid beta 1-40 and amyloid beta 1-42. In other words, the set of first and second measurement items was amyloid beta 1-40 and amyloid beta 1-42. However, the set of first and second measurement items is not limited to the above. The set of first and second measurement items may be any measurement items that increase the reliability of the calculated value of the calculated item obtained from the measured values ​​of the first and second measurement items by ensuring that the time difference between the measurements of the first and second measurement items falls within a predetermined time.

[0178] If such conditions are met, for example, the first measurement item may be a first type of amyloid beta or amyloid beta precursor protein, and the second measurement item may be a second type of amyloid beta or amyloid beta precursor protein different from the first type. The first and second measurement items may be amyloid beta or amyloid beta precursor protein.

[0179] Specifically, the first measurement item may be one of amyloid beta 1-42 and amyloid beta precursor protein 669-711, and the second measurement item may be the other of amyloid beta 1-42 and amyloid beta precursor protein 669-711. In other words, the pair of first and second measurement items may be amyloid beta 1-42 and amyloid beta precursor protein 669-711. In this case, for example, the ratio between the measured value of amyloid beta 1-42 and amyloid beta precursor protein 669-711 can be used as the calculation value of the calculation item.

[0180] In the first and second embodiments, the calculated value of the calculation item is a ratio obtained by dividing the measurement value of the second measurement item by the measurement value of the first measurement item, but it may also be a ratio obtained by dividing the measurement value of the first measurement item by the measurement value of the second measurement item. Also, the calculated value of the calculation item may be a value obtained by subtracting the value obtained by multiplying the measurement value of the first measurement item by a predetermined value from the value obtained by multiplying the measurement value of the second measurement item by a predetermined value.

[0181] In embodiments 1 and 2, the calculated value of the calculation item was a calculated value obtained from the measurement value of the first measurement item and the measurement value of the second measurement item, but it may also be a calculated value obtained from three or more measurement values ​​including the measurement value of the first measurement item and the measurement value of the second measurement item.

[0182] For example, the measurement items may be amyloid beta 1-40, amyloid beta 1-42, and amyloid beta precursor protein 669-711, and the calculated values ​​of the calculation items may be obtained from the measured values ​​of each measurement item. In this case, the control unit 101 may obtain the calculated values ​​using an arithmetic expression including, for example, the ratio of amyloid beta 1-40 to amyloid beta 1-42 and the ratio of amyloid beta 1-42 to amyloid beta precursor protein 669-711. The control unit 101 may also perform at least one of the following processes: a process for adjusting the time difference between the measurement of amyloid beta 1-40 and the measurement of amyloid beta 1-42 to a predetermined time; and a process for adjusting the time difference between the measurement of amyloid beta 1-42 and the measurement of amyloid beta precursor protein 669-711 to a predetermined time.

[0183] In embodiments 1 and 2, an administrator who performs maintenance on sample analyzer 1 operates screen 230 in Figures 9 and 10 to input the measurement time difference conditions and the temperature conditions within measurement device 2. However, the time difference conditions and temperature conditions may be set by a user other than the administrator (for example, an operator who normally operates sample analyzer 1). In this case, another screen corresponding to screens 220 and 230 that can be operated with the operator's authority may be displayed on display unit 103, and the other screen may be configured to accept conditions that are stricter than the conditions set by the administrator.

[0184] In the first and second embodiments, as shown in FIG. 17, when a pair of measurement items is not set in the measurement order (step S12: NO), the pair of measurement items is measured when the operator inputs a measurement instruction for the pair of measurement items (step S16: YES) as a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time. However, when a pair of measurement items is not set in the measurement order, the pair of measurement items may be measured automatically without an operator's instruction as a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time. In this case, for example, when the determination in step S12 in FIG. 17 is NO, the control unit 101 sets the pair of measurement items in the measurement order and proceeds to step S14. As a result, the pair of measurement items is measured automatically.

[0185] In the first and second embodiments, the first and second measurement items are measured consecutively, but these two measurements do not necessarily have to be consecutive. For example, in the measurement order settings shown in Figures 4 to 7, the control unit 101 may accept an input such that the blocks 211a of the first and second measurement items are not adjacent to each other.

[0186] In this case, when a block 211a of a measurement item other than the calculation item is positioned between the blocks 211a of the first and second measurement items, the control unit 101 may determine whether the time difference between the measurements of the first and second measurement items falls within a predetermined time based on the normal time required to measure the other measurement items. If the control unit 101 determines that the time difference between the first and second measurement items does not fall within the predetermined time, it may not accept an input to move the block 211a of the other measurement item between the blocks 211a of the first and second measurement items. This causes the time difference between the measurements of the first and second measurement items to fall within the predetermined time.

[0187] 4 to 7, the control unit 101 may automatically set the order of measurements of the measurement items set in the measurement order so that the time difference between measurements of the first and second measurement items falls within a predetermined time. For example, even if the first and second measurement items are not set to be measured consecutively on the screen 210, the first and second measurement items may be measured consecutively in the pair processing shown in FIG. 17. This allows the time difference between measurements of the first and second measurement items to fall within a predetermined time.

[0188] In the first and second embodiments, the time difference ΔT1 in Fig. 23 and the time difference ΔT2 in Fig. 30 are acquired as the time difference between the measurement of the first measurement item and the measurement of the second measurement item, but this is not limiting, and the time difference between the processing timing of the same step of two measurement items may also be acquired. For example, the time difference between the processing timing of step S302 in Fig. 21 for the first measurement item and the processing timing of step S302 in Fig. 21 for the second measurement item may be acquired.

[0189] In embodiments 1 and 2, in step S110 of Figures 19, 27, and 29, the calculated values ​​of the calculation items are output to the display unit 103, but this is not limited to this, and the calculated values ​​of the calculation items may be output to another computer, etc. via the communication unit 105.

[0190] In embodiment 1, as a process for keeping the time difference between the measurement of the first measurement item and the measurement of the second measurement item within a predetermined time, the control unit 101 performed the pre-measurement start check of step S101 in Figure 19 during the pair processing of step S14 in Figure 17. However, when the pre-measurement start check of step S101 is performed when registering a measurement order, if any of steps S203, S204, and S205 in Figure 20 is judged to be NO, the registration of measurement items 1-40 and 1-42 in the measurement order may be prohibited, or a message may be displayed on the display unit 103 indicating that measurement items 1-40 and 1-42 cannot be registered.

[0191] In the first and second embodiments, when the control unit 101 determines NO in the output permission determination of step S108 in FIGS. 19, 27, and 29, the control unit 101 inhibits the output of the measured values ​​of measurement items 1-40 and 1-42 and the calculated values ​​of calculation items AB42 / 40. However, if the measured values ​​of measurement items 1-40 and 1-42 have been acquired, the control unit 101 may output the measured values ​​of measurement items 1-40 and 1-42 and inhibit the output of the calculated values ​​of calculation items AB42 / 40. In this case, the control unit 101 may output information indicating that the reliability of the calculated values ​​of calculation items AB42 / 40 is low, along with the calculated values. The control unit 101 may also output the measured values ​​of measurement items 1-40 and 1-42 and the calculated values ​​of calculation items AB42 / 40. In this case, the control unit 101 may output information indicating that the reliability of the measured values ​​of measurement items 1-40 and 1-42 and the calculated values ​​of calculation items AB42 / 40 is low, along with the measured values ​​and calculated values.

[0192] FIG. 31 is a diagram showing a state in which information indicating that reliability is low is displayed on screen 200 displayed on display unit 103. In FIG.

[0193] The job shown in the bottom row of Figure 31 shows a state in which measured values ​​for measurement items 1-40 and 1-42 were acquired, but the output permission determination for the calculated values ​​in step S108 returned a NO. In this case, in addition to displaying the measured values ​​for measurement items 1-40 and 1-42 and the calculated values ​​for calculation items AB42 / 40, icons 201a and 202a are displayed as information indicating that the reliability of the calculated values ​​for calculation items AB42 / 40 is low. By referring to icons 201a and 202a, the operator can understand that the reliability of the displayed calculated values ​​is low.

[0194] In the first and second embodiments, the control unit 101 automatically generates a measurement order including measurement items 1-40 and 1-42 in step S111 in FIGS. 19, 27, and 29. However, in step S111, screens 240, 240a, and 240b (see FIGS. 11 to 13) for registering a measurement order may be displayed on the display unit 103 to accept input of measurement items from the operator. In this case, when the operator registers a measurement order including only one of measurement items 1-40 and 1-42, the control unit 101 may display a message on the display unit 103 prompting the operator to register the other measurement item, such as the notification screen 260 in FIG. 18. Furthermore, when the operator registers a measurement order including only one of measurement items 1-40 and 1-42, the control unit 101 may automatically add the other measurement item to the measurement order.

[0195] The sample analyzer 1 of embodiments 1 and 2 displays the measurement values ​​of measurement items 1-40 and 1-42 on the display unit 103, but the measurements of measurement items 1-40 and 1-42 may be performed only to obtain the calculated value of calculation item AB42 / 40, and the obtained measurement values ​​may not be output.

[0196] Although the sample analyzer 1 in the first and second embodiments is an immunoassay analyzer, it may also be a mass spectrometer that ionizes molecules to be measured, mass separates the ionized molecules, and detects the moving ions.

[0197] The embodiments of the present invention can be modified in various ways as appropriate within the scope of the technical idea defined in the claims. [Explanation of symbols]

[0198] 1. Sample analyzer 2. Measuring equipment 101 Control section

Claims

1. A sample analysis method for analyzing a sample for multiple measurement items, comprising: a step of measuring a first measurement item and a second measurement item based on a measurement order to obtain a measurement value of the first measurement item and a measurement value of the second measurement item, wherein the substance corresponding to the first measurement item and the substance corresponding to the second measurement item are each a substance that decreases over time; a step of executing a process for fitting a time difference between the measurement end timing of the first measurement item and the measurement end timing of the second measurement item to a predetermined time, wherein, by executing the fitting process, the measurement value of the first measurement item and the measurement value of the second measurement item become measurement values ​​obtained by measurements in which the time difference falls within the predetermined time; and obtaining a calculated value from a ratio based on the measurement value of the first measurement item and the measurement value of the second measurement item.

2. The sample analysis method of claim 1, wherein the first measurement item is a first type of amyloid beta or amyloid beta precursor protein, and the second measurement item is a second type of amyloid beta or amyloid beta precursor protein different from the first type.

3. The sample analysis method of claim 2, wherein the first type of amyloid beta or amyloid beta precursor protein is one of amyloid beta 1-40 and amyloid beta 1-42, and the second type of amyloid beta or amyloid beta precursor protein is the other of amyloid beta 1-40 and amyloid beta 1-42.

4. 3. The sample analysis method of claim 2, wherein the first type of amyloid beta or amyloid beta precursor protein is one of amyloid beta 1-42 and amyloid beta precursor protein 669-711, and the second type of amyloid beta or amyloid beta precursor protein is the other of amyloid beta 1-42 and amyloid beta precursor protein 669-711.

5. The sample analysis method according to claim 1 , wherein the process for storing is performed before the start of the measurement step.

6. The sample analysis method according to claim 5 , wherein the process for confining includes a process for determining whether the time difference will be confined to the predetermined time when the measurement step is performed.

7. The sample analysis method according to claim 6 , wherein the process for confining the time difference further comprises a process for prohibiting the start of the measurement step when it is determined that the time difference does not fall within the predetermined time.

8. The sample analysis method according to claim 6 or 7, wherein the determination process includes determining whether the remaining amount of reagent used for measuring the first measurement item and the second measurement item is greater than or equal to the amount required for measuring both the first measurement item and the second measurement item.

9. The sample analysis method according to claim 6 , wherein the determination process includes determining whether or not reagents used in the measurements of the first measurement item and the second measurement item are within their expiration dates.

10. 10. The sample analysis method according to claim 6, wherein the determination process includes determining whether or not an environmental temperature of the measurement is within a predetermined temperature range.

11. The sample analysis method according to claim 1 , wherein the process for settling includes a process for accepting the measurement order of the measurement items so that the measurement interval between the first measurement item and the second measurement item is within a predetermined range.

12. The sample analysis method according to claim 1 , wherein the process for storing is performed during the measurement step.

13. The sample analysis method according to claim 12 , wherein the process for confining includes a process for measuring the time difference so that the time difference is within the predetermined time.

14. The sample analysis method of claim 13, wherein the settling process includes a process of stopping the measurement of the other of the first measurement item and the second measurement item when the predetermined time has elapsed between the start of the measurement of the other of the first measurement item and the second measurement item.

15. The sample analysis method according to claim 1 , wherein the storing process is performed after the measurement process is completed.

16. The sample analysis method of claim 15, wherein the process for settling includes a process for generating a measurement order including the first measurement item and the second measurement item based on the time difference exceeding the predetermined time in the measurement process.

17. A sample analysis method according to any one of claims 1 to 16, wherein the process for storing includes a process for notifying a user that the measurement order includes only one of the first measurement item and the second measurement item in response to determining that the measurement order includes only one of the first measurement item and the second measurement item.

18. The method further includes determining whether the measurement order includes the first measurement item and the second measurement item; The sample analysis method according to claim 1 , wherein the measurement step is performed in response to determining that the measurement order includes the first measurement item and the second measurement item.

19. The measuring step further includes a step of monitoring a temperature of a measurement environment for measuring the first measurement item and the second measurement item, the first measurement item is amyloid beta 1-40, and the second measurement item is amyloid beta 1-42; 19. The sample analysis method according to claim 1, wherein the allowable temperature range for measurement of the first measurement item is narrower than the allowable temperature range for measurement of the second measurement item.

20. 20. The sample analysis method according to claim 1, wherein the calculated value is a ratio between the measurement value of the first measurement item and the measurement value of the second measurement item.

21. 21. The sample analysis method according to claim 1, wherein the measuring step includes a step of preparing a first measurement sample for detecting the substance corresponding to the first measurement item, and a step of preparing a second measurement sample for detecting the substance corresponding to the second measurement item.

22. A sample analyzer that analyzes a sample for multiple measurement items, a measuring device for measuring the sample; a control unit, The control unit controlling the measurement device to measure a first measurement item and a second measurement item based on a measurement order, thereby obtaining measured values ​​of the first measurement item and the second measurement item, wherein the substance corresponding to the first measurement item and the substance corresponding to the second measurement item are each a substance that decreases over time; execute a process for fitting a time difference between the measurement end timing of the first measurement item and the measurement end timing of the second measurement item to a predetermined time, and by executing the process for fitting, the measurement value of the first measurement item and the measurement value of the second measurement item become measurement values ​​obtained by measurements in which the time difference falls within the predetermined time; A sample analyzer that obtains a calculated value from a ratio based on the measured value of the first measurement item and the measured value of the second measurement item.

23. The sample analyzer of claim 22 , wherein the control unit executes the settling process before starting measurements of the first measurement item and the second measurement item.

24. The sample analyzer of claim 22 or 23, wherein the control unit executes the settling process while measurements of the first measurement item and the second measurement item are being performed.

25. The sample analyzer of claim 22 , wherein the control unit executes the storing process after the first measurement item and the second measurement item have been measured.

26. The sample analyzer of claim 22 , wherein the calculated value is a ratio between the measurement value of the first measurement item and the measurement value of the second measurement item.

27. 27. The sample analyzer of claim 22, wherein the first measurement item is a first type of amyloid beta or amyloid beta precursor protein, and the second measurement item is a second type of amyloid beta or amyloid beta precursor protein that is different from the first type.

28. The sample analyzer of claim 27, wherein the first type of amyloid beta or amyloid beta precursor protein is one of amyloid beta 1-40 and amyloid beta 1-42, and the second type of amyloid beta or amyloid beta precursor protein is the other of amyloid beta 1-40 and amyloid beta 1-42.

29. The sample analyzer of claim 27, wherein the first type of amyloid beta or amyloid beta precursor protein is one of amyloid beta 1-42 and amyloid beta precursor protein 669-711, and the second type of amyloid beta or amyloid beta precursor protein is the other of amyloid beta 1-42 and amyloid beta precursor protein 669-711.

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