Measuring device and precision management method

Abstract

The present invention discloses a measuring device and a method for precision management. The technical problem of precision management is solved by a measuring device, which comprises: a measuring unit for measuring a management sample for precision management, a display unit, and a processing unit for displaying an input interface for setting an evaluation standard used in the precision management on the display unit, wherein the processing unit displays the precision management result of the inspection item on the display unit based on the measurement result of the management sample and the evaluation standard.

Description

Technical Field

[0001] The present disclosure relates to a measuring device and a precision management method. Background Art

[0002] In cell analysis using a particle analyzer, when the same cells are measured using the same detection reagent, the results of independent analyses performed at different dates and times must be consistent. In particular, in clinical cell analysis tests that process clinical samples, internal accuracy management is necessary to maintain the accuracy of the analysis (Non-Patent Document 1).

[0003] Internal quality control is performed to monitor the reproducibility and variation of analysis. This reproducibility monitoring is performed by measuring control samples such as commercially available quality control samples and quality control samples collected at each facility before measuring normal clinical samples.

[0004] Prior art literature

[0005] Non-patent literature

[0006] Non-patent document 1: Flow Cytometry checklist (07.28.2015, FLO.23737 QC - Reagents / Stain Phase II);

[0007] Non-patent literature 2: Beckman Coulter, Introduction to precision management for FCM: 1. Internal precision management by managing samples ( https: / / www.bc-cytometry.com / QC / QC-4- 1.html ). Summary of the invention

[0008] Technical problem to be solved by the invention

[0009] In a measuring device for sample inspection, when measuring the same sample, there is a requirement for reproducibility of the measurement, and therefore, precision management of the measurement accuracy is required. In particular, in a particle analysis device such as a flow cytometer, when detecting multiple antigens and nucleic acids in one inspection, a cell sample including the following substances is generally used as a management sample in internal precision management: microbeads having the same fluorescence wavelength as the fluorescent pigment used to label the inspection object cell, living cells of the same cell type or cell system as the inspection object cell, or cells obtained by fixing and preserving living cells. For inspection items with a high frequency of commissioned inspections, especially inspection items using in vitro diagnostic reagents, precision management samples are sold on the market. However, inspection items with a low frequency of commissioned inspections, especially management samples used for precision management of research reagents, are generally not sold on the market.

[0010] In the United States, even for such inspection items for which control samples are not provided, internal quality control is required, as shown in Non-Patent Document 1. Therefore, when control samples are not available on the market, each inspection room needs to prepare quality control samples.

[0011] In addition, accuracy management is generally performed on a daily, weekly, or monthly basis, or on a reagent batch basis. Therefore, when a management sample is provided, management information such as the degree to which the detection sensitivity of the measuring device should be maintained when measuring the management sample, and the degree to which the measuring conditions such as how to perform fluorescence correction should be maintained are generally provided by the provider of the management sample or the provider of the measuring device. In this case, the allowable range of accuracy, that is, information related to the evaluation criteria, will also be provided together with the management sample. However, when the management sample is not provided by the provider of the management sample or the provider of the measuring device, an evaluation benchmark for accuracy management must also be set in each inspection room.

[0012] Furthermore, generally speaking, in particle analyzers, the results of measuring the management samples sold on the market are rarely managed by the system that manages the particle analyzers, and the management system attached to the particle analyzers has not been able to perform time monitoring according to user requirements. Until now, the management of the monitoring results of the management samples has been performed by creating management charts such as Xbar-R management charts in Excel (registered trademark) and the like. However, the creation of such management charts and the judgment and reading of accuracy management information from the management charts have always depended on the experience of users who are familiar with particle analysis.

[0013] In the present disclosure, a technical problem is to assist the accuracy management when the user sets the evaluation criteria of the accuracy management corresponding to the inspection items in the measuring device as described above. Another technical problem is to assist so that the accuracy management of the measuring device can be performed even without relying on the user's professional skills related to cell analysis.

[0014] Technical means to solve technical problems

[0015] One embodiment of the present disclosure relates to a measuring device (1000), the measuring device (1000) comprising: a measuring unit (200) for measuring a management sample for precision management, a display unit (17), and a processing unit (10) for displaying an input interface for setting an evaluation standard used in the precision management on the display unit (17), wherein the processing unit (10) displays the precision management result of the inspection item on the display unit (17) based on the measurement result of the management sample and the evaluation standard. According to this embodiment, the precision management result can be displayed on the display unit (17) connected to the control unit (100) of the measuring device (1000). In this way, the quality of the measurement data can be improved, the management cost can be reduced, and the business time can be shortened.

[0016] Preferably, the evaluation criteria are set according to the inspection items. According to this embodiment, accuracy management can be performed according to the inspection items.

[0017] Preferably, the evaluation criteria are set by the user. This embodiment enables accuracy management of the inspection items desired by the user.

[0018] Preferably, the evaluation criteria are stored in a storage unit of the particle analysis device (1000) in a format readable by the processing unit (10) of the particle analysis device (1000). This embodiment enables the evaluation criteria for quality management to be exported to the application software of the measurement device (1000).

[0019] Preferably, the measuring device (1000) further comprises an input unit for setting the evaluation criterion on the input interface. This embodiment can assist the user in setting the evaluation criterion.

[0020] Preferably, the particle is a cell, and the test item corresponds to the measurement target cell. More preferably, the target molecule is an antigen. This embodiment enables the control unit (100) to perform precision management of cell analysis.

[0021] Preferably, the inspection items include more than one measurement item, and the evaluation criteria are set for each measurement item. More preferably, the measurement items include detection items corresponding to more than two target molecules of the detection object detected separately by different light-receiving elements. This embodiment enables the setting of the evaluation criteria for each measurement item (subset panel) to be performed separately.

[0022] Preferably, the evaluation criterion is determined based on the intensity of light detected by each light receiving element. According to this embodiment, the evaluation criterion can be set based on the histogram.

[0023] Preferably, the evaluation criterion is set based on a particle distribution diagram developed by the intensity of light of two measurement items. This embodiment enables the evaluation criterion to be set on a scatter plot. Preferably, the evaluation criterion is set based on a certain gate. More preferably, the gate is set by a user. This embodiment enables the evaluation criterion to be set within a certain gate.

[0024] Preferably, the evaluation criterion includes an upper limit value and a lower limit value of light intensity or particle size. With this embodiment, the evaluation criterion can be set based on light intensity or particle size.

[0025] Preferably, the evaluation criterion is set based on statistical information. More preferably, the statistical information is selected from the number of cells in the gate, the median of the light intensity, the mean of the light intensity, or the standard deviation of the light intensity. This embodiment enables the evaluation criterion to be set based on various statistical information.

[0026] Preferably, at least one of an input area for receiving text input by a user, an icon for receiving a selection by a user, and a drop-down list for receiving a selection by a user is displayed on the input interface. This embodiment can improve user usability.

[0027] Preferably, a histogram or a scatter plot is displayed on the input interface. In this embodiment, the user can view the histogram or the scatter plot displayed on the input interface. Figure 1 While setting the evaluation criteria.

[0028] Preferably, the input interface displays a character string corresponding to each light receiving element. This embodiment enables setting evaluation criteria for each light receiving element.

[0029] Preferably, the light is fluorescence and / or scattered light. With this embodiment, evaluation criteria can also be set for fluorescence and scattered light.

[0030] Preferably, when the light is fluorescence and a plurality of light receiving elements are sensitive to one type of fluorescence, the processing unit (10) further sets a fluorescence correction condition for adjusting the sensitivity of the plurality of light receiving elements when setting the evaluation criterion. With this embodiment, fluorescence correction can be automatically performed when fluorescence of a plurality of wavelengths is used.

[0031] Preferably, the particle analysis device (1000) is a flow cytometer. According to this embodiment, an evaluation criterion can be set in a flow cytometer, particularly a multi-color flow cytometer.

[0032] Preferably, the result of the quality control is displayed every time a management sample for each quality control is measured. According to this embodiment, the quality control result can be monitored in real time.

[0033] Preferably, the result of the precision management is a precision management result for each channel, which is displayed in a chart expanded with several channels as axes. With this embodiment, the precision management results of several channels can be displayed on one interface.

[0034] Preferably, the result of the quality management is displayed together with the result of the quality management at a time point in the past. More preferably, the result of the quality management is displayed in a time series chart. This embodiment enables the change of the quality management result within a day or between several days to be clearly understood.

[0035] Preferably, when the result of the quality management is bad, a warning is displayed together with the result of the quality management. With this embodiment, the user can grasp the quality management abnormality as early as possible.

[0036] One embodiment of the present disclosure relates to a precision management method, which includes the following steps: a display step of displaying an input interface for setting an evaluation benchmark corresponding to an inspection item, a measurement step of measuring a management sample for precision management based on the evaluation benchmark, and an output step of outputting a precision management result of the management sample measured by the measurement step. According to this embodiment, the precision management result can be displayed on a display unit 17 connected to a control unit (100) of a measurement device (1000). Therefore, it is possible to improve the quality of measurement data, reduce management costs, shorten business time, etc.

[0037] Preferably, in the accuracy management method, the evaluation criteria are set according to the inspection items. According to this embodiment, accuracy management can be performed according to the inspection items.

[0038] Preferably, in the accuracy management method, the evaluation criteria are set by the user. This embodiment enables accuracy management to be performed on the inspection items desired by the user.

[0039] Preferably, in the accuracy management method, the inspection items include more than one measurement item, and the evaluation criteria are set for each measurement item. More preferably, the measurement items include measurement items corresponding to target molecules of more than two measurement objects that are measured separately by different light-receiving elements. This embodiment enables the evaluation criteria to be set for each measurement item (subset panel).

[0040] Preferably, in the accuracy management method, the evaluation criterion is determined based on the intensity of light measured by each light receiving element. According to this embodiment, the evaluation criterion can be set based on the histogram.

[0041] Preferably, in the precision management method, the evaluation criterion is set based on a particle distribution diagram developed by the intensity of light of two measurement items. This embodiment enables the evaluation criterion to be set on a scatter plot. Preferably, the evaluation criterion is set based on a certain gate. More preferably, the gate is set by a user. This embodiment enables the evaluation criterion to be set within a certain gate.

[0042] Preferably, in the accuracy management method, the evaluation criterion includes an upper limit value and a lower limit value of light intensity or particle size. With this embodiment, the evaluation criterion can be set based on light intensity or particle size.

[0043] Preferably, in the accuracy management method, the evaluation criterion is set based on statistical information. With this embodiment, the evaluation criterion can be set based on various statistical information.

[0044] Preferably, in the accuracy management method, a histogram or a scatter plot is displayed on the input interface. In this embodiment, the user can view the histogram or the scatter plot displayed on the input interface. Figure 1 While setting the evaluation criteria.

[0045] Preferably, in the accuracy control method, the light is fluorescence and / or scattered light. With this embodiment, an evaluation criterion can be set for fluorescence and scattered light.

[0046] Preferably, the accuracy management method is performed using a flow cytometer. This embodiment enables setting an evaluation criterion in a flow cytometer, particularly a multi-color flow cytometer.

[0047] Preferably, in the output step of the quality management method, the quality management result is displayed each time a management sample for each quality management is measured. According to this embodiment, the quality management result can be monitored in real time.

[0048] Preferably, in the output process, the result of the quality management is the quality management result for each channel, which is displayed in a graph expanded with a plurality of channels as axes. With this embodiment, the quality management results of a plurality of channels can be displayed on one interface.

[0049] Preferably, in the output step, the result of the quality management is displayed in a time series graph. According to this embodiment, the change of the quality management result within one day or between several days can be grasped at a glance.

[0050] Another embodiment of the present disclosure relates to a measuring device (1000), which comprises: a measuring unit (200) for measuring a management sample for precision management, a display unit (17), and a processing unit (10) for displaying the precision management result of the inspection item on the display unit, wherein the processing unit (10) obtains information corresponding to the management sample and displays a precision management setting interface or a precision management interface of the corresponding inspection item on the display unit based on the obtained information. According to this embodiment, the precision management setting interface or the precision management interface can be displayed according to the management sample.

[0051] Preferably, the information corresponding to the management sample is display mode information corresponding to the management sample, and the display unit displays the precision management setting interface or precision management interface of the inspection item corresponding to the acquired display mode information and enables switching with the precision management setting interface or precision management interface corresponding to other display mode information. With this embodiment, different precision management setting interfaces or precision management interfaces of management samples can be displayed on one interface.

[0052] Preferably, the processing unit reads the reagent information from the barcode attached to the test reagent container or package, and displays the accuracy management setting interface or the accuracy management interface of the test item corresponding to the display mode information on the display unit. With this embodiment, the reagent information can be easily obtained even if the user does not input the reagent information. This is useful when the in vitro diagnostic reagent is used as a detection reagent.

[0053] The processing unit obtains reagent information through input by the input unit or from the network, and displays the accuracy management setting interface or accuracy management interface of the inspection item corresponding to the display mode information on the display unit. In this embodiment, reagent information can also be input when using research reagents.

[0054] Preferably, the managed sample is a managed sample of an in vitro diagnostic reagent or a managed sample prepared using a research reagent, and the display mode information includes information on whether the managed sample is a managed sample of the in vitro diagnostic reagent or a managed sample prepared using a research reagent. This embodiment enables accuracy management of managed samples of in vitro diagnostic reagents and managed samples prepared using research reagents.

[0055] Preferably, when a management sample prepared using a research reagent is used as a management sample, an interface for setting an evaluation criterion is displayed, and when a management sample of an in vitro diagnostic reagent is used as a management sample, an interface for setting an evaluation criterion is displayed. With this embodiment, the accuracy management interface when using an in vitro diagnostic reagent and the accuracy management setting interface and accuracy management interface when using a research reagent can be displayed on one interface.

[0056] Other embodiments of the present disclosure relate to a precision management method, which includes the following steps: a step of acquiring information corresponding to a management sample, a step of displaying a precision management setting interface or a precision management interface of an inspection item corresponding to the management sample, a step of measuring the management sample for precision management, and a step of outputting a precision management result of the management sample measured by the measuring step. This embodiment enables displaying a precision management setting interface or a precision management interface corresponding to the management sample.

[0057] Preferably, in the precision management method, the information corresponding to the management sample is display mode information corresponding to the management sample, and the precision management setting interface or precision management interface of the inspection item corresponding to the acquired display mode information is displayed on the display unit and can be switched with the precision management setting interface or precision management interface corresponding to other display mode information. With this embodiment, different precision management setting interfaces or precision management interfaces of management samples can be displayed on one interface.

[0058] Preferably, in the precision management method, the reagent information is read from a barcode attached to a test reagent container or package, and a precision management setting interface or a precision management interface of the test item corresponding to the display mode information is displayed on the display unit. With this embodiment, the reagent information can be easily obtained even if the user does not input the reagent information. This is useful when an in vitro diagnostic reagent is used as a detection reagent.

[0059] Preferably, in the precision management method, the reagent information is input by the input unit or obtained from the network, and the precision management setting interface or the precision management interface of the inspection item corresponding to the display mode information is displayed on the display unit. With this embodiment, the reagent information can also be input when using research reagents.

[0060] Preferably, the managed sample is a managed sample of an in vitro diagnostic reagent or a managed sample prepared using a research reagent, and the display mode information includes information on whether the managed sample is a managed sample of the in vitro diagnostic reagent or a managed sample prepared using a research reagent. This embodiment enables accuracy management of managed samples of in vitro diagnostic reagents and managed samples prepared using research reagents.

[0061] Preferably, in the accuracy management method, when a management sample prepared using a research reagent is used as a management sample, an interface for setting an evaluation criterion is displayed, and when a management sample of an in vitro diagnostic reagent is used as a management sample, an interface for setting an evaluation criterion is displayed. According to this embodiment, the accuracy management interface when using an in vitro diagnostic reagent and the accuracy management setting interface and the accuracy management interface when using a research reagent can be displayed on one interface.

[0062] Effects of the Invention

[0063] According to the present embodiment, even when the management sample is not provided by the provider of the management sample or the provider of the measurement device, the conditions for performing the accuracy control can be easily set and the accuracy control can be performed. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] Figure 1 is a schematic diagram of the present disclosure;

[0065] Figure 2 It is a schematic diagram of the measurement system;

[0066] Figure 3 is a diagram showing an example of the configuration of hardware of a control device;

[0067] Figure 4 is a diagram showing a configuration example of a measuring unit;

[0068] Figure 5 is a diagram showing an example of a display of a login interface;

[0069] Figure 6 is a diagram showing an example of a display of the main interface;

[0070] Figure 7 This is an example of a flow chart for the device quality control (QC) setting process;

[0071] Figure 8 is a diagram showing an example of a display of a precision management setting interface;

[0072] Fig. 9 is a diagram showing an example of a display of a precision management setting interface;

[0073] Fig.10 is a diagram showing an example of a display of a precision management setting interface;

[0074] Fig.11 is a diagram showing an example of a display of a precision management setting interface;

[0075] Fig.12 is a diagram showing an example of a display of a precision management setting interface;

[0076] FIG. 13-1 is a diagram showing an example of a flow chart of a panel registration process;

[0077] FIG. 13-2 is a diagram showing an example of a flow chart of a panel registration process;

[0078] FIG. 13-3 is a diagram showing an example of a flow chart of a panel registration process;

[0079] Fig.14 is a diagram showing an example of a display of a precision management setting interface;

[0080] Fig.15 is a diagram showing an example of a display of a precision management setting interface;

[0081] Fig.16 is a diagram showing an example of a display of a precision management setting interface;

[0082] Fig.17 is a diagram showing an example of a display of a precision management setting interface;

[0083] Fig.18 is a diagram showing an example of a display of a precision management setting interface;

[0084] Fig.19 is a diagram showing an example of a display of a precision management setting interface;

[0085] Fig. 20 is a diagram showing an example of a display of a precision management setting interface;

[0086] Fig.21 is a diagram showing an example of a display of a precision management setting interface;

[0087] Fig. 22 is a diagram showing an example of a display of a precision management setting interface;

[0088] Fig.23 is a diagram showing an example of a display of a precision management setting interface;

[0089] Fig.24 is a diagram showing an example of a display of a precision management setting interface;

[0090] Fig.25 is a diagram showing an example of a display of a precision management setting interface;

[0091] Fig.26is a diagram showing an example of a display of a precision management setting interface;

[0092] Fig. 27 is a diagram showing an example of a display of a precision management setting interface;

[0093] Fig.28 is a diagram showing an example of a display of a precision management setting interface;

[0094] Fig.29 is a diagram showing an example of a display of a precision management setting interface;

[0095] Figure 30-1 is an example of a flowchart for baseline setting;

[0096] Figure 30-2 is an example of a flowchart for baseline setting;

[0097] Fig.31 is a diagram showing an example of a display of a precision management setting interface;

[0098] Fig.32 is a diagram showing an example of a display of a precision management setting interface;

[0099] Fig.33 is a diagram showing an example of a display of a precision management setting interface;

[0100] Fig.34 This is an example of a flow chart for daily quality control (QC);

[0101] Fig.35 is a diagram showing an example of a display of a precision management interface;

[0102] Fig.36 is a diagram showing an example of a display of a precision management interface;

[0103] Fig.37 is a diagram showing an example of a display of a precision management interface;

[0104] Fig.38 is a diagram showing an example of a display of a precision management interface;

[0105] Fig.39 is a diagram showing an example of a display of a precision management interface;

[0106] Fig.40 is a diagram showing an example of a display of a precision management interface;

[0107] Fig.41 is a diagram showing an example of a display of a precision management interface;

[0108] Fig.42 is a diagram showing an example of a display of a precision management interface;

[0109] Fig.43 is a diagram showing an example of a display of a precision management interface;

[0110] Fig.44 is a diagram showing an example of a display of a precision management interface;

[0111] Fig.45 is a diagram showing an example of a display of a precision management interface;

[0112] Fig.46 is a diagram showing an example of a display of a precision management interface;

[0113] Fig.47 is a diagram showing an example of a display of a precision management interface;

[0114] Fig.48 This is an example flowchart of the measurement process. DETAILED DESCRIPTION

[0115] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the following description and the accompanying drawings, the same reference numerals represent the same or similar components, and therefore, the description of the same or similar components will be omitted.

[0116] [Overview of the present disclosure]

[0117] use Figure 1 The present disclosure is briefly described. In the following description, the particle analysis device 1000 is used as an example of the measuring device 1000, but the measuring device 1000 is not limited to a measuring device for analyzing particles. Examples of measuring devices include nucleic acid amplification devices, nucleic acid sequence analysis devices, immunoassay devices, biochemical measuring devices, coagulation measuring devices, urine testing devices, etc. The structure of the particle analysis device 1000 is shown in FIG. Figure 2 . One form of the present disclosure relates to assisting precision management in the particle analysis device 1000. In addition, another form relates to precision management in the particle analysis device 1000. More preferably, it relates to assisting precision management for inspection items for which measurement conditions of a management sample used to manage particle measurement precision in the particle analysis device 1000 are not provided by a provider. More preferably, an evaluation criterion for precision management corresponding to the inspection item is generated in a file format that can be exported in the process of precision management in the particle analysis device 1000 and stored in the auxiliary storage unit 13. The setting is accepted before the analysis of the measurement sample or at a certain period of time when the measurement sample is analyzed.

[0118] To start the particle analyzer 1000 , a user accesses the control unit 100 of the particle analyzer 1000 , and the startup process of the particle analyzer 1000 starts (step S1 ). After the startup process ends, the processing unit 10 of the control unit 100 starts the accuracy management of the measuring unit 200 of the particle analyzer 1000 .

[0119] For example, the accuracy management of the measurement unit 200 includes the accuracy management of the hardware of the measurement unit 200 itself regardless of the inspection items (also called device accuracy management or device QC), and the accuracy management corresponding to the inspection items in order to monitor the degradation of the measurement reagents, etc. (inspection item accuracy management). Figure 1 As shown, after the user performs the startup operation of the particle analyzer 1000, the processing unit 10 performs the startup process of the particle analyzer 1000 (step S1), and the processing unit 10 performs step S2 for performing the device quality control (QC) of the measuring unit 200. Next, the processing unit 10 performs the quality control of the inspection item. In order to perform the quality control corresponding to the inspection item (also called panel), the evaluation standard of the quality control corresponding to the inspection item is required. For the inspection item for which the evaluation standard has been set, the existing evaluation standard is used. For the new inspection item, the processing unit 10 accepts the setting of the evaluation standard for performing the quality control corresponding to the inspection item (from step S3 to step S6). Or even if the evaluation standard has been set, for example, when the quality control sample batch is changed, the processing unit 10 needs to perform the process for setting the evaluation standard. When the evaluation standard of the new inspection item is to be set, the processing unit 10 accepts the registration of the inspection item (panel) by the user (step S3). Next, the registration of the precision management file (QC file) for the registered inspection item (panel) is accepted (step S4) and the setting of the baseline using the management sample for the registered precision management (QC) file is performed (step S5). When the registered evaluation criteria are to be updated, steps S4 and S5 are performed. As needed, the processing unit 10 prepares a report on the set evaluation criteria (step S6). In step S7, the processing unit 10 uses the set evaluation criteria to perform precision management on each inspection item before the measurement every day. This precision management is also called daily precision management (QC). The results of daily precision management (QC) can also be output as a report (step S8). After performing daily precision management (QC), that is, after step S7 or after step S8, step S9 of measuring the measurement sample prepared from the sample can also be included. In addition, the measurement results of the measurement sample can also be output as a report (step S10).

[0120] The screens required in steps S3 to S6 for accepting the setting of the evaluation criteria for quality management according to the inspection items may be collectively referred to as a quality management setting screen.

[0121] In the present disclosure, the user is assumed to be the operator of the measuring device. The operator includes, for example, a clinical examination technician, a researcher, a technician, a laboratory assistant, a student, a manager of the measuring system, etc. The user who sets the evaluation criteria described later preferably has the skills of a measuring device manager, for example. The skills of a manager can be listed as a person who is proficient in the measurement field, such as the head of the inspection room, the director, the manager, the measuring system manager, etc. The daily precision management (QC) described later can be performed by a person who does not have the skills of a manager.

[0122] [Particle Analysis System]

[0123] First, the particle analysis to be controlled in the present disclosure will be described.

[0124] Particle analysis is the analysis of particles. Preferably, particles emit one or more kinds of light when irradiated with a certain light. The light emitted from particles when irradiated with a certain light is collectively referred to as light from particles. The light from particles includes scattered light and fluorescence, etc. The light from particles can be of any wavelength, but preferably the peak wavelength is in the range of 350nm to 850nm. More specifically, it is preferred that the light from particles is fluorescence. The light from particles can also be light emitted by the substance contained in the particles themselves. Alternatively, regarding the light from particles, particles can also be labeled with luminescent substances such as fluorescent substances and the light emitted by the luminescent substances can be detected as light from particles. In addition, it is preferred that the peak wavelength of the light from particles is different for each measurement item.

[0125] The particles may be artificial particles such as magnetic beads, plastic beads, etc. In addition, the particles may be biological components such as casts, or particles such as microorganisms, animal cells, and plant cells.

[0126] The particles are detected by the detection reagent. Preferably, the particles are detected by binding the target molecule present in the particles to the fluorescent dye contained in the detection reagent.

[0127] The target molecule is not particularly limited as long as it is a substance present in the particle. Preferably, the particle is a cell, and the target molecule may be a molecule present on the cell membrane, in the cell membrane, or in the cell. The target molecule may also be a cell organelle (nucleus, nuclear membrane, nucleolus, mitochondria, endoplasmic reticulum, Golgi apparatus, lysosome, cell membrane, cytoplasm, etc.) itself. The target molecule may also be a molecule obtained by gene transfer, etc. The target molecule is preferably at least one selected from the group consisting of antigens and nucleic acids.

[0128] The reagents used to detect the target molecule, including antibodies bound to fluorescent pigments, nucleic acids bound to fluorescent pigments, or dyes that emit fluorescent signals, are called detection reagents. The detection reagents can be appropriately combined with several detection reagents according to the detection items (target molecules) contained in the inspection commission. Preferably, when the target molecule is an antigen and is detected, the antibody used to detect the antigen is called a detection antibody.

[0129] When the particles are from an organism, there is no particular limitation on the sample being cells, tissues, body fluids containing cells, etc. collected from an individual. Before the measurement, the cell sample obtained by diluting or fixing the sample or the cells from the sample is mixed with a detection reagent to prepare a measurement sample (a suspension of cells bound to a fluorescent dye) that can be measured in the particle analysis device 1000. The sample is preferably peripheral blood, bone marrow, urine, etc. For example, when performing multicolor flow cytometry, generally, one or more, preferably several, detection items contained in the inspection items are divided into one to several tests (also referred to as tests) for analysis for one cell sample. A group of one or more, preferably several, detection items contained in the inspection items is also referred to as an inspection item (panel). A group of several detection items measured in one test is also referred to as a measurement item (subset panel). Therefore, the inspection item includes a measurement item (subset panel), the measurement item (subset panel) includes one or more, preferably several, detection items, and the inspection item (panel) includes one or more, preferably several, measurement items (subset panel). For example, when the inspection items (panel) include 20 test items, the test items are generally divided into 4 to 10 measurement items (subset panel) for measurement.

[0130] In the present disclosure, particle analysis is performed by a particle analysis device 1000. Figure 2 As shown, the particle analysis device 1000 includes, for example, a measuring unit 200 for performing particle analysis and a control unit 100 for controlling the analysis in the measuring unit 200. The measuring unit 200 and the control unit 100 may be connected to each other by wire or wirelessly via a network, or the measuring unit 200 and the control unit 100 may be formed integrally. In addition, the particle analysis device 1000 may be connected to the client terminal 300 by wire or wirelessly via a network 99 to form a particle analysis system 5000.

[0131] The control unit 100 is composed of, for example, a general-purpose computer, and generates precision management data in a file format that can be exported in the process for precision management of the particle analyzer, based on the process shown in the flowchart described later, for the combination of the detection reagents for detecting the particles whose measurement conditions of the management sample for managing the particle analysis precision in the particle analyzer are not provided by the provider, by setting the measurement conditions of the precision management sample corresponding to the detection reagents. The user mixes the detection reagent with the particle sample to prepare the measurement sample 29. The prepared measurement sample 29 is stored in the sample container 28, placed in the measurement unit 200, and the particles are analyzed.

[0132] Here, as an example, the control unit 100 controls the particle analysis in the particle analysis device 1000 and generates data including management conditions for precision management based on the measurement data of the management sample, but data including evaluation criteria for precision management can also be generated by a conventional computer different from the control unit 100 and sent to the control unit 100.

[0133] [Hardware structure of the control device]

[0134] Figure 3 2 shows an example of the hardware configuration of the control unit 100. The control unit 100 includes a processing unit 10. The control unit 100 may further include an input unit 16 and an output unit 17.

[0135] The control unit 100 includes: a processing unit 10 for performing the data processing described later, that is, a CPU (Central Processing Unit), a memory 12 used as a work area for data processing, an auxiliary storage unit 13 for storing the programs described later and the processed data, a bus 14 for transmitting data between the units, and an interface unit 15 (hereinafter referred to as "I / F unit") for inputting and outputting data and communicating with an external device. The interface unit for communicating in the interface unit 15 is a communication unit 151. The input unit 16 and the output unit 17 are connected to the processing unit 10. In this disclosure, the memory and the auxiliary storage unit 13 are sometimes referred to as a storage unit. As an example, the input unit 16 and the output unit 17 (display unit or printer, etc.) can be integrated as a touch screen input display device. In addition, as the input unit 16, a reading device such as a barcode reader can also be connected together with a keyboard and a mouse. The reading device can, for example, read a barcode attached to the package of the detection reagent, which registers information on the detection reagent, etc.

[0136] In addition, in order to perform the various steps of auxiliary precision management described below, the control unit 100 stores the program involved in the present disclosure in advance in the auxiliary storage unit 13, for example, in an executable format (for example, generated by a compiler converting from a programming language), and the processing unit 10 uses the program stored in the auxiliary storage unit 13 for processing.

[0137] The processing unit 10 temporarily stores necessary data (intermediate data during processing, etc.) using the memory 12 as a work area, and appropriately stores data to be stored for a long time, such as calculation results, in the auxiliary storage unit 13 .

[0138] [Structure of particle analysis device]

[0139] The measurement unit 200 includes an aspirating unit 21, a fluid circuit 22, and a measuring unit 23. The measurement unit 200 aspirates a measurement sample 29 stored in a sample container 28 by the aspirating unit 21, transports the aspirated measurement sample 29 in the form of a fluid by the fluid circuit 22, and measures the transported measurement sample 29 in the measuring unit 23.

[0140] In this embodiment, the control operation of the measuring unit 200 is concurrently performed by the control unit 100. That is, the optical information measured by the measuring unit 23 is sent to the control unit 100, and the control unit 100 performs the analysis corresponding to the number of particles and each antigen based on the optical information sent from the measuring unit 23. The control unit 100 pre-stores a computer program that specifies the processing flow for controlling the measuring unit 200 and the processing flow for measuring the measurement value sent from the measuring unit 23 in the auxiliary storage unit 13 described later. The control unit 100 executes the computer program through the processing unit 10 described later, thereby controlling the measuring unit 200.

[0141] The aspiration unit 21 is, for example, a nozzle capable of aspirating and discharging a measurement sample. The fluid circuit 22 is a flow path for a fluid, and the fluid is transported, for example, by a syringe pump. The particle analysis system 1000 is, for example, a flow cytometer. Preferably, it is a multicolor flow cytometer. The flow cytometer performs optical measurement of a sample by flow cytometry. The following is an example in which the particle is a cell and the detection reagent includes an antibody for detecting a target molecule present in the cell.

[0142] The number of fluorescence detection light-receiving elements (e.g., photomultiplier tubes) provided in the measuring section 23 is determined according to the number of fluorescent pigments that can be processed by the measuring unit 200. For example, if the measuring unit 200 can process fluorescent pigments of 10 colors in one test, the measuring unit 200 has a total of 10 fluorescence detection light-receiving elements in the measuring section 23. Fig.12 , the optical system of a flow cytometer is described by taking the case of simultaneously measuring several fluorescences as an example. Figure 4 The dotted line indicated by the reference numeral 77 in the figure means that the light receiving element which is originally present is omitted from the figure.

[0143] exist Figure 4An example of an optical system of a flow cytometer is shown as an example of a measuring unit 23. The flow cytometer includes: a chamber 27 for storing a cell-containing liquid containing cells in a measurement sample, light sources 201 and 224 for irradiating light to cells passing through the chamber 27, and light receiving elements 200A to 200F for detecting optical information from the light of the cells and outputting detection signals converted into electrical signals. In reality, there are not only two light sources, but three, but for the sake of convenience, the light sources 201 and 224 are used as an example. In addition, in conjunction with Figure 3 In the following description of the flow cytometer, a case where the measurement sample 29 is a mixture of blood and an antibody reagent is described as an example.

[0144] Preferably, the cells emit one or more kinds of light when irradiated with a certain light. The light emitted from the cells when irradiated with a certain light is generally referred to as light from the cells. The light from the cells includes scattered light and fluorescence, etc. The light from the cells can be of any wavelength, but preferably the light has a peak wavelength in the range of 350nm to 850nm. More specifically, the light from the cells is preferably fluorescence. The light from the cells can be light emitted by the substances contained in the cells themselves. Alternatively, regarding the light from the cells, the light emitted by the fluorescent pigment contained in the detection reagent in the analysis of the above-mentioned cells can be detected as light from the cells. In addition, the light from the cells preferably has a peak wavelength that is different for each antigen. In the first embodiment, the fluorescence from the cells comes from the fluorescent pigment labeled on each antibody contained in the detection reagent.

[0145] The cell-containing liquid is a liquid containing the measurement sample aspirated from the sample into the flow cytometer, and contains a diluent as needed. Optical information is information contained in one or more light wavelength spectra emitted from cells. The light wavelength spectrum includes each light wavelength, light wavelength region, and the intensity of each light wavelength or light wavelength region contained in the light wavelength spectrum. Each light wavelength and wavelength region can be specified by which of the one or more light receiving elements described later receives light. In addition, the intensity of each light wavelength or light wavelength region can be specified by the electrical signal output by the light receiving element that receives light.

[0146] The following is a specific description of the case where the light from the cells is scattered light and fluorescence. The light emitted from the light source 201 is irradiated to the chamber 27 through the collimating lens 202, the dichroic mirror 203, and the condenser 204. The forward scattered light from the light of the cells passing through the chamber 27 is collected by the condenser 205, and is incident on the light receiving element 200A through the beam stopper 206, the aperture plate 207, and the bandpass filter 208.

[0147] On the other hand, the side scattered light and side fluorescence from the light of the cells passing through the chamber 27 are collected by the condenser 209. The side scattered light passes through the dichroic mirror 210, the dichroic mirror 211, the dichroic mirror 212, the aperture plate 213, and the band pass filter 214 to enter the light receiving element 200B. The side fluorescence with a wavelength of 520 nm or more and 542 nm or less passes through the dichroic mirrors 210 and 211, is reflected by the dichroic mirror 212, and passes through the aperture plate 215 and the band pass filter 216 to enter the light receiving element 200C. In addition, the side fluorescence with a wavelength of 570 nm or more and 620 nm or less passes through the dichroic mirror 210, is reflected by the dichroic mirror 211, and passes through the aperture plate 217 and the band pass filter 218 to enter the light receiving element 200D. The side fluorescence with a wavelength of 670 nm to 800 nm is reflected by the dichroic mirror 210 , passes through the dichroic mirror 219 , passes through the aperture plate 220 and the bandpass filter 221 , and is incident on the light receiving element 200E.

[0148] The light emitted from the light source 224 is irradiated to the chamber 27 through the collimating lens 225, the dichroic mirror 203, and the condensing mirror 204. The side fluorescence from the light of the cells passing through the chamber 27 is condensed by the condensing mirror 209. The side fluorescence of 662.5 nm or more and 687.5 nm or less is reflected by the dichroic mirror 210, and after being reflected by the dichroic mirror 219, it passes through the aperture plate 222 and the bandpass filter 223 and enters the light receiving element 200F.

[0149] exist Figure 4 In the example shown, the light source 201 uses a laser diode with a wavelength of 488 nm, and the light source 224 uses a laser diode with a wavelength of 642 nm. The chamber 27 uses a sheath flow cell. The light receiving element 200A for receiving forward scattered light uses a photodiode, and the light receiving element 200B for receiving side scattered light uses an avalanche photodiode (APD). The light receiving elements 200C to 200F for receiving side fluorescence use photomultiplier tubes (PMT).

[0150] In this way, Figure 4 In the flow cytometer shown, for the sake of convenience, the number of light receiving elements 200C to 200F that receive side fluorescence is 4. However, there are actually 10. Therefore, the flow cytometer shown in this example has 4 light receiving elements for fluorescence detection, and can simultaneously measure 4 colors of fluorescence in one test. However, in fact, the flow cytometer has 10 light receiving elements for fluorescence detection, and can simultaneously measure 10 colors of fluorescence in one test.

[0151] Each detection signal output from each light receiving element 200A to 200F is amplified in an amplifier circuit (not shown), and converted into a digital signal by an A / D converter (not shown). The detection signal converted into a digital signal is sent to the control unit 100 in this embodiment to perform cell analysis. The amplifier circuit is a known amplifier circuit composed of, for example, an operational amplifier or the like.

[0152] The light source may be one or more than two. Preferably, the flow cytometer is equipped with at least three light sources. The light source is selected according to the wavelength region of the light from the cells. When there are more than two light sources, it is preferred that these light sources emit light with different peak wavelengths.

[0153] The number of photodiodes, dichroic mirrors and bandpass filters can be changed according to the number of peak wavelengths of light from cells. In addition, the types of photodiodes, dichroic mirrors and bandpass filters can also be selected according to the peak wavelength or wavelength range and intensity of light from cells.

[0154] The control unit 100 sends to the measuring unit 23 information related to the detection sensitivity when the measuring unit 23 detects scattered light and fluorescence, information related to the fluorescence correction corresponding to the detected fluorescence combination, and information related to gating for selecting the distribution area of ​​the cells to be detected, and controls the measuring unit 23 based on this information so that it can obtain appropriate optical information according to the antigen.

[0155] [Overview of the operation of the control unit]

[0156] In the control unit 100, the processing unit 10 receives, for example, a request from a physician for an examination to determine whether a patient has a certain disease (e.g., leukemia). The user prepares a measurement sample 29 according to a plurality of measurement items corresponding to the received examination request and places it in the measurement unit 200. Afterwards, in response to the user's input of a measurement start instruction, the measurement of each target molecule is performed in the measurement unit 200 according to the processing flow of the cell analysis described later.

[0157] [Client terminal]

[0158] Furthermore, the particle analysis device 1000 can be connected to the client terminal 300 via the network 99. For example, the inspection request instructed by the doctor via the client terminal 300 is sent to the particle analysis device 1000 via the network. The client terminal 300 is composed of, for example, a general computer having a processing unit 10 and a memory. The sample of the inspection object is separately handed over to the user. The client terminal 300 sends the input inspection request to the control unit 100. In addition, the particle analysis device 1000 can also send the measurement result to the client terminal 300.

[0159] [Assistance methods for precision management and precision management methods]

[0160] The present disclosure relates to assisting the accuracy management of cell analysis performed in the particle analysis apparatus 1000. First, the outline of the accuracy management will be described.

[0161] (Overview of precision management and the effects of supporting methods)

[0162] There are internal precision management for managing the analysis precision in each inspection room and external precision management for managing the analysis precision between several independent inspection rooms. The present disclosure relates to internal precision management. In the present disclosure, "precision management" or "QC" only means internal precision management.

[0163] The precision management of particle analysis is to monitor the reproducibility and deviation of the analysis. The precision management includes the precision management related to the analytical performance of the measurement unit 200 itself (device precision management or device QC) and the precision management of the inspection items reflecting the quality of the detection reagent and the preparation method of the measurement sample (inspection item precision management). In the present disclosure, the precision management is preferably the inspection item precision management.

[0164] Hereinafter, the method of assisting the precision management will be described by taking a cell analysis using a flow cytometer as the measurement unit 200 and a detection antibody as a detection reagent as an example.

[0165] Generally, when performing device quality control (QC), a control sample (device control sample) for device quality control, which includes fluorescent beads corresponding to the fluorescence wavelength measured by the measuring unit 200, is used. Specifically, when the measuring unit 200 is started, it is preferred to measure such a device control sample at the beginning to confirm that the detection system of the measuring unit 200 is operating normally. Regarding the results of device quality control, it is preferred to store the records in the auxiliary storage unit 13, including the contents, on each quality control implementation day and when an abnormality occurs.

[0166] Next, the inspection item precision management corresponding to the inspection item is performed. Generally, the inspection items are recorded in the inspection entrustment form, etc., which are equivalent to the types of particles that are expected to be inspected. When the inspection items are inspected, several target molecules corresponding to the types of particles are measured in the measurement unit 200 as detection items. For example, the inspection item (cell type) is CD4-positive T cells, and the detection items (types of target molecules) that meet the entrustment are CD3 and CD4 as surface antigens of T cells. Inspection item precision management is preferably performed for each inspection item separately, and for all detection items contained in each inspection item. Therefore, inspection item precision management is preferably performed using cells that are the same or similar to the cell types of the inspection items, and using a management sample (inspection item management sample) prepared with the same detection reagent as when preparing the measurement sample from the sample to meet the inspection entrustment. Inspection item precision management is preferably performed before the measurement of the measurement sample. Regarding the results of the inspection item precision management, it is preferred to store the records in the auxiliary storage unit 13, including its contents, on each precision management implementation day and when an abnormality occurs.

[0167] The above-mentioned device quality control and inspection item quality control are performed at least once when the device is started up or before measuring a measurement sample, for example, on a measurement day, and therefore are sometimes referred to as daily quality control (QC).

[0168] In the present disclosure, the device management sample and the inspection item management sample are sometimes collectively referred to as the management sample. When the device management sample is obtained from the provider of the management sample or the provider of the particle analysis device 1000, generally speaking, information such as the measurement conditions of the device management sample in the particle analysis device 1000 is also provided. On the other hand, regarding the inspection item management sample, even if it is assumed that the inspection item management sample is obtained from the provider, in most cases, the information of the measurement conditions of the inspection item management sample is not provided. In particular, when the particle analysis device 1000 is a multicolor flow cytometer, the information of the measurement conditions of the inspection item management sample is not provided.

[0169] In addition, the types of management samples provided by management sample providers or particle analysis device providers are limited, and commercialized inspection item management samples may not always be available in response to inspection requests. In this case, management samples, especially inspection item management samples, need to be prepared in each inspection room.

[0170] Therefore, the user needs to set measurement conditions of inspection item management samples and / or evaluation criteria for performing accuracy management, in particular, in each inspection room.

[0171] Conventionally, the device accuracy management is managed in the control unit 100 of the particle analysis device 1000. On the other hand, the results of the accuracy management of the sample using the inspection item management have not been managed by the system that manages the particle analysis device 1000. Therefore, each inspection room needs to manage the results of the accuracy management of the sample using a system different from the system that controls the particle analysis device 1000.

[0172] In the present disclosure, setting of conditions for quality management using the inspection item management sample and management of the quality management results measured based on the set conditions can be performed in the control unit 100 that controls the particle analysis apparatus 1000. In other words, the evaluation criteria used in the quality management using the inspection item management sample are input to the control unit 100, and the results of the quality management performed are displayed on the application interface of the particle analysis apparatus 1000 based on the input evaluation criteria.

[0173] (Assisted method of precision management)

[0174] exist Figure 1 In step S1, after the user inputs an instruction for starting processing to the control unit 100 (for example, starting the application software for particle analysis), the processing unit 10 displays Figure 5 The processing unit 10 receives input of, for example, a user ID and a password from the login interface, and displays the information on the output unit (display unit) 17. Figure 6 Main interface B is shown.

[0175] First of all, Figure 6 The main interface B shown and each process for assisting precision management are described. Each interface is a user interface that accepts user input in order to assist precision management. The "input area" used in the following description is an area where the user inputs necessary information by entering text from the input unit. The "icon" is a selection area in which an interface for performing a process that the user wishes to operate is displayed by selecting the area by the user. The user can operate the input unit 16 and select an icon. The "drop-down list" is a list in which, if the user selects the area using a mouse or a touch screen, the options stored in the memory 12 or the auxiliary storage unit 13 are displayed in a list, and the user can select each item displayed in the list.

[0176] ・Main interface

[0177] Figure 6 , a main interface B for performing operations to control the particle analysis device 1000 is illustrated. The main interface B is an interface that is displayed after the control unit 100 is started and an application for controlling the particle analysis device 1000 is started. The main interface B includes a main operation area B1, a work list area B2, a particle analysis condition setting area B3, an analysis status display area BA, and an analysis operation area B6.

[0178] The main operation area B1 displays a main (Main) icon B11 for displaying the main operation area, a precision management (QC) icon B12 for displaying the precision management area, a setting icon B13 for displaying the particle analysis condition setting area B3, a maintenance icon B14 for displaying the maintenance area, and an exit icon B15 when the user exits from the main interface. The computer program for assisting precision management in the present disclosure can be accessed from the precision management (QC) icon B12.

[0179] The work list area B2 displays, in a selectable manner, a work list tab B22 for displaying a list of measurement samples to be measured and an inspection item management (panel master) tab B23 for setting inspection items to be measured for each measurement sample.

[0180] In the particle analysis condition setting area B3 , a setting tab B33 for setting measurement conditions and a stop tab B34 for performing an analysis end operation are displayed in a selectable manner.

[0181] The analysis status display area BA displays the home tab BA1 for displaying the light received from the measurement sample in real time or as a recorded image, and tabs BA2 to BA5 for performing other operations in a selectable manner. The home tab BA1 displays the graph (plot) tab BA10 for plotting the light received from the measurement sample as a scatter diagram, and the report tab BA5 for displaying the results, etc. in a selectable manner.

[0182] Displayed in the analysis operation area B6 are: a measuring device status display area B60 for operating the measuring unit 200, a measuring device name display area B61, a measurement start icon B62, a measurement stop icon B63, a measurement cancel icon B64, areas B66 to 68 for displaying the number of measured particles and the measurement time, an icon B70 for displaying the remaining reagent amount, an icon B71 for displaying the waste liquid status, an icon B72 for indicating the printer status, an error display icon B73, a measurement sample information input area B74, a message display area B75, a measurement mode display area B76, and a user information display area B77.

[0183] The operation interface described below including the main interface is displayed by, for example, the processing unit 10 executing application software stored in the auxiliary storage unit 13 .

[0184] ・Device quality control (QC) setting process

[0185] The processing unit 10 Figure 1In step S2, the device quality control (QC) setting process is performed. The following is an example of the device quality control (QC) setting process. In order to set the management conditions for managing the measurement data of the sample by the user, for example, the processing unit 10 receives the user's Figure 6 Selection of the quality control (QC) icon B12 of the main interface B for controlling the operation of the particle analysis apparatus 1000 ( Figure 7 Step S101 is shown), as Figure 8 As shown, a quality control (QC) file list area BQC0 and a measurement item (subset panel) list display area BQC3 are displayed instead of the work list area B2. In the quality control (QC) file area BQC0, a quality control (QC) file operation area BQC1 for operating a quality control (QC) file and a list display area BQC2 for displaying a list of quality control (QC) files are displayed. In the quality control (QC) file operation area BQC1, a quality control (QC) icon X1 for selecting, for example, a quality control (QC) file in the list display area BQC2 with a cursor, a setting icon X2 for setting a quality control (QC) file, a device quality control (QC) file registration icon X3 for registering a new quality control (QC) file, a measurement item (subset panel) selection icon X4, and a delete icon X5 are displayed. The quality control (QC) file corresponds to each inspection item (panel). In the measurement item (subset panel) file area BQC3, a list BQC4 is displayed, which displays the measurement items (subset panel) included in each inspection item (panel) selected by the cursor or the like in the list display area BQC2.

[0186] In addition, Figure 7 In step S101, as shown in Figure 8 As shown, the processing unit 10 displays an area BQC5 showing the measurement results of the management sample instead of the particle analysis condition setting area B3. The area BQC5 displays a radar chart label BQC6 showing the measurement results for each channel and an LJ chart label BQC7 showing the measurement results for each channel in time series.

[0187] exist Figure 7 In step S102, the processing unit 10 displays the icon X3 by accepting the user's selection. Fig. 9 A device quality control (QC) file dialog box for setting new management conditions for measurement data of a management sample is shown (step S103 ).

[0188] The quality control (QC) file registration dialog box X3D is displayed. The device quality control (QC) file registration dialog box X3D displays, for example: a drop-down list area X3D1 for selecting the name of the inspection item (panel) indicating the quality control (QC) file of the device, a drop-down list area X3D2 for selecting the device management sample name, an area X3D4 for inputting the batch number of the device management sample, an area X3D5 for inputting the expiration date of the device management sample, an OK icon X3DE for confirming the input and proceeding to the next step, and a cancel icon X3DC for terminating the setting.

[0189] In step S104, the processing unit 10 accepts the user's selection of the drop-down list area X3D1. The processing unit 10 will accept the batch number of the device management sample entered by the user in area X3D4 and / or the expiration date of the device management sample entered in area X3D5 as needed. Then, in step S105, the processing unit 10 stores the input contents entered into the device precision management (QC) file registration dialog box X3D according to the user's selection of the OK icon X3DE, and closes the device precision management (QC) file registration dialog box X3D. Interface display returns Fig.10 The main interface B showing the quality control (QC) file BQC0 is shown (step S106 ).

[0190] In step S107, the processing unit 10 selects the quality control (QC) file to be set according to the user's designation of the quality control (QC) file listed in the device quality control (QC) file list BQC2 (step S107), and accepts the instruction of the quality control (QC) file setting to set the baseline according to the user's selection of the setting icon X2 (step S108).

[0191] Next, the processing unit 10 displays a baseline dialog box X2D for setting a baseline ( Fig.11) (Step S109). The baseline dialog box X2D displays: a start icon X2D1 for starting the measurement, a measurement item (subset panel) list display area X2D2, a light receiving element status display area X2D4, an OK icon X2DE for confirming the input and proceeding to the next step, and a cancel icon X2DC for terminating the setting. The measurement item (subset panel) list display area X2D2 displays the measurement item (subset panel) list X2D3. In addition, in the area displayed in the light receiving element status display area X2D4, the voltage and variance (Rubust Coefficient Value: rCV) of each light receiving element (PMT) are displayed for each channel (type of received light). The PMT voltage and rCV include an area for displaying the target value (Target) and an area for displaying the actual value (Value). The light receiving elements involved in precision management include elements that receive fluorescence, elements that receive forward scattered light (FSC), and elements that receive side scattered light (SSC).

[0192] After performing step S109 or before step S109 , the user prepares the device management sample and places it in the pipetting unit 21 of the particle analysis device 1000 .

[0193] In step S110, the processing unit 10 receives the user's selection of the start icon X2D1 and starts measuring the device management sample. Fig.12 The PMT voltage and rCV of each channel of the management sample being measured are shown (step S111). The processing unit 10 stores the target values ​​of each PMT voltage and rCV when the management sample is measured by the measurement unit 200 in the storage unit in advance. Therefore, when the management sample is measured by the measuring device, the voltage applied to the light receiving element is automatically adjusted so that the measured value of the PMT voltage is close to the target value, preferably within ±300V of each target value (step S112).

[0194] After the adjustment of the PMT voltage of the light-receiving element for all channels is completed, the processing unit 10 automatically ends the measurement. After the measurement is completed, the confirmation icon X2DE can be selected. The processing unit 10 accepts the user's selection of the selectable confirmation icon X2DE (step S113), and stores the PMT voltage value of each channel and the rCV calculated by the processing unit 10 as the setting value of the inspection item precision management (QCpanel) (step S114). The processing unit 10 ends the device precision management (QC) setting process, closes the baseline dialog box X2D, and displays the main interface B that displays the work list area B2 (step S115).

[0195] (Registration of inspection items (panels))

[0196] In order to assist the precision management using the management samples prepared in each inspection room, the present invention is disclosed by Figure 1 Steps S3 to S6 of the operation Figures 14 to 22 , Fig.24 The setting process of the inspection item precision management (QC) is performed using the illustrated interface. That is, the setting process of the inspection item precision management (QC) can include the registration process step S3 of the inspection item (panel), the registration process of the precision management (QC) file (step S5), and the setting process of the baseline (step S6). The setting process of the inspection item precision management (QC) can also further include the report preparation process (step S7).

[0197] ・Inspection item quality control (QC) setting process・・Inspection item (panel) registration

[0198] The following describes an example of the inspection item quality control (QC) setting process. In the inspection item quality control (QC) setting process, first, the processing unit 10 receives the user's registration of the inspection item (panel). The processing unit 10 receives the user's registration of the inspection item (panel). Figure 6 The selection of the inspection project management (panel master) tab B23 displayed in the work list area B2 of the main interface B is shown (FIG. 13-1, step S301). The processing unit 10 displays the inspection project management (panel master) tab B23 (FIG. 13-1, step S302). In the case where the inspection project management (panel master) tab B23 is displayed from the beginning, steps S301 and S302 can be skipped. Figure 6As shown, in the inspection item management (panel master) tab B23, the inspection item management (panel master) tab B23 displays the inspection item (panel) list area B230 and the inspection item (panel) setting list B231, wherein the inspection item (panel) list area B230 includes the inspection item (panel) registration icon B222 selected when starting the setting of a new inspection item precision management (QC), the inspection item (panel) change icon B223 for changing the inspection item precision management (QC) that has been registered, the copy icon B225 for copying the inspection item precision management (QC) that has been registered, the delete icon B226 for deleting the inspection item precision management (QC) that has been registered, the import icon B228 for reading the inspection item precision management (QC) that has been registered, and the export icon B229 for starting to write the inspection item precision management (QC). In addition, the measurement item (subset panel) list display area B232 is displayed in the horizontal direction of the inspection item (panel) list area B230. When the user selects one of the panel settings listed in the panel setting list B231, a list of subset panels included in the panel setting is displayed in the subset panel list display area B232. A copy icon G8 for copying the subset panel setting and an erase icon for deleting the setting are displayed in the subset panel list display area B232.

[0199] In step S303 of FIG. 13-1 , the processing unit 10 receives the user's selection of the inspection item (panel) registration icon B222 in the inspection item (panel) list area B230 and displays Fig.14The inspection item management (panel master) registration dialog box G1D is shown. The inspection item management (panel master) registration dialog box G1D displays: an inspection item (panel) name input area G1D1 for inputting inspection item names, etc., a panel ID input area G1D2 for inputting identification numbers of inspection items (panels), a comment input area G1D3 for inputting comments on inspection items, etc., a measurement item management (subset panel master) display area G1D4 for displaying a list of measurement items included in the inspection item (panel), a confirmation icon G1DE for selection when confirming the inspection item management (panel master) registration dialog box G1D, and a cancel icon G1DC for selection when canceling settings. The measurement item management (subset panel master) area G1D4 displays: a measurement item (subset panel) list G1D41, a measurement item (subset panel) registration icon H1 for registering a new measurement item (subset panel), a measurement item (subset panel) update icon H2 for selecting when updating the settings of a registered measurement item (subset panel), a delete icon H3 for deleting the settings of the measurement item (subset panel), and a copy icon H4 for copying the settings of the measurement item (subset panel).

[0200] In step S305 of FIG. 13-1 , the processing unit 10 receives input from the user into each input area of ​​the examination item management (panel master) registration dialog box G1D. Fig.14 In the example, “6CTBNK” is input in the inspection item (panel) name input area G1D1. In the example, “1234” is input in the panel ID input area G1D2. Next, in step S306, the processing unit 10 receives the user's selection of the measurement item (subset panel) registration icon H1.

[0201] Next, in step S307 of FIG. 13-1 , the processing unit 10 displays Fig.15The measurement item (subset panel) registration dialog box H1D is shown. The measurement item (subset panel) registration dialog box H1D displays: a measurement item (subset panel) name input area H1D1 for inputting a measurement item (subset panel) name, etc., a measurement item (subset panel) ID input area H1D2, a comment input area H1D3 for inputting a comment as needed, a detection reagent name input area H1D4 for inputting a name of a detection reagent, a detection reagent ID input area H1D5 for inputting an identification number of a detection reagent, a confirmation icon H1DE for confirming the input, and a cancel icon H1DC for terminating the setting. In step S308 of FIG. 13 , the processing unit 10 receives the user's input to each input area of ​​the measurement item (subset panel) registration dialog box H1D. Here, as an example, "CD3 / CD4 / CD8 / CD16+..." is input in the measurement item (subset panel) name input area H1D1, and "1234" is input in the subset panel ID input area H1D2. Multiple measurement items (subset panel) can be registered.

[0202] After the user inputs to the measurement item (subset panel) registration dialog box H1D, the processing unit 10 accepts the user's selection of the confirmation icon H1DE and closes the measurement item (subset panel) registration dialog box H1D. Next, the processing unit 10 accepts the user's selection of the confirmation icon G1DE in the examination item management (panel master) registration dialog box H1D and closes the examination item management (panel master) registration dialog box H1D (FIG. 13-1, step S310).

[0203] After closing the inspection item management (panel master) registration dialog box G1D, the processing unit 10 Fig.16 As shown, the name of the newly registered inspection item (panel) setting is displayed in the inspection item (panel) setting list B231 of the inspection item management (panel master) label B23 of the main interface B through the processing of the above steps S301 to S309. (Here, "6CTBNK" is displayed. In addition to the inspection item (panel) name, the inspection item (panel) setting list B231 can also display the date and time when the inspection item (panel) was registered.

[0204] Next, the processing unit 10 allows the user to select a newly registered inspection item (panel) for the precision management (QC) inspection item from the inspection item (panel) setting list B231, and the processing unit 10 accepts the selection (FIG. 13-2, step S311). As an example, "6CTBNK" is selected here. After the user selects one inspection item (panel), as shown in FIG. Fig.17 As shown, the processing unit 10 displays a channel condition setting area B335 for setting the light receiving conditions such as the gain of each light receiving element in the setting label B33 of the particle analysis condition setting area B3, and accepts the user's input or selection of each area (Figure 13-2, step S312). In the area B335, FSC represents forward scattered light, and SSC represents side scattered light. An input area B334 for the user to input information such as what kind of light each light receiving element detects is displayed at the name (Name). Gain (Gain / PMT) represents the amplification voltage of the light receiving element. The threshold (Threshold) is usually set for FSC, which is a critical value set to receive light with an intensity above a fixed level. Time indicates whether to obtain the time axis, Logic indicates the theoretical acquisition condition of the threshold (Threshold), Height indicates whether to obtain the peak value of the fluorescence intensity, and Area indicates whether to obtain the area value. For each light receiving element, input areas B336 and B337 for the user to input values ​​are displayed in the columns of Gain (Gain / PMT) and Threshold (Threshold). Regarding the input to this area, the processing unit 10 may accept the value input by the user, or the processing unit 10 may display the gain (Gain / PMT) and threshold (Threshold) settings for each light receiving element stored in the storage unit in accordance with each light receiving element. The input settings are temporarily stored in the memory 12 when switching tabs or switching inspection items (panels).

[0205] In the channel condition setting area B335, the user can change the display area by using the scroll key SC. Fig.17 In the example shown, the number of light receiving elements for receiving fluorescence can be set from FL1 to FL10, and the number of light receiving elements can depend on the number of laser light sources mounted in the measurement unit 200.

[0206] The user scrolls down the channel condition setting area B335, and the processing unit 10 displays the channel condition setting area B335 below the channel condition setting area B335. Fig.18The flow rate setting area B341 is shown as an example, and a setting area B351 for the laser to be used is further displayed below the flow rate setting area B341, and the user's input or selection of each area is accepted (Figure 13-2, step S313, step S314). The flow rate setting area B341 is provided with a flow rate adjustment bar B342 that can adjust the flow rate of the flow cytometer in stages. The processing unit 10 accepts the adjustment of the flow rate adjustment bar B342 by the user's operation, and controls the flow rate of the liquid in the flow chamber 27 of the measurement unit 200 through the I / F unit 15. The laser setting area B351 is provided with an icon B352 for the laser that the user can select to use. For example, if the user selects the icon B352 under the wavelength that is not used, the processing unit 10 changes the color of the icon to indicate that the laser is not selected, and the processing unit 10 sends the information that the icon is selected to the measurement unit 200 through the I / F unit 15. Another embodiment may be as follows: when the user selects the icon B352 under the wavelength to be used, the processing unit 10 changes the color of the icon to indicate that the laser has been selected, and transmits information indicating that the icon has been selected to the measuring unit 200 via the I / F unit 15 .

[0207] Next, the processing unit 10 receives the user's selection of the stop tab B34. Then, the processing unit 10 displays Fig.19 The stop label B34 shown in the example accepts the user's input or selection for each area (FIG. 13-2, step S315). The stop label B34 includes: a stop logic setting area B361 for accepting input of the stop condition setting, an event count area B362, and a time area B363. The stop logic setting area B361 includes a stop condition logic setting icon B3611. If it is set to "or", the setting cannot be changed. The event count area B362 includes a drop-down list display area B3621 for setting the stop condition and an input area B3622 for the number of cells to be measured at the stop measurement. The time area B363 includes an input area B3631 for inputting the time setting for ending the measurement at a certain time. Either the event count area B362 or the time area B363 can be selected. When a condition input by the user is satisfied, the processing unit 10 sends a command to stop the measurement to the measuring unit 200 via the I / F unit 15 .

[0208] The inputted setting is temporarily stored in the memory 12 when switching the tab or switching the inspection item (panel), or is automatically stored in the storage unit in the auxiliary storage unit 13 ( FIG. 13-2 , step S316 ).

[0209] Next, the processing unit 10 accepts the user's insertion of a new chart. Fig. 20 The input of a new graph input to the plot tag of the home tab BA1 displayed in the area BA is accepted. In addition, when the home tab BA1 is not displayed, before accepting the input of a new graph input to the plot tag, the user's selection of the home tab BA1 is accepted (Figure 13-3, step S317). The home tab BA1 includes a graph insertion area BA1A for inserting a drawing and a graph display area BA1B for displaying a graph. The graph insertion area BA1A includes: a gate area BA1A1 including an icon for inserting a gate, an add graph (Add Plot) area BA1A2 including an icon for adding a graph to the graph display area BA1B, an area BA1A3 for displaying the parent gate (ParentGate) of only the particles in the gate (gate) set in the upper gate (gate) in the graph, and an edit (Edit) area BA1A4 including a delete icon for deleting the graph. The processing unit 10 receives the user's selection of an icon displayed in the add graph (AddPlot) area BA1A2 , and additionally displays an empty graph corresponding to the selected icon in the graph display area BA1B ( FIG. 13-3 , step S317 ).

[0210] Next, the processing unit 10 accepts the user's setting for the graph added in step S316. Specifically, the user selects the view tab BA2 and displays the graph. Fig.21The view tab of the example (step S318). The view tab BA2 displays: a chart setting area BA2A for setting the display of each chart, and a chart display area BA1B for displaying each chart. The chart setting area BA2A also includes a scaling area BA2A1 and a histogram style area BA2A2. The scaling area BA2A1 displays an input area for setting the X-axis and Y-axis of each chart. For each axis, there are: a drop-down list for setting the light receiving element displayed on the axis (BA21 for the X axis and BA211 for the Y axis), a drop-down list for selecting linear display or logarithmic display (BA22 for the X axis and BA212 for the Y axis), an input area for inputting the minimum value of the axis (BA23 for the X axis and BA213 for the Y axis), an input area for inputting the maximum value of the axis (BA24 for the X axis and BA214 for the Y axis), and a drop-down list for displaying one parameter of the bi-exponential axis, namely, negative % (BA25 for the X axis and BA215 for the Y axis). In addition, in the histogram style area BA2A2, the auto scaling selection area BA221 for allowing the user to select whether to automatically set the axis, and the area BA222 for inputting the display area of ​​the Y axis of the selected histogram, namely, the max count, are included in the chart setting area BA2A. The graph display area BA1B includes a graph (plot) tab BA10 for displaying a graph and a report tab BA20 for generating a report.

[0211] exist Fig.21 In the plot label shown, as an example, the light signal received by the measuring unit 200 is displayed as a two-axis scatter plot of different combinations of light receiving elements in six graphs of graphs 1 to 6, but each graph can be displayed according to the number of different combinations of light receiving elements. In addition, the graph is not only a scatter plot, but the light signal received by the measuring unit 200 can also be displayed as a histogram of the light receiving element to express the light intensity and the number of particles.

[0212] The user can select each graph by, for example, clicking on the displayed graph, etc. With respect to the graph selected by the user, the processing unit 10 receives the setting of the axis set by the automatic scaling function for displaying the range of the maximum and minimum values ​​of the measured particles for the selected graph, or receives the selection or input of the user for each area of ​​the graph setting area BA2A for each graph ( FIG. 13-3 , step S319 ).

[0213] When the user completes the setting of all the charts, the processing unit 10 accepts the input of this information (FIG. 13-3, step S320). When the processing unit 10 accepts the input of this information (Yes), when switching the tab or switching the inspection item (panel), the content set for each chart is temporarily stored in the memory 12, or automatically stored in the storage unit in the auxiliary storage unit 13 (step S321). When the input of this information is not completed, it returns to step S319 and accepts the user's further selection and input of the chart.

[0214] Next, the processing unit 10 sets a gate for the chart whose settings have been completed and saved in step S320. The processing unit 10 receives the user's selection of the home tab BA1 and displays the chart insertion area BA1A (see Fig. 20 The chart is inserted into the chart display area BA1A). Next, the user's selection of the chart is accepted in the same manner as step S318, and the gate corresponding to a gate icon displayed in the gate area BA1A1 selected by the user by clicking, touching, etc. is displayed in the chart selected in the chart display area BA1B. The gate displayed in the chart can be moved in response to the user's selection and dragging, and operations on the arrow keys of the keyboard. The processing unit 10 accepts the position of the gate determined by the user as the setting of the gate (Figure 13-3, step S322). When the user completes the setting of all charts, the processing unit 10 accepts the input of this information (Figure 13-3, step S323). When the processing unit 10 receives the input of the information that it has been completed (Yes), when switching labels or switching inspection items (panels), the content set for each chart is temporarily stored in the memory 12, or automatically stored in the storage unit to the auxiliary storage unit 13 (step S324). When the input of this information has not been completed, return to step S3222 and accept further user selection of charts and setting of gates.

[0215] Next, the processing unit 10 measures the test item management sample prepared by the user in the measuring unit 200, and accepts further adjustments by the user on the settings of each chart set in steps S322 to S329 (FIG. 13-3, step S325). The user places the sample on the aspiration unit 21 of the measuring unit 200 and selects Fig. 22The processing unit 10 receives the user's selection of the measurement start icon B62 and sends a command to start the measurement to the measurement unit 200 via the I / F unit 15. In addition, the processing unit 10 receives information on the light signal detected by each light receiving element of the measurement unit 23 via the I / F unit 15. The processing unit 10 displays the information on the received light signal in the form of a graph corresponding to the light intensity and / or a graph corresponding to the cell size in the graph corresponding to each light receiving element in the graph display area BA1B (FIG. 13-3, step S326, Fig. 22 ). The chart is preferably a scatter plot or a histogram. The user selects the drawing and readjusts the axis and / or gate while viewing each chart, and the processing unit 10 accepts the user's selection of the chart and the readjustment of the axis and / or gate (Figure 13-3, step S327). When the user completes the settings for all charts, the processing unit 10 accepts the input of this information (Figure 13-3, step S328). When the processing unit 10 receives the input of the information that this has been completed (Yes), when switching labels or switching inspection items (panels), the content set for each chart is temporarily stored in the memory 12, or automatically stored in the storage unit 13 in the storage unit (step S329). When the input of this information has not been completed, return to step S326 to accept further user selection of charts and setting of gates.

[0216] ・・Quality Control (QC) document registration

[0217] After the registration process of the inspection item (panel) is completed, the processing unit 10 then receives the registration of the quality control (QC) file by the user ( Figure 1 , step S4). Accept the user's Fig. 22 Select the quality management (QC) icon B12 and display the quality management (QC) file BQC0 ( Fig.24 ). Next, the processing unit 10 receives the user's selection of the quality control (QC) file registration icon X3 in the quality control (QC) file operation area BQC1 and displays Fig.25 The QC file registration dialog box shown in X3DT ( Fig.23, step S401). The precision management (QC) file registration dialog box X3DT includes: an inspection item (panel) name drop-down list area X3DT1 for displaying the name of the registered inspection item (panel), a comment display area X3DT2 for displaying the comments attached to the registered inspection item (panel), a measurement item (subset panel) display area X3DT3 for displaying the measurement items (subset panel) registered in the inspection item (panel), an archive icon X3DTE for confirming the setting and closing the precision management (QC) file registration dialog box X3DT, and a cancel icon X3DTC for closing the precision management (QC) file registration dialog box X3DT without archiving the setting.

[0218] The drop-down list area X3DT1 displays a list of inspection item (panel) names set in the above-mentioned “Registration of inspection item (panel)”. The comment display area X3DT2 displays the contents input to the comment input area G1D3 of the inspection item management (panel master) registration dialog box G1D.

[0219] The measurement item (subset panel) display area X3DT3 displays the measurement item (subset panel) name input in step S308 of FIG. 13 .

[0220] Next, if Fig.26 As shown, the processing unit 10 receives the user's selection of an inspection item (panel) name from the drop-down list of inspection item (panel) names, and displays the measurement item (subset panel) list corresponding to the selected inspection item (panel) name in the measurement item (subset panel) display area X3DT3 ( Fig.23 , step S402). One measurement item (subset panel) list includes columns for displaying the position number (Pos.) of the reagent, the measurement item (subset panel) name, the expiration date (Expiration Date) of the reagent, and comments. The position number, expiration date, and comments of the reagent are input by receiving input from the user, and the processing unit 10 receives the input ( Fig.23 , step S402). Fig.26 In the reagent expiration date, the user selects a date mark in the reagent expiration date column, or clicks on it to display a calendar and select a date from the calendar, or directly enter a date.

[0221] Next, the processing unit 10 receives the user's confirmation of the input, that is, the user's selection of the archive icon X3DTE ( Fig.23, step S403), and close the quality control (QC) file registration dialog box X3DT. At this time, the processing unit 10 stores the content input by the user in the memory 12 or the auxiliary storage unit 13. Next, the processing unit 10 receives the user's Fig.24 Select the measurement item (subsetpanel) selection icon X4, and the Fig. 27 The baseline setting interface T ( Fig.23 , step S403).

[0222] ・・Baseline setting

[0223] In the baseline setting interface T, the processing unit 10 receives settings of the evaluation criteria of the quality management, etc., based on the measurement data obtained by measuring the inspection item management samples prepared in each inspection room by the particle analyzer 1000 in step S325 of FIG. 13-3. This setting is Figure 1 The baseline setting process in step S5 is performed.

[0224] exist Fig. 27 The baseline setting interface T shown can display: the display area T1 for the inspection item (panel) name, the display area T2 for the inspection item (panel) comment, the display area T3 for the measurement item (subset panel) name, the display area T4 for the measurement item (subset panel) comment, the setting area (QCItem) for each channel T5, the particle distribution display area T6, the list display area T61 for displaying the settings of the upper gate (gate), the target MFI display area T62 for inputting the fluorescence intensity corresponding to the voltage value, the fixed range setting area T63 for the evaluation standard (Limit) of the precision management, the area T64 for manually inputting the upper limit value (UpperLimited) of the evaluation standard of the precision management, the area T65 for manually inputting the lower limit value (LowerLimited) of the evaluation standard of the precision management, the OK icon TO for confirming the setting, and the Cancel icon TC for terminating the setting. Fig. 27 In the example, the list display area T61 and the fixed range setting area T63 showing the settings of the upper gate are displayed in the form of a drop-down list, but can also accept text input by the user. Statistical information can be entered in the fixed range setting area T63. Statistical information is, for example, ±1SD (SD is standard deviation), ±2SD, ±3SD, mean, median, number of cells, etc.

[0225] In addition, the PMT value / gain setting label T51, the compensation label T52 for fluorescence correction, and the statistics label T53 are displayed in a switchable manner in the setting area T5 of each channel. A check box is provided horizontally where the label name "PMT value / gain", "compensation", "statistics", etc. is displayed, and the user can select it by clicking or touching. The item of the label selected by selecting the check box can be used as a management item for quality management. The PMT value / gain setting label T51 includes an item area for selecting each channel (light receiving element) and a target area for selecting the management object (PMT value and / or rCV). The value set in the device quality management (QC) is displayed in the target area. Symbol T54 indicates an icon selected by the user when adding a channel. SSC, FSC, FL4, FL1, FL5, FL8, FL6, FL2, etc. displayed in the item area are text strings corresponding to each channel (light receiving element). "H" indicates the height value, and "A" indicates the area value. Fig. 20 The axis numbers of each graph displayed in the plot tab correspond to each other and are displayed by the processing unit 10. Whether or not to be a management item for accuracy management can be set in each tab unit by the user by clicking a check box, or can be set for each light receiving element by double-clicking the option of the target area.

[0226] In the particle distribution display area T6, the vertical axis is the number of particles and the horizontal axis is the fluorescence intensity, and the distribution of particles when measuring the inspection item management sample is displayed. In the particle distribution display area T6, a graph corresponding to the intensity of light and / or a graph corresponding to the cell size is displayed, preferably a histogram or a scatter plot. In the particle distribution display area T6, it is possible to switch between displaying by a histogram and displaying by a scatter plot. The particle distribution display area T6 displays Fig. 22 The graphs shown are displayed in the plot tab BA10. Fig. 27 This is an example of a histogram showing particle distribution. In this area, the gate is set to the peak range of the particle group you want to manage. The position and width of the gate can be adjusted by the user moving the T8 area with a mouse.

[0227] The range for acquiring the fluorescence signal is displayed as a gate T8 in the particle distribution display area T6.

[0228] The panel name display area T1 displays the panel name information set in the "Registration of panel" above. The panel comment display area T2 displays the content input to the comment input area G1D3 of the panel master registration dialog box G1D. The measurement item (subset panel) name display area T3 displays the measurement item (subset panel) name input in step S308 of FIG. 13. The measurement item (subset panel) comment display area T4 displays the measurement item (subset panel) name, respectively. Fig.15 Comments accepted by comment input area H1D3 are shown.

[0229] If the user selects the compensation tag T52, Fig.28 As shown in FIG. 1 , the processing unit 10 displays a table in which the values ​​indicating the fluorescence intensity are inputted and the numbers of the light receiving elements are arranged in the column direction and the row direction, instead of displaying the item area and the target area. When the setting for automatic fluorescence correction is made when registering the inspection item (panel), the table displays the values ​​stored in the auxiliary storage unit 13 or the memory 14 by the processing unit 10 when measuring the management sample. The row direction indicates the Area value, and the column direction indicates the detector. For example, "100" is displayed in the cell of row FL1 and column FL1. This means that the light in the fluorescence wavelength range that the light receiving element of FL1 should detect is detected by the light receiving element of FL1 at 100%. On the other hand, for example, "4.1" is displayed in the cell of row FL2 and column FL1. This means that the light in the fluorescence wavelength range that the light receiving element of FL2 should detect is detected by the light receiving element of FL1 at 4.1%. At this time, it means that when combining FL1 and FL2 for particle detection, it is necessary to perform correction so that the light detected by the light receiving element of FL1 is reduced by 4.1% of the spectral amount.

[0230] When the compensation tab T52 is selected, the particle distribution display area T6 switches to a graph display. Fig.28 In the example above, only the parent gate can be selected.

[0231] If the user selects the Statistics tab T53, Fig.29 As shown in FIG. 1 , the processing unit 10 displays statistical results of gates in each graph set by measuring a management sample when registering an inspection item (panel). Fig.29In the example of FIG. 1 , the first column of the statistical result displays a number, which indicates an item name, for example, a panel name - a marker for lymphocytes. The processing unit 10 displays the item name. Fig. 22 The name of the gate of the graph labeled BA10 shown in the graph (plot). Lymph is divided into CD3 positive (CD3+) and CD3 negative (CD3-) groups. The CD3+ group is further divided into CD4+ / CD8+, CD4+ / CD8-, CD4- / CD8+, and CD4- / CD8- according to the type of lymphocytes. The CD3- group is divided into CD19+ / CD16+, CD19+ / CD16-, CD19- / CD16+, and CD19- / CD16-. The second column of the statistical results shows the number of cells counted (#Count). For example, in the row Lymph, it means that 10,000 cells were counted. The row of CD3+ means that there are 8721 CD3+ cells in Lymph. In addition, CD4+ / CD8+ means that there are 5102 CD4+ / CD8+ cells in CD3+. X_rCV shows the variance of the fluorescence intensity on the X axis. Y_mean represents the arithmetic mean of the fluorescence intensity on the Y axis.

[0232] If the user selects the Statistics tab T53, a histogram or scatter plot corresponding to the item is displayed in the particle distribution display area T6. In addition, a fixed range setting area T63 for setting the evaluation criterion for precision management (Limit), an area T64 for manually inputting the upper limit value (UpperLimited) of the evaluation criterion for precision management, and an area T65 for manually inputting the lower limit value (LowerLimited) of the evaluation criterion for precision management are displayed. The processing unit 10 accepts the user's selection of these areas or input to these areas.

[0233] ・・Setting of evaluation criteria for quality management

[0234] Taking Figure 30-1 as an example, Figure 1 The method of setting the baseline (setting the evaluation standard for quality management) shown in step S5 will be described.

[0235] In step S501 of FIG30-1 , the processing unit 10 receives the user's selection of a channel of the PMT gain (PMT / gain) label T51. If the PMT gain (PMT / gain) label T51 is not selected, the user's selection of the PMT gain (PMT / gain) label T51 is received before step S501, and the PMT gain (PMT / gain) label T51 is displayed.

[0236] Next, the processing unit 10 displays a histogram or a scattergram corresponding to the selected channel (step S502 ).

[0237] Next, the processing unit 10 accepts the user's adjustment of the gate T8 (step S503 ).

[0238] Next, the processing unit 10 receives the user's input or selection of the list display area T61 displaying the settings of the upper gate, the target MFI display area T62, and the fixed range setting area T63 or the area T64 for manually inputting the upper limit value (UpperLimited) and the area T65 for manually inputting the lower limit value (LowerLimited) (step S504). This step is a step of setting the evaluation criteria.

[0239] Next, if the user performs an operation indicating that all settings are completed, the processing unit 10 assumes that all channel settings are completed (YES) and proceeds to the next step. If the user does not perform an operation indicating that all settings are completed, the process returns to step S501 and accepts the next channel selection.

[0240] Next, after the setting of the PMT gain (PMT / gain) tab T51 is completed, the user's selection of the compensation tab T52 is accepted and the compensation tab T52 is displayed ( FIG. 30-2 , step S506 ).

[0241] Next, the processing unit 10 receives the user's selection of the Statistics tab T53 and displays the Statistics tab T53 ( FIG. 30-2 , step S507 ).

[0242] Next, the processing unit 10 receives user input or selection in the fixed range setting area T63 or the area T64 for manually inputting an upper limit value (UpperLimited) and the area T65 for manually inputting a lower limit value (LowerLimited) ( FIG. 30-2 , step S508 ). This step is a step of setting evaluation criteria based on statistical values.

[0243] Next, the processing unit 10 accepts the user's selection of the OK icon TO of the baseline setting interface T ( FIG. 30-2 , step S509 ). After accepting the selection of the OK icon TO, the processing unit 10 closes the baseline setting interface T and displays the quality control (QC) file registration dialog box X3DT ( FIG. 30-2 , step S509 ).

[0244] Next, the processing unit 10 receives the user's selection of the archive icon X3DTE of the quality control (QC) file registration dialog box X3DT, and stores the evaluation criterion setting in the storage unit as data in a file format that can be exported by the program for controlling the operation of the particle analyzer 200 in the daily quality control (QC) process described later by the processing unit 10. The processing unit 10 stores the evaluation criterion setting in the memory 12 or the auxiliary storage unit 13, preferably in a non-volatile manner in the auxiliary storage unit 13 (FIG. 30-2, step S510).

[0245] Next, the processing unit 10 displays the display screen as the output unit 17. Fig.31 The selection interface dialog box S for the quality management method is shown (step S511). Area S1 of the selection interface S is an example for allowing the user to select a quality management method. The Yes area S2 is an area for allowing the user to confirm the selection, and the No area S3 is an area for accepting a selection for canceling the setting. When the user selects ○ of NotUpdate in area S1, the processing unit 10 uses the evaluation criteria of the quality management set by the method described in the setting of the inspection item quality management (QC) to perform the quality management described below. After accepting the user's selection of the Yes area S2 or the No area S3, the processing unit 10 closes the selection interface dialog box S for the quality management method and displays Fig.32 The main interface B including the quality control (QC) file BQC (FIG. 30-2, step S512).

[0246] ・・Report preparation

[0247] Next, the processing unit 10 performs Figure 1 The report generation process is shown in step S6. Fig.33 As shown, the processing unit 10 displays the quality control (QC) file "6CTBNK" in which the evaluation criteria for quality management are set in the quality control (QC) file operation area BQC1. If the user selects the quality control (QC) file in the quality control (QC) file operation area BQC1, a list of measurement items (subset panels) is displayed in the list BQC4. Here, a list of measurement items (subset panels) of "CD3 / CD4 / CD8 / CD16+..." is displayed. After the user selects the measurement item (subset panel) list and the processing unit 10 receives the processing of selecting archivebuttonAcB, the processing unit 10 displays the report in the report tab BA20. The results selected by the user are displayed in the report tab BA20. For example, the sample information display area BA201, the chart display area BA202, the counting result display area BA203, the measurer signature area BA204, etc. are displayed.

[0248] Preferably Figure 1 In steps S1 to S5, the user's access rights are limited. Figure 5 The password entered in the login interface L shown is managed only by users with management authority. In this way, the evaluation criteria of the set accuracy management can be prevented from being arbitrarily changed.

[0249] (Precision Management Method)

[0250] The control unit 100 performs quality management in daily inspection (also referred to as "daily quality management (QC)") using the evaluation criteria for quality management of each measurement item (subset panel) set in the above "setting of inspection item quality management (QC)". In this case, the control unit 100 is a quality management device.

[0251] ・Daily quality control (QC) processing

[0252] Daily quality control (QC) is performed using control samples prepared in each inspection room. Figure 1 Here, the setting of the evaluation criteria for quality management does not need to be performed before each daily quality management (QC), and can be performed at regular intervals such as once a week or once a month, or when the batches of test reagents and management samples are changed. Sometimes, the interfaces required for daily quality management (QC) are collectively referred to as quality management interfaces.

[0253] Fig.34 This shows the daily quality control (QC) process flow. Fig.35 2 illustrates a login interface L for performing daily quality control (QC). Daily quality control (QC) can also be performed by a user without authority, so the login interface L is not essential. In step S701 , the processing unit 10 receives a user's selection of a quality control (QC) icon B12 .

[0254] Next, in step S702, Fig.36 As shown, the processing unit 10 displays a quality control (QC) file list area BQC0 and a measurement item (subset panel) list display area BQC3 .

[0255] Next, in step S703, the processing unit 10 accepts the user's selection of the quality control (QC) inspection item (panel) generated in the quality control (QC) setting process displayed in the quality control (QC) file list area BQC0. Next, in step S704, the processing unit 10 accepts the user's selection of the quality control (QC) icon X1 for displaying the content of the quality control (QC) file.

[0256] Next, in step S705, the processing unit 10 displays Fig.37 The daily quality control (QC) dialog box X1D is shown. The daily quality control (QC) dialog box X1D displays the following in the daily quality control (QC) dialog box X1D: ​​a start icon X1D1 for starting measurement, a measurement item (subset panel) list display area X1D2, a light receiving element status display area X1D4, an OK icon X1DE for confirming input and advancing to the next step, and a cancel icon X1DC for terminating the setting. The measurement item (subset panel) list display area X1D2 displays a measurement item (subset panel) list X1D3. In addition, in the area displayed in the light receiving element status display area X1D4, the voltage and variance (rCV) of each light receiving element (PMT) are displayed for each channel. The PMT voltage and rCV include an area for displaying a target value (Target) and an area for displaying an actual value (Value). The target value determined in advance is displayed in the area for displaying the target value. The user places the device management sample in the aspiration section 21 of the particle analysis device 1000 after step S705 or before step S705.

[0257] In step S706, the processing unit 10 Fig.38 The PMT voltage value of each channel when the device management sample is being measured and the rCV calculated by the processing unit 10 are displayed, and the user selects the start icon X1D1 to start the measurement of the device management sample. Fig.23 As shown, the PMT voltage is automatically set so that the PMT voltage becomes a value close to the target value according to the measurement item. After the PMT voltage is set, the confirmation icon X1DE can be selected. The processing unit 10 accepts the user's selection of the confirmation icon X1DE and closes the daily quality control (QC) dialog box X1D.

[0258] Next, the user places the inspection item management sample prepared in the inspection room on the aspiration unit 21. The processing unit 10 starts measuring the inspection item management sample prepared in the inspection room according to the measurement start instruction input by the user (step S707). After the measurement is completed, the processing unit 10 outputs the accuracy management result (step S708). The accuracy management result can be displayed as a numerical value or as a chart or other chart. The chart can illustrate a chart (such as a radar chart) that is expanded by several axes with each channel as the axis. In addition, the chart can illustrate a time series chart such as an Xbar-R management chart (Levey-jenningscharts: L-Jcharts) and an Xbar-Rs-R management chart for each channel. Each channel can also be displayed as a PMT voltage value and / or an rCV value of each channel. The results of the accuracy management can be displayed each time daily accuracy management (QC) is performed.

[0259] A chart with multiple axes is preferred because it can display the results of one daily quality control (QC) on multiple axes in one interface. In addition, a time series chart is displayed together with the quality control results of at least one time point in the past, so that changes within a day and changes between days can be monitored. The quality control interface that displays the quality control results can include at least an area that displays the quality control results for each test item and the evaluation criteria for each test item.

[0260] For example, for each channel, the output unit 17 is an output of the display, for example Fig.39 shown. Fig.39 The left side shows an example of a radar chart label BQC6 of the area BQC5 showing the measurement results of the inspection item management sample. The measurement results of the inspection item management sample are displayed as a Radar chart. Fig.40 The figure shows a radar chart with each channel as the axis. Fig.41 The diagram in the figure shows the meaning of the lines displayed in each Radar. LowerLimit represents the lower limit of the management limit. UpperLimit represents the upper limit of the management limit. The graph represents the actual measured value, and Target represents the target value. FL1 and FL2 represent each channel. Each axis of the radar chart represents each detection object in each channel. There is no limit to the number of axes of the radar chart, and it is preferably 3 to 6 so that the displayed text can be recognizable. By displaying the precision management data in this way, in the event of poor precision management, the user can clearly understand which channel has a problem at a glance.

[0261] Fig.42 This is a display example of L-J graph label BQC7. Fig.43 This is an enlarged view of the L-J chart label BQC7. In the L-J chart label BQC7, the measurement data of each management sample is graphed in a time series together with the management limit, so that the user can understand the changes in analysis accuracy at a glance. The L-J chart label BQC7 displays: an item display area LJ1 that displays the channel object item name corresponding to each chart, and a chart display area LJ2 that displays the accuracy management chart (preferably the Xbar-R management chart). The L-J chart label BQC7 also displays: an icon Y1 for displaying the details of each chart, an icon Y2 for deleting a chart from the chart, and an icon Y3 for inserting comments. Use Fig.44If the display in the L-J chart label BQC7 is explained in more detail, each chart corresponds to one precision management measurement. It can be selected by matching the precision management cursor CS with it. In addition, the measurement date and time of the chart on the cursor are displayed horizontally to the cursor CS. In addition, for example, when poor precision management is detected, the comment icon cm1 is displayed. In addition, regarding the symbols of the chart, ● means that the measurement value of the management sample is within the management limit, and × means that the measurement value exceeds the management limit. ○ means that it is data that deviates from management. The cursor represented by the symbol cm2 means when the precision management starts, and the cursor represented by the symbol cm3 means that the reagent batch has changed.

[0262] In the LJ graph tab BQC7, the user can browse the accuracy control data of the date and time desired by placing the cursor CS at a position desired by the user.

[0263] The user confirms the displayed accuracy management result, and ends the accuracy management when the accuracy management is good. The display method of the comments such as the above-mentioned poor accuracy management is not limited to the above. The display method can be selected to change the color of the graph judged as poor accuracy management, change the shape of the drawing symbol, display an exclamation mark, etc.

[0264] ・Report output

[0265] Next, the processing unit 10 performs Figure 1 The report generation process is shown in step S8. Fig.45 As shown, the processing unit 10 displays the quality control (QC) file "6CTBNK" in which the evaluation criteria for quality control are set in the quality control (QC) file operation area BQC1. After the user selects the quality control (QC) file in the quality control (QC) file operation area BQC1, the list of measurement items (subset panel) is displayed in the list BQC4. Here, the measurement item (subset panel) list of "CD3 / CD4 / CD8 / CD16+..." is displayed. After the user selects the measurement item (subset panel) list and the processing unit 10 accepts the processing of selecting the acceptance button (archive button) AcB, the processing unit 10 displays the report in the report tab BA20. The report tab BA20 displays the results selected by the user according to his own ideas. For example, the sample information display area BA201, the graph display area BA202, the counting result display area BA203, the measurement person signature area BA204, etc. are displayed. In addition, after accepting the user's selection of the export icon EX, the processing unit 10 outputs the report to the output unit 17.

[0266] (Measurement of the measurement sample)

[0267] After daily quality control (QC) is completed, Figure 1 In step S9, the processing unit 10 Fig.48 The specific processing of step S8 is shown in FIG. 8. In step S801, the processing unit 10 receives the user's Figure 6 Selection of the main (Main) icon B11 of the main interface B is shown. Fig.46 The main interface B displayed by the processing unit when the main icon B11 is selected is shown in FIG. The registered inspection item (panel) "6CTBNK" is displayed in the inspection item (panel) list. Next, in step S802, the processing unit 10 receives the user's selection of the registered inspection item (panel) and displays Figure 6 In step S803, the processing unit 10 receives the user's input of measurement conditions in the particle analysis condition setting area B3. Figure 6 The user then places the measurement sample 29 on the aspirating unit 21 and selects Figure 6 The processing unit 10 accepts this selection and starts the measurement process. The processing unit 10 can automatically end the measurement after measuring a fixed number of cells, or it can end the measurement according to the user's Figure 6 The measurement can be ended by selecting the measurement stop icon B63 in the analysis operation area B6. Fig.47 The measurement results are shown in the plot label BA10.

[0268] [Computer Program]

[0269] Other embodiments of the present disclosure relate to a computer program for causing a computer to execute steps S301 to S329 and Fig.23 S401 to S403 shown in FIG. 30-1 and FIG. 30-2, steps S501 to S513, Fig.34 S701 to S708 or Fig.48 The computer program is the application software of the particle analysis device 1000 .

[0270] Furthermore, one embodiment of the present disclosure relates to a program product such as a storage medium storing the auxiliary program. That is, the computer program is stored in a storage medium such as a hard disk, a semiconductor memory element such as a flash memory, or an optical disk. The storage format of the program stored in the storage medium is not particularly limited as long as the prompt device can read the program. The storage in the storage medium is preferably non-volatile. The storage medium can be provided as a program product.

[0271] [Other forms]

[0272] In the above embodiment, the method of placing the management sample and the measurement sample in the aspiration unit 21 is described. For example, regarding the management sample and the measurement sample, the particles and the detection reagent can be mixed in the sample preparation device and the prepared substances can be placed in the particle analysis device 1000 according to the sample rack for measurement.

[0273] The following are different forms of setting inspection items (panel) and / or daily quality management (QC): the processing unit 10 of the measuring device 1000 obtains display mode information corresponding to the management sample, and displays the quality management setting interface or quality management interface of the inspection item corresponding to the obtained display mode information on the display unit 17, and enables it to switch to the quality management setting interface or quality management interface corresponding to other display mode information.

[0274] The inspection item management sample can include the management sample of in vitro diagnostic reagents or the management sample prepared using research reagents. The management sample of in vitro diagnostic reagents is mostly provided by the provider of the management sample and the provider of the measuring device. At this time, the evaluation benchmark will also be provided together with the management sample for in vitro diagnosis. Therefore, the evaluation benchmark for the precision management of the management sample using in vitro diagnostic reagents is, for example, preinstalled in the auxiliary storage unit 13, or can be obtained by the processing unit 10 from the network 99 via the communication unit 151. On the other hand, the management sample prepared using research reagents will not be provided with an evaluation benchmark like the management sample of in vitro diagnostic reagents, so the user needs to set the evaluation benchmark. Therefore, when the management sample of in vitro diagnostic reagents is used to set the inspection items (panel) and / or daily precision management (QC) and the management sample prepared using research reagents is used to set the inspection items (panel) and / or daily precision management (QC), the display mode of the precision management setting interface and the precision management interface is sometimes different. The processing unit 10 obtains information corresponding to the management sample. The information corresponding to the management sample can include information for a specific reagent (reagent name, reagent identification number, etc.), batch number, expiration date, display mode information, etc. The display mode information can include information on whether the management sample is a management sample for the in vitro diagnostic reagent or a management sample prepared using a research reagent. By obtaining the display mode information, the display of the precision management setting interface and the precision management interface can be switched. The display mode information can be obtained by the processing unit 10 as information input by the user from the input unit 16. It can also be: the display mode information is attached as a bar code on the packaging and container of the detection reagent, and the bar code is read by a reading device connected to the control unit 100, and the information is read by the processing unit 10. Furthermore, the processing unit 10 can obtain the display mode information preinstalled in the auxiliary storage unit 13, or it can obtain the display mode information from the network 99 via the communication unit 151.

[0275] Explanation of symbols

[0276] 1000 measuring devices

[0277] 200 measurement units

[0278] 10. Processing Unit

[0279] 17 Output section

[0280] 16 Input section

[0281] 12 Memory

[0282] 13 Auxiliary storage unit

[0283] 21. Pipetting unit

Claims

1. A measuring device comprising: A measuring unit for measuring a management sample for precision management; Display unit; a processing unit for displaying, on the display unit, an input interface for setting an evaluation criterion used in the accuracy management; in, The inspection items include one or more measurement items, the processing unit accepts a user's setting of a particle analysis condition corresponding to the inspection item, and causes the measurement unit to measure a management sample corresponding to the inspection item based on the particle analysis condition set by the user; The input interface includes a channel setting area for setting a channel related to the type of received light, an evaluation criterion setting area for setting the evaluation criterion of a management sample for performing precision management corresponding to the inspection item, and a particle distribution display area for displaying a particle distribution obtained by measuring the management sample. The particle distribution display area displays a histogram or a scatter plot corresponding to the channel set by the user in the channel setting area, and accepts the designation of a range on the histogram or the scatter plot. The evaluation criterion setting area receives settings of upper and lower limits of light intensity, size, or number of particles contained in the designated range on the histogram or scattergram; The processing unit displays the accuracy management result of the inspection item on the display unit based on the measurement data of the management sample and the evaluation standard set by the user through the input interface.

2. The measuring device according to claim 1, characterized in that: The device further includes a storage unit for storing the evaluation criteria in a format readable by the processing unit.

3. The measuring device according to claim 1, characterized in that: An input unit for setting the evaluation criteria on the input interface is further provided.

4. The measuring device according to claim 1, characterized in that: The test items correspond to the cells to be measured.

5. The measuring device according to claim 1, characterized in that: The evaluation criteria are set for each measurement item.

6. The measuring device according to claim 5, characterized in that: The measurement items include detection items corresponding to two or more types of target molecules to be detected independently by different light receiving elements.

7. The measuring device according to claim 6, characterized in that: The target molecule is an antigen.

8. The measuring device according to claim 1, characterized in that: The evaluation criteria are set based on a certain gate.

9. The measuring device according to claim 8, characterized in that: The evaluation criteria are set based on statistical information.

10. The measuring device according to claim 9, characterized in that: The statistical information is selected from the number of cells within the gate, the median of the light intensity, the mean of the light intensity, or the standard deviation of the light intensity.

11. The measuring device according to claim 1, characterized in that: An input area for accepting text input by a user is displayed on the input interface.

12. The measuring device according to claim 1, characterized in that: An icon for accepting user selection is displayed on the input interface.

13. The measuring device according to claim 1, characterized in that: A drop-down list is displayed on the input interface to accept user selection.

14. The measuring device according to claim 1, characterized in that: The input interface displays a character string corresponding to each light receiving element.

15. The measuring device according to claim 1, characterized in that: The light is fluorescent light and / or scattered light.

16. The measuring device according to claim 15, characterized in that: When the light is fluorescence and a plurality of light receiving elements are sensitive to one type of fluorescence, the processing unit further sets a fluorescence correction condition for adjusting the sensitivity of the plurality of light receiving elements when setting the evaluation criterion.

17. The measuring device according to claim 1, characterized in that: The measuring device is a flow cytometer.

18. The measuring device according to claim 1, characterized in that: The result of the quality control is displayed every time a management sample used for each quality control is measured.

19. The measuring device according to claim 18, characterized in that: The result of the precision management is the precision management result for each channel, and is displayed in a chart expanded with several channels as axes.

20. The measuring device according to claim 18, characterized in that: The results of quality management are displayed together with the results of quality management performed at a point in time in the past.

21. The measuring device according to claim 20, characterized in that: The results of the accuracy management are displayed in a time series chart.

22. The measuring device according to claim 18, characterized in that: When the result of the quality control is not good, a warning is displayed together with the result of the quality control.

23. A precision management method, characterized in that: The following steps are required: a display step of displaying an input interface for setting an evaluation standard of an inspection item, a step of measuring a management sample for quality control based on the evaluation criteria, an outputting step of outputting a precision management result of the management sample measured in the measuring step; in, The accuracy management method further includes: accepting a user's setting of a particle analysis condition corresponding to the inspection item, and measuring a management sample corresponding to the inspection item based on the particle analysis condition set by the user; The inspection items include one or more measurement items. In the display step, the input interface displays a channel setting area for setting a channel related to the type of received light, an evaluation criterion setting area for setting the evaluation criterion of a management sample for performing precision management corresponding to the inspection item, and a particle distribution display area for displaying a particle distribution obtained by measuring the management sample. The particle distribution display area displays a histogram or a scatter plot corresponding to the channel set by the user in the channel setting area, and accepts the designation of a range on the histogram or the scatter plot. The evaluation criterion setting area receives settings of upper and lower limits of light intensity, size, or number of particles contained in the designated range on the histogram or scattergram; In the output step, the accuracy management result of the management sample is output based on the measurement data of the management sample and the evaluation standard set by the user through the input interface.

24. The accuracy management method according to claim 23, characterized in that: The evaluation criteria are set for each measurement item.

25. The accuracy management method according to claim 24, characterized in that: The measurement items include detection items corresponding to two or more types of target molecules to be detected independently by different light receiving elements.

26. The accuracy management method according to claim 23, characterized in that: The light is fluorescent light and / or scattered light.

27. The accuracy management method according to claim 23, characterized in that: In the measurement step, the managed sample is detected by flow cytometry.

28. The accuracy management method according to claim 23, characterized in that: In the output step, the result of the quality control is displayed every time a management sample used for each quality control is measured.

29. The accuracy management method according to claim 23, characterized in that: In the output process, the result of the quality control is displayed in a graph developed with a plurality of channels as axes.

30. The accuracy management method according to claim 28, characterized in that: In the output step, the result of the quality management is displayed in a time series graph.

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