Sample analyzer

Abstract

To provide a sample analyzer capable of achieving shortening of a measurement time and improvement of efficiency, in an inspection using a reaction to a plurality of kinds of reaction substances whose measurement ranges are largely different.SOLUTION: A sample analyzer 1 includes: a measurement unit 23 as an imaging device for capturing an image including light reception information based on each reaction between a first reaction substance group comprising a plurality of kinds of reaction substances reacting to a component included in a sample and a second reaction substance which reacts to the component included in the sample and is a different type from a reaction substance included in the first reaction substance group; and a control unit 50 as a control device for analyzing, in the light reception information in the image, the light reception information on the basis of a first determination value corresponding to a first substance group and the light reception information on the basis of a second determination value corresponding to a second substance.SELECTED DRAWING: Figure 10

Description

Technical Field

[0001] The present invention relates to a sample analyzer.

Background Art

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

Prior Art Document

Patent Document

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] By the way, in order to examine whether a subject has an allergic constitution, a specific IgE test or a non-specific IgE test may be performed. Compared with a specific IgE test that measures the concentration of IgE that specifically reacts with multiple types of reactants (antigens), the non-specific IgE test that measures the concentration of IgE itself has a significantly different measurement range. Therefore, the measurements of the specific IgE test and the non-specific IgE test are measured separately, such as by changing the imaging conditions. There was room for improvement in the technique of examining using reactions with multiple types of reactants having significantly different measurement ranges from the viewpoints of shortening the measurement time and improving efficiency.

[0005] The present invention has been made in view of such a situation, and an object thereof is to provide a sample analyzer capable of shortening the measurement time and improving efficiency in an examination using reactions with multiple types of reactants having significantly different measurement ranges.

Means for Solving the Problems

[0006] To achieve the above object, one aspect of the present invention is an imaging device that captures an image including light reception information based on each of the reactions between a first reaction substance group composed of a plurality of types of reaction substances that react with components contained in a sample, and a second reaction substance of a type different from the reaction substances included in the first reaction substance group that reacts with the components contained in the sample, and a control device that analyzes the light reception information with respect to the light reception information in the image based on a first determination value corresponding to the first reaction substance group and analyzes the light reception information based on a second determination value corresponding to the second reaction substance. The sample analyzer includes:

Advantages of the Invention

[0007] According to the present invention, it is possible to provide a sample analyzer capable of shortening the measurement time and improving the efficiency in an inspection using reactions with a plurality of types of reaction substances having greatly different measurement ranges.

Brief Description of the Drawings

[0008]

Figure 1

Figure 2

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Figure 10

Figure 11

Figure 12

Mode for Carrying Out the Invention

[0009] 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.

[0010] 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 the present embodiment. FIG. 3 is a perspective view of the test kit 2 of the present embodiment.

[0011] 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, or the like.

[0012] 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 a 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.

[0013] <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 the present 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.

[0014] 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.

[0015] The chip holder rotation unit 22 is a chip rotation device that rotates the analysis chip 10. In the present embodiment, the injection assist operation when injecting liquid (specimen and reagent) into the flow path of the analysis chip 10 and the drainage treatment operation for draining the injected liquid are performed by utilizing 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.

[0016] 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 capturing the light emission on the analysis chip 10. The measurement unit 23 has a dark box 231 that forms a dark room, and can capture the light emission on the analysis chip 10 inside the dark box 231.

[0017] 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 the present embodiment. As shown in FIG. 4, the dispensing unit 24 has a dispensing nozzle 241 for attaching the pipette tip 40. The dispensing unit 24 sucks and discharges liquid through the pipette tip 40. The pipette tip 40 of the present embodiment is a disposable type that can be replaced for each classification of the liquid to be dispensed.

[0018] The cartridge holder 25 houses the cartridge 30. The cartridge 30 houses 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.

[0019] 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.

[0020] The control unit 50 shown in FIG. 2 is a computer composed of a processor such as a CPU and a memory as a storage unit. 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 reading control of the code reader 26, rotation of the chip holder rotation unit 22, movement of the chip holder rotation unit 22, movement and dispensing process of the dispensing unit 24, and 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, etc.

[0021] <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.

[0022] 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.

[0023] The first substrate 11 is formed in a disc shape. A frustum-shaped pedestal 111 is formed at the center of the first substrate 11. In addition, a wall portion 112 surrounding the pedestal 111 is formed on the outer peripheral portion of the first substrate 11. Note that a circular index M1 and a triangular index M2 as marker portions are formed on the pedestal 111.

[0024] On the upper surface of the base portion 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.

[0025] 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 allergy-causing substances. The first reactant group includes, for example, 45 items (45 types) of reactants.

[0026] 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.

[0027] By the way, compared with a specific IgE test that measures the concentration of IgE that specifically reacts with each of a plurality of 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 specific IgE tests and the second reactant for non-specific IgE tests 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 reactants are relatively largely diluted and immobilized compared to the specific IgE test.

[0028] Note that in this example, there are two classifications: the first reactant group for specific IgE tests and the second reactant for non-specific IgE tests, but the configuration may be such that the number of classifications is freely changed, not limited to the test items, such as being classified according to characteristics.

[0029] The second substrate 12 is formed in a disc 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 portion 111. Accordingly, the injection port 121 is located inside the pedestal portion 111 in a plan view.

[0030] A gap G is formed between the upper surface of the pedestal portion 111 of the first substrate 11 and the lower surface of the second substrate 12, through which the liquid injected from the injection port 121 is introduced using capillary action. This gap G is formed over the entire outer circumference of the injection port 121. This gap G serves as the flow path of the analysis chip 10.

[0031] The absorber 13 is composed of a water-retaining member and is formed in a ring shape larger than the diameter of the pedestal portion 111. The absorber 13 is disposed in the liquid replenishment space between the pedestal portion 111 and the wall portion 112. Due to the centrifugal force generated 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.

[0032] A plurality of air communication ports 14 are formed outside the pedestal portion 111 in a plan view. The inside and outside of the analysis chip 10 communicate with each other through these air communication ports 14, 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 positions (a plurality) on the second substrate 12 at equal intervals in the circumferential direction.

[0033] In FIG. 6, only one air communication port 14 is shown due to the sectional position relationship. As shown in FIG. 6, the air communication port 14 is inclined so as to approach the rotation axis center 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.

[0034] Next, with reference to FIG. 7, the first identification information holding portion 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.

[0035] As shown in FIG. 7, a first identification information holding portion 15 is provided on the bottom surface of the first substrate 11 of the analysis chip 10. The first identification information holding portion 15 is a two-dimensional code containing information readable by the code reader 26. The first identification information holding portion 15 includes, as the first identification information, information on the type of the test kit and the manufacturing lot. The type of the test kit includes information indicating that the analysis chip 10 is the object to be read.

[0036] <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 has a reagent storage portion 31 for storing various reagents necessary for causing antigen-antibody reaction and luminescence reaction, and a chip storage portion 32 for storing three (a plurality of) pipette tips 40.

[0037] The reagent storage portion 31 has a specimen diluent storage portion 311, a labeled antibody storage portion 312, a hydrogen peroxide solution storage portion 313, a luminescent substrate storage portion 314, a washing solution storage portion 315, and a sealing member 316. The upper openings of the specimen diluent storage portion 311, the labeled antibody storage portion 312, the hydrogen peroxide solution storage portion 313, the luminescent substrate storage portion 314, and the washing solution storage portion 315 are all sealed by the sealing member 316. The sealing member 316 is formed of, for example, a sheet mainly composed of aluminum.

[0038] The specimen diluent storage portion 311 also serves as a specimen addition portion where the specimen diluent is stored and the specimen is dispensed. The labeled antibody storage portion 312 stores the labeled antibody, the hydrogen peroxide solution storage portion 313 stores the hydrogen peroxide solution, and the luminescent substrate storage portion 314 stores the luminescent substrate. The washing solution storage portion 315 stores the washing solution. The liquid suction at each dispensing is performed after performing a piercing operation of piercing the sealing member 316 with the pipette tip 40 attached to the dispensing nozzle 241 of the dispensing unit 24 without removing the sealing member 316 from the cartridge 30.

[0039] The chip housing unit 32 is configured to be able to accommodate three pipette tips 40 used for each of the specimen, labeled antibody, and luminescent substrate in order to prevent contamination.

[0040] 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.

[0041] The second identification information holding unit 35 includes, as the second identification information, information such as the type and manufacturing lot of the test kit, expiration date, correction values for each item of the reactant, etc. 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.

[0042] The correction values for each item of the reactant include the correction value set for each of the first reactant groups 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 shipment of the test kit 2, such as during manufacturing.

[0043] Each correction value for each item of the reactant is set for each manufacturing lot. Each correction value is set in advance based on the degree of luminescence of the control specimen or international reference material. That is, even for the same-shaped analysis chip 10 and cartridge 30, different values are set if the manufacturing lot is different.

[0044] <Measurement process> Next, with reference 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 contents of the flowchart shown in FIG. 9 are merely examples and can be appropriately changed according to the circumstances.

[0045] 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.

[0046] 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, so that 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 diluent 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, so that the first identification information holding unit 15 of the analysis chip 10 is read. Thereby, information on the type and manufacturing lot of the analysis chip 10, information on the type and manufacturing lot of the cartridge 30, the expiration date, and correction values for each item of the reactant are registered in the control unit 50.

[0047] 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.

[0048] If the control unit 50 determines that the combination of the cartridge 30 and the analysis chip 10 is inappropriate, 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 inappropriate. The information indicating that the combination of the cartridge 30 and the analysis chip 10 is inappropriate 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.

[0049] When 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 setting operation of the cartridge 30 to the cartridge holder 25 and the setting operation of the analysis chip 10 to the chip holder rotation unit 22.

[0050] In step S5, the dispensing unit 24 performs a dispensing process of injecting the liquid of 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.

[0051] 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.

[0052] 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, a simultaneous test of specific IgE and non-specific IgE is performed by a series of processes.

[0053] 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 processes and contents of the flowchart shown in FIG. 10 are also merely examples and can be appropriately changed according to circumstances.

[0054] 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 the present 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 portions. 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.

[0055] 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 marker for specifying the position of the analysis chip 10. As the marker portion, for example, an index of a circular index M1 for discriminating the horizontal direction position and an index of a triangular index M2 for discriminating the rotational direction position are 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 also be used. In the present embodiment, the control unit 50 performs image analysis for detecting the position of the marker portion with respect to the bright-field image acquired in step S101.

[0056] In step S103, the control unit 50 executes a coordinate determination process for correcting the item-by-item coordinates of a preset reactant 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 reactant groups and the analysis chip 10 of the second reactant, and are registered in advance in the control unit 50. The control unit 50 can specify the positions of the reactants corresponding to the respective items on the analysis chip 10 by correcting the arrangement position information based on the position information of the marker portion.

[0057] 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 or subtraction processing for removing dark current components can be considered.)

[0058] 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 values 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 the determination value.

[0059] The unit of the calculated determination value is, for example, concentration (IU / mL). In this embodiment, considering the differences in luminescence amounts and measurement ranges between multiple types of specific IgE tests and non-specific IgE tests in the same image, concentrations as determination values are 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 in terms of concentration (IU / mL). The concentration (TA value) of specific IgE is calculated, for example, by an approximation curve with a control specimen. The concentration (IU / mL) of non-specific IgE is calculated, for example, by an approximation curve with an international reference material.

[0060] 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 value obtained for each item. The control unit 50 of this embodiment performs determination using two types of determination values, namely, a first determination value set for multiple types of specific IgE tests and a second determination value set for non-specific IgE tests. That is, based on the same image information, the control unit 50 analyzes the light reception information for the specific IgE test (the first reactant group) based on the first determination value corresponding to the light reception information in the image, and analyzes the light reception state based on the second determination value corresponding to the non-specific IgE test (the second reactant). Thereby, the analysis can be performed very efficiently.

[0061] 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 multiple types of specific IgE tests.

[0062] The first determination value is a threshold value that divides the determination numerical value (concentration) into multiple levels. 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; 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; when it is 100 or more, the class is 6. The items determined as class 2 to class 6 are all positive. The class indicates the degree of allergy to the causative substance.

[0063] 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 a different order of the determination numerical value.

[0064] In this example, when the determination numerical value of the 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; when it is 1000 or more, the class is 6. The class indicates the degree of allergic constitution.

[0065] The control unit 50 discriminates classes using a first determination value for each concentration (TA value) of a plurality of types of specific IgE tests. Also, the control unit 50 discriminates classes using a 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 in the flowchart of 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.

[0066] In this embodiment, the lower limit threshold of the concentration of the specific IgE test and the lower limit threshold of the concentration of the non-specific IgE test, which are output as the same class in terms of display, differ by 10 times or more. Similarly, the upper limit threshold of the concentration of the specific IgE test and the upper limit threshold of the concentration of the non-specific IgE test, which are output as the same class in terms of display, differ by 10 times. For example, the lower limit threshold (e.g., 3.5) of the concentration of the specific IgE test classified into class 3 and the lower limit threshold (e.g., 100) of the concentration of the non-specific IgE test differ by 10 times or more in terms of display. Even in the case of including a plurality of reactants whose calculated concentration values can be significantly different, such as the specific IgE test and the 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 easily and sensibly understandable by a simple process.

[0067] 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 for the sample analyzer 1 may be included.

[0068] Also, in the above embodiment, the correction value for correcting the received light amount is described as an example of the 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.

[0069] Also, in the above embodiment, the first identification information holding unit and the second identification information holding unit are configured by two-dimensional codes, but the configuration is not limited thereto. For example, the first identification information holding unit or the second identification information holding unit may be configured by an electronic component such as RFID (Radio Frequency Identification).

[0070] 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 thereto. Three or more types of determination values can be used.

[0071] According to the sample analyzer 1 of the present embodiment, there are the following effects. The sample analyzer 1 includes a measurement unit 23 as an imaging device that captures an image including light reception information based on the reactions of a first reactant group composed of a plurality of types of reactants (antigens) that react with the components contained in the specimen, and a second reactant of a type different from the reactants contained in the first reactant group that reacts with the components contained in the specimen, 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 reactant group and analyzes the light reception information based on a second determination value corresponding to the second reactant.

[0072] Thereby, even when the difference in the light emission amounts of the reactants contained in the first reactant group and the second reactant is large, simultaneous measurement of the light emission state can be performed using the same image, and shortening and efficiency of the measurement time can be realized.

[0073] Also, the control unit 50 of the present embodiment analyzes the light reception information based on correction values set for each of the reactants contained in the first reactant group and the second reactant, and the light reception amount in the image.

[0074] Thereby, even when the degree of the light emission state differs depending on the production lot for the same reactant, it is adjusted by the correction value, so that the accuracy of the analysis process can be further improved.

[0075] Further, the sample analyzer 1 of the present embodiment further includes a touch panel 21 as a display device for displaying the analysis results of the control unit 50, and the control unit 50 outputs the analysis results for the first reactant group and the analysis results for the second reactant to the touch panel 21.

[0076] Thereby, the analysis results of the simultaneous measurement of the second reactant of a type different from the first reactant group can be grasped easily and promptly.

[0077] In addition, in the present embodiment, the plurality of types of reactants included in the first reactant group specifically react with the component (IgE) contained in the specimen, and the second reactant non-specifically reacts with the component (IgE) contained in the specimen.

[0078] Thereby, even when the measurement ranges are greatly different, such as in specific IgE tests and non-specific IgE tests, simultaneous measurement using the same image can be realized.

[0079] 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.

[0080] Depending on the intensity of the light emission, there may be a case where the imaging limit of the measurement unit 23 is reached and the received light amount cannot be appropriately determined. In particular, in the non-specific IgE test, since it reacts with the entire component (IgE) contained in the specimen, the light emission amount becomes large and it is easy to reach the imaging limit. In this regard, with the configuration of the present embodiment, since exposure is performed in multiple steps to increase the range of the imaging limit, it is possible to prevent the occurrence of analysis defects due to the imaging limit.

[0081] Further, 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 a specimen, 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 holds correction information used for analysis processing of reactions, and an inspection kit 2. The sample analyzer 1 also includes 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 by reflecting the correction information (correction value).

[0082] Accordingly, even when the degree of luminescence varies depending on the production lot for the same reactant, the 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, it is possible to easily and surely reflect the differences in luminescence states that vary depending on the production lot in the sample analyzer.

[0083] 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 the reagents, 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 in the cartridge 30 and holds second identification information for identifying the cartridge 30.

[0084] Accordingly, it is possible to determine whether the analysis chip 10 and the cartridge 30 are in an appropriate combination. It is possible to prevent the occurrence of a situation in which the analysis processing is corrected due to an incorrect combination.

[0085] Further, 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.

[0086] As a result, since an identification code such as a QR code (registered trademark) can be used, an inspection kit 2 for reflecting correction information in the analysis process of the sample analyzer 1 can be realized with a simple configuration.

[0087] Further, 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 contains a larger amount of information than the first identification information holding unit 15.

[0088] As a result, compared with the analysis chip 10, a larger amount of information can be read by the control unit 50 using the cartridge 30 that can secure a larger display area because the reaction liquid is accommodated.

[0089] Further, in the present embodiment, the analysis information holding unit also serves as the second identification information holding unit 35 and includes the second identification information in addition to the correction information.

[0090] As a result, since the cartridge 30 that can secure a larger display area can be used, even when there are many measurement items as in the present embodiment, the correction information for each item can be included in the second identification information.

[0091] Further, the inspection kit 2 of the present embodiment includes a plurality of types of reactants that react with the components contained in the sample, a reagent used for the reaction between the sample and the reactants, and a second identification information holding unit 35 as an analysis information holding unit that contains correction information used for the analysis process of the light reception information based on the reaction.

[0092] With this configuration of the inspection kit 2, even when the degree of light emission differs depending on the production lot in 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.

[0093] The preferred embodiment and modification example of the sample analyzer 1 of the present invention have been described above. 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

[0094] 1 Sample analyzer 2 Inspection kit 10 Analysis chip 15 First identification information holding unit 23 Measurement unit (imaging device) 26 Code reader (analysis information acquisition unit) 30 Cartridge 35 Second identification information holding unit (analysis information holding unit) 50 Control unit (control device)

Claims

1. An imaging device that captures an image including light reception information based on each of the reactions of a first reactant group composed of a plurality of types of reactants that react with components contained in a sample, and a second reactant of a type different from the reactants included in the first reactant group that reacts with components contained in the sample, a control device that analyzes the light reception information with respect to the light reception information in the image based on a first determination value corresponding to the first reactant group and analyzes the light reception information based on a second determination value corresponding to the second reactant, A sample analyzer comprising:

2. The control device analyzes the light reception information based on correction values set for each reactant included in the first reactant group and the second reactant, and the light reception amount in the image. The sample analyzer according to claim 1.

3. Further comprising a display device that displays the analysis result of the control device, The control device outputs the analysis result for the first reactant group and the analysis result for the second reactant to the display device. The sample analyzer according to claim 1 or 2.

4. The plurality of types of reactants included in the first reactant group each specifically react with components contained in the sample, The second reactant reacts non-specifically with components contained in the sample. The sample analyzer according to claim 1 or 2.

5. The imaging device acquires the plurality of images by dividing the exposure time into a plurality of parts, The control device integrates the plurality of images and analyzes the light reception information. The sample analyzer according to claim 1 or 2.

Images