Automatic analysis device and automatic analysis method

Abstract

The present application provides an automatic analysis device and an automatic analysis method, which can improve analysis accuracy using a stable concentration of a test object, and improve the utilization efficiency of the test object by minimizing the amount of test object waste. The automatic analysis device includes a test object holding unit that holds a test object container in which a test object is stored; a dispensing container holding unit that holds a plurality of dispensing containers; a dispensing probe that dispenses a prescribed amount of the test object from the test object container and dispenses the test object into the dispensing container; a probe cleaning device that cleans the front end of the dispensing probe with a cleaning solution after the test object is dispensed into the dispensing container and before the next prescribed amount of test object is dispensed; and a control unit that controls the driving of the dispensing probe, the control unit including a calculation processing unit that calculates the concentration of each test object after the test object in the test object container is diluted by the cleaning solution adhered to the front end of the dispensing probe, and sets an upper limit number of dispensing from the test object container to the dispensing container based on the concentration.

Description

Technical Field

[0001] This invention relates to an automatic analysis device and an automatic analysis method. Background Technology

[0002] An automated analytical device for analyzing biological components contained in samples such as blood and urine has dispensing probes for dispensing samples, diluted samples, and reagents into a reaction vessel, as well as a cleaning function for cleaning these dispensing probes.

[0003] Regarding this type of automated analysis device, Patent Document 1 describes that "when the sample pipette 22 enters the dilution container 11, the sampling pump 27 operates to aspirate, for example, 5 μl of diluted sample. When the sample pipette 22 enters the reaction tube 51, the sampling pump 27 operates to discharge 5 μl of diluted sample. As a result, 1 μl of sample is injected into the reaction tube. The sample pipette 22 is cleaned in the cleaning tank 28. Similar to the dilution pipette, its inner side is cleaned by a high-pressure cleaning pump HWP, and its outer side is cleaned by a low-pressure cleaning pump LWP. These cleaning solutions are discharged into the waste tank."

[0004] Existing technical documents

[0005] Patent documents

[0006] Patent Document 1: Japanese Patent Application Publication No. 8-194004 Summary of the Invention

[0007] The problem the invention aims to solve

[0008] Furthermore, in the aforementioned automated analysis device, the sample pipette is cleaned each time a diluted sample (examination sample) is dispensed from the dilution container into the reaction tube. Therefore, the more times the sample is dispensed from the dilution container into the reaction tube, the more cleaning solution is carried into the dilution container from the cleaned sample pipette, resulting in a more dilute concentration of the diluted sample (examination sample) in the dilution container.

[0009] However, the dispensing volume of the diluted sample (examination specimen) varies depending on the specific test item, and the test items also differ for each specimen. Therefore, after one dispensing, the amount of diluted sample (examination specimen) remaining in the dilution container is not fixed, and the dilution rate of the sample (examination specimen) diluted by the introduced cleaning solution also varies. Consequently, when the number of dispensings from one dilution container is limited to a fixed number, there is a possibility that even if the concentration of the specimen in the dilution container is sufficient, some diluted sample (examination specimen) may still be discarded.

[0010] Therefore, the object of the present invention is to provide an automatic analysis device and an automatic analysis method that can improve the analysis accuracy by using a stable concentration of test sample and improve the utilization efficiency of test sample by minimizing the amount of test sample waste.

[0011] Solution for solving the problem

[0012] To achieve this objective, the present invention provides an automatic analysis apparatus and an automatic analysis method implemented therein, the automatic analysis apparatus comprising: a specimen holding unit for holding a specimen container storing specimens; a dispensing container holding unit for holding a plurality of dispensing containers; a dispensing probe for dispensing a predetermined amount of specimens from the specimen container and dispensing the dispensed specimens into the dispensing containers; a probe cleaning device for cleaning the tip of the dispensing probe with a cleaning fluid after dispensing the specimens into the dispensing containers and before dispensing the next predetermined amount of specimens from the specimen container; and a control unit for controlling the driving of the dispensing probes, wherein the control unit includes a computational processing unit that calculates, for each specimen, the concentration of the specimen in the specimen container after dilution by the cleaning fluid adhering to the tip of the dispensing probe in the probe cleaning device, and sets an upper limit number of times the specimens are dispensed from the specimen container into the dispensing containers based on the calculated concentration.

[0013] The effects of the invention

[0014] According to the present invention, an automatic analysis apparatus and an automatic analysis method are provided that can improve the accuracy of analysis by using a stable concentration of test sample and improve the utilization efficiency of test sample by minimizing the amount of waste test sample. Attached Figure Description

[0015] Figure 1 This is a schematic structural diagram showing the automatic analysis device involved in the embodiment.

[0016] Figure 2 This is a block diagram of the automatic analysis device involved in the implementation method.

[0017] Figure 3 This is a diagram illustrating the structure of the probe cleaning device provided in the automated analysis apparatus according to the embodiment and the cleaning of the diluted test probe.

[0018] Figure 4 This is a flowchart illustrating an automatic analysis method using an automatic analysis apparatus according to an embodiment.

[0019] Explanation of reference numerals in the attached figures

[0020] 1: Automatic analysis device; 1b: Control unit; 2: Test sample holding unit; 3: Diluted test sample holding unit (test sample holding unit, dispensing container holding unit); 6: Reaction container holding unit (dispensing container holding unit); 21: Dispensing probe; 21b: Diluted test sample probe (dispensing probe); 30: Probe cleaning device; 54: Processing unit; L: Cleaning solution; P2: Test sample container; P3: Diluted test sample container (test sample container, dispensing container); P6: Reaction container (dispensing container); Sp: Diluted test sample (test sample); [a]: Amount of cleaning solution carried in; [C] i [i]: Dilution concentration of the test sample; [i]: Injection order; [imax]: Maximum number of injections; [Sav]: Average amount of diluted test sample used; [S]: Average amount of test sample used. i [V0]: Dilution volume of test sample (test sample usage); [V0]: Initial volume. Detailed Implementation

[0021] <<Automatic Analysis Device>>

[0022] Figure 1 This is a schematic structural diagram showing the automated analysis device according to the embodiment. As an example, it is a schematic structural diagram of the automated analysis device 1 in a biochemical analysis device for analyzing biological components contained in samples such as blood and urine, in which the present invention is applied. As shown in the figure, the automated analysis device 1 includes a measuring unit 1a and a control unit 1b.

[0023] The measuring unit 1a includes, for example, a test sample holding unit 2, a diluted test sample holding unit 3, a first reagent holding unit 4, a second reagent holding unit 5, and a reaction vessel holding unit 6. Additionally, the measuring unit 1a includes a dilution stirring device 11, a dilution vessel cleaning device 12, a first reaction stirring device 13, a second reaction stirring device 14, a measuring unit 15, and a reaction vessel cleaning device 16.

[0024] In addition, the measuring unit 1a includes multiple dispensing devices 20 and a probe cleaning device 30. Each dispensing device 20 here is, for example, a sample dispensing device 20a, a diluted sample dispensing device 20b, a first reagent dispensing device 20c, and a second reagent dispensing device 20d. Each dispensing device 20 is equipped with a dispensing probe 21.

[0025] Figure 2 This is a block diagram of the automatic analysis device 1 according to the embodiment. As shown in the figure, the control unit 1b includes a display unit 51, an input unit 52, a storage unit 53, an arithmetic processing unit 54, and an input / output control unit 55.

[0026] Below, based on Figure 1 and Figure 2The details of these constituent elements will be explained in the order of measuring unit 1a and control unit 1b.

[0027] <Measurement Section 1a>

[0028] [Examine the body holding section 2]

[0029] The test specimen holding section 2 holds multiple test specimen containers P2 containing test specimens. Such a test specimen holding section 2 is, for example, turntable-shaped, and is a structure that holds multiple test specimen containers P2 in multiple rows along its periphery and conveys the held test specimen containers P2 in both circumferential directions. This test specimen holding section 2 is supported by a drive mechanism (not shown) so that it can rotate circumferentially. In addition to storing the test specimens to be measured, each test specimen container P2 held by the test specimen holding section 2 can also store control test specimens for accuracy management. The test specimen holding section 2 is configured to hold these various test specimens in predetermined positions.

[0030] Furthermore, in addition to holding the examination body container P2, the examination body holding unit 2 can also hold a diluent container containing diluent and a cleaning container containing cleaning solution. Additionally, the examination body holding unit 2 described above can also have the function of cooling the held examination body container P2 and other containers.

[0031] [Dilution test sample holding section 3]

[0032] The diluted test sample holder 3 holds a diluted test sample container P3 containing diluted test samples (hereinafter referred to as "diluted test samples"). Such a diluted test sample holder 3 is, for example, turntable-shaped, and is a structure that holds multiple diluted test sample containers P3 along its periphery and conveys the held diluted test sample containers P3 in both circumferential directions. This diluted test sample holder 3 is supported by a drive mechanism (not shown) so that it can rotate circumferentially.

[0033] The diluted test sample stored in the diluted test sample container P3 is a test sample taken from the test sample container P2 disposed in the test sample holding section 2 and dispensed after being diluted to a specified concentration. Therefore, the diluted test sample container P3 is both a test sample container for storing test samples and a dispensing container for dispensing test samples. In addition, the diluted test sample holding section 3 used to hold such a diluted test sample container P3 is both a test sample holding section and a dispensing container holding section.

[0034] Furthermore, the diluted test sample holding unit 3 can hold the diluted test sample container P3 containing the diluted test sample, and also hold the container containing the undiluted test sample. In this case, the container is a container into which the undiluted test sample, dispensed from the test sample container P2 disposed in the test sample holding unit 2, is dispensed in its original state. Alternatively, the automatic analysis device 1 may not include the diluted test sample holding unit 3, but here we will describe a structure with the diluted test sample holding unit 3 included.

[0035] [First reagent holding section 4 and second reagent holding section 5]

[0036] The first reagent holding part 4 is, for example, turntable-shaped, holding a plurality of first reagent containers P4 along its periphery. Similarly, the second reagent holding part 5 is, for example, turntable-shaped, holding a plurality of second reagent containers P5 along its periphery. Furthermore, the first reagent holding part 4 and the second reagent holding part 5 are structures that convey the respective held first reagent containers P4 and second reagent containers P5 in a bidirectional circumferential direction. These first reagent holding parts 4 and the second reagent holding part 5 are supported by a drive mechanism (not shown) to enable circumferential rotation. Moreover, the reagent holding parts provided in the automatic analysis device 1 are not limited to just the first reagent holding part 4 and the second reagent holding part 5; there may be one, or even three or more. When there is only one reagent holding part in the automatic analysis device 1, it may be a structure in which either the first reagent dispensing device 20c or the second reagent dispensing device 20d, described later, is provided corresponding to the reagent holding part.

[0037] [Reaction Vessel Holding Section 6]

[0038] The reaction container holding section 6 is one of the dispensing container holding sections that holds the dispensing container, which serves as the dispensing destination for the test sample. Such a reaction container holding section 6 is disposed between the dilution test sample holding section 3, the first reagent holding section 4, and the second reagent holding section 5. This reaction container holding section 6 is, for example, turntable-shaped, and is a structure that holds multiple reaction containers P6 (i.e., dispensing containers) along its periphery and transports the held reaction containers P6 in both circumferential directions. The reaction container holding section 6 is supported by a drive mechanism (not shown) to enable circumferential rotation.

[0039] The reaction container P6, held by the reaction container holding section 6, is a container into which a predetermined amount of dilution test sample taken from dilution test sample container P3 of the dilution test sample holding section 3, a first reagent taken from first reagent container P4 of the first reagent holding section 4, and a second reagent taken from second reagent container P5 of the second reagent holding section 5 are dispensed. Furthermore, within this reaction container P6, the dilution test sample is stirred with at least one of the first and second reagents to induce a reaction.

[0040] The reaction vessel holding section 6 described above is configured to maintain a constant temperature of the reaction vessel P6 via a thermostat (not shown). Furthermore, if the automatic analysis device 1 does not have a dilution sample holding section 3, the sample taken from the sample container P2 in the sample holding section 2 is dispensed into the reaction vessel P6 held by the reaction vessel holding section 6.

[0041] [Dilution stirring device 11]

[0042] A dilution stirring device 11 is disposed around the dilution test body holding part 3. The dilution stirring device 11 has a stirring mechanism and a drive mechanism for driving the stirring mechanism. The dilution stirring device 11 stirs the test body and the diluent in the dilution test body container P3 held in the dilution test body holding part 3, and adjusts the diluted test body obtained by mixing the test body and the diluent.

[0043] [Dilution Container Cleaning Device 12]

[0044] The dilution container cleaning device 12 is disposed around the dilution test body holding part 3. The dilution container cleaning device 12 is a device for cleaning the dilution test body container P3 after the dilution test body is dispensed by the dilution test body dispensing device 20b, which will be described later.

[0045] [First reaction stirring device 13 and second reaction stirring device 14]

[0046] The first reaction stirring device 13 and the second reaction stirring device 14 are disposed around the reaction vessel holding part 6. Within the reaction vessel P6 held by the reaction vessel holding part 6, the first reaction stirring device 13 and the second reaction stirring device 14 stir the diluted test sample with either the first reagent or the second reagent to promote the reaction between the diluted test sample and the first and second reagents. The first reaction stirring device 13 and the second reaction stirring device 14 can have the same structure as the dilution stirring device 11.

[0047] [Measurement Department 15]

[0048] The measuring unit 15 is configured to face the outer wall of the reaction vessel holding section 6 around the reaction vessel holding section 6. The measuring unit 15 is a multi-wavelength spectrophotometer for optically measuring the diluted test sample after the first reagent and the second reagent corresponding to the test item have reacted in the reaction vessel P6. It outputs the amount of various components in the test sample as absorbance to detect the reaction state of the diluted test sample.

[0049] [Reaction Vessel Cleaning Device 16]

[0050] The reaction vessel cleaning device 16 is disposed around the reaction vessel holding part 6. The reaction vessel cleaning device 16 is a device for cleaning the inside of the reaction vessel P6 after inspection.

[0051] [Specimen dispensing device 20a]

[0052] The sample dispensing device 20a is one of the dispensing devices 20. It includes a sample probe 21a, which is a thin tubular dispensing probe 21. The sample dispensing device 20a is disposed around the sample holding section 2 and the diluted sample holding section 3. According to a pre-set measurement program, the sample dispensing device 20a, via a drive mechanism (not shown), inserts the axially vertical tip of the sample probe 21a into the sample container P2 held in the sample holding section 2, and draws a predetermined amount of sample into the sample probe 21a, thereby dispensing a predetermined amount of sample from the sample container P2. At this time, the sample holding section 2, according to a pre-set measurement program, moves the sample container P2, held at a predetermined position in the sample holding section 2, to a predetermined sample dispensing position.

[0053] Furthermore, the sample dispensing device 20a inserts the tip of the sample probe 21a into the dilution sample container P3 of the sample holding section 3, and discharges the sample aspirated into the sample probe 21a and a predetermined amount of diluent (e.g., physiological saline) supplied by the sample dispensing device 20a itself into the dilution sample container P3. At this time, the dilution sample holding section 3, according to a pre-set measurement program, moves the dilution sample holding container P3, which is held at a predetermined position in the dilution sample holding section 3, to a predetermined sample discharge position. Thus, the sample is diluted to a predetermined concentration within the dilution sample container P3. Furthermore, the sample dispensing device 20a cleans the inner wall of the sample probe 21a using a probe cleaning device (not shown). At this time, the probe cleaning device (not shown) also cleans the outer wall of the sample probe 21a.

[0054] Furthermore, in the absence of a dilution sample holding section 3 in the automatic analysis device 1, the sample dispensing device 20a inserts the tip of the sample probe 21a into the reaction vessel P6 of the reaction vessel holding section 6. The sample aspirated into the sample probe 21a is then discharged into the reaction vessel P6.

[0055] [Dilution test sample dispensing device 20b]

[0056] The dilution test sample dispensing device 20b is one of the dispensing devices 20. It includes a dilution test sample probe 21b, which is a thin tubular dispensing probe 21. The dilution test sample dispensing device 20b is disposed between the dilution test sample holding section 3 and the reaction vessel holding section 6. Following a pre-set measurement procedure, the dilution test sample dispensing device 20b, via a drive mechanism (not shown), inserts the tip of the dilution test sample probe 21b into the dilution test sample container P3, which is moved to a predetermined dilution test sample dispensing position in the dilution test sample holding section 3, and draws a predetermined amount of dilution test sample from the tip of the dilution test sample probe 21b, which is filled with system water. Additionally, the dilution test sample dispensing device 20b inserts the tip of the dilution test sample probe 21b into the reaction vessel P6, which is moved to a predetermined dilution test sample discharge position in the reaction vessel holding section 6, and discharges the dilution test sample drawn into the dilution test sample probe 21b into the reaction vessel P6. Furthermore, if the automatic analysis device 1 does not have a dilution test body holding unit 3, then the automatic analysis device 1 does not need to have a dilution test body dispensing device 20b.

[0057] [First reagent dispensing device 20c, second reagent dispensing device 20d]

[0058] Reference Figure 1 The first reagent dispensing device 20c and the second reagent dispensing device 20d are one of the dispensing devices 20, and have the same structure as the other dispensing devices. The first reagent dispensing device 20c is disposed between the reaction vessel holding section 6 and the first reagent holding section 4, and the second reagent dispensing device 20d is disposed between the reaction vessel holding section 6 and the second reagent holding section 5. The first reagent dispensing device 20c dispenses the first reagent from the first reagent container P4 in the first reagent holding section 4 to the reaction vessel P6 according to a preset measurement program. Similarly, the second reagent dispensing device 20d dispenses the second reagent from the second reagent container P5 in the second reagent holding section 5 to the reaction vessel P6 according to a preset measurement program.

[0059] [Probe Cleaning Device 30]

[0060] The probe cleaning device 30 is used to clean the front ends of the dispensing probes 21 in each dispensing device 20. The probe cleaning device 30 is arranged on a track for the dispensing probes 21 to move on. Figure 1 As an example, the illustration shows a state in which a probe cleaning device 30 is provided on the track of the dilution test probe 21b between the dilution test body holding section 3 and the reaction vessel holding section 6.

[0061] Figure 3This diagram illustrates the structure of the probe cleaning apparatus 30 provided in the automated analysis device according to the embodiment, and the cleaning of the diluted test probe 21b. As shown in the diagram, the probe cleaning apparatus 30 includes a cleaning tank 31 and a cleaning fluid supply pipe 32 for supplying cleaning fluid L to the cleaning tank 31. The cleaning tank 31 includes a drain pipe (not shown here). Furthermore, the cleaning fluid supply pipe 32 discharges the cleaning fluid L at predetermined time intervals via a drive mechanism (not shown). The cleaning fluid L is typically water; cleaning water is used.

[0062] Regarding the cleaning of the diluted test probe 21b using such a probe cleaning device 30, the cleaning is repeated in the following order, following a dispensing cycle of one dispensing of diluted test sample Sp using the diluted test probe 21b.

[0063] That is, in one dispensing cycle, the dilution test sample dispensing device 20b inserts the dilution test sample probe 21b into the dilution test sample container P3 of the dilution test sample holding section 3 according to a preset measurement procedure. Furthermore, a predetermined amount of dilution test sample Sp is drawn into the dilution test sample probe 21b to dispense a predetermined amount of test sample from the dilution test sample container P3. Next, the dilution test sample dispensing device 20b inserts the dilution test sample probe 21b into a reaction vessel P6 of the reaction vessel holding section 6 and discharges the dilution test sample Sp drawn into the dilution test sample probe 21b to dispense a predetermined amount of dilution test sample Sp into the reaction vessel P6. Afterwards, the dilution test sample dispensing device 20b moves the tip of the dilution test sample probe 21b into the cleaning tank 31. Thereby, the probe cleaning device 30, according to a preset measurement procedure, supplies cleaning fluid L through the cleaning fluid supply pipe 32 via a drive mechanism (not shown) to clean the outer wall of the dilution test sample probe 21b inserted into the cleaning tank 31. At this time, the dilution sample dispensing device 20b also cleans the inner wall of the dilution sample probe 21b.

[0064] Taking the above as one dispensing cycle, the dilution test body dispensing device 20b will insert the dilution test body probe 21b, whose outer wall has been cleaned in the cleaning tank 31, back into the dilution test body container P3 of the dilution test body holding part 3, and repeat the same action thereafter.

[0065] Furthermore, the probe cleaning device 30 with the structure described above can use either the specimen container P2 held by the specimen holding part 2 or the dilution specimen container P3 held by the dilution specimen holding part 3 as the cleaning tank 31. As an example, when the probe cleaning device 30 is arranged on the track of the dilution specimen probe 21b as described above, the cleaning tank 31 of the probe cleaning device 30 can be one of the dilution specimen containers P3.

[0066] <Control Unit 1b>

[0067] Reference Figure 1 and Figure 2 The control unit 1b is connected to the drive mechanism and measuring unit 15, which constitute the components of the measuring unit 1a described above. This control unit 1b includes a display unit 51, an input unit 52, a storage unit 53, an arithmetic processing unit 54, and an input / output control unit 55, all interconnected. The arithmetic processing unit 54 and the input / output control unit 55 are configured as a computer, such as a microcomputer. The computer includes a CPU (Central Processing Unit), ROM (Read Only Memory), and RAM (Random Access Memory), and controls the operation of each component within the automatic analysis device 1. The details of each component of the control unit 1b will be described below.

[0068] [Display Unit 51]

[0069] In addition to displaying the measurement results from the measuring unit 15, the display unit 51 also displays various setting information and historical data from the automatic analysis device 1.

[0070] [Input Section 52]

[0071] The input unit 52 receives various settings-related inputs and other inputs from the operator of the automatic analysis device 1, and outputs the input signals to the input / output control unit 55. This input unit 52 may use, for example, a mouse, keyboard, or a touch panel provided on the display surface of the display unit 51. Alternatively, it may include a barcode reader that reads the barcode of the inspection body container P2 held by the inspection body holding unit 2.

[0072] [Storage Department 53]

[0073] The storage unit 53 may be composed of a high-capacity recording device such as an HDD (Hard disk drive) or semiconductor memory. Furthermore, a portion of the storage unit 53 may be configured as the aforementioned computer. This storage unit 53 stores various programs executed by the input / output control unit 55, which will be described later, as well as various setting information for executing those programs.

[0074] The setting information stored in the storage unit 53 includes dispensing information associated with each measurement item and dispensing information shared by all measurement items. This information is either information that is stored in the storage unit 53 in advance or information that is stored in the storage unit 53 based on input from the input unit 52.

[0075] The dispensing information associated with the assay includes the dilution conditions of the diluted test samples used in the analytical processing of each assay, the dispensing order between assays, and the amount of diluted test samples used in the analytical processing of each assay [S]. i Information related to this. This information is assumed to be stored in storage unit 53 in a manner associated with each measurement item.

[0076] Additionally, the shared dispensing information includes the amount of cleaning fluid carried in [a], dispensing loss [b], initial amount [V0], and upper limit of dilution rate [Rmax] during the dispensing of diluted test sample from dilution sample container P3 to reaction container P6. The amount of cleaning fluid carried in [a] is the amount of cleaning fluid L carried into dilution sample container P3 by dilution sample probe 21b from probe cleaning device 30 after one dispensing cycle. The dispensing loss [b] is the amount of diluted test sample that needs to be additionally dispensed by dilution sample probe 21b from dilution sample container P3 to ensure dispensing accuracy. The initial amount [V0] is the initial amount of diluted test sample stored in dilution sample container P3. This initial amount [V0] can be set as information input from input unit 52 at the start of analysis. In addition, the upper limit of dilution rate [Rmax] is the upper limit of the dilution rate corresponding to the initial concentration of the diluted test sample Sp in the diluted test sample container P3, and is the upper limit of the dilution rate when the diluted test sample Sp is diluted with the cleaning solution L.

[0077] [Computation Processing Unit 54]

[0078] The processing unit 54 sets an upper limit [imax] for the number of dispensings from one dilution sample container P3 to multiple reaction containers P6 based on the information input from the input unit 52 and the information stored in the storage unit 53. The process by which the processing unit 54 sets the upper limit [imax] for dispensings will be explained in detail in the following automatic analysis method.

[0079] [Input / Output Control Unit 55]

[0080] The input / output control unit 55 controls the operation of the drive mechanisms of each part constituting the measurement unit 1a based on signals from the input unit 52, the storage unit 53 and the arithmetic processing unit 54, and performs analysis and processing of the examination body contained in the examination body container P2 of the examination body holding unit 2.

[0081] <<Automatic Analysis Methods>>

[0082] Figure 4 This is a flowchart illustrating the automatic analysis method using the automatic analysis device 1 of the embodiment. Below, according to... Figure 4 The order shown in the flowchart is as previously illustrated. Figure 1 and Figure 2 The automatic analysis method using the automatic analysis apparatus 1 of the embodiment will be explained. The automatic analysis method illustrated using these figures is a process applied as a procedure performed before dispensing the test sample from the diluted test sample container P3 into the reaction container P6.

[0083] This process is achieved through the use of... Figure 2 The CPU of the described arithmetic processing unit 54 and input / output control unit 55 executes the program stored in the storage unit 53 as follows.

[0084] <Step S001>

[0085] In step S001, the input / output control unit 55 determines whether inspection body information has been input from the input unit 52, and stands still until it determines that inspection body information has been input (yes). Here, inspection body information refers to information related to the inspection body in the inspection body container P2 held by the inspection body holding unit 2, which includes ID information related to the inspection body and the measurement items set for the inspection body. In addition, the inspection body information may also include the initial amount [V0] of the diluted inspection body stored in the diluted inspection body container P3. Such inspection body information may be, for example, barcode information affixed to the inspection body container P2, which is information read by a barcode reader as the input unit 52. If the input / output control unit 55 determines that such inspection body information has been input (yes), it proceeds to the next step S002.

[0086] <Step S002>

[0087] In step S002, the input / output control unit 55, based on the test body information input in step S001, acquires dispensing information associated with the measurement items under the same dilution conditions for the test body held in a test body container P2 at a specific location in the test body holding unit 2.

[0088] That is, in the automatic analysis device 1, the automatic analysis process for the specimen is started by inputting specimen information about the specimen in the specimen container P2 from the input unit 52. In this case, based on the specimen information input from the input unit 52, analysis processing for multiple measurement items is started for the specimen in the specimen container P2.

[0089] Therefore, firstly, the input / output control unit 55, based on the examination body information input from the input unit 52 and the dispensing information stored in the storage unit 53, groups the test items set for the examination body in the examination body container P2 as the target according to the same dilution conditions. Next, for each group with the same dilution conditions, the input / output control unit 55 retrieves the dispensing information associated with each test item from the storage unit 53. The dispensing information associated with the test items retrieved here, as shown in Table 1 below, includes the dispensing order (i) between test items, and the amount of diluted examination body used in the analysis and processing of each test item [S]. i Furthermore, the dispensing order [i] is assigned to each measurement item based on the dispensing order among the measurement items stored in the storage unit 53, and each measurement item is set for a test body in a test body container P2 that is the target.

[0090] [Table 1]

[0091] Distribution information

[0092]

[0093] Furthermore, in Table 1, the test items for groups with the same dilution conditions are assigned item numbers. Also, only the dispensing information for one group with the same dilution conditions is shown here; dispensing information for other groups with the same dilution conditions is obtained similarly. Moreover, in the subsequent steps 003 and beyond, the same treatment is performed in parallel for each group, or in the order of each group.

[0094] <Step S003>

[0095] In step S003, the input / output control unit 55 performs the process of setting the dilution container number [N] to [N] = 1. Additionally, the number of measurement items [M] is set to the total number of measurement items obtained in step S002. Here, based on Table 1 above, the number of measurement items [M] is set to 15.

[0096] <Step S004>

[0097] In step S004, the processing unit 54 sets an upper limit [imax] for the number of dispensings from a dilution sample container P3. At this time, the processing unit 54 sets the upper limit [imax] for the number of dispensings from a dilution sample container P3 based on the dispensing information associated with the test items obtained in step S002 and the shared dispensing information stored in the storage unit 53, as described below. Furthermore, the dispensing information associated with the test items, as previously explained, includes the dispensing order (i) between test items, i.e., the number of dispensings [i], and the amount of dilution sample used in the analysis and processing of each test item [S]. iAdditionally, the shared dispensing information, as previously described, includes the amount of cleaning fluid carried in [a], dispensing loss [b], initial volume [V0], and upper limit of dilution rate [Rmax] during the dispensing of the diluted test sample from dilution test sample container P3 to reaction container P6.

[0098] First, the arithmetic processing unit 54 calculates the amount of residual diluted test fluid [V] remaining in the diluted test fluid container P3 after the completion of each dispensing cycle [i] in each dispensing cycle [i], i.e., after the dispensing cycle of one dispensing cycle [i], as described in equations (1) to (6) below. i ] and dilution of the test sample concentration [C i ]. Dilution of specimen concentration [C] i The concentration of the sample in the sample dilution container P3 is the concentration after the cleaning solution L attached to the tip of the sample dilution probe 21b in the probe cleaning device 30 is brought into the sample dilution container P3 and diluted.

[0099] [Number 1]

[0100] When the number of bets [i] = 1

[0101] The residual volume of the diluted test sample [V1] = [V0] + [a] - [b] - [S1]... Equation (1)

[0102] Dilution of test sample concentration

[0103]

[0104] [Number 2]

[0105] When the number of bets [i] = 2

[0106] The residual volume of the diluted test sample [V2] = [V1] + [a] - [b] - [S2]... Equation (3)

[0107] Dilution of test sample concentration

[0108] [Number 3]

[0109] When the bet is divided into [i] times

[0110] Dilution of residual fluid volume of the test body [V] i ] = [V i-1 ]+[a]-[b]-[S i ...Equation (5)

[0111] Dilution of test sample concentration

[0112] Then, based on the diluted specimen concentration [C] calculated as above... iTo set the maximum number of times [imax]. In this case, for example, if the initial dilution concentration [C0] before the aliquot is performed is set to 100%, the dilution concentration [C] will be subtracted from the initial dilution concentration [C0]. i The obtained value is ([C0]-[C]). i The dilution rate [R] of the diluted sample Sp at the end of a single infusion cycle [i] is calculated. i The dilution rate [Ri] calculated here is the dilution rate [R] of the diluted sample Sp in the diluted sample container P3 before the start of the next saturation cycle [i+1]. i ].

[0113] In Table 2 below, the dilution rate [R] of the diluted test sample Sp, with dilution container number [N] = 1, will be calculated as described above. i [V] and the amount of residual liquid from the diluted test sample i ] and the concentration of diluted test sample [C i [Shown together]

[0114] [Table 2]

[0115] Table of Calculations for Diluted Sample Concentration / Dilution Rate ([N] = 1)

[0116]

[0117] The amount of cleaning solution introduced [a] = 0.1 μl

[0118] Infusion loss [b] = 3.0 μl

[0119] Initial amount [V0] = 150 μl

[0120] The maximum dilution rate [Rmax] = 1.5%.

[0121] Then, the arithmetic processing unit 54 calculates the dilution rate [R]. i The number of dispensing operations [i] exceeding the upper limit value [Rmax] of the dilution rate stored in the storage unit 53 is set as the upper limit number of dispensing operations [imax]. In the example shown in Table 2 above, the calculated dilution rate [Rmax] is... i The number of bets [i] exceeding the preset dilution rate limit [Rmax] is [i] = 12 to 15. Therefore, the lowest number of bets exceeding the preset dilution rate limit [Rmax], i.e., bets [i] = 12, is set as the upper limit of bets [imax].

[0122] In addition, the dilution rate [R] calculated by the arithmetic processing unit 54 in the final dispensing [i] iIf the dilution rate does not exceed the upper limit value [Rmax], a number larger than the number of test items [M] set in step S003, such as the number of test items [M] + 1, is set as the upper limit number of times [imax].

[0123] Alternatively, the concentration of the test sample can be diluted [C]. i The upper limit number of times [imax] is set by comparing the concentration of the diluted sample with the lower limit value. In this case, the lower limit value of the diluted sample concentration is stored in advance in the storage unit 53. Moreover, the calculated diluted sample concentration [C] is... i The lowest number of injections [i] that is less than the lower limit of the concentration of the diluted test sample stored in the storage unit 53 (e.g., 98.5% here) is set as the upper limit of injections [imax].

[0124] <Step S005>

[0125] In step S005, the input / output control unit 55 compares the number of measurement items [M] with the upper limit number of times [imax] calculated by the arithmetic processing unit 54 to determine whether the number of measurement items [M] is greater than the upper limit number of times [imax]. If the input / output control unit 55 determines that the number of measurement items [M] is greater than the upper limit number of times [imax] (yes), it proceeds to the next step S006. On the other hand, if the input / output control unit 55 determines that the number of measurement items [M] is not greater than the upper limit number of times [imax] (no), it proceeds to step S009.

[0126] In the example shown in Table 2 above, the number of measurement items [M] = 15 and the maximum number of times [imax] = 12. Therefore, it is determined that the number of measurement items [M] is greater than the maximum number of times [imax] (yes), and proceed to the next step S006.

[0127] <Step S006>

[0128] In step S006, the input / output control unit 55 creates a list of dispensing items with respect to the dilution container number [N] (e.g., [N] = 1), ranging from dispensing times [i] = 1 to the maximum number of dispensing times [imax] (e.g., [imax] = 12). Table 3 below shows the dispensing item list for dilution container number [N] = 1 created in this way.

[0129] [Table 3]

[0130] List of betting items with [N] = 1

[0131]

[0132] Furthermore, after creating the dispensing item list, based on the dispensing item list created in step S006, the test sample and diluent can be discharged from the test sample container P2 to a dilution test sample container P3 (e.g., [N] = 1), thereby adjusting the amount of diluted test sample to be equivalent to the initial amount [V0], and dispensing the diluted test sample from the dilution test sample container P3 to each reaction container P6 can begin. In this case, a dilution test sample container P3 is configured to contain the diluted test sample Sp diluted according to the corresponding dilution conditions. Additionally, such adjustments to the diluted test sample and dispensing of the adjusted diluted test sample can be performed after the series of processes shown in this flowchart is completed.

[0133] <Step S007>

[0134] In step S007, the input / output control unit 55 performs a process to set the number of measurement items [M] to [M] = [M] = [imax]. Additionally, it performs a process to set the dilution container number [N] to [N] = [N] + 1.

[0135] <Step S008>

[0136] In step S008, the input / output control unit 55 regroups the sub-sub ...

[0137] [Table 4]

[0138] Betting information (regrouped)

[0139]

[0140] Then, return to step S004 and repeat the subsequent steps.

[0141] <Step S009>

[0142] Step S009 is the step entered after step S005 determines that the number of test items [M] is not greater than the upper limit number of times [imax] (No), that is, the number of test items [M] is less than the upper limit number of times [imax]. In this step S009, the input / output control unit 55 creates a list of all items [M] starting from the number of dispensing times [i] = 1, based on the dilution container number [N].

[0143] Here, in step S004, which is performed prior to step S009, the upper limit of the number of bets is set as previously explained.

[0144] As an example, we will explain the case where the dispensing information in Table 4 has been obtained at the time point S004. In this case, in step S004, the calculation processing unit 54 first calculates the amount of residual diluted test sample [V] based on the dispensing information in Table 4. i ], Dilution of the test sample concentration [C i ] and the dilution rate [R] of the diluted sample Sp. i The dilution rate [R] of the diluted test sample Sp, with dilution container number [N] = 2, will be calculated as described above in Table 5 below. i [V] and the amount of residual liquid from the diluted test sample i ] and the concentration of diluted test sample [C i Show them together.

[0145] [Table 5]

[0146] Table of Calculations for Diluted Sample Concentration / Dilution Rate ([N] = 2)

[0147]

[0148] The amount of cleaning solution introduced [a] = 0.1 μl

[0149] Infusion loss [b] = 3.0 μl

[0150] Initial amount [V0] = 150 μl

[0151] The maximum dilution rate [Rmax] = 1.5%.

[0152] Next, the arithmetic processing unit 54 calculates the dilution rate [R]. i The number of times [i] the dilution rate exceeds the upper limit value [Rmax] stored in storage unit 53 is calculated as the upper limit number of times [imax] the dilution rate is calculated in the last time [i]. i The dilution rate does not exceed the upper limit value [Rmax]. Therefore, in step S004, a number greater than the number of measurement items [M] (here [M] = 3), for example, the number of measurement items [M] + 1, is set as the upper limit number of times [imax] (here [imax] = 4).

[0153] Therefore, in step S005, which was performed before step S009, it was determined that the number of measurement items [M] (=3) was not greater than the upper limit number of times [imax] (=4) (No), that is, the number of measurement items [M] was below the upper limit number of times [imax].

[0154] Then, in this step S009, the input / output control unit 55 creates a list of all items [M] starting from the first dispensing [i] = 1, with respect to the dilution container number [N] (for example, [N] = 2). The list of dispensing items for dilution container number [N] = 2 created in this way is shown in Table 6 below.

[0155] [Table 6]

[0156] List of betting items with [N] = 2

[0157]

[0158] Then, after step S009, the series of processes ends. Furthermore, after creating the dispensing item list, based on the dispensing item list created in step S009, the test sample and diluent can be discharged from the test sample container P2 to a dilution test sample container P3 (e.g., [N] = 2), thereby adjusting the amount of diluted test sample equivalent to the initial amount [V0], and dispensing the diluted test sample from this dilution test sample container P3 to each reaction container P6 begins. In this case, the dilution test sample container P3 is configured to contain the diluted test sample Sp diluted according to the corresponding dilution conditions, and is a different dilution test sample container P3 (e.g., [N] = 2) from the dilution test sample container used in the dispensing based on the dispensing item list created in step S006. Additionally, such adjustments to the diluted test sample and dispensing of the adjusted diluted test sample can be performed after the series of processes shown in this flowchart is completed.

[0159] <<Effects of the Implementation Method>>

[0160] In the automatic analysis apparatus 1 and automatic analysis method described above, the upper limit number of dispensings from the diluent sample Sp is set for each sample based on the concentration of the diluent sample Sp when the cleaning fluid L attached to the tip of the diluent sample probe 21b is carried into the diluent sample container P3 in each dispensing cycle. Therefore, even regarding the amount of diluent sample used [S], i Even when multiple different assays are performed, analysis can be carried out using diluted specimens at stable concentrations, thereby improving analytical accuracy and minimizing specimen waste to improve specimen utilization efficiency.

[0161] <<Variation Examples>>

[0162] Next, variations of the automatic analysis device and automatic analysis method will be described.

[0163] The automatic analysis device for the modified example is the same as that used previously. Figures 1-3The difference between the previously described automatic analysis device 1 and the one described above lies in the setting information stored in the storage unit 53 of the control unit 1b. Furthermore, the automatic analysis device in this modified example differs from the one previously used... Figures 1-3 The difference between the automatic analysis device 1 described earlier and the automatic analysis method program implemented by the arithmetic processing unit 54 and the input / output control unit 55 is that... Figure 4 The flowchart shows the process of step S004'. The other components are the same as those of the previously described automatic analysis device 1 and automatic analysis method; therefore, only the differences mentioned above will be explained below.

[0164] <Control Unit 1b>

[0165] [Storage Department 53]

[0166] The automatic analysis device 1 is configured to store, in its storage unit 53, dispensing information associated with each measurement item and dispensing limit [imax] derivation information as setting information. This information is either pre-stored in the storage unit 53 or stored in the storage unit 53 based on input from the input unit 52.

[0167] The dispensing information associated with the assay is the same as previously described, including the dilution conditions of the diluted test sample used in the analytical processing of each assay, the dispensing order between assays (i.e., dispensing times), and the amount of diluted test sample used in the analytical processing of each assay (S). i Information related to this measurement is stored in storage unit 53 in a manner associated with each measurement item.

[0168] Additionally, the upper limit number of dispensings [imax] is used to derive the upper limit number of dispensings [imax] from one dilution test container P3 to the reaction container P6. An example of the upper limit number of dispensings [imax] is shown in Table 7 below.

[0169] [Table 7]

[0170]

[0171] As shown in Table 7, the maximum number of times [imax] is derived, for example, from the initial amount [V0] of the diluted sample Sp contained in the diluted sample container P3 and the average amount [Sav] of the diluted sample used, as described below.

[0172] First, based on the following equation (7), an approximate value of the diluted specimen concentration [Ca] at the end of a saccharification cycle for a saccharification [i] is calculated. i ].

[0173] [Number 4]

[0174] When the number of bets [i] = 1

[0175] Approximate value of the concentration of the diluted sample

[0176]

[0177] In addition, the amount of cleaning fluid carried in [a] is the amount of cleaning fluid L carried in from the probe cleaning device 30 by the dilution test probe 21b to the dilution test container P3 after one dispensing cycle, and is a fixed value. The dispensing loss [b] is the amount of diluted test sample that needs to be additionally dispensed from the dilution test container P3 to the dilution test probe 21b to ensure the dispensing accuracy of the dilution test probe 21b, and is a fixed value. The initial amount [V0] is the initial amount of diluted test sample stored in the dilution test container P3, and is a variable. Dispensing times [i] is the dispensing order between the test items. The average amount of diluted test sample used [SaV] is based on the amount of diluted test sample used [S]. i The quantity of the average value of the measured items [M] is a variable.

[0178] Here, under the conditions that cause variations in the average value [Sav] of the initial amount [V0] and the amount of diluted test sample used, an approximate value [Ca] of the diluted test sample concentration is calculated based on the above equation (7) with the number of injections [i] as a parameter. i ].

[0179] Then, based on the approximate value of the diluted specimen concentration calculated as above [Ca], i To set the maximum number of times [imax]. In this case, the initial diluted sample concentration [C0] is set to 100%, and the approximate value of the diluted sample concentration [Ca] is subtracted from the initial diluted sample concentration [C0]. i The obtained value ([C0] = [Ca]) i The dilution rate [R] of the dilution test sample Sp after the completion of each infusion cycle [i] is calculated. i Then, for each condition, the average value of the initial amount [V0] and the amount of diluted test sample used [Sav] will be used to calculate the dilution rate [R]. i The number of injections [i] exceeding the upper limit value [Rmax] of the dilution rate stored in the storage unit 53 is calculated as the upper limit number of injections [imax] corresponding to each condition, and the above Table 7 is obtained.

[0180] Alternatively, the concentration of the diluted sample can be approximated by [Ca]. iThe upper limit number of times [imax] is set is by comparing the concentration of the diluted sample with the lower limit value. In this case, the lower limit value of the diluted sample concentration is stored in advance in the storage unit 53. Moreover, the approximate value [Ca] of the calculated diluted sample concentration is stored in the storage unit 53. i The lowest number of injections [i] that is less than the lower limit of the concentration of the diluted test sample stored in the storage unit 53 (e.g., 98.5% here) is set as the upper limit of injections [imax], and the above Table 7 is obtained.

[0181] <Step S004>

[0182] In step S004', the arithmetic processing unit 54 calculates the maximum number of dispensing operations [imax] from a dilution test container P3 as follows.

[0183] That is, the processing unit 54 calculates the maximum number of tests [imax] based on the dispensing information associated with the test item, the initial amount [V0] of the diluted test sample Sp contained in the diluted test sample container P3, and the maximum number of tests [imax] shown in Table 7 above. The dispensing information associated with the test item is the information obtained in step S002, and the average value [Sav] of the diluted test sample usage is calculated based on this dispensing information. The average value [Sav] of the diluted test sample usage calculated here is the amount of diluted test sample usage [S] of the dispensing information shown in Table 1. i The average value of [b] (=6.47μl) is added to the amount of injection loss [b] (e.g., [b]=3μl) to obtain the value (e.g., [Sav]=9.47μl).

[0184] Furthermore, the calculated average amount of diluted test sample used [Sav] (=9.47μl) and the initial amount [V0] (e.g. [V0]=150μl) were compared with the upper limit number of times [imax] shown in Table 7 to derive the upper limit number of times [imax] (=13).

[0185] The following steps are the same as before. Figure 4 The process described in the flowchart can be implemented in the same way.

[0186] <<Effects of the Variation>>

[0187] Even in the modified structure described above, the upper limit number of dispensing cycles [imax] for each sample is set based on an approximate value of the concentration of the diluted sample Sp when the cleaning solution L attached to the tip of the diluted sample probe 21b is carried into the diluted sample container P3 in each dispensing cycle. Therefore, similar to the embodiment described above, improved analytical accuracy and sample utilization efficiency can be achieved. Furthermore, since the upper limit number of dispensing cycles [imax] shown in Table 7 is prepared in advance, the calculation process for setting the upper limit number of dispensing cycles [imax] can be easily performed. Thus, the setting of the upper limit number of dispensing cycles [imax] and the resulting high-speed analytical processing can be achieved.

[0188] Furthermore, in the embodiments protecting the above-described modified examples, the application of the present invention to the dispensing of samples from the diluted test sample container P3 to the reaction container P6 has been described. However, the present invention can also be applied to dispensing samples from the test sample container P2 to the diluted test sample container P3, and from the test sample container P2 to the reaction container P6, achieving the same effects when the present invention is applied. Additionally, the test sample holding unit 2 can be a test sample holder conveying device that conveys a test sample holder containing multiple test sample containers, and the test sample container P2 can also be a test sample container conveyed by the test sample holder conveying device.

Claims

1. An automatic analysis device comprising: a test sample holding section for holding a test sample container in which a test sample is stored; a dispensing container holding section for holding a plurality of dispensing containers; a dispensing probe that dispenses a prescribed amount of test sample from the test sample container and dispenses the dispensed test sample into the dispensing container; a probe cleaning device that cleans a front end of the dispensing probe with a cleaning solution after the test sample is dispensed into the dispensing container and before a next prescribed amount of test sample is dispensed from the test sample container; and a control section that controls driving of the dispensing probe, wherein the control section comprises a calculation processing section that calculates, for each test sample, a concentration of the test sample in the test sample container after the test sample is diluted by the cleaning solution adhering to the front end of the dispensing probe in the probe cleaning device, and sets an upper limit number of times of dispensing the test sample from the test sample container to the dispensing container based on the calculated concentration, wherein the calculation processing section calculates the concentration based on an initial amount of test sample stored in the test sample container, a test sample usage amount for a plurality of measurement items set for the test sample, and a carry-in amount of the cleaning solution carried into the test sample container, and wherein the calculation processing section sets a lowest number of dispensing times at which the calculated concentration is lower than a predetermined concentration as the upper limit number of times of dispensing.

2. The automatic analysis device according to claim 1, wherein the calculation processing section calculates an average value of test sample usage amounts for a plurality of measurement items set for the test sample based on the test sample usage amounts, and sets the upper limit number of times of dispensing based on the calculated average value of test sample usage amounts, the initial amount of test sample stored in the test sample container, and derived information of the upper limit number of times of dispensing prepared in advance.

3. The automatic analysis device according to claim 1 or 2, wherein dispensing of the test sample from the test sample container to the dispensing container by the dispensing probe is performed in a dispensing order among a plurality of measurement items set for the test sample.

4. The automatic analysis device according to claim 3, wherein in a case where a number of the plurality of measurement items set for the test sample is greater than the upper limit number of times set by the calculation processing section, the control section causes the test sample holding section to hold a plurality of the test sample containers in which the test sample is stored, and the calculation processing section sets the upper limit number of times of dispensing of the test sample for the plurality of test sample containers in turn.

5. The automatic analysis device according to claim 1 or 2, wherein the test sample container is a diluted test sample container that stores the test sample in a state in which the test sample is diluted to a prescribed concentration, and the dispensing container is a reaction container into which a reagent is dispensed together with the test sample.

6. An automatic analysis method of an automatic analysis device comprising: a test sample holding section for holding a test sample container in which a test sample is stored; a dispensing container holding section for holding a plurality of dispensing containers; a dispensing probe that dispenses a prescribed amount of test sample from the test sample container and dispenses the dispensed test sample into the dispensing container; a probe cleaning device that cleans a front end of the dispensing probe with a cleaning solution after the test sample is dispensed into the dispensing container and before a next prescribed amount of test sample is dispensed from the test sample container; and a control section that controls driving of the dispensing probe, wherein the control section comprises a calculation processing section that calculates, for each test sample, a concentration of the test sample in the test sample container after the test sample is diluted by the cleaning solution adhering to the front end of the dispensing probe in the probe cleaning device, and sets an upper limit number of times of dispensing the test sample from the test sample container to the dispensing container based on the calculated concentration, wherein the calculation processing section calculates the concentration based on an initial amount of test sample stored in the test sample container, a test sample usage amount for a plurality of measurement items set for the test sample, and a carry-in amount of the cleaning solution carried into the test sample container, and wherein the calculation processing section sets a lowest number of dispensing times at which the calculated concentration is lower than a predetermined concentration as the upper limit number of times of dispensing. wherein ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ a dispensing probe that dispenses a prescribed amount of the test substance from the test substance container and dispenses the dispensed test substance into the dispensing container; a probe cleaning device that cleans the front end of the dispensing probe with a cleaning solution after the test substance is dispensed into the dispensing container and before the next prescribed amount of test substance is dispensed from the test substance container; and a control unit that controls driving of the dispensing probe, in the automatic analysis method, for each of the test substances, a concentration of the test substance in the test substance container diluted by the cleaning solution adhered to the front end of the dispensing probe in the probe cleaning device is calculated, and based on the calculated concentration, an upper limit number of times of dispensing the test substance from the test substance container into the dispensing container is set, wherein the concentration is calculated based on an initial amount of the test substance stored in the test substance container, a test substance usage amount for a plurality of measurement items set for the test substance, and a carry-in amount of the cleaning solution carried into the test substance container, and a minimum number of times of dispensing at which the calculated concentration is lower than a preset concentration is set as the upper limit number of times of dispensing.

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