Sample analysis device and inspection kit

Abstract

To provide a sample analysis device and an inspection kit that can easily and accurately reflect a difference in level of reaction differing with manufacture lots etc., on analytic processing.SOLUTION: A sample analysis device 1 comprises: an inspection kit which comprises a plurality of kinds of reaction substance reacting with a component included in an analyte, a reagent (a labeled antibody, a luminescent substrate, etc.,) used for antigen antibody reaction, and a second identification information holding part 35 as an analytic information holding part including correction information used for analytic processing on the antigen antibody reaction; a code reader 26 as an analytic information acquisition part acquiring the correction information from the second identification information holding part 35; and a control unit 50 as a controller performing the analytic processing on the antigen antibody reaction while reflecting the correction information (correction value).SELECTED DRAWING: Figure 9

Description

Technical Field

[0001] The present invention relates to a sample analyzer and an inspection kit.

Background Art

[0002] Techniques for analyzing a specimen by using a reactant that reacts with an antibody contained in the specimen are known. For example, Patent Document 1 describes this type of technique.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] By the way, in an antigen-antibody reaction using a reactant such as an antigen, variations may occur depending on the production lot. In this case, even for the same specimen, there may be a difference in the amount of luminescence depending on the antigen or antibody and the reagent used for the reaction. It is conceivable to grasp the degree of reaction in advance during the production of an inspection kit containing the antigen or antibody to be reacted and reflect the grasped information in the analysis process. However, it is necessary to input the information at the time of production into the sample analyzer, which is a very laborious task. There was room for improvement in the prior art from the viewpoint of easily and surely reflecting the differences in reactions depending on the production lot in the sample analyzer.

[0005] The present invention has been made in view of such circumstances, and an object thereof is to provide a sample analyzer and an inspection kit that can easily and accurately reflect differences in the degree of reaction depending on the production lot or the like in the analysis process.

Means for Solving the Problems

[0006] To achieve the above object, one aspect of the present invention provides a test kit comprising a plurality of types of reactants that react with components contained in a specimen, a reagent used for an antigen-antibody reaction, and an analysis information holding unit that holds correction information used for analysis processing of the reaction; a sample analyzer comprising an analysis information acquisition unit that acquires the correction information from the analysis information holding unit, and a control device that performs the analysis processing on the reaction while reflecting the correction information.

[0007] In addition, one aspect of the present invention provides a test kit including an analysis chip on which a plurality of types of reactants are arranged, a cartridge that houses a reagent, a first identification information holding unit that is arranged on the analysis chip and holds first identification information for identifying the analysis chip, and a second identification information holding unit that is arranged on the cartridge and holds second identification information for identifying the cartridge.

Advantages of the Invention

[0008] According to the present invention, it is possible to provide a sample analyzer and a test kit that can easily and accurately reflect differences in the degree of reaction due to manufacturing lots or the like in analysis processing.

Brief Description of the Drawings

[0009]

Figure 1

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Figure 9

Figure 10

Figure 11

Figure 12

Mode for Carrying Out the Invention

[0010] Hereinafter, a preferred embodiment of the sample analyzer 1 as the sample analyzer of the present invention will be described with reference to the drawings.

[0011] FIG. 1 is a perspective view of the sample analyzer 1 according to an embodiment of the present invention. FIG. 2 is a block diagram showing the functional configuration of the sample analyzer 1 of this embodiment. FIG. 3 is a perspective view of the test kit 2 of this embodiment.

[0012] The sample analyzer 1 is an immunoluminescence measurement device that performs allergy tests and the like by utilizing the antigen-antibody reaction between the components contained in the specimen and the reactant. The sample analyzer 1 performs tests by measuring the luminescence state, for example, by the CLEIA method, the FEIA method, the FIA method, etc.

[0013] In addition, the sample analyzer 1 performs an allergy test using the test kit 2. The test kit 2 is composed of, for example, an analysis chip 10 on which the reactant is immobilized, and a cartridge 30 that houses a plurality of types of reagents and the like used for the reaction with the components contained in the specimen. The reagents are used for the antigen-antibody reaction.

[0014] <Overall Configuration of the Sample Analyzer> First, the overall configuration of the sample analyzer 1 will be described. As shown in FIGS. 1 and 2, the sample analyzer 1 of this embodiment includes a touch panel 21, a chip holder rotation unit 22, a measurement unit 23, a dispensing unit 24, a cartridge holder 25, a code reader 26, and a control unit 50.

[0015] The touch panel 21 is a display device that also serves as the operation device of the sample analyzer 1. The touch panel 21 accepts various settings and operations, and also displays measurement results, analysis results, etc.

[0016] The chip holder rotation unit 22 is a chip rotation device that rotates the analysis chip 10. In this embodiment, the injection assist operation when injecting liquid (specimen and reagent) into the flow path of the analysis chip 10 and the drainage process operation for draining the injected liquid are performed using the rotation of the analysis chip 10 by the chip holder rotation unit 22. The detailed configuration of the analysis chip 10 will be described later.

[0017] The measurement unit 23 is an imaging device that captures an image including light reception information for confirming the light emission state on the analysis chip 10 based on the reaction between the components contained in the specimen and the reactant. The measurement unit 23 acquires image information of the light emission state by imaging the light emission on the analysis chip 10. The measurement unit 23 has a dark box 231 that forms a dark room, and can image the light emission on the analysis chip 10 inside the dark box 231.

[0018] The dispensing unit 24 dispenses liquid to the analysis chip 10 set in the chip holder rotation unit 22. FIG. 4 is a perspective view of the dispensing unit 24 and the cartridge holder 25 of this embodiment. As shown in FIG. 4, the dispensing unit 24 has a dispensing nozzle 241 for attaching a pipette tip 40. The dispensing unit 24 sucks and discharges liquid through the pipette tip 40. The pipette tip 40 of this embodiment is a disposable type that can be replaced for each classification of the liquid to be dispensed.

[0019] The cartridge holder 25 houses the cartridge 30. The cartridge 30 contains various liquids and the like necessary for causing antigen-antibody reactions and luminescence reactions. The detailed configuration of the cartridge 30 will be described later.

[0020] The code reader 26 is a device that reads the identification codes assigned to the analysis chip 10 and the cartridge 30 (see Fig. 1). The identification code is, for example, a two-dimensional code such as a QR code (registered trademark) (see Figs. 7 and 8). Note that the identification code is not limited to two-dimensional codes. Other types of identification codes such as barcodes can also be used.

[0021] The control unit 50 shown in Fig. 2 is a computer composed of a processor such as a CPU, a memory as a storage unit, and the like. The touch panel 21, the chip holder rotation unit 22, the measurement unit 23, the dispensing unit 24, the code reader 26, etc. are electrically connected to the control unit 50. The control unit 50 controls various operations such as the reading control of the code reader 26, the rotation of the chip holder rotation unit 22, the movement of the chip holder rotation unit 22, the movement and dispensing process of the dispensing unit 24, and the imaging by the measurement unit 23. In addition, the control unit 50 also performs image processing, setting of inspection conditions, storage, and output of analysis data.

[0022] <Analysis chip> Next, the analysis chip 10 will be described. Fig. 5 is an exploded perspective view of the analysis chip 10 of the present embodiment, and Fig. 6 is a cross-sectional view of the analysis chip 10 of the present embodiment.

[0023] As shown in Figs. 5 and 6, the analysis chip 10 includes a first substrate 11, a second substrate 12, an absorber 13, and an air communication port 14.

[0024] The first substrate 11 is formed in a disc shape. In the center of this first substrate 11, a frustum-shaped pedestal 111 is formed. Also, on the outer peripheral portion of the first substrate 11, a wall portion 112 surrounding the pedestal 111 is formed. Note that on the pedestal 111, a circular indicator M1 and a triangular indicator M2 as marker portions are formed.

[0025] On the upper surface of the pedestal 111, a plurality of types of reactants A (such as antigens) are formed. The plurality of types of reactants are arranged at intervals from each other. The plurality of types of reactants include a first reactant group composed of a plurality of types of reactants for performing a specific IgE (immunoglobulin E) test and a second reactant for performing a non-specific IgE test.

[0026] The first reactant group includes, for example, food systems such as eggs, grains, tubers, beans, seeds, fruits and vegetables, meats, and fish, inhalation systems such as house dust, insects, tree pollen, weed pollen, molds, fungi, and animals, anisakis, etc., and is used for identifying allergens. The first reactant group includes, for example, 45 items (45 types) of reactants.

[0027] The second reactant is an anti-human IgE antibody for measuring the concentration of IgE in the body, reacts to bronchial asthma, atopic dermatitis, allergic rhinitis, hay fever, parasitic infections, acute hepatitis, chronic hepatitis, liver cirrhosis, primary liver cancer, collagen diseases, multiple myeloma, etc., and is used for testing allergic constitutions.

[0028] Incidentally, compared with a specific IgE test that measures the concentration of IgE that specifically reacts with multiple types of reactants, a non-specific IgE test that measures the concentration of IgE itself has a larger measurement range. For example, in a test method measured by imaging the luminescent state, if the measurement ranges are too different, there is a risk that the received light information cannot be appropriately analyzed from the same image captured by the measurement unit 23. Therefore, the first reactant group for the specific IgE test and the second reactant for the non-specific IgE test immobilized on the analysis chip 10 are prepared so that the degree of luminescence is generally within 10 times. As described above, since the non-specific IgE test has a large measurement range, the reactant is relatively largely diluted and immobilized compared to the specific IgE test.

[0029] Note that in this example, there are two classifications: the first reactant group for the specific IgE test and the second reactant for the non-specific IgE test. However, the number of classifications may be freely changed not limited to the test items, such as being classified according to characteristics.

[0030] The second substrate 12 is formed in a disk shape from a light-transmissive material and is joined to the upper part of the first substrate 11. A circular injection port 121 into which various liquids are injected is formed at the center of the second substrate 12. The injection port 121 is formed with a diameter smaller than that of the pedestal 111. Therefore, in a plan view, the injection port 121 is located inside the pedestal 111.

[0031] A gap G through which the liquid injected from the injection port 121 is introduced using capillary action is formed between the upper surface of the pedestal 111 of the first substrate 11 and the lower surface of the second substrate 12. This gap G is formed over the entire outer periphery of the injection port 121. This gap G serves as the flow path of the analysis chip 10.

[0032] The absorber 13 is composed of a water-retaining member and is formed in a ring shape larger than the diameter of the pedestal 111. The absorber 13 is disposed in the liquid replenishment space between the pedestal 111 and the wall portion 112. Due to the centrifugal force caused by the rotation of the analysis chip 10, the liquid discharged from the flow path is absorbed by the absorber 13 in the liquid capture space.

[0033] A plurality of air communication ports 14 are formed outside the base portion 111 in a plan view. Through the air communication ports 14, the inside and outside of the analysis chip 10 communicate with each other, and the air inside the analysis chip 10 is discharged to the outside during liquid injection. The air communication ports 14 are arranged at three (a plurality of) circumferential positions on the second substrate 12 at equal intervals.

[0034] In FIG. 6, only one air communication port 14 is shown in terms of the cross-sectional position relationship. As shown in FIG. 6, the air communication port 14 is inclined so as to approach the center of the rotation axis of the analysis chip 10 from bottom to top in the thickness direction of the second substrate 12. By forming the air communication port 14 to be inclined toward the rotation axis side, the occurrence of a situation where the liquid leaks to the outside of the analysis chip 10 during centrifugation is prevented.

[0035] Next, referring to FIG. 7, the first identification information holding unit 15 disposed in the analysis chip 10 will be described. FIG. 7 is a bottom view of the analysis chip 10 of the present embodiment.

[0036] As shown in FIG. 7, the first identification information holding unit 15 is provided on the bottom surface of the first substrate 11 of the analysis chip 10. The first identification information holding unit 15 is a two-dimensional code including information readable by the code reader 26. The first identification information holding unit 15 includes information on the type of inspection kit and the manufacturing lot as the first identification information. The type of inspection kit includes information indicating that the reading target is the analysis chip 10.

[0037] <Cartridge> FIG. 8 is a rear view of the cartridge 30 of the present embodiment. As shown in FIG. 8, the cartridge 30 of the present embodiment includes a reagent storage unit 31 that stores various reagents necessary for causing antigen-antibody reactions and luminescence reactions, and a chip storage unit 32 that stores three (a plurality of) pipette tips 40.

[0038] The reagent storage unit 31 includes a specimen diluent storage unit 311, a labeled antibody storage unit 312, a hydrogen peroxide solution storage unit 313, a luminescent substrate storage unit 314, a cleaning solution storage unit 315, and a sealing member 316. The specimen diluent storage unit 311, the labeled antibody storage unit 312, the hydrogen peroxide solution storage unit 313, the luminescent substrate storage unit 314, and the cleaning solution storage unit 315 are all sealed at their upper openings by the sealing member 316. The sealing member 316 is formed of, for example, a sheet mainly composed of aluminum.

[0039] The specimen diluent storage unit 311 is also a specimen addition unit where the specimen diluent is stored and the specimen is dispensed. The labeled antibody storage unit 312 stores the labeled antibody, the hydrogen peroxide solution storage unit 313 stores the hydrogen peroxide solution, the luminescent substrate storage unit 314 stores the luminescent substrate, and the cleaning solution storage unit 315 stores the cleaning solution. Liquid suction during each dispensing is performed after a piercing operation of passing through the sealing member with a pipette tip 40 attached to the dispensing nozzle 241 of the dispensing unit 24 without removing the sealing member 316 from the cartridge 30.

[0040] The tip storage unit 32 is configured to be able to store three pipette tips 40 used for each of the specimen, the labeled antibody, and the luminescent substrate in order to prevent contamination.

[0041] In addition, a second identification information holding unit 35 is arranged in the cartridge 30 of the present embodiment. The second identification information holding unit 35 is a two-dimensional code given to the cartridge 30. The second identification information holding unit 35 includes second identification information that can be read by the code reader 26.

[0042] The second identification information holding unit 35 includes, as the second identification information, information such as the type of the test kit, the manufacturing lot number, the expiration date, and the correction values for each item of the reactants, in addition to the information of the test kit. The type of the test kit is information indicating that the reading target is the cartridge 30. The expiration date is information specifying, for example, the manufacturing date and the expiration period.

[0043] The correction values for each item of the reactants include the correction values set for each of the first reactant group and the correction value set for the second reactant. The correction value is a coefficient for converting to a concentration set according to the degree of luminescence. This correction value is set before the inspection kit 2 is shipped, such as during manufacturing.

[0044] Each correction value for each item of the reactants is set for each production lot. Each correction value is set in advance based on the degree of luminescence of the control sample or the international standard substance. That is, the correction values for each item will be different if the production lot is different even for the analysis chip 10 and the cartridge 30 of the same shape.

[0045] <Measurement process> Next, referring to FIG. 9, the allergy test using the sample analyzer 1 will be described. FIG. 9 is a flowchart showing an example of the processing flow of the allergy test by the sample analyzer 1 of the present embodiment. Note that the processing and content of the flowchart shown in FIG. 9 are merely examples and can be appropriately changed according to the circumstances.

[0046] In step S1, the code reader 26 reads the first identification information holding unit 15 of the analysis chip 10 and the second identification information holding unit 35 of the cartridge 30.

[0047] For example, the user of the sample analyzer 1 moves the second identification information holding unit 35 of the cartridge 30 to the reading position of the code reader 26, whereby the second identification information holding unit 35 of the cartridge 30 is read. At this time, a display guiding the injection of the sample into the sample dilution liquid storage unit 311 may be displayed on the touch panel 21. Next, the user moves the first identification information holding unit 15 of the analysis chip 10 to the reading position of the code reader 26, whereby the first identification information holding unit 15 of the analysis chip 10 is read. Thereby, information on the type and production lot of the analysis chip 10, information on the type and production lot of the cartridge 30, the expiration date, and the correction values for each item of the reactants are registered in the control unit 50.

[0048] In step S2, the control unit 50 determines whether the combination of the cartridge 30 and the analysis chip 10 is appropriate based on the first identification information of the analysis chip 10 and the second identification information of the cartridge 30. For example, the control unit 50 determines whether the information on the type and manufacturing lot of the test kit included in the first identification information corresponds to the information on the type and manufacturing lot of the test kit included in the second identification information. Also, the control unit 50 determines whether the cartridge 30 and the analysis chip 10 are within the expiration date based on the expiration date included in the second identification information.

[0049] If the control unit 50 determines that the combination of the cartridge 30 and the analysis chip 10 is not appropriate, the process proceeds to step S3 (step S2; No). In step S3, the control unit 50 causes the touch panel 21 to display information indicating that the combination of the cartridge 30 and the analysis chip 10 is not appropriate. The information indicating that the combination of the cartridge 30 and the analysis chip 10 is not appropriate includes, for example, that the cartridge 30 and the analysis chip 10 are not a corresponding combination based on the determination result of step S2, and that the cartridge 30 and the analysis chip 10 are not within the expiration date.

[0050] If the control unit 50 determines that the combination of the cartridge 30 and the analysis chip 10 is appropriate, the process proceeds to step S4 (step S2; Yes). In step S4, when the control unit 50 detects that a start operation has been performed by the touch panel 21 or the like, the process proceeds to step S5. The start operation includes the operation of setting the cartridge 30 in the cartridge holder 25 and the operation of setting the analysis chip 10 in the chip holder rotation unit 22.

[0051] In step S5, the dispensing unit 24 performs a dispensing process of injecting the liquid in the cartridge 30 into the analysis chip 10. In the dispensing process, injection operations of various liquids such as a specimen, a labeled antibody, hydrogen peroxide solution, a luminescent substrate, and a cleaning solution into the analysis chip 10 are performed. When injecting various liquids into the flow path of the analysis chip 10 and when discharging the injected various liquids, the analysis chip 10 is rotated by the chip holder rotation unit 22.

[0052] In step S6, the control unit 50 analyzes the luminescence state based on the image captured by the measurement unit 23 and executes an analysis process for performing an allergy test. Details of this analysis process will be described later.

[0053] In step S7, the control unit 50 displays information indicating the result of the analysis process on the touch panel 21. The information indicating the result of the analysis process includes the degree of allergy to the causative substance by the test of 45 items (45 types) of specific IgE which is the first reactant group, and the result for confirming the degree of allergic constitution by the test of non-specific IgE which is the second reactant. As described above, the simultaneous test of specific IgE and non-specific IgE is performed by a series of processes.

[0054] Next, referring to FIG. 10, the analysis process will be described. FIG. 10 is a flowchart showing an example of the flow of the analysis process by the sample analyzer 1 of the present embodiment, and is a subroutine corresponding to the process of step S6 in the flowchart of FIG. 9. Note that the process and content of the flowchart shown in FIG. 10 are also merely examples and can be appropriately changed according to circumstances.

[0055] In step S101, the measurement unit 23 executes an imaging process for capturing a measurement image of the analysis chip 10. In the imaging process of this embodiment, two types of imaging, a bright-field image and a dark-field image, are performed. The bright-field image is position-specifying information for specifying the position of the analysis chip 10 during measurement. The bright-field image is captured, for example, with the analysis chip 10 illuminated by an illumination device (not shown) such as an LED in the dark box 231. The dark-field image is light-receiving information for confirming the light-emitting state. Also, for the dark-field image, exposure is acquired in multiple steps. That is, the measurement unit 23 performs imaging multiple times. Note that the imaging order of the bright-field image and the dark-field image is not particularly limited.

[0056] In step S102, the control unit 50 executes a position detection process for detecting the position of the marker portion of the analysis chip 10. The marker portion is a label for specifying the position of the analysis chip 10. For the marker portion, for example, an index of a circular index M1 for discriminating the horizontal direction position or an index of a triangular index M2 for discriminating the rotational direction position is used. Note that the shape of the analysis chip 10 such as the arrangement position of the injection port 121 and the plurality of air communication ports 14 may be used. In this embodiment, the control unit 50 performs image analysis for detecting the position of the marker portion on the bright-field image acquired in step S101.

[0057] In step S103, the control unit 50 executes a coordinate determination process for correcting the item-by-item coordinates of the reaction substances preset based on the detected marker portion. The item-by-item coordinates are, for example, arrangement position information indicating the arrangement positions of a plurality of types of first reaction substance groups and the second reaction substance on the analysis chip 10, and are registered in advance in the control unit 50. The control unit 50 can specify the positions of the reaction substances corresponding to each item on the analysis chip 10 by correcting the arrangement position information based on the position information of the marker portion.

[0058] In step S104, the control unit 50 executes a light reception amount quantification process for quantifying the light reception amount for each item based on the corrected item-by-item coordinates. In the present embodiment, the control unit 50 performs image analysis for detecting the light reception amount on the dark field image acquired in step S101. The control unit 50 executes the quantification process of the light reception amount for each item after integrating a plurality of images by dividing the number of exposure times. In the quantification process, information indicating the brightness in the image is quantified by a predetermined conversion formula. (For example, binning processing for noise removal, subtraction processing for removing dark current components, etc. are conceivable.)

[0059] In step S105, the control unit 50 executes a determination value calculation process for calculating a determination value based on the light reception amount for each item. In the present embodiment, the control unit 50 corrects the light reception amount with the item-by-item correction value included in the second identification information holding unit 35 of the cartridge 30, and converts the corrected light reception amount into concentration or density. The control unit 50 converts the numerical value indicating the corrected light reception amount into a numerical value indicating concentration or density by a predetermined conversion formula, and acquires a determination value.

[0060] The unit of the calculated determination value is, for example, concentration (IU / mL). In the present embodiment, considering the differences in the emission amount and measurement range between a plurality of types of specific IgE tests and non-specific IgE tests in the same image, the concentration as the determination value is calculated by different calculation methods. In this example, specific IgE is calculated as a concentration (TA value) approximated to the concentration (IU / mL), and non-specific IgE is calculated as a concentration (IU / mL). The concentration (TA value) of specific IgE is calculated, for example, by an approximation curve with a control sample. The concentration (IU / mL) of non-specific IgE is calculated, for example, by an approximation curve with an international standard substance.

[0061] In step S106, the control unit 50 executes a determination process of outputting a determination result for each item by using a preset determination value for the determination numerical values acquired for each item. The control unit 50 of the present embodiment performs determination using two types of determination values: a first determination value set for a plurality of types of specific IgE tests and a second determination value set for a non-specific IgE test. That is, based on the same image information, the control unit 50 analyzes the light reception information for the specific IgE test (first reactant group) based on the first determination value corresponding to the specific IgE test, and analyzes the light reception state based on the second determination value corresponding to the non-specific IgE test (second reactant). Thereby, analysis can be performed very efficiently.

[0062] Referring to FIG. 11, the first determination value will be described. FIG. 11 is a table showing an example of the first determination value for the specific IgE test which is the determination criterion of the control unit 50. As shown in FIG. 11, the first determination value is a first determination table used for a plurality of types of specific IgE tests.

[0063] The first determination value is a threshold value that divides the determination numerical value (concentration) into a plurality of stages. In this example, classes from 0 to 6 are divided by the threshold value. When the determination numerical value of the specific IgE test is less than 0.35, the class is 0, and when it is 0.35 or more and less than 0.7, the class is 1. The items determined as class 1 and class 2 are both negative. On the other hand, when the determination numerical value of the specific IgE is 0.7 or more and less than 3.5, the class is 2, when it is 3.5 or more and less than 17.5, the class is 3, when it is 17.5 or more and less than 50, the class is 4, when it is 50 or more and less than 100, the class is 5, and when it is 100 or more, the class is 6. The items determined as class 2 to 6 are all positive. The class indicates the degree of allergy to the causative substance.

[0064] Referring to FIG. 12, the second determination value will be described. FIG. 12 is a table showing an example of the second determination value for the non-specific IgE test which is the determination criterion of the control unit 50. As shown in FIG. 12, the second determination value is the second determination table used for the non-specific IgE test. The second determination value is a threshold value that divides the determination numerical value (concentration) into multiple levels, but the criteria are different from those of the first determination value of the specific IgE test with different orders of determination numerical values.

[0065] In this example, when the determination numerical value of non-specific IgE is less than 20, the class is 0; when it is 20 or more and less than 40, the class is 1; when it is 40 or more and less than 100, the class is 2; when it is 100 or more and less than 200, the class is 3; when it is 200 or more and less than 400, the class is 4; when it is 400 or more and less than 1000, the class is 5; and when it is 1000 or more, the class is 6. The class indicates the degree of allergic constitution.

[0066] The control unit 50 discriminates the class using the first determination value for the concentration (TA value) of each of the plurality of types of specific IgE tests. Also, the control unit 50 discriminates the class using the second determination value for the concentration (IU / mL) of non-specific IgE. Thus, the specific IgE test and the non-specific IgE test are determined based on different criteria. After the determination process, the process moves to the process of step S7 of the flowchart in FIG. 9, and the information based on the determination result is displayed on the touch panel 21. On the touch panel 21, as the analysis result, the concentration and class of each of the specific IgE and non-specific IgE may be displayed.

[0067] In addition, in the present embodiment, the lower limit threshold of the concentration of the specific IgE test output as the same class and the lower limit threshold of the concentration of the non-specific IgE test are different by 10 times or more in terms of display. Similarly, the upper limit threshold of the concentration of the specific IgE test output as the same class and the upper limit threshold of the concentration of the non-specific IgE test are different by 10 times in terms of display. For example, in terms of display, the lower limit threshold of the concentration of the specific IgE test classified into class 3 (for example, 3.5) and the lower limit threshold of the concentration of the non-specific IgE test (for example, 100) are different by 10 times or more. Even in the case of including a plurality of reactants whose calculated concentration values can be greatly different, such as a specific IgE test and a non-specific IgE test, by performing analysis using a first determination value and a second determination value different from the first determination value, it is possible to perform a display that is easy to understand intuitively by simple processing.

[0068] In the above embodiment, the first identification information includes information on the type and manufacturing lot, and the second identification information includes information on the type and manufacturing lot, the use period, and the correction value for each item of the reactant, but the information to be held is not limited to this information. For example, information specifying an operation flow such as a dispensing process or an analysis process and analysis items may be included in the sample analyzer 1.

[0069] Also, in the above embodiment, the correction value for correcting the received light amount has been described as an example of correction information, but the configuration is not limited to this. For example, the correction information may be information specifying a correction pattern preset in the sample analyzer 1.

[0070] Also, in the above embodiment, the first identification information holding unit and the second identification information holding unit are configured by a two-dimensional code, but the configuration is not limited to this. For example, the first identification information holding unit and the second identification information holding unit may be configured by an electronic component such as RFID (Radio Frequency Identification).

[0071] Also, in the above embodiment, the control unit 50 executes the determination process using two types of determination values, the first determination value and the second determination value, but the configuration is not limited to this. Three or more types of determination values can be used.

[0072] According to the sample analyzer 1 of this embodiment, the following effects are obtained. The sample analyzer 1 includes a first reaction substance group composed of a plurality of types of reaction substances (antigens) that react with components contained in a specimen, and a second reaction substance of a type different from the reaction substances contained in the first reaction substance group that reacts with components contained in the specimen, and a measurement unit 23 as an imaging device that captures an image including light reception information based on each reaction of the two, and a control unit 50 as a control device that analyzes the light reception information based on a first determination value corresponding to the first reaction substance group and also analyzes the light reception information based on a second determination value corresponding to the second reaction substance.

[0073] Thereby, even when the difference in the emission amounts of the reaction substances contained in the first reaction substance group and the second reaction substance is large, simultaneous measurement of the emission states can be performed using the same image, and shortening and efficiency improvement of the measurement time can be realized.

[0074] Further, the control unit 50 of this embodiment analyzes the light reception information based on correction values set for each of the reaction substances contained in the first reaction substance group and the second reaction substance, and the light reception amount in the image.

[0075] Thereby, even when the degree of the emission state differs depending on the production lot for the same reaction substance, it is adjusted by the correction value, so that the accuracy of the analysis process can be further improved.

[0076] Further, the sample analyzer 1 of this embodiment further includes a touch panel 21 as a display device that displays the analysis result of the control unit 50, and the control unit 50 outputs the analysis result for the first reaction substance group and the analysis result for the second reaction substance to the touch panel 21.

[0077] Thereby, the analysis results of the simultaneous measurement of the second reaction substance of a type different from the first reaction substance group can be grasped easily and promptly.

[0078] In addition, in the present embodiment, a plurality of types of reactants included in the first reactant group specifically react with a component (IgE) contained in the sample, and the second reactant reacts non-specifically with the component (IgE) contained in the sample.

[0079] As a result, even when the measurement ranges are significantly different, such as in specific IgE tests and non-specific IgE tests, simultaneous measurement using the same image can be achieved.

[0080] In addition, in the present embodiment, the measurement unit 23 acquires a plurality of images by dividing the exposure time into a plurality of parts, and the control unit 50 integrates the plurality of images and analyzes the received light information.

[0081] Depending on the intensity of the light emission, there may be cases where the imaging limit of the measurement unit 23 is reached and the received light amount cannot be appropriately determined. In particular, in non-specific IgE tests, since the test reacts with the entire component (IgE) contained in the sample, the amount of light emission increases and it is easy to reach the imaging limit. In this regard, with the configuration of the present embodiment, exposure is performed in multiple steps to increase the range of the imaging limit, so that it is possible to prevent the occurrence of analysis failures due to the imaging limit.

[0082] In addition, the sample analyzer 1 of the present embodiment has the following effects. The sample analyzer 1 of the present embodiment includes a plurality of types of reactants that react with components contained in the sample, reagents (labeled antibodies, luminescent substrates, etc.) used in antigen-antibody reactions, and a second identification information holding unit 35 as an analysis information holding unit that includes correction information used for analysis processing of the reaction, a test kit 2, a code reader 26 as an analysis information acquisition unit that acquires correction information from the second identification information holding unit 35, and a control unit 50 as a control device that performs analysis processing on the reaction reflecting the correction information (correction value).

[0083] As a result, even when the degree of light emission differs depending on the production lot for the same reactant, analysis processing is executed using the correction information read by the code reader 26. By simply reading the correction information with the code reader 26, the difference in the light emission state depending on the production lot can be easily and surely reflected in the sample analyzer.

[0084] Further, the inspection kit 2 of the present embodiment includes an analysis chip 10 on which a plurality of types of reactants are arranged, a cartridge 30 that houses a reagent, a first identification information holding unit 15 that is arranged on the analysis chip 10 and holds first identification information for identifying the analysis chip 10, and a second identification information holding unit 35 that is arranged on the cartridge 30 and holds second identification information for identifying the cartridge 30.

[0085] Thereby, it is possible to determine whether the analysis chip 10 and the cartridge 30 are in an appropriate combination, and it is possible to prevent the occurrence of a situation where the analysis process is corrected by an incorrect combination.

[0086] In addition, the first identification information holding unit 15 and the second identification information holding unit 35 of the present embodiment display an identification code (two-dimensional code) from which information is acquired by image analysis. The code reader 26 reads the identification code by image analysis.

[0087] Thereby, since an identification code such as a QR code (registered trademark) can be used, the inspection kit 2 for reflecting correction information in the analysis process of the sample analyzer 1 can be realized with a simple configuration.

[0088] In the present embodiment, the display area of the identification code of the second identification information holding unit 35 is larger than that of the identification code of the first identification information holding unit 15, and the second identification information holding unit includes a larger amount of information than the first identification information holding unit.

[0089] Thereby, compared with the analysis chip 10, it is possible to cause the control unit 50 to read a larger amount of information by using the cartridge 30 in which a larger display area can be secured because the reaction liquid is accommodated.

[0090] In the present embodiment, the analysis information holding unit also serves as the second identification information holding unit and includes the second identification information in addition to the correction information.

[0091] As a result, since the cartridge 30 that can secure a large display area can be used, even when there are a large number of measurement items as in the present embodiment, correction information for each item can be included in the second identification information.

[0092] Further, the inspection kit 2 of the present embodiment includes a plurality of types of reactants that react with the components contained in the specimen, a reagent used for the reaction between the specimen and the reactants, and a second identification information holding unit 35 as an analysis information holding unit that holds correction information used for the analysis process of the light reception information based on the reaction.

[0093] With this configuration of the inspection kit 2, even when the degree of light emission differs depending on the production lot for the same reactant, on the sample analyzer 1 side, the analysis process is executed using the correction information, so the influence of the difference in production lot is suppressed and the analysis process can be stably executed.

[0094] As described above, the preferred embodiment and modification examples of the sample analyzer 1 of the present invention have been described. However, the present invention is not limited to the individual forms shown in these embodiments, and it goes without saying that various changes based on the idea of the present invention are possible.

Explanation of Reference Numerals

[0095] 1 Sample Analyzer 2 Inspection Kit 10 Analysis Chip 15 First Identification Information Holding Unit 23 Measurement Unit (Imaging Device) 26 Code Reading Device (Analysis Information Acquisition Unit) 30 Cartridge 35 Second Identification Information Holding Unit (Analysis Information Holding Unit) 50 Control Unit (Control Device)

Claims

1. An inspection kit comprising: a plurality of types of reactants that react with components contained in a sample; a reagent used for an antigen-antibody reaction; and an analysis information holding unit that holds correction information used for analysis processing of the reaction. An analysis information acquisition unit that acquires the correction information from the analysis information holding unit. A control device that performs the analysis processing on the reaction by reflecting the correction information. A sample analyzer comprising the above.

2. An inspection kit for the sample analyzer according to Claim 1, An analysis chip on which the plurality of types of reactants are arranged. A cartridge that houses the reagent. A first identification information holding unit that is arranged on the analysis chip and holds first identification information for identifying the analysis chip. A second identification information holding unit that is arranged on the cartridge and holds second identification information for identifying the cartridge. An inspection kit comprising the above.

3. The inspection kit according to Claim 2, wherein the first identification information holding unit and the second identification information holding unit display identification codes from which information is acquired by image analysis. The inspection kit according to Claim 2.

4. The inspection kit according to Claim 3, wherein the identification code of the second identification information holding unit has a larger display area than the identification code of the first identification information holding unit, and the second identification information holding unit contains a larger amount of information than the first identification information holding unit. The inspection kit according to Claim 3.

5. The inspection kit according to Claim 4, wherein the analysis information holding unit also serves as the second identification information holding unit, and contains the second identification information in addition to the correction information. The inspection kit according to Claim 4.

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