Reagent selection assistance device, method, program, storage medium, and measurement device

Abstract

The present invention provides a multicolor flow cytometer system capable of measuring a measurement sample prepared from a sample and a plurality of fluorescently-labeled antibodies, comprising: a flow cytometer; and a computer connected to the flow cytometer, in which the flow cytometer comprises: a flow cell in which the measurement sample flows; a light source configured to irradiate the measurement sample flowing in the flow cell with light; and a light-receiving element configured to receive fluorescence of different colors from the fluorescence-labeled antibody in the measurement sample, and wherein the computer comprises a database storing antibody reagent information relating to a list of groups, each of the groups comprising combinable fluorescently labeled antibodies, the computer performing an operation in response to an input specifying a target antigen to be determined, the operations include determining a plurality of the groups from the list to detect the target antigen, where each of the determined groups includes the fluorescently-labeled antibody corresponding to the target antigen, where the target antigen is assayed in a plurality of assays, where the assays include the fluorescently-labeled antibody corresponding to the target antigen. Each of a plurality of said assays corresponds to a respective said group, said determined group being presented.

Description

[0001] This application is a divisional application of the Chinese invention patent application filed by the same applicant with application number 201810235194.1, application date March 21, 2018, and name “reagent selection support device, method, program, storage medium and measuring device”. Technical Field

[0002] The present invention relates to a reagent selection support device, method, program, storage medium and sample measuring device. Background Art

[0003] For example, as described in Patent Document 1 listed below, flow cytometry can detect various antigens present on the cell surface and inside the cell by combining it with immunofluorescence staining, and is particularly useful for cell analysis.

[0004] If flow cytometry is used to detect multiple antigens at once, the number of antigens to be detected increases, and the number of tests per sample also increases. Therefore, multicolor flow cytometry, which can detect several antigens in one test, is very useful. In multicolor flow cytometry, the antigens to be detected need to be fluorescently stained in advance. For fluorescent staining of antigens, a test reagent called a mixed antibody reagent is used. In the mixed antibody reagent, several frequently used antibodies are combined and their cross-reactivity is prepared in advance.

[0005] However, in order to detect multiple antigens in one test, in addition to selecting antigens according to the cell type of the test object, other matters need to be known in advance, such as that the detection antibody does not cross-react with other antigens detected simultaneously other than the target antigen. Before the immunostained cells are provided to the flow cytometer, it is necessary to understand the characteristic information of the antibody, for example, if there is cross-reactivity, several cross-reactive antigens are assigned to different tests. Therefore, under the current circumstances, in order to obtain highly reliable results with high reproducibility in multi-color flow cytometry, the measurer in charge of multi-color flow cytometry needs to know in advance the types of all antibodies used in flow cytometry and the cross-reactivity of the antibodies. In addition, the number of fluorescent pigments that can be used will also vary depending on the number of light sources and the number of dichroic mirrors installed in the flow cytometer used, so the measurer is required to have knowledge about flow cytometry and fluorescent pigments. Under the above background, multi-color flow cytometry has become a technical means that can only be used by measurers with highly professional knowledge.

[0006] On the other hand, flow cytometry is a technology that has made great contributions to the diagnosis of diseases, determination of disease stages, and decision of treatment plans. With the popularization of flow cytometry, the cell system of tumor cells has been correctly understood, and the diagnosis of hematopoietic tumors, which was previously based on cell morphology observation, enzyme staining, and immunostaining, has mostly become a diagnosis based on cell surface marker analysis. Physicians who diagnose diseases entrust the tester with several antigens used for diagnosis as measurement items of flow cytometry.

[0007] Generally speaking, if you want to determine the cell system, even if you just want to identify whether it is a B-cell tumor, you need to detect 10 to 30 surface markers for one sample. In addition, in order to detect all the target surface markers, multicolor flow cytometry using several detection antibodies in each test needs to be performed multiple times for each sample. On this basis, the combination of detection antibodies selected by the flow cytometer must be a combination of appropriate detection antibodies that can meet the measurement items entrusted by the physician or technician, and must be a combination of detection antibodies that can be obtained with existing detection antibodies during the inspection. In addition, cells used for flow cytometry must be measured within 24 hours after collection, so it is necessary to study the combination of detection antibodies that can efficiently measure one sample. In this case, it is necessary to efficiently select a mixed antibody reagent for fluorescent staining of detection antibodies from the existing mixed antibody reagent inventory.

[0008] Based on this situation, flow cytometry is currently performed by a specialist who has knowledge of the characteristics of the detection antibodies, and the selection of mixed antibody reagents according to the measurement items requested by doctors or technicians is also performed by a specialist who has the above-mentioned professional knowledge.

[0009] Prior art literature Patent Literature Patent Document 1: Japanese Patent Publication No. 2011-85587. Summary of the invention

[0010] Technical problem to be solved by the invention Inspection sites such as hospitals usually need to "provide stable inspection results quickly when needed." In reality, however, inspections using flow cytometry have deviated far from the above requirements as the professional requirements for the testers in charge of flow cytometry have increased, and inspections using flow cytometry have become increasingly complex. Even if people other than professional testers accept the measurement items of several antigens specified by doctors or technicians, it is difficult for them to efficiently select a combination of mixed antibody reagents for detecting the several antigens shown in the measurement items. Although a technical solution can be adopted to detect the several antigens included in the measurement items one by one by flow cytometry, considering the requirement that the above cells must be measured within 24 hours after collection, this solution is obviously unrealistic. The inspection site of the hospital needs a solution that can efficiently select a combination of mixed antibody reagents that meet the several antigen measurement items entrusted by the physician.

[0011] In addition, the method of Patent Document 1 is a method for simplifying the setting of flow cytometers and other instruments, but it is a method for testers with certain professional knowledge and is not a user-friendly method for beginners. The method of Patent Document 1 is not a method that can meet the needs of hospital examination sites.

[0012] Technical solutions to technical problems One form of the present invention is a reagent selection support device. In an embodiment, the reagent selection support device (100) is a reagent selection support device (100) that supports the selection of a mixed antibody reagent containing several antibodies, and comprises: an acquisition unit (15, 16) that acquires a measurement instruction with several antigens as the measurement object; a processing unit (10A, 10B) that determines several mixed antibody reagents used in several tests for detecting several antigens according to the measurement instruction obtained by the acquisition unit (15, 16); an output unit (17) that outputs information on several mixed antibody reagents used for several tests determined by the processing unit. Thus, even if the examiner does not have professional knowledge, he or she can select an appropriate antibody reagent combination that meets the measurement instruction.

[0013] The preferred technical solution is: it also has a memory unit (12, 13) for memorizing information of several mixed antibody reagents composed of different antibody combinations; wherein the processing unit (10A, 10B) determines several mixed antibody reagents used for several tests according to the information of several mixed antibody reagents read from the memory unit (12, 13) and the measurement instructions. Thus, even if the examiner does not have professional knowledge, he can select an appropriate antibody reagent combination that meets the measurement instructions based on the information of several mixed antibody reagents pre-memorized in the memory unit.

[0014] The preferred technical solution is that several mixed antibody reagents are respectively composed of different combinations of antibodies, thereby increasing the number of fluorescent species that can be measured simultaneously and shortening the number of measurements and the measurement time.

[0015] The preferred technical solution is that the processing unit (10A, 10B) determines the antibody reagent that can be used together with the mixed antibody reagent in at least one of the multiple tests, and the output unit (17) outputs the information of the antibody reagent that can be used together with the mixed antibody reagent. As a result, the types of fluorescence that can be measured simultaneously are increased, and the number of measurements and the measurement time can be shortened.

[0016] The preferred technical solution is that the processing unit (10A, 10B) determines a first candidate composed of a combination of mixed antibody reagents used for multiple tests and a second candidate composed of a combination of mixed antibody reagents different from the first candidate according to the measurement instruction, and the output unit (17) outputs the first candidate and the second candidate determined by the processing unit (10A, 10B). Thus, the user can perform efficient inspections using the antibody reagents currently in stock.

[0017] A preferred technical solution is that the output unit (17) can output the first candidate and the second candidate in a manner that can be distinguished from each other. Thus, the user can more accurately understand whether the antibody reagents currently in stock can be used to perform the measurement that satisfies the measurement instruction.

[0018] The preferred technical solution is that if the processing unit (10A, 10B) receives input of a designation of a mixed antibody reagent to be used for any one of the first candidate and the second candidate, the processing unit (10A, 10B) changes the display form of the mixed antibody reagent corresponding to the designation for the first candidate and the second candidate, respectively. The user inputs information of the antibody reagents currently in stock into the reagent selection support device (100), whereby the display form of the antibody reagents currently in stock is changed when output through the output unit (17). In this way, the user can more accurately understand whether the antibody reagents currently in stock can be used to perform a measurement that satisfies the measurement instruction.

[0019] The preferred technical solution is that the processing unit (10A, 10B) presents the first candidate and the second candidate according to the number of mixed antibody reagents used and / or the magnitude relationship of the number of measurements, so that the user can perform efficient inspections using the antibody reagents currently in stock.

[0020] A preferred technical solution is that if there are multiple results with the same number of mixed antibody reagents used, the processing unit (10A, 10B) prompts the first candidate and the second candidate with the same number of mixed antibody reagents used according to the magnitude relationship of the number of measurements. Thus, the user can perform efficient inspections using the antibody reagents currently in stock.

[0021] The preferred technical solution is that the processing unit (10A, 10B) presents the first candidate and the second candidate according to the degree of consistency between the several antibodies and the several antigens contained in the mixed antibody reagent, thereby enabling the user to perform efficient inspections using the antibody reagents currently in stock.

[0022] One form of the present invention is a reagent selection support method. In an embodiment, the reagent selection support method supports the selection of a mixed antibody reagent containing several antibodies, including: an acquisition step (S1) of obtaining a measurement instruction with several antigens as the measurement object; a determination step (S2 to S5) of determining several mixed antibody reagents used for several tests for detecting several antigens according to the obtained measurement instruction; an output step (S6) of outputting information of the determined several mixed antibody reagents for several tests. Thus, even if the examiner does not have professional knowledge, he can select a combination of appropriate antibody reagents that meets the measurement instruction.

[0023] The preferred technical solution is: it further comprises a reading step of reading information of several mixed antibody reagents composed of different antibody combinations from a memory unit, and a determining step of determining several mixed antibody reagents used for several tests based on the information of several mixed antibody reagents read from the memory unit in the reading step and the measurement instruction. Thus, even if the examiner does not have professional knowledge, he or she can select an appropriate antibody reagent combination that meets the measurement instruction based on the information of several mixed antibody reagents pre-memorized in the memory unit.

[0024] The preferred technical solution is that the several mixed antibody reagents are respectively composed of different antibody combinations, thereby increasing the number of fluorescence species that can be measured simultaneously and shortening the number of measurements and the measurement time.

[0025] The preferred technical solution is: the determination step determines the antibody reagent that can be used together with the mixed antibody reagent in at least one of the multiple assays, and the output step outputs the information of the antibody reagent that can be used together with the mixed antibody reagent. Thus, the types of fluorescence that can be measured simultaneously are increased, and the number of measurements and the measurement time can be shortened.

[0026] The preferred technical solution is: the determination step determines the first candidate composed of the mixed antibody reagents used in the multiple tests and the second candidate composed of the mixed antibody reagents different from the first candidate according to the measurement instruction, and the output step outputs the first candidate and the second candidate determined in the determination step. Thus, the user can perform efficient inspections using the antibody reagents currently in stock.

[0027] A preferred technical solution is that: the output step outputs the first candidate and the second candidate in a manner that can be distinguished from each other. Thus, the user can more reliably understand whether the antibody reagents currently in stock can be used to perform the measurement that satisfies the measurement instruction.

[0028] The preferred technical solution is: it also includes the following steps: an acceptance step of accepting input of a designation of the mixed antibody reagent to be used for any one of the first candidate and the second candidate; and a change step of changing the display form of the mixed antibody reagent corresponding to the designation for the first candidate and the second candidate respectively. The user inputs the information of the antibody reagent in stock into the reagent selection support device (100), thereby changing the display form of the antibody reagent in stock output to the output unit (17). In this way, the user can more effectively understand whether the antibody reagent in stock can be used to perform a measurement that satisfies the measurement instruction.

[0029] The preferred technical solution is that the determination step prompts the first candidate and the second candidate according to the relationship between the number of mixed antibody reagents used and / or the number of measurements, so that the user can perform efficient inspections using the antibody reagents currently in stock.

[0030] The preferred technical solution is: if there are multiple results with the same number of mixed antibody reagents used, the determination step prompts the first candidate and the second candidate with the same number of mixed antibody reagents used according to the magnitude relationship of the number of measurements. Thus, the user can perform efficient inspections using the antibody reagents currently in stock.

[0031] The preferred technical solution is that the determination step prompts the first candidate and the second candidate according to the degree of consistency between the several antibodies and the several antigens contained in the mixed antibody reagent. Thus, the user can perform efficient inspection using the antibody reagents currently in stock.

[0032] One form of the present invention is a computer program. In an embodiment, the computer program is a program that enables a computer to implement the following functions: an acquisition function (S1) of an assay instruction with several antigens as the assay object; a determination function (S2 to S5) of several mixed antibody reagents used for several assays for detecting several antigens according to the acquired assay instruction; and an output function (S6) of outputting information of the determined several mixed antibody reagents used for several assays.

[0033] One form of the present invention is a computer-readable, non-temporary, tangible storage medium. In an embodiment, the computer-readable, non-temporary, tangible storage medium stores a program that enables a computer to implement the following functions: an acquisition function (S1) of obtaining a measurement instruction for measuring a plurality of antigens; a determination function (S2 to S5) of determining a plurality of mixed antibody reagents used for a plurality of tests for detecting a plurality of antigens according to the obtained measurement instruction; and an output function (S6) of outputting information on the determined plurality of mixed antibody reagents used for a plurality of tests.

[0034] One form of the present invention is a reagent selection support device. In an embodiment, the reagent selection support device (100) supports the selection of a mixed antibody reagent containing several antibodies, and comprises: an acquisition unit (15, 16) that acquires a measurement instruction with several antigens as the measurement object; a processing unit (10) that determines several antibody reagents that can be used in combination in an assay for detecting several antigens based on the measurement instruction acquired by the acquisition unit (15, 16); and an output unit (17) that outputs information on several antibody reagents that can be used in combination in an assay determined by the processing unit (10).

[0035] One form of the present invention is a sample measuring device. In an embodiment, the sample measuring device (1000) measures a sample (29) obtained by mixing a mixed antibody reagent containing several antibodies with several antigens as the measuring object, and comprises: a reagent selection support device (100) for determining several mixed antibody reagents used in several tests for detecting several antigens in the sample (29); a measuring device body (200) comprising: an aspirating unit (21) for aspirating a sample (29) obtained by mixing one of the mixed antibody reagents corresponding to the test for each test determined by the reagent selection support device (100); a fluid circuit (22) for transporting the sample (29) aspirated by the aspirating unit (21); and a detection unit (23) for measuring the sample (29) transported by the fluid circuit (22).

[0036] Effects of the Invention According to the present invention, even if the examiner does not have professional knowledge, he or she can select an appropriate antibody reagent combination that meets the measurement instructions. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 An example of an interface display of the reagent selection support device involved in the present invention; Figure 2 A schematic diagram for explaining an inspection system according to a first embodiment of the present invention; Figure 3 is an exemplary schematic diagram of an optical system of a flow cytometer according to the present invention; Figure 4 A block diagram of the hardware structure of the reagent selection support device involved in the present invention; Figure 5 A block diagram for explaining the functions of the inspection system according to the first embodiment of the present invention; Figure 6 A flowchart for determining candidate antibody reagent combinations according to the present invention; Figure 7 A flowchart for determining candidate antibody reagent combinations according to the present invention; Figure 8 A flowchart for determining candidate antibody reagent combinations according to the present invention; Fig. 9 A flowchart for determining candidate antibody reagent combinations according to the present invention; Fig.10 A flowchart for determining candidate antibody reagent combinations according to the present invention; Fig.11 A flow chart of grasping an antibody reagent combination that satisfies a measurement instruction according to the present invention; Fig.12 An example of an interface display of the reagent selection support device involved in the present invention; Fig.13 An example of an interface display of the reagent selection support device involved in the present invention; Fig.14 An example of an interface display of the reagent selection support device involved in the present invention; Fig.15 An example of an interface display of the reagent selection support device involved in the present invention; Fig.16 An example of an interface display of the reagent selection support device involved in the present invention; Fig.17 A schematic diagram for explaining an inspection system according to a second embodiment of the present invention; Fig.18 This is a block diagram for explaining the function of the inspection system according to the second embodiment of the present invention. DETAILED DESCRIPTION

[0038] Next, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the following description and drawings, the same reference numerals represent the same or similar components, and thus descriptions of the same or similar components will be omitted.

[0039] <Definition of terms> In the following description, antigen refers to the target to be detected. Antigens are present in cells and can be present on the cell membrane, in the cell membrane, or in the cell. In addition, several antigens refer to several antigens. Several antigens refer to the same or different biological molecules (proteins, sugar chains, lipids, glycoproteins, glycolipids, lipoproteins, and nucleic acids, etc.), preferably different biological molecules.

[0040] A mixed antibody reagent is a reagent that includes a mixture of several antibodies that can bind to different or the same antigen. For example, one mixed antibody reagent can include 2 to 5 antibodies. Here, each antibody contained in one mixed antibody reagent must satisfy at least one antibody that binds to one antigen. In addition, each antibody contained in a mixed antibody reagent can also be designed to bind to more than two antibodies and one antigen. The number of antibodies contained in one mixed antibody reagent is called the mixed number. In addition, a single antibody reagent refers to a reagent that includes one antibody that can bind to an antigen. Each antibody can be labeled with a fluorescent dye. Preferably, each antibody contained in one mixed antibody reagent is labeled with a different fluorescent dye. Different fluorescent dyes mean that the peak wavelength of the fluorescence spectrum of each fluorescent dye can be optically distinguished. In addition, it is preferred that the antibodies contained in the single antibody reagent are labeled with a fluorescent dye that is not used in the mixed antibody reagent.

[0041] Mixed antibody reagents and single antibody reagents are collectively referred to as antibody reagents. The information of the antibody reagent includes: the type of antibody contained in the antibody reagent, the type of antigen recognized by the antibody, the type of labeled fluorescent pigment, etc. Preferably, the information of the antibody reagent includes: the information of the mixed antibody reagent, and the information of the single antibody reagent that can be used together with the mixed antibody reagent.

[0042] [Summary of the Invention] Figure 1 The interface display of the reagent selection support device 100 according to the present invention is illustrated. The reagent selection support device 100 according to the present invention automatically determines the candidate antibody reagent combination for detecting the antigen specified by the measurement instruction based on the measurement instruction and the antibody reagent information, and displays the result as follows: Figure 1 Output in the form of examples. Figure 1 The reagent selection support device 100 can determine and present several antibody reagent combination candidates, using the exemplary "first candidate" and "second candidate". Figure 6 to Figure 10 The flowchart is described below.

[0043] Next, Figure 1 The example of the "first candidate" is described in detail. For example, the combination of the mixed antibody reagent of CD3 / CD4 / CD8 and the single antibody reagent of CD25 shown in the first row is the combination of antibody reagents used in one assay. In addition, for example, in the assay shown in the second row, the mixed antibody reagent of CD16 / CD56 / CD57 is the antibody reagent used in one assay. In the assay shown in the second row, no single antibody reagent was used. That is, in the example of the "first candidate", all the antigens specified by the assay instruction can be detected through 7 assays and 7 measurements in total. In the example of the "second candidate", all the antigens specified by the assay instruction can be detected through 8 assays and 8 measurements in total.

[0044] When determining which combination candidate of the antibody reagent combination candidates shown in the "first candidate" and the "second candidate" is actually to be used, the combination candidate can be compared with the antibody reagents actually in stock and the determination can be made in a dialog form. The method of comparing the antibody reagent combination candidate automatically determined in a dialog form with the antibody reagents actually in stock will be described later. Fig.11 Flowchart and Figure 12 to Figure 16 An example of the interface display is used to illustrate.

[0045] The measurement instruction refers to the examination items instructed by the physician or technician. Preferably, the examination items are necessary for the physician to determine whether the patient suffers from a certain disease. In other words, the measurement instruction is the type of one or more antigens to be measured in flow cytometry. The information of the antibody reagent refers to the information of the antibody reagent including the mixed antibody reagent that can be used by the measurement device body 200 for measuring the sample. Therefore, even if the user of the sample measurement device 1000 does not have the relevant professional knowledge of the measurement instruction and the antibody reagent, he can efficiently select the combination of appropriate antibody reagents that meet the measurement instruction.

[0046] <First embodiment> [Structure Overview] Figure 2 The inspection system according to the first embodiment shown in the figure includes a sample measuring device 1000. The sample measuring device 1000 can be connected to a client terminal 300 via a network 99. For example, a measurement instruction given by a physician or the like via the client terminal 300 is sent to the sample measuring device 1000 via the network. The client terminal 300 is composed of, for example, a general-purpose computer having a CPU and a memory. The inspection object sample (for example, blood) is delivered to the user of the sample measuring device 1000 via another route.

[0047] The sample measurement device 1000 includes a reagent selection support device 100 and a measurement device main body 200 for measuring a sample.

[0048] The reagent selection support device 100 may be composed of a general purpose computer, for example, and determines a combination of appropriate antibody reagents that conform to the measurement instruction according to the sequence shown in the flowchart described below. The user of the sample measurement device 1000 mixes the antibody reagents with the measurement target sample according to the antibody reagent combination determined by the reagent selection support device 100 to prepare the sample 29, and sets it in the measurement device main body 200 for measurement.

[0049] The measuring device body 200 includes an aspirating unit 21, a fluid circuit 22, and a detection unit 23. The measuring device body 200 aspirates a sample 29 contained in a sample container 28 by the aspirating unit 21, transfers the aspirated sample 29 through the fluid circuit 22, and measures the transferred sample 29 in the detection unit 23.

[0050] In this embodiment, the control of the measuring device main body 200 is also in the charge of the reagent selection support device 100. That is, the optical information detected by the detection unit 23 is sent to the reagent selection support device 100, and the reagent selection support device 100 performs analysis corresponding to the number of cells and each antigen based on the optical information sent from the detection unit 23. The reagent selection support device 100 pre-stores a computer program in the recording unit 13 described later, and the computer program specifies the processing order for controlling the measuring device main body 200 and the processing order for measuring the measured value sent from the detection unit 23. The reagent selection support device 100 executes the computer program through the CPU 11 described later, thereby controlling the measuring device main body 200.

[0051] The aspiration unit 21 is, for example, a nozzle that can aspirate and discharge a sample. The fluid circuit 22 is a flow path of a fluid, and the fluid is transported therein by, for example, a syringe pump. The sample measuring device 1000 is, for example, a flow cytometer. The flow cytometer performs optical measurement of the sample by flow cytometry. The flow cytometer can simultaneously measure several types of fluorescence released from the sample by using a mixed antibody reagent as an antibody reagent, which can shorten the measurement time.

[0052] The number of photodetectors (such as photomultiplier tubes) for detecting fluorescence that the detection unit 23 has is determined according to the number of mixed antibody reagents that the measurement device body 200 can handle. For example, if the measurement device body 200 can handle mixed antibody reagents with a mixing number of "3", then the measurement device body 200 must be equipped with a total of 4 photodetectors for detecting fluorescence in the detection unit 23. In this way, the detection unit 23 can simultaneously measure a total of 4 colors of fluorescence, including 3 colors of fluorescence of the mixed antibody reagent and 1 color of fluorescence of the single antibody reagent in one test. Figure 3 , the optical system of the flow cytometer is described by taking the case of simultaneously measuring a total of four colors of fluorescence as an example.

[0053] Figure 3 An example of an optical system of a flow cytometer is given as an example of the detection unit 23. The flow cytometer comprises: a pool 27 for receiving a cell-containing liquid containing cells in a sample; light sources 201, 224 for irradiating light on particles passing through the pool 27; and photodetectors 200A to 200F for detecting optical information of light from cells and outputting detection signals converted into electrical signals. Here, the sample refers to a suspension of cells aspirated by the flow cytometer. About Figure 3The following description of the flow cytometer is based on an example in which the sample is a mixture of blood and an antibody reagent.

[0054] 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 collectively referred to as light from the cells. The light from the cells includes scattered light and luminescence, etc. The light from the cells can be light of any wavelength, preferably light with a peak wavelength in the range of 400nm to 850nm. More specifically, the light from the cells is preferably fluorescence. The light from the cells can also be light emitted by the substance contained in the cells themselves. Alternatively, the light from the cells can also be detected as follows: the cells are labeled with luminescent substances such as fluorescent pigments, and the light emitted by the luminescent substances is detected as light from the cells. In addition, in the preferred embodiment, the peak wavelength of the light from the cells is different for each antigen. In the first embodiment, the fluorescence from the cells comes from the fluorescent pigments labeled in each antibody contained in the detection reagent.

[0055] The cell-containing liquid refers to a liquid including a cell suspension aspirated from a sample into a flow cytometer, and may further include a diluent as needed. Optical information refers to 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 determined based on which of the one or more photodetectors described later receives the light. In addition, the intensity of each light wavelength or light wavelength range can be determined by the electrical signal output by the photodetector that receives the light.

[0056] Next, a specific description will be given by taking the case where the light from the cells is scattered light and fluorescence as an example. The light emitted from the light source 201 is irradiated to the pool 27 via 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 pool 27 is condensed by the condenser 205, and is incident on the photodetector 200A via the beam stopper 206, the aperture plate 207, and the bandpass filter 208.

[0057] On the other hand, the side scattered light and side fluorescence from the light of the cells passing through the pool 27 are condensed by the condenser 209. The side scattered light enters the photodetector 200B via the dichroic mirrors 210, 211, 212, the aperture plate 213, and the band pass filter 214. The side fluorescence with a wavelength of 520 nm to 542 nm passes through the dichroic mirrors 210 and 211, is reflected by the dichroic mirror 212, and enters the photodetector 200C via the aperture plate 215 and the band pass filter 216. In addition, the side fluorescence with a wavelength of 570 nm to 620 nm passes through the dichroic mirror 210, is reflected by the dichroic mirror 211, and enters the photodetector 200D via the aperture plate 217 and the band pass filter 218. 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 , and then enters the photodetector 200E via the aperture plate 220 and the bandpass filter 221 .

[0058] The light emitted from the light source 224 is irradiated into the pool 27 via the collimating lens 225, the dichroic mirror 203, and the condensing lens 204. The side fluorescence from the light of the cells passing through the pool 27 is condensed by the condensing lens 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 is incident on the photodetector 200F via the aperture plate 222 and the bandpass filter 223.

[0059] exist Figure 3 In the example shown, a laser diode with a wavelength of 488 nm is used as the light source 201, and a laser diode with a wavelength of 642 nm is used as the light source 224. A sheath flow cell is used as the cell 27. The photodetector 200A for receiving forward scattered light uses a photodiode, and the photodetector 200B for receiving side scattered light uses an avalanche photodiode (APD). The photodetectors 200C to 200F for receiving side fluorescence use photomultiplier tubes (PMT).

[0060] As mentioned above, in Figure 3 In the flow cytometer shown, the number of photodetectors 200C to 200F that receive side fluorescence is 4. Therefore, the flow cytometer in this example has 4 photodetectors for detecting fluorescence, and can simultaneously measure a total of 4 colors of fluorescence, which is the sum of 3 colors of fluorescence based on the mixed antibody reagent and 1 color of fluorescence based on the single antibody reagent, in one assay.

[0061] Each detection signal output from each photodetector 200A to 200F is amplified in an amplifier circuit (not shown) and converted into digital data by A / D conversion in an A / D converter (not shown). In this embodiment, the digitized detection signal is sent to the reagent selection support device 100 for cell analysis. The amplifier circuit is a known amplifier circuit composed of an operational amplifier or the like.

[0062] The light source may be one or more than two. The light source is selected according to the wavelength region of the light from the cells. If there are more than two light sources, it is preferred that these light sources emit light with different peak wavelengths.

[0063] 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, wavelength range, and intensity of light from cells.

[0064] The reagent selection support device 100 sends to the detection unit 23 the information related to the detection sensitivity when the detection unit 23 detects scattered light and fluorescence, the information related to the fluorescence correction corresponding to the detected fluorescence combination, and the information related to the gating used to select the distribution area of ​​the cells to be detected, and controls the detection unit 23 so that the detection unit 23 can obtain appropriate optical information for the antigen based on this information.

[0065] [Operation Summary] In the first embodiment, information about antibody reagents that can be used by the measuring device main body 200 is pre-stored in the reagent selection support device 100. First, for example, a doctor or the like who is responsible for examining a patient inputs a necessary measurement instruction into the client terminal 300 to determine whether the patient suffers from a certain disease (such as leukemia). The client terminal 300 sends the input measurement instruction to the reagent selection support device 100. The reagent selection support device 100 determines the candidate antibody reagent combination used when detecting the antigen specified by the measurement instruction based on the obtained measurement instruction and the information about the antibody reagents including the mixed antibody reagent that can be used by the measuring device main body 200, and outputs the result. Thus, the user of the sample measuring device 1000 can select an appropriate combination of antibody reagents that meets the measurement instruction.

[0066] Furthermore, the user inputs information of mixed antibody reagents and single antibody reagents currently in stock into the reagent selection support device 100. Thus, the user can refer to the result of the antibody reagent combination candidate determined by the reagent selection support device 100 to more accurately understand whether the measurement that satisfies the measurement instruction can be performed using the antibody reagents currently in stock.

[0067] Then, the user mixes the antibody reagent into the sample 29 for each combination, i.e., for each test, based on the antibody reagent combination that can perform the measurement that satisfies the measurement instruction and that is in stock, and performs the measurement in the measurement device main body 200. The antigen specified by the measurement instruction is detected by the measurement device main body 200, and the test result is sent to the client terminal 300.

[0068] [Hardware structure] Figure 4 The reagent selection support device 100 shown includes a processing unit 10 ( 10A, 10B), an input unit 16 , and an output unit 17 .

[0069] The processing unit 10 includes: a CPU (Central Processing Unit) 11 for performing data processing described below; a memory 12 used as a work area for data processing; a recording unit 13 for storing programs described below and processed data; a bus 14 for transmitting data between the units; and an interface unit 15 (hereinafter referred to as an "I / F unit") for inputting and outputting data with an external device. An input unit 16 and an output unit 17 are connected to the processing unit 10. As an example, the input unit 16 and the output unit 17 can be integrated into a touch screen input display device.

[0070] In addition, as an example, the processing unit 10 performs the following Figure 6 to Figure 11 The program involved in the present invention is pre-stored in the recording unit 13 in an executable form (for example, generated by converting from a programming language by a compiler) to perform the processing of each step described in the above, and the processing unit 10 uses the program stored in the recording unit 13 to perform processing.

[0071] In the following description, unless otherwise specified, the processing performed by the processing unit 10 is actually the processing performed by the CPU 11 of the processing unit 10 according to the program stored in the recording unit 13 or the memory 12. The CPU 11 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 recording unit 13.

[0072] [Functional modules] Figure 5 The processing unit 10A of the reagent selection support device 100 according to the first embodiment shown includes an antigen information acquisition unit 101, a candidate reagent determination unit 102, an output control unit 103, and a reagent designation receiving unit 104. The program according to the present invention is installed in the recording unit 13 or the memory 12 of the processing unit 10A and executed by the CPU 11, thereby realizing the above-mentioned functional modules.

[0073] In the first embodiment, an antibody reagent information database 401 (hereinafter referred to as "antibody reagent information DB401") is pre-stored in the recording unit 13 or the memory 12 of the processing unit 10A. The antibody reagent information DB401 is information on antibody reagents including a mixed antibody reagent that can be used by the measurement device main body 200.

[0074] The client terminal 300 includes an input unit 301 for receiving an input of a measurement instruction, and a data transmission and reception unit 302 for transmitting the measurement instruction to the detection reagent selection support device 100 .

[0075] [Method for determining candidate antibody reagent combinations] The method of determining the candidate antibody reagent combination performed by the reagent selection support device 100 will be described using a case where a patient is suspected of having leukemia as an example.

[0076] Table 1-1 to Table 1-3 (hereinafter collectively referred to as “Table 1”) show an example of information of antibody reagents stored in the antibody reagent information DB 401 used in the first embodiment.

[0077] Table 1-1 Table 1-2 Table 1-3 The information of the antibody reagent shown in Table 1 includes: information of the mixed antibody reagent and information of a single antibody reagent that can be used in combination with the mixed antibody reagent. In the following description, the variable N is used to determine the mixing number of the mixed antibody reagent. The variable N is a natural number (a positive integer other than 0). In the example of Table 1, the mixing number of the mixed antibody reagent is "3" and the value of the variable N is "3". In addition, in the following description, the candidate antibody reagent combination is determined based on the information of the antibody reagent including the mixed antibody reagent with a mixing number of "3", but the mixing number of the mixed antibody reagent is not limited to this. The mixing number of the mixed antibody reagent used can be appropriately changed according to the mixing number of the mixed antibody reagent that the measuring device body 200 can handle in one test. For details, please refer to the <Remarks> column described later.

[0078] In the following description, variables x and y are used to identify mixed antibody reagents and single antibody reagents in the antibody reagent information or antibody reagent candidates shown in Table 1. Variables x and y are natural numbers (positive integers other than 0).

[0079] In the following description, mixed antibody reagent (x) refers to mixed antibody reagent No. x. For example, in the information of antibody reagents shown in Table 1, mixed antibody reagent (2) refers to the mixed antibody reagent shown in "No. 2" of Table 1, which combines three antibodies CD117, CD34 and CD45. Single antibody reagent (y) refers to single antibody reagent No. y. For example, in the information of antibody reagents shown in Table 1, single antibody reagent (3) that can be used together with mixed antibody reagent (2) refers to antibody No. 3 "CD38" among the six single antibody reagents "CD56, HLA-DR, CD38, CD11b, CD33, CD7" that can be used together with the mixed antibody reagent shown in "No. 2" of Table 1.

[0080] The measurement instructions used as an example in the first embodiment are as follows: The measurement instructions are "HLA-DR, CD38, CD10, CD11c, CD19, CD20, CD22, CD23, CD103, Igκ, Igλ, CD2, CD3, CD4, CD8, CD5, CD7, CD25, CD16, CD56".

[0081] The processing unit 10A of the reagent selection support device 100 performs Figure 6 to Figure 10 The operation shown in the flowchart. Figure 5 To explain the functional blocks shown in FIG. 1 , the process of step S1 is performed by the antigen information acquisition unit 101. The processes of steps S2 to S5, steps S11 to S20, steps S151 to S158, and steps S161 to S170 other than steps S1 and S6 are performed by the candidate reagent determination unit 102. The process of step S6 is performed by the output control unit 103.

[0082] Reference Figure 6 Flowchart In step S1, the processing unit 10A obtains a measurement instruction from the client terminal 300. The measurement instruction is transmitted from the data transmission and reception unit 302 in the form of text information, for example.

[0083] In step S2, the processing unit 10A sets an initial value "1" for the variable x, and first selects the mixed antibody reagent No. 1 (1).

[0084] In step S3, the processing unit 10A determines whether one or more antibodies included in the mixed antibody reagent (x) No. x are present in the measurement instruction. If so, the processing unit 10A performs the processing of step S11 described below. If not, the processing unit 10A performs the determination of step S4.

[0085] That is, in order to present several candidate antibody reagent combinations by repeatedly performing the processing of steps S3 to S5, the processing unit 10A first selects the mixed antibody reagent No. 1 (1) and determines whether the mixed antibody reagent No. 1 (1) is a reagent candidate. If it is a reagent candidate, the processing unit 10A continues to perform Figure 7 The processing of steps S11 to S20 described above is for determining the degree of consistency with the antigen in the measurement instruction and for determining whether it can be used in combination with a single antibody reagent. If it is not a reagent candidate, the processing unit 10A performs the processing of steps S4 to S5 and similarly determines whether it is a reagent candidate in step S3 for the No. 2 mixed antibody reagent (2).

[0086] Specifically, by repeating the processing of steps S3 to S5, 12 mixed antibody reagents represented by variables x=3, 5, 7, 10 to 18 among the 18 mixed antibody reagents shown in Table 1 become the mixed antibody reagents initially extracted from the measurement instruction shown in step S11. That is, the processing of step S3 can be regarded as a processing for determining the mixed antibody reagent (x) initially extracted from the measurement instruction in step S11. If the mixed antibody reagent initially extracted from the measurement instruction changes, the candidates for the mixed antibody reagent to be extracted from the measurement instruction next will also be restricted accordingly, and therefore, the candidates for the antibody reagent combination will also change. As a result, several candidates for the antibody reagent will eventually be prompted.

[0087] In step S4, the processing unit 10A determines whether the mixed antibody reagent No. x+1 (x+1) exists in the antibody reagent information DB 401. If it exists, the processing unit 10A increases the variable x by "1" in step S5 and then performs the determination in step S3. If it does not exist, it means that the determination process for all mixed antibody reagents in the antibody reagent information DB 401 has been completed, so the processing unit 10A performs the process in step S6.

[0088] In step S6, the processing unit 10A displays the determined candidate antibody reagent combination as a reagent candidate. The processing unit 10A displays the determined result, that is, the display order of the candidate antibody reagent combination, in any order. For example, the processing unit 10A can display the determined candidate antibody reagent combination in the order of the number of reagents used or the number of measurements. In addition, the processing unit 10A can also display the determined candidate antibody reagent combination in the order of the evaluation score described later.

[0089] Reference Figure 7 Flowchart of the process. Figure 7 The processing of steps S11 to S20 shown is the processing performed when there are one or more types of antibodies included in the mixed antibody reagent No. x (x) in the measurement order in step S3.

[0090] In step S11, the processing unit 10A extracts the antibodies included in the mixed antibody reagent (x) from the measurement order and updates the measurement order. The antibodies extracted from the measurement order are the antibodies included in the mixed antibody reagent (x) determined to be present in the measurement order in step S3.

[0091] In step S12, the processing unit 10A adds the mixed antibody reagent (x) to the new reagent candidates.

[0092] In step S13, the processing unit 10A adds the number of antibodies that match the measurement instruction to the new evaluation score. The number of antibodies that match the measurement instruction is the number of antibodies included in the mixed antibody reagent (x) determined to be present in the measurement instruction in step S3.

[0093] In step S14, the processing unit 10A sets an initial value "3" for the variable N indicating the number of mixed antibody reagents.

[0094] In step S15, the processing unit 10A performs a mixed antibody reagent search process. The mixed antibody reagent search process will be referred to below. Figure 8 If the value of the variable N is "3", the mixed antibody reagent search process is a process of first determining whether all three antibodies included in the mixed antibody reagent (x) are included in the measurement instruction.

[0095] In step S16, the processing unit 10A performs a single antibody reagent search process. The single antibody reagent search process is a process for determining a single antibody reagent that can be used together with the mixed antibody reagent (x). The single antibody reagent search process is referred to later. Fig. 9 and Fig.10 Provide explanation.

[0096] In step S17, the processing unit 10A determines whether or not there is any antibody in the measurement command.

[0097] If not, in step S18, the processing unit 10A stores the new reagent candidate added in step S12 and the new evaluation score added in step S13, and performs the determination in step S4 again.

[0098] If so, the processing unit 10A determines in step S19 whether the variable N can be subtracted, and then subtracts "1" from the variable N in step S20. Then, the processing unit 10A performs the mixed antibody reagent search process in step S15 with the value of the subtracted variable N. If the value of the variable N is "2", the mixed antibody reagent search process is a process for determining whether two of the three antibodies contained in the mixed antibody reagent (x) are included in the measurement instruction.

[0099] Reference Figure 8 Flowchart of the process. Figure 8The processing of steps S151 to S158 shown is a mixed antibody reagent search process.

[0100] In step S151, the processing unit 10A sets an initial value "1" for the variable x, and first selects the mixed antibody reagent No. 1 (1).

[0101] In step S152, the processing unit 10A searches for the mixed antibody reagent (x) No. x in the measurement order, and in step S153, the processing unit 10A determines whether there are N or more antibodies included in the mixed antibody reagent (x) in the measurement order. If there are N or more antibodies, the processing unit 10A performs the processing of step S154, and if there are not N or more antibodies, the determination of step S157 is performed.

[0102] In step S154, the processing unit 10A extracts the antibodies contained in the mixed antibody reagent (x) from the measurement order and updates the measurement order. The antibodies extracted from the measurement order are the N antibodies contained in the mixed antibody reagent (x) determined to be present in the measurement order in step S153.

[0103] In step S155, the processing unit 10A adds the mixed antibody reagent (x) to the reagent candidates.

[0104] In step S156, the processing unit 10A adds the value N to the evaluation score. After step S156 is completed, the processing of step S15 is recursively called, and the processing unit 10A continues the processing of step S15.

[0105] In step S157, the processing unit 10A determines whether the mixed antibody reagent No. x+1 (x+1) exists in the antibody reagent information DB 401. If it does, the processing unit 10A adds "1" to the variable x in step S158 and then performs the determination in step S153. If it does not exist, the processing unit 10A ends the mixed antibody reagent search process in step S15. At the end of step S15, the mixed antibody reagents in the reagent candidates and the remaining measurement instructions at this time are listed. After the processing of step S15 is completed, the processing unit 10A performs Figure 7 The process of step S16 is shown.

[0106] Reference Fig. 9 and Fig.10 Flowchart of the process. Fig. 9 and Fig.10 The processing of steps S161 to S170 shown is a single antibody reagent search process.

[0107] In step S161, the processing unit 10A sets initial values ​​"1" to variables x and y, respectively. Variable x indicates mixed antibody reagent No. 1 among the reagent candidates, and variable y indicates single antibody reagent No. 1 that can be used together with the mixed antibody reagent (x).

[0108] In step S162, the processing unit 10A searches for single antibody reagent (y) No. y in the measurement order. In step S163, the processing unit 10A determines whether the antibody represented by the single antibody reagent (y) exists in the measurement order. If it exists, the processing unit 10A performs the processing of step S164. If not, it performs the determination of step S167.

[0109] In step S164, the processing unit 10A extracts the antibody represented by the single antibody reagent (y) from the measurement order, and updates the measurement order.

[0110] In step S165 , the processing unit 10A adds the single antibody reagent (y) to the reagent candidates.

[0111] In step S166, the processing unit 10A adds a value "1" to the evaluation score. After step S166 is completed, the processing of step S16 is recursively called, and the processing unit 10A continues the processing of step S16.

[0112] In step S167, the processing unit 10A determines whether the single antibody reagent y+1 (y+1) exists in the antibody reagent information DB 401 for the mixed antibody reagent x (x). If it exists, the processing unit 10A increases the variable y by "1" in step S168 and then performs the determination in step S163. If it does not exist, the processing unit 10A performs the determination in step S169.

[0113] In step S169, the processing unit 10A determines whether the mixed antibody reagent x+1 exists in the reagent candidates. If so, the processing unit 10A increments the variable x by "1" in step S170 and then performs the determination in step S163. If not, the processing unit 10A ends the single antibody reagent search process in step S16. At the end of step S16, the mixed antibody reagents in the reagent candidates, the single antibody reagents in the reagent candidates, and the remaining measurement instructions are listed. After the processing of step S16 is completed, the processing unit 10A performs Figure 7 The determination of step S17 is shown.

[0114] After the processing of step S17, the reagent candidates and evaluation scores stored in step S18 are processed in step S6, for example, Fig.12 The output is output to the output unit 17 of the reagent selection support device as shown. Fig.12 In the example shown, the processing unit 10A displays the reagent candidate combination with the highest evaluation score as the first candidate on the left side of the screen, and displays the reagent candidate combination with the second highest evaluation score as the second candidate on the right side of the screen.

[0115] In summary, the user of the reagent selection support device 100 can mix the antibody reagents with the sample 29 according to the combination of antibody reagents determined by the reagent selection support device 100, and set it in the measurement device body 200 for measurement. Thus, the user can select an appropriate combination of antibody reagents that meets the measurement instructions.

[0116] [Antibody reagent selection support method based on dialogue format] The user can also input information about the mixed antibody reagents and single antibody reagents currently in stock into the reagent selection support device 100. Thus, the user can refer to the determined antibody reagent combination candidates in a dialog form to understand whether the measurement that satisfies the measurement instruction can be performed with the antibody reagents currently in stock. Fig.11 Flowchart and Figure 12 to Figure 16 The following is an example of the interface display.

[0117] The processing unit 10A of the reagent selection support device 100 includes an output control unit 103 and a reagent designation receiving unit 104. The reagent designation receiving unit 104 obtains the designation of the reagent candidate input by the user through the input unit 16 and sends it to the output control unit 103. The output control unit 103 controls the display form of the designated reagent candidate on the output unit 17 according to the designation of the reagent candidate received from the reagent designation receiving unit 104. In addition, the reagent designation receiving unit 104 counts the number of designations of the reagent candidate input as the number of reagents used and displays the number on the interface. Specifically, the number of designations of the reagent candidate is equal to the number of checked check boxes.

[0118] The processing unit 10A of the reagent selection support device 100 can detect the input in the check box, and performs the operation when the input is detected. Fig.11 The operation shown in the flowchart. Figure 5 To explain the functional blocks shown in FIG. 1 , the processing of steps S31 and S32 is performed by the reagent specification receiving unit 104 , and the processing of steps S33 and S34 is performed by the output control unit 103 .

[0119] Fig.12 The combination of antibody reagents determined by the reagent selection support device 100 is displayed. The user confirms the information of the mixed antibody reagents and the information of the single antibody reagents currently in stock. Fig.12 If the displayed antibody reagent combinations include antibody reagents currently in stock, check the checkbox in the corresponding column.

[0120] For example, if the user has a CD25 single antibody reagent, the user checks the check box 51 corresponding to the CD25 single antibody reagent in the first candidate antibody reagent combination. In step S31, after the processing unit 10A obtains the designation of the reagent candidate for the first candidate antibody reagent combination, in step S32, the processing unit 10A determines whether the second candidate antibody reagent combination includes the same reagent candidate as the above designation.

[0121] If the second candidate also includes the same reagent candidate as the one specified in the first candidate, in step S33, Fig.13 As shown, the processing unit 10A checks the check box 52 for the second candidate antibody reagent candidate in conjunction with the check in the check box in the first candidate. The check box 52 is a check box corresponding to the CD25 single antibody reagent in the second candidate antibody reagent combination. If the reagent candidate identical to the one designated in the first candidate is not included in the second candidate, the processing unit 10A ends the processing. After the processing unit 10A detects the input in the check box, it starts the processing again from step S31.

[0122] In step S34, the processing unit 10A changes the display form of the checked check boxes 51 and 52. The changed display form is, for example, hatched display.

[0123] Next, the user continues to confirm the information of the mixed antibody reagents and single antibody reagents in stock. Fig.13 If the displayed antibody reagent combinations include antibody reagents currently in stock, check the box in the corresponding column.

[0124] For example, if the user has a CD3 / CD4 / CD8 mixed antibody reagent, the user checks the check box 53 corresponding to the CD3 / CD4 / CD8 mixed antibody reagent in the first candidate antibody reagent combination. The CD3 / CD4 / CD8 mixed antibody reagent is also included in the second candidate. Fig.14 As shown, the processing unit 10A checks the check box 54 for the second candidate antibody reagent in linkage. The check box 54 is a check box corresponding to the CD3 / CD4 / CD8 mixed antibody reagent in the second candidate antibody reagent combination. The check boxes 53 and 54 are displayed with hatching.

[0125] Similarly, the user then checks the information of the mixed antibody reagent and the information of the single antibody reagent currently in stock for the combination of the first candidate antibody reagent and inputs the information to the reagent selection support device 100 .

[0126] exist Fig.15 In the status shown, only one measurement instruction "CD38" remains among the measurement instructions to be detected.

[0127] For example, if the user has a CD38 single antibody reagent, the user can check the check box 55. As a result, all the antibody reagent combinations shown in the first candidate are checked and displayed with hatching. The fact that all the antibody reagents shown in the first candidate are displayed with hatching means that the user can perform the measurement that satisfies the measurement instruction using the mixed antibody reagents and single antibody reagents currently in stock. Then, the user can use the measurement device body 200 to detect the antibody specified by the measurement instruction based on the antibody reagent combination shown in the first candidate.

[0128] On the other hand, if the user does not have a CD38 single antibody reagent, the user cannot check the check box 55. In this case, the user continues to confirm the information of the mixed antibody reagent and the single antibody reagent in stock for the antibody reagent combination shown in the second candidate. For example, if the user has a CD2 / CD7 / CD3 mixed antibody reagent, the user checks the check box 56 corresponding to the CD2 / CD7 / CD3 mixed antibody reagent in the second candidate antibody reagent combination.

[0129] Next, similarly to the above, the user confirms the information of the mixed antibody reagent and the information of the single antibody reagent currently in stock for the second candidate antibody reagent combination, and inputs the information to the reagent selection support device 100 .

[0130] For example, next Fig.15 In the state shown, if the user has a CD5 single antibody reagent and a CD38 / CD56 / CD19 mixed antibody reagent, the user can check the check boxes 57 and 58. Fig.16 As shown, all the antibody reagent combinations shown in the second candidate are checked and displayed with hatching. The fact that all the antibody reagents shown in the second candidate are displayed with hatching means that the user can use the mixed antibody reagents and single antibody reagents in the existing inventory to perform the measurement that meets the measurement instruction. Then, the user can use the measurement device body 200 to detect the antibody specified by the measurement instruction based on the antibody reagent combination shown in the second candidate.

[0131] As described above, the user of the reagent selection support device 100 can also input information of mixed antibody reagents and single antibody reagents currently in stock into the reagent selection support device 100. Thus, the user can refer to the determined antibody reagent combination candidates in an interactive manner to understand whether the measurement that satisfies the measurement instruction can be performed using the antibody reagents currently in stock.

[0132] <Second embodiment> In the first embodiment, information on antibody reagents that can be used by the measurement device main body 200 is pre-stored in the reagent selection support device 100. In the second embodiment, information on antibody reagents that can be used by the measurement device main body 200 is obtained from the external server 400. The external server 400 is composed of, for example, a general-purpose computer having a CPU and a memory.

[0133] Fig.17 The inspection system according to the second embodiment shown includes a server 400 in addition to the sample measurement device 1000 and the client terminal 300 . The server 400 , the sample measurement device 1000 , and the client terminal 300 are connected to each other via a network 99 .

[0134] Fig.18 The processing unit 10B of the reagent selection support device 100 according to the second embodiment shown in the figure is provided with a reagent information acquisition unit 105 in addition to the processing unit 10A according to the first embodiment. That is, the processing unit 10B is provided with an antigen information acquisition unit 101, a candidate reagent determination unit 102, an output control unit 103, a reagent designation receiving unit 104, and a reagent information acquisition unit 105. The program according to the present invention is installed in the recording unit 13 or the memory 12 of the processing unit 10B, and the CPU 11 executes the program to realize the above-mentioned functional modules.

[0135] The external server 400 includes a data transmission and reception unit 402 that transmits the antibody reagent information DB 401 to the detection reagent selection support device 100 .

[0136] If using Fig.18 10B, and the reagent information acquisition unit 105 acquires the antibody reagent information DB 401 from the external server 400 and stores it in the recording unit 13 or the memory 12 of the processing unit 10B. By updating the antibody reagent information DB 401 stored in the external server 400 to the latest state, the detection reagent selection support device 100 can determine the combination of antibody reagent candidates according to the latest antibody reagent information DB 401 at any time. The second embodiment is the same as the first embodiment in terms of the method for determining the antibody reagent combination candidate and the antibody reagent selection support method based on the dialogue form. The processing performed by the reagent information acquisition unit 105 as a functional module is actually performed by Figure 4 The processing section 10B shown is performed.

[0137] As described above, the inspection system according to the second embodiment can achieve the effects of the inspection system according to the first embodiment and can also keep the information on the antibody reagents that can be used by the measurement device main body 200 in the latest state.

[0138] <Remarks> As mentioned above, although the present invention has been described by using specific embodiments, the present invention is not limited to the embodiments.

[0139] In the first and second embodiments, the processing units 10A and 10B are designed as an integrated device, but the processing units 10A and 10B are not limited to an integrated device, and the CPU 11, the memory 12, the recording unit 13, etc. may be arranged in different places and connected via a network. The processing units 10A and 10B, the input unit 16, and the output unit 17 do not necessarily have to be arranged in one place, and may be arranged in different places and connected in a manner that they can communicate with each other via a network.

[0140] In the first and second embodiments, each functional module - antigen information acquisition unit 101, candidate reagent determination unit 102, output control unit 103, reagent designation acceptance unit 104 and reagent information acquisition unit 105 is executed by a single CPU 11, but the above-mentioned functional modules do not necessarily have to be executed by a single CPU 11, and can also be distributedly processed by several CPUs.

[0141] In the first and second embodiments, Figure 6 to Figure 11 The program used for processing each step described is pre-stored in the recording unit 13, but the program can be installed into the processing units 10A, 10B from a computer-readable non-temporary tangible storage medium such as a CD-ROM (not shown in the figure). For example, the processing units 10A, 10B can be connected to the network 99 and the program can be downloaded from an external server 400 through the network 99 for installation.

[0142] In the first and second embodiments, the input unit 16 and the output unit 17 are integrated into a touch screen display device, but the input unit 16 may be formed by a keyboard or a mouse, and the output unit 17 may be formed by a liquid crystal display, etc. In addition, the output unit 17 may be formed by a printer, etc., and the candidate antibody reagent combination determined by the reagent selection support device 100 may be printed.

[0143] In the first and second embodiments, the measurement instruction is transmitted from the client terminal 300 to the reagent selection support device 100 via the network 99, but the measurement instruction may be inputted via the input unit 16 provided in the reagent selection support device 100. In this case, the measurement instruction is transmitted to the user of the reagent selection support device 100 via e-mail, telephone or other means, and the user inputs the transmitted measurement instruction into the reagent selection support device 100 via the input unit 16.

[0144] In the first and second embodiments, if the measuring device body 200 can identify more than three colors of fluorescent pigments, as an example, a mixed antibody reagent with a mixing number of "3" can be used for one test, and the reagent selection support device 100 can determine the candidate antibody reagent combination based on the information of the antibody reagent including the mixed antibody reagent with a mixing number of "3". The mixing number of the mixed antibody reagent is not particularly limited as long as it is 2 or more. For example, if the measuring device body 200 can identify more than four colors of fluorescent pigments, a mixed antibody reagent with a mixing number of "4" can be used for one test, and the reagent selection support device 100 can determine the candidate antibody reagent combination based on the information of the antibody reagent including the mixed antibody reagent with a mixing number of "4". At this time, the measuring device body 200 is equipped with a total of 5 optical detectors for detecting fluorescence in the detection unit 23, and the detection unit 23 simultaneously measures a total of 5 colors of fluorescence including 4 colors of fluorescence based on the mixed antibody reagent and 1 color of fluorescence based on the single antibody reagent. For example, if the measuring device main body 200 can recognize more than two colors of fluorescent dyes, a mixed antibody reagent with a mixing number of "2" can be used to perform one test, and the reagent selection support device 100 only needs to determine the candidate antibody reagent combination based on the information of the antibody reagent including the mixed antibody reagent with a mixing number of "2". In this case, the measuring device main body 200 is equipped with a total of three light detectors for detecting fluorescence in the detection unit 23, and the detection unit 23 simultaneously measures a total of three colors of fluorescence including two colors of fluorescence based on the mixed antibody reagent and one color of fluorescence based on the single antibody reagent.

[0145] In the first and second embodiments, the display of the antibody reagents currently in stock is displayed in a hatched display after inputting in the check box, but the display form is not limited to this. Instead of hatched display, for example, there are: black and white inversion display; or highlighting the box of the check box with double lines or other methods. That is, the change in the display form can be any form that the user can visually grasp.

[0146] The present invention includes a third embodiment described below in addition to the first and second embodiments. The detailed description of the third embodiment except for the following contents is the same as that of the first and second embodiments.

[0147] In the third embodiment of the present invention, the reagent selection support device 100 is a reagent selection support device that supports the selection of a mixed antibody reagent containing several antibodies, and comprises: an acquisition unit 15, 16, which obtains a measurement instruction with several antigens as the measurement object; a processing unit 10, which determines several antibody reagents that can be used together in the test for detecting several antigens based on the measurement instruction obtained by the acquisition unit 15, 16; and an output unit 17, which outputs information on the several antibody reagents that can be used together in the test determined by the processing unit 10.

[0148] The information of several antigens refers to the information of antigens of more than 2, more than 3, more than 4, more than 5, more than 6, more than 10, or more than 15. The antibody reagent is either a mixed antibody reagent, or a combination of a mixed antibody reagent and a single antibody reagent, or a combination of different mixed antibody reagents. Determining several antibody reagents means determining more than two antibody reagents to be used in one assay. Regarding the meaning of being able to be used in combination, if the first antibody reagent and the second antibody reagent are used for one assay, the meaning is that at least one color fluorescent pigment contained in the first antibody reagent and at least one color fluorescent pigment contained in the second antibody reagent can be identified and detected. The first antibody reagent can be either a mixed antibody reagent or a single antibody reagent. If the first antibody reagent is a mixed antibody reagent, the second antibody reagent is preferably a single antibody reagent or a mixed antibody reagent. If the second antibody reagent is a mixed antibody reagent, the first antibody reagent is preferably a single antibody reagent or a mixed antibody reagent. Both the first antibody reagent and the second antibody reagent can also be mixed antibody reagents. For example, if at least 4 fluorescent dyes are used for detection in one assay, the first antibody reagent may be selected as a mixed antibody reagent with a mixing number of "2" or more, and the second antibody reagent may be selected as a mixed antibody reagent with a mixing number of "2" or more, and then one assay may be performed. In addition, if the first antibody reagent is a single antibody reagent, the second antibody reagent may also be a mixed reagent with a mixing number of "3". In addition, if the combination of the first antibody reagent and the second antibody reagent still cannot assay 4 measurement items at one time, the first antibody reagent and the second antibody reagent may be used together in the first assay to assay 3 measurement items, and the third antibody reagent may be selected in the second assay to assay the remaining measurement items. The third antibody reagent may be either a mixed antibody reagent or a single antibody reagent.

[0149] Explanation of symbols 10, 10A, 10B processing unit; 12 memory; 13 recording unit; 14 bus; 15 interface unit; 16 input unit; 17 output unit; 21 aspiration unit; 22 fluid circuit; 23 detection unit; 27 sheath flow cell; 28 sample container; 29 sample; 99 network; 100 reagent selection support device; 101 antigen information acquisition unit; 102 candidate reagent determination unit; 103 output control unit; 104 reagent designation receiving unit; 105 reagent information acquisition unit; 200 measurement device body; 300 client terminal; 301 input unit; 302 data sending and receiving unit; 400 server; 401 antibody reagent information database; 402 data sending and receiving unit; 1000 sample measurement device.

Claims

1. A multicolor flow cytometer system capable of measuring a measurement sample prepared from a sample and a plurality of fluorescently labeled antibodies, the multicolor flow cytometer system comprising: Flow cytometry; as well as a computer connected to the flow cytometer, Wherein, the flow cytometer comprises: a flow cell in which the measurement sample flows; a light source configured to irradiate the measurement sample flowing in the flow cell with light; and a light receiving element configured to receive fluorescence of a different color from the fluorescent-labeled antibody in the measurement sample; and wherein the computer comprises a database storing antibody reagent information, the antibody reagent information being associated with a list of groups, each of the groups comprising combinable fluorescently labeled antibodies, The computer performs operations in response to input specifying a target antigen to be assayed, the operations comprising: determining a plurality of said groups from said list to detect said target antigen, wherein each of said determined groups comprises said fluorescently labeled antibody corresponding to said target antigen, wherein said target antigen is determined in a plurality of assays, each of said plurality of assays corresponding to a respective said group, The determined groups are presented.

2. The multicolor flow cytometer system according to claim 1, characterized in that: The computer further performs analysis of cells in the measurement sample measured by the flow cytometer.

3. The multicolor flow cytometer system according to claim 1, characterized in that: The operations performed by the computer further include: Determining reagent inventory information related to the determined group based on the target antigen and the antibody reagent information in the database; and The determined inventory information of the reagent is output.

4. The multicolor flow cytometer system according to claim 1, characterized in that: The operations performed by the computer further include: determining a first candidate and a second candidate of the determined group from the list; and The determined first candidate and the determined second candidate are outputted.

5. The multicolor flow cytometer system according to claim 4, characterized in that: The operations performed by the computer further include: The determined first candidate and the second candidate are outputted so that they can be distinguished from each other.

6. The multicolor flow cytometer system according to claim 1, characterized in that: The light receiving element is configured to receive forward scattered light and to receive side scattered light.

7. The multicolor flow cytometer system according to claim 1, further comprising a pipette configured to aspirate the measurement sample from a sample container containing the measurement sample, wherein The light receiving element is configured to receive the fluorescence of the different color from the fluorescent-labeled antibody in the measurement sample aspirated by the pipette.

8. The multicolor flow cytometer system according to claim 1, characterized in that: The operations performed by the computer further include: determining respective combinations of the groups from the list to detect the target antigen to be determined in a plurality of the assays; and The combinations of the respective groups determined are presented.

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