Immuno-chromatographic test device

Abstract

The detection device of the present application is provided with: a loading section that detachably loads a reagent kit provided with a carrier having a droplet addition region to which a test object is added and a detection region; a photographing section that photographs the detection region; and a processor that performs determination of whether the test object is positive or negative, i.e., main determination, based on a detection region image photographed by the photographing section. The detection region image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix shape, and the processor performs the following abnormality determination: determination of whether the detection region image is abnormal or not, and use of at least one of a difference between a relatively large pixel value and a relatively small pixel value in at least one column in the detection region image, a standard deviation based on the pixel values in each column, and a variation coefficient as a determination index, and the processor determines the processing content involved in the main determination based on the presence or absence of abnormality.

Description

Technical Field

[0001] This invention relates to an immunochromatographic detection device. Background Technology

[0002] Among immunoassay methods, immunochromatography is widely used because it is simple to operate and can detect antibodies in a short time.

[0003] In immunochromatography, an immunochromatographic carrier is used, which has a detection region formed by immobilizing antibodies that specifically bind to an antigen, which is the analyte. When the labeled antibody, which specifically binds to the antigen, and the analyte contained in the antigen are diffused together on the immunochromatographic carrier, the antigen binds to the antibody immobilized in the detection region, and the labeled substance is captured by the antigen. The detection region develops color due to the captured labeled substance in the detection region; therefore, a positive result is determined when the colorimetric concentration in the detection region is above a reference value.

[0004] Japanese Patent Application Publication No. 2009-115470 discloses a detection device for optically analyzing the color development state of the detection area of ​​an immunochromatographic carrier. The detection device includes a sensor for optically detecting the reaction state and a measuring unit for determining whether the result is positive or negative based on the detection result. In Japanese Patent Application Publication No. 2009-115470, to suppress false judgments caused by the deterioration of the immunochromatographic carrier, a determination of whether the immunochromatographic carrier has deteriorated is performed before judgment. At this time, with the sample diffused, the change in brightness within a specified area on the immunochromatographic carrier is measured, and if it exceeds a preset specification value, the immunochromatographic carrier is determined to have deteriorated. Therefore, false judgments associated with the deterioration of the immunochromatographic carrier can be suppressed. Summary of the Invention

[0005] The technical problem to be solved by the invention

[0006] In detection devices, besides false positives caused by the deterioration of the immunochromatographic carrier, color development due to the non-specific adsorption of labeled substances in or near the detection area can sometimes lead to a false positive even if the result was originally negative. False positives caused by such non-specific adsorption of labeled substances can impair the reliability of immunochromatographic detection. A new detection device is expected to provide results with higher reliability than previously thought.

[0007] The present invention was made in view of the above circumstances, and its object is to provide an immunochromatographic detection device that can provide results with higher reliability than previous determinations.

[0008] means for solving technical problems

[0009] The immunochromatographic detection device of the present invention includes: a filling section for detachably filling a reagent kit, the reagent kit having a dropping area in which a sample is dropped and a detection area in which the color development state changes depending on whether the sample is positive or negative;

[0010] The camera department, the camera inspection area; and

[0011] The processor determines whether the subject is positive or negative based on the detection area image captured by the imaging unit; this is the primary determination.

[0012] When the diffusion direction of the analyte on the carrier is set as the row direction, and the direction intersecting the row direction is set as the column direction, the detection area is a linear region extending along the column direction.

[0013] The detection region image is an image in which multiple pixels are arranged in a matrix-like two-dimensional structure.

[0014] The processor performs the following anomaly detection: determines whether there is an anomaly in the detection region image, and uses at least one of the following criteria: the difference between the relatively large and relatively small pixel values ​​in at least one column of the detection region image; the standard deviation and coefficient of variation of the pixel values ​​in each column; or the difference between the relatively large and relatively small representative values ​​of each row derived from multiple pixels in different columns of the same row in the detection region image; the standard deviation and coefficient of variation of the representative values ​​in each row.

[0015] The processor determines the processing content involved in the main decision based on whether there is an anomaly.

[0016] In the immunochromatographic detection device of the present invention, the processing content may include any one of the following methods: whether to perform a main determination and to indicate the determination result of the main determination.

[0017] In the immunochromatographic detection device of the present invention, the processor can perform the main determination and display the determination result when there is no abnormality, and does not perform the main determination when there is an abnormality.

[0018] Preferably, in the immunochromatographic detection device of the present invention, the processor displays a message indicating that no main determination is to be performed when no main determination is to be performed.

[0019] In the immunochromatographic detection device of the present invention, the processor can indicate the presence of potentially contaminated content in the detection area when an abnormality is detected.

[0020] In the immunochromatographic detection device of the present invention, the processor can indicate the determination result of the main determination when there is no abnormality, and when there is an abnormality and the determination result of the main determination is positive, it can retain the abnormal content of the detection area image to indicate the determination result of the main determination or not indicate the determination result of the main determination.

[0021] In the immunochromatographic detection device of the present invention, the processor can perform a main determination and perform an anomaly determination when the determination result is positive.

[0022] In the immunochromatographic detection device of the present invention, the processor can indicate the determination result of the main determination when there is no abnormality, and when there is an abnormality, retain the abnormal content of the detection area image to indicate the determination result of the main determination or not indicate the determination result of the main determination.

[0023] In the immunochromatographic detection apparatus of the present invention, the imaging unit may be an image sensor that outputs an observation image including an observation area by capturing an imaging area including a detection area. The observation image is an image in which multiple pixels are arranged in a matrix in a two-dimensional manner. The processor can derive a distribution map of the row direction based on the representative values ​​of each column in the observation image, and extract the detection area image corresponding to the detection area from the observation image based on the derived distribution map.

[0024] Invention Effects

[0025] The immunochromatographic detection device according to the present invention can provide results with higher reliability than previous methods. Attached Figure Description

[0026] Figure 1 This is a perspective view showing the appearance of the immunochromatographic detection device according to the first embodiment.

[0027] Figure 2 This is a 3D view of the reagent kit.

[0028] Figure 3 This is an exploded 3D view of the reagent kit.

[0029] Figure 4 This is a diagram showing the positional relationship between the test strip, multifunctional component, first reagent holding section, and second reagent holding section within the kit.

[0030] Figure 5 This is an illustrative diagram of immunochromatography.

[0031] Figure 6 This is a partial cross-sectional side view of the testing device containing the reagent kit.

[0032] Figure 7 This is a partial cross-sectional side view of the testing device in the state where the reagent kit is filled and the second reagent supply mechanism is in operation.

[0033] Figure 8 It is a diagram that schematically represents the observed image and the image of the detection area.

[0034] Figure 9 middle, Figure 9 A and Figure 9 B stands for capturing an image. Figure 9 C represents from respectively Figure 9 The first detection area L1A of A and Figure 9 The image shows the shifted pixel values ​​in one pixel column extracted from the second detection region L1B of B.

[0035] Figure 10 This is an explanatory diagram of data processing used to derive the judgment indicators for anomaly detection.

[0036] Figure 11 This is an illustrative diagram illustrating the method for extracting images of the detection region.

[0037] Figure 12 This is a diagram showing the processing order of exception detection.

[0038] Figure 13 This is a diagram representing the first detection process.

[0039] Figure 14 This is a diagram showing the detection process performed in an immunochromatographic assay device.

[0040] Figure 15 This is the first example of a diagram showing the detailed processing order of the main decision with anomaly detection.

[0041] Figure 16 This is the second example of a diagram showing the detailed processing order of the main decision with anomaly detection.

[0042] Figure 17 This is the third example of a diagram showing the detailed processing order of the main decision with anomaly detection.

[0043] Figure 18 This is the fourth example of a diagram showing the detailed processing order of the main decision with anomaly detection.

[0044] Figure 19 This is the fifth example of a diagram showing the detailed processing sequence of the main decision that includes anomaly detection. Detailed Implementation

[0045] The embodiments of the immunochromatographic detection device of the present invention will be described with reference to the accompanying drawings.

[0046] Figure 1 This is a perspective view showing the appearance of the immunochromatographic detection device 110 (hereinafter simply referred to as the detection device 110) according to the first embodiment. Figure 2 This is an external view of the reagent kit 100 installed in the detection device 110. Figure 3 This is an exploded 3D view of reagent kit 100. Figure 4 This is a diagram showing the positional relationship of the main housing components within the kit 100.

[0047] Kit 100 is a single-use kit, one for each test subject (i.e., the specimen). Figure 3 As shown, the kit 100 contains a test strip 1 containing an immunochromatographic carrier 2 (hereinafter referred to as carrier 2). A detection area L1 is provided in the carrier 2, and the color development state changes depending on whether the sample contains the test substance, i.e., whether the sample is positive or negative.

[0048] As a test subject, any sample that may contain the substance to be tested is acceptable; there are no particular limitations on the test subject. Test subjects can be biological samples, especially bodily fluids such as blood, serum, plasma, cerebrospinal fluid, tears, sweat, urine, pus, nasal discharge, nasal swabs, pharyngeal swabs, nasal aspiration fluid, or sputum from animals (specifically humans), or excrement, organs, tissues, mucous membranes, and skin, or swabs containing them, or liquid samples containing the animal or plant itself or their dried bodies. Examples of test substances include antigens, antibodies, proteins, and low-molecular-weight compounds.

[0049] In this example, the detection device 110 is filled with a reagent kit 100 containing the test sample. The detection device 110 then detects the color development of the detection area L1 of the filled reagent kit 100 to determine whether the test sample is positive or negative and displays the test result. Hereinafter, the determination of whether the test sample is positive or negative will be referred to as the main determination. When testing multiple test samples, the reagent kit 100 for each test sample is filled into the detection device 110 one by one.

[0050] Furthermore, the following description of the kit 100 assumes it is loaded into the detection device 110, but the kit 100 in this example has a structure that allows the user to visually confirm whether the sample is positive or negative without using the detection device 110. This type of kit 100 is also referred to as an immunochromatographic assay device or an immunochromatographic assay kit, etc.

[0051] like Figure 1 As shown, the detection device 110 includes a frame 111, which has a loading section 112 for detachably loading a reagent kit 100. As an example, an opening for inserting the reagent kit 100 into the frame 111 and an opening / closing cap 112a are provided on the front of the frame 111. When loading the reagent kit 100, the opening / closing cap 112a is opened, the reagent kit 100 is inserted into the frame 111, and the opening / closing cap 112a is closed when the loading section 112 is filled. Detection is performed with the opening / closing cap 112a closed.

[0052] Furthermore, a power switch 113 is provided on the front of the frame 111, and a display 119 is provided on the top of the frame 111. The display 119 displays the detection results and error messages, etc. As an example, the display 119 is a touch panel display that displays various operation screens. Through the operation screens, the user can input commands to start processing and select the detection sequence, etc.

[0053] like Figure 2 and Figure 3 As shown, the kit 100 includes a housing 9 consisting of an outer shell component 20 and a cap component 10. The housing 9 is made of, for example, resin material. The outer shell component 20 has an opening at the top, and inside it houses not only the test strip 1, but also a first reagent holding part 40 and a second reagent holding part 45. The cap component 10 covers the opening of the outer shell component 20 by being installed in the opening portion of the outer shell component 20. The housing 9 is elongated in shape to accommodate the elongated shape of the test strip 1.

[0054] In this example, a dispensing port 16, an observation window 18, a first pressing part 11, and a second pressing part 12 are provided on the upper part of the housing 9, which is formed by the cover part 10. As an example, these parts are integrally formed with the cover part 10. The dispensing port 16 is an opening for dispensing the test sample into the interior of the housing 9. A boss is erected facing upwards on the edge of the dispensing port 16. The observation window 18 is a window for observing the detection area L1 from the outside, and as an example, it is formed of a transparent part. In this example, the size of the observation window 18 is such that it can not only observe the detection area L1, but also the control area L2 and the color development area L3 (described later).

[0055] The first pressed part 11 is for holding the first reagent 41 (see reference) in the first reagent holding part 40. Figure 4 The second pressing part 12 is an operating part that supplies the second reagent 46 in the second reagent holding part 45 to the carrier 2. As will be described later, the first reagent 41 and the second reagent 46 are amplifying agents used to amplify the colorimetric detection region L1 when the subject 50 is positive.

[0056] When a pressing force is applied to the first pressed portion 11 from the outside, the first pressed portion 11 deforms. For example, the first pressed portion 11 is in the shape of a square pyramid; when a pressing force is applied from above to the area including the apex of the pyramid, the apex of the pyramid deforms by sinking into the interior of the housing 9. When the first pressed portion 11 deforms in this way, a pressing force is applied to the first reagent holding portion 40 inside the housing 9. The first reagent holding portion 40 deforms due to the pressing force applied by the first pressed portion 11. Through this deformation, the first reagent 41 held in the first reagent holding portion 40 is supplied to the test strip 1.

[0057] Furthermore, the first pressed portion 11 preferably maintains its deformed state after being deformed by pressing. The reason is as follows. As will be described later, the detection device 110 of this example can be filled with the reagent kit 100 in a state where the first pressed portion 11 has been pre-pressed by the user. This is because, when the first pressed portion 11 is pressed by the user before being filled into the detection device 110, the deformation of the first pressed portion 11 is maintained even after the user releases their grip, making it easier to continuously supply the first reagent 41.

[0058] Similarly, when a pressing force is applied to the second pressed portion 12 from the outside, the second pressed portion 12 deforms. Like the first pressed portion 11, the second pressed portion 12 in this example is also pyramidal in shape. When a pressing force is applied from above to the area including the apex of the pyramid, the apex of the pyramid deforms by sinking into the interior of the housing 9. When the second pressed portion 12 deforms in this way, a pressing force is applied to the second reagent holding portion 45 inside the housing 9. The second reagent holding portion 45 deforms due to the pressing force applied by the second pressed portion 12. Through this deformation, the second reagent 46 held in the second reagent holding portion 45 is supplied to the test strip 1. In this example, an abutting portion 12b (see reference) is provided on the second pressed portion 12 that abuts against the second reagent holding portion 45. Figure 6 and Figure 7 ).

[0059] As described below, the detection device 110 in this example can select multiple detection processes. Among the selectable detection processes in the detection device 110, when selecting a process that supplies the second reagent 46 to the detection device 110, the second pressed portion 12 is pressed by the internal mechanism of the detection device 110. Therefore, the second pressed portion 12 only needs to be pressable by the internal mechanism. When selecting a detection process that fills the reagent kit 100 into the detection device 110 after supplying the first reagent 41 and the second reagent 46, it is preferable that the second pressed portion 12 of the reagent kit 100 can also be pressed by the user.

[0060] like Figure 3 and Figure 4 As shown, the outer casing 20 houses the test strip 1 containing the carrier 2 along its length. In the outer casing 20, at one end along the length direction ( Figure 4 The first reagent holding portion 40 is disposed on the upstream side shown. In the housing component 20, a first receiving portion 24 with a concave shape is formed in the portion where the first reagent holding portion 40 is disposed, in accordance with the shape of the first reagent holding portion 40. One end of the test strip 1 is disposed above the first reagent holding portion 40 which is received in the first receiving portion 24.

[0061] The first reagent holding part 40 holds the first reagent 41. The first reagent holding part 40 is formed, for example, of a resin material and consists of a container 42 with an opening on one side and a breakable sheet member 43 covering the opening of the container 42. The first reagent 41 is filled in the container 42, and the opening of the container 42 is sealed by the sheet member 43. The first reagent holding part 40 is disposed within the first receiving part 24 with the sheet member 43 facing upwards. The pressing pressure applied from the first pressing part 11 is transmitted via the end of the test strip 1 to the sheet member 43 of the first reagent holding part 40, causing the sheet member 43 to break (see reference). Figure 6 and Figure 7 The first reagent 41 is supplied to the test strip 1 by being broken open by the sheet member 43. Additionally, in this example, a protruding strip 11b is provided on the first pressed portion 11 that abuts against the sheet member 43 (see reference). Figure 6 and Figure 7 In order to make it easy to break the sheet-like part 43, the protrusion 11b is, for example, an elongated shape that extends in the length direction along the width direction of the test paper 1 and has a shape in which the front end faces the tip of the sheet-like part 43.

[0062] Furthermore, the reagent kit 100 includes a multifunctional component 30 that functions to accommodate the second reagent holding portion 45. The multifunctional component 30 is disposed at the other end of the outer casing component 20. Figure 4 (As shown downstream) and above the test strip 1. The multifunctional component 30 is a component in which the second receiving part 32 and the flow path forming part 35 are integrally formed. The second receiving part 32 is the part that receives the second reagent holding part 45. The second receiving part 32 has a box-shaped shape with an opening at the top. Figure 4 As shown, a protrusion 34 for breaking the sheet-like component 48 of the second reagent holding part 45 (described later) and an opening 33 for allowing the second reagent 46 flowing out of the second reagent holding part 45 to flow to the carrier 2 are formed at the bottom of the second receiving part 32.

[0063] A flow path forming section 35 is connected to the second receiving section 32 and disposed upstream. The flow path forming section 35 is flat and is positioned opposite the detection area L1 and the like in the longitudinal direction of the carrier 2, spaced apart from the carrier 2. Furthermore, the flow path forming section 35 forms a flow path between the carrier 2, allowing the second reagent 46 flowing from the second receiving section 32 to flow to the detection area L1 and the like. Thus, the flow path forming section 35 is disposed between the observation window 18 and the detection area L1 and the like of the carrier 2. Therefore, the flow path forming section 35 is formed of a transparent component, allowing the detection area L1 and the like to be observed through the observation window 18.

[0064] The second reagent holding part 45 holds the second reagent 46. The second reagent holding part 45 is formed, for example, of a resin material, and consists of a container 47 with an opening on one side and a breakable sheet-like member 48 covering the opening of the container 47. The second reagent 46 is filled in the container 47, and the opening of the container 47 is sealed by the sheet-like member 48. The second reagent holding part 45 is disposed within the second receiving part 32 with the sheet-like member 48 facing downwards. Thus, within the second receiving part 32, the sheet-like member 48 is positioned opposite the protrusion 34.

[0065] The pressing force applied from the second pressed portion 12 to the second reagent holding portion 45 acts in the direction of pressing the second reagent holding portion 45 downwards, thereby pressing the sheet-like component 48 against the protrusion 34. By pressing the sheet-like component 48 against the protrusion 34, the sheet-like component 48 is broken open (see reference). Figure 6 and Figure 7 The second reagent 46 is supplied to the carrier 2 through the opening 33 at the bottom of the second receiving part 32 and the flow path formed by the flow path forming part 35 after being broken open by the sheet-like component 48.

[0066] like Figure 4 As shown, a gap D corresponding to the flow path of the second reagent 46 is formed between the back surface 36 of the flow path forming portion 35 of the multifunctional component 30 and the carrier 2 of the test strip 1. The gap D is, for example, in the range of 0.01 mm to 1 mm. The second reagent 46 flows from the opening 33 at the bottom of the second receiving portion 32 to the carrier 2, and the flowing second reagent 46 flows through the flow path formed by the gap D to reach at least the detection area L1. The second reagent 46 that reaches the detection area L1 is soaked into the detection area L1 from the flow path.

[0067] In the test strip 1, an absorbent pad 6 (described later) is disposed at the downstream end. In the housing component 20, a support portion 22 is formed opposite to the absorbent pad 6 to support the end of the test strip 1 containing the absorbent pad 6. A second receiving portion 32 of a multifunctional component 30 is disposed above the absorbent pad 6. The support portion 22 also supports the multifunctional component 30 via the absorbent pad 6. Furthermore, a support portion 21 is formed in the housing component 20 to support the central portion of the test strip 1.

[0068] The test strip 1 includes a carrier 2, a liquid delivery pad 4, and an absorption pad 6. Furthermore, the carrier 2 is fixed and supported on the adhesive backing sheet 7.

[0069] The carrier 2 is a porous, insoluble carrier for diffusing the sample, and includes a detection region L1, a control region L2, and a colorimetric region L3. Furthermore, the carrier 2 includes a label holding pad 3. The label holding pad 3 constitutes a dropping area where the sample has been dropped. With the dropping area as a reference, and the direction towards the detection region L1 as the downstream side of the carrier 2, the colorimetric region L3 is positioned downstream of the detection region L1. In this example, the detection region L1, the control region L2, and the colorimetric region L3 are all linear regions extending in a direction perpendicular to the diffusion direction of the sample in the carrier 2.

[0070] The diagram shows the detection area L1, control area L2, and color development area L3 displayed as lines, but these are not always displayed. Details will be explained later. When the subject is 50 (reference) Figure 5 ), Reagent 1 41 (Reference) Figure 4 ) and the second reagent 46 (reference) Figure 4 Before diffusion, the colors of the detection area L1 and control area L2 are almost identical to the color of the carrier 2 (e.g., white). Therefore, at this stage, the detection area L1 and control area L2 cannot be clearly visually identified. The detection area L1 appears as a line as the colorimetric concentration increases when the sample 50 diffuses and the diffused sample 50 is positive. This allows for visual identification of the detection area L1. The color development of the detection area L1 is amplified by silver amplification (described later), thus the detection area L1 is developed as black.

[0071] The control region L2 also appears as a line due to the increased staining concentration during the diffusion of sample 50. This allows for visual identification of the control region L2. Because the control region L2 is also amplified by silver, it appears black.

[0072] On the other hand, the color-developing region L3 appears as a dark green line with black undertones (hereinafter referred to as dark green) even before the diffusion of the first reagent 41, and is visually recognizable. However, the color-developing region L3 appears as an orange line when the dark green turns orange during the diffusion of the first reagent 41.

[0073] As the carrier 2, for example, a porous material such as a nitrocellulose membrane can be used. Furthermore, the adhesive backing sheet 7 that fixes the carrier 2 is a sheet-like substrate with the adhesive side of the carrier 2 being adhered to.

[0074] like Figure 5As shown, a labeling substance 53 is fixed on the label holding pad 3. The labeling substance 53 is modified by a first binding substance 52 that specifically binds to the test substance 51 contained in the test subject 50. The label holding pad 3 is fixed on the carrier 2 at a position opposite to the dispensing port 16 of the cap member 10. Therefore, the test subject 50 is dispensed from the dispensing port 16 onto the label holding pad 3. Thus, the label holding pad 3 corresponds to the dispensing area for dispensing the test subject 50.

[0075] The marker holding pad 3 is fixed at approximately the center of the carrier 2 along its length. As the marker material 53, for example, gold colloidal particles (EM.GC50, manufactured by BBI Corporation) with a diameter of 50 nm can be used. Furthermore, the marker material 53 is not limited to gold colloids; metal sulfides used in conventional chromatography, coloring particles used in immunoagglutination reactions, etc., can be used, with metal colloids being particularly preferred. Examples of metal colloids include gold colloids, silver colloids, platinum colloids, iron colloids, aluminum hydroxide colloids, and composite colloids thereof. Especially when the particle size is suitable, gold colloids are preferred for displaying a red color, silver colloids are preferred for displaying a yellow color, and gold colloids are most preferred.

[0076] like Figure 5 As shown, the detection area L1 contains a second binding substance 56 that specifically binds to the test substance 51, thereby capturing the test substance 51. Within the detection area L1, when the test substance 51 is captured by binding to it via the second binding substance 56, a first binding substance 52 and a labeling substance 53 bound to the test substance 51 are also captured. When the test substance 51 is present in the test sample 50, the colorimetric concentration of the detection area L1 rises above a preset reference level by capturing the test substance 51 and the labeling substance 53 within the detection area L1. The detection area L1 is used to confirm the presence or absence of the test substance 51 based on a labeling signal originating from the labeling substance 53 captured by the test substance 51. Furthermore, the test substance 51 detected in one kit 100 is not limited to one type; multiple detection areas L1 can be provided to simultaneously detect multiple different test substances 51. For example, multiple detection areas L1 can be provided, such as a first detection area L1A and a second detection area L1B (see reference). Figure 9 The first detection region L1A contains a second binding substance 56 that specifically binds to the first test substance 51, and the second detection region L1B contains a second binding substance 56 that specifically binds to a second test substance 51 that is different from the first test substance 51.

[0077] Control region L2 contains a third binding substance 58 that specifically binds to the first binding substance 52, and the labeled substance 53 is captured via the first binding substance 52. When the test subject 50 is dropped onto the label holding pad 3, the labeled substance 53 modified by the first binding substance 52, including those not bound to the test subject 51, diffuses along with the test subject 50 toward the detection region L1 within the carrier 2. The labeled substance 53 not bound to the test subject 51 passes through the detection region L1 without being captured there. Because the first binding substance 52 binds to the third binding substance 58, the labeled substance 53 that has passed through the detection region L1 is captured by the control region L2 via the first binding substance 52. Because the labeled substance 53 is captured within the control region L2, the colorimetric concentration of the control region L2 rises above a preset reference. The control region L2 is used to confirm the end of diffusion of the test subject 50 based on a labeling signal originating from the labeled substance 53 captured via the first binding substance 52. Therefore, the control area L2 is sometimes also referred to as the confirmation area.

[0078] Regarding the first binding substance 52 that modifies the labeling substance 53 and specifically binds to the test substance 51, for example, when the test substance 51 is an antigen, it is an antibody corresponding to the antigen; when the test substance 51 is an antibody, it is an antigen corresponding to the antibody; when the test substance 51 is a protein or low molecular weight compound, it is an aptamer corresponding to the protein or low molecular weight compound, etc., which specifically binds to the test substance 51.

[0079] Regarding the second binding substance 56, which is immobilized in the detection region L1 and specifically binds to the test substance 51, for example, when the test substance 51 is an antigen, it is an antibody corresponding to the antigen; when the test substance 51 is an antibody, it is an antigen corresponding to the antibody; when the test substance 51 is a protein or low molecular weight compound, it is an aptamer corresponding to the protein or low molecular weight compound, etc., or other substances that specifically bind to the test substance 51. The first binding substance 52 and the second binding substance 56 can be the same substance or different substances.

[0080] The third binding substance 58 that specifically binds to the first binding substance 52 can be the test substance 51 itself, or a compound having the site to be identified by the first binding substance 52, such as compounds that bind derivatives of the test substance 51 to proteins.

[0081] For example, when the tested substance 51 is influenza A virus or its biomarker, anti-influenza monoclonal antibody (Anti-Influenza ASPTN-5 7307, manufactured by Medix Biochemica) can be used as the first binding substance 52 and the second binding substance 56, and anti-mouse IgG antibody (anti-mouse IgG (H+L), rabbit F(ab')2, model 566-70621, manufactured by FUJIFILM Wako Pure Chemical Corporation) can be used as the third binding substance 58.

[0082] The chromogenic region L3 contains a substance whose color development state changes upon reaction with the first reagent 41. The chromogenic region L3 indicates that the first reagent 41 has diffused into the region by reacting with the first reagent 41 and developing color or by a color change. For example, when the first reagent 41 is a mixed aqueous solution of ferric nitrate and citric acid (manufactured by FUJIFILM Wako Pure Chemical Corporation, 038-06925), it is preferable to construct the chromogenic region L3 by immobilizing bromocresol green (manufactured by FUJIFILM Wako Pure Chemical Corporation) into linear lines. This is the configuration of the chromogenic region L3 in this example. As described above, the chromogenic region L3 in this example is dark green before reacting with the first reagent 41, and turns orange when the first reagent 41 reaches the chromogenic region L3. Furthermore, since the chromogenic region L3 indicates the time point at which the first reagent 41 diffuses and is supplied to the second reagent 46 by a change in color development state, it is sometimes also referred to as the amplification index region.

[0083] The delivery pad 4 is positioned at one end of the carrier 2 and delivers the first reagent 41 from the upstream side of the dispensing area (composed of the mark holding pad 3) to the carrier 2. When the first pressing part 11 is pressed, one end of the delivery pad 4 is immersed in the first reagent holding part 40. The delivery pad 4 is formed of a porous material, absorbs the first reagent 41, and delivers the absorbed first reagent 41 to the carrier 2 through capillary action.

[0084] The absorbent pad 6 is disposed at the other end of the carrier 2 and absorbs the test subject 50, the first reagent 41, and the second reagent 46 that diffuse on the carrier 2. The absorbent pad 6 is also formed of a porous material.

[0085] In this embodiment, the first reagent 41 and the second reagent 46 are amplifying agents that amplify the colorimetric region L1 and the control region L2 by reacting together. As shown in this example, when a metal-based labeling substance such as gold colloid is used as the labeling substance 53, silver amplification is used, for example, as a method to amplify the labeling signal of the labeling substance 53. As an example, the first reagent 41 and the second reagent 46 are amplifying agents used for silver amplification, and the reaction of the first reagent 41 and the second reagent 46, with the labeling substance 53 as a catalyst, is an amplification reaction. Through the amplification reaction, silver particles 60 (refer to) with a particle size relatively larger than the labeling substance 53 are generated. Figure 5 ).

[0086] More specifically, in this example, reagent 41 is a reducing agent for reducing silver ions, and reagent 46 is silver ions. When reagent 41 (as a reducing agent) and reagent 46 (as silver ions) come into contact with labeled substance 53, silver particles 60 are generated (see reference). Figure 5 The generated silver particles 60 are deposited on the labeled material 53 with the labeled material 53 as the nucleus. Through the deposition of silver particles on the labeled material 53, silver particles 60 with a particle size larger than the labeled material 53 are generated (see reference). Figure 5 As a result, the labeling signal emitted by the labeling substance 53 is amplified, and consequently, the color development of the labeling substance 53 is amplified in the detection region L1 and the control region L2.

[0087] (Reagent 1)

[0088] Regarding the reducing agent as the first reagent 41, any inorganic / organic material, or a mixture thereof, can be used as long as it can reduce the silver ions used as the second reagent 46 to silver. As an inorganic reducing agent, Fe is preferably preferred. 2+ V 2+ or Ti 3+ Reducing metal salts and reducing metal complexes are those that alter the oxidation state of metal ions. When using inorganic reducing agents, it is necessary to complex or reduce oxide ions to remove or render them harmless. For example, when Fe... 2+ In systems used as reducing agents, citric acid or EDTA (ethylenediaminetetraacetic acid) can be used to form Fe as an oxide. 3+ The complex is used for harmless treatment. In this system, such inorganic reducing agents are preferred, and Fe is even more preferred. 2+ Metal salts.

[0089] Additionally, developing agents used in wet silver halide photographic materials (e.g., methyl gallate, hydroquinone, substituted hydroquinone, 3-pyrazolone, p-aminophenol, p-phenylenediamine, hindered phenol, amidoxime, azazine, catechol, pyrogallol, ascorbic acid (or its derivatives), and colorless pigments) can also be used, as well as other materials that are obvious to those skilled in the art, such as those described in U.S. Patent No. 6,020,117.

[0090] As a reducing agent, ascorbic acid reducing agents are preferred. Useful ascorbic acid reducing agents include ascorbic acid and its analogues, isomers and derivatives thereof. For example, preferred examples include D- or L-ascorbic acid and its sugar derivatives (e.g., γ-lactose ascorbic acid, glucose ascorbic acid, fucose ascorbic acid, glucohepose ascorbic acid, maltose ascorbic acid), sodium salts of ascorbic acid, potassium salts of ascorbic acid, isoascorbic acid (or L-red ascorbic acid: erythroascorbic acid), their salts (e.g., alkali metal salts, ammonium salts or salts known in the art), enol ascorbic acid, enamine alcohol ascorbic acid, thioenol ascorbic acid, etc., especially preferred are D, L or D,L-ascorbic acid (and its alkali metal salt) or isoascorbic acid (or its alkali metal salt), with sodium salts being preferred. Mixtures of these reducing agents can be used as needed.

[0091] (Second Reagent)

[0092] The solution containing silver ions used as the second reagent 46 is preferably a solution in which a silver-containing compound is dissolved in a solvent. As the silver-containing compound, organic silver salts, inorganic silver salts, or silver complexes can be used. Inorganic silver salts or silver complexes are preferred. As the inorganic silver salt, silver-containing compounds with high solubility in solvents such as water can be used, such as silver nitrate, silver acetate, silver lactate, silver butyrate, and silver thiosulfate. Silver nitrate is particularly preferred. As the silver complex, silver complexes coordinated to ligands having water-soluble groups such as hydroxyl or sulfone groups are preferred, such as silver hydroxysulfide.

[0093] <Immunochromatography>

[0094] refer to Figure 5 The immunochromatographic method will be explained here. This explanation assumes that the sample 50 contains the test substance 51, i.e., the sample 50 is positive.

[0095] First, the test sample 50 is dropped onto the label holding pad 3, which serves as the dropping area (step S1). The test substance 51 in the test sample 50 dropped onto the label holding pad 3 specifically binds to the first binding substance 52 of the modifying labeling substance 53 contained in the label holding pad 3. The test sample 50 diffuses downstream from the label holding pad 3 within the carrier 2 via capillary action on the carrier 2. A portion of the test sample 50 also diffuses upstream. Arrow S indicates the diffused state of the test sample 50.

[0096] Next, the first reagent 41 is supplied (step S2). The first reagent 41 is supplied from the liquid delivery pad 4 side. The first reagent 41 is supplied to the carrier 2 via the liquid delivery pad 4 and diffuses downstream.

[0097] Then, it waits until the first reagent 41 diffuses downstream (processes S3-S4). Figure 5 The “Wait” indicated is in standby mode. The first reagent 41 diffuses slowly downstream, and the test subject 50, which diffuses from the label holding pad 3, and the labeling substance 53 modified by the first binding substance 52 diffuse downstream by being pressed by the first reagent 41 (step S3).

[0098] The test substance 51, which diffuses downstream and reaches the detection area L1, is captured by the second binding substance 56 in the detection area L1. That is, the marker substance 53 is captured in the detection area L1 via the test substance 51 and the first binding substance 52. On the other hand, the marker substance 53 that is not bound to the test substance 51 is not captured but passes through the detection area L1 and is captured by the third binding substance 58 in the control area L2.

[0099] The diffusion of the first reagent 41 progresses. When the first reagent 41 reaches the colorimetric region L3 (step S4), the colorimetric region L3 reacts with the first reagent 41, and the colorimetric state changes. In this example, the colorimetric region L3 is dark green before reacting with the first reagent 41, and turns orange after reacting with the first reagent 41.

[0100] After the first reagent 41 has fully diffused, the second reagent 46 is supplied to the carrier 2 (step S5). The second reagent 46 is supplied to the carrier 2 from the downstream side of the colorimetric region L3 and diffuses upstream. Here, the first reagent 41 is a first amplification solution containing a reducing agent of reduced silver ions, and the second reagent 46 is a second amplification solution containing silver ions. By reacting the first amplification solution with the second amplification solution, the labeled substance 53, i.e., gold colloidal particles, is used as a catalyst to generate silver particles 60. As a result, the labeled signal is amplified (step S6).

[0101] Figure 6 and Figure 7 This is a partial cross-sectional side view of the detection device 110 in its state of containing the reagent kit 100. Hereinafter, using... Figure 6 and Figure 7 The structure and function of the detection device 110 are explained.

[0102] The detection device 110 in this example can select one of the following three detection processes: the first detection process, the second detection process, and the third detection process. In any of the first to third detection processes, the test subject 50 needs to be added to the carrier 2 of the reagent kit 100 before filling.

[0103] The first detection process is a process of detecting the reagent kit 100 in the state of adding the test subject 50 and supplying the first reagent 41 before filling. In the case of the first detection process, after the reagent kit is filled into the detection device 110, the detection device 110 supplies only the second reagent 46 of the first reagent 41 and the second reagent 46 to the carrier 2.

[0104] The second detection process involves testing the kit 100, which has only had the sample 50 added, before filling. In the second detection process, after the kit is filled into the detection device 110, both the first reagent 41 and the second reagent 46 are supplied to the carrier 2 through the detection device 110.

[0105] The third detection process involves testing the kit 100 with the sample 50 added, the first reagent 41 supplied, and the second reagent 46 supplied before loading. In the case of the third detection process, after the kit is loaded into the detection device 110, the first reagent 41 and the second reagent 46 are not supplied to the detection device 110.

[0106] The structure of the detection device 110 will be described below, followed by an explanation of the first detection process.

[0107] (Structure of detection device 110)

[0108] like Figure 6 and Figure 7 As shown, the detection device 110 includes a first reagent supply mechanism 116 and a second reagent supply mechanism 118 as internal mechanisms. The first reagent supply mechanism 116 is a mechanism for initiating the supply of the first reagent 41 to the carrier 2 from the first reagent holding section 40. The first reagent supply mechanism 116 uses, for example, an actuator such as a solenoid equipped with an electromagnet and a plunger movable relative to the electromagnet. For example, by moving the plunger, the plunger abuts against the first pressed section 11 and presses the first pressed section 11. The first reagent supply mechanism 116 is positioned on the loaded reagent kit 100 opposite to the first pressed section 11.

[0109] The first reagent supply mechanism 116 is a pressing mechanism that applies pressure to the first pressed portion 11 of the reagent kit 100 from the outside by pressing the first pressed portion 11. When the first pressed portion 11 is pressed by the first reagent supply mechanism 116, the first reagent 41 is supplied from the first reagent holding portion 40 to the carrier 2 through the above-described action. The first reagent supply mechanism 116 is not used in the first detection process and the third detection process, but is only used in the second detection process.

[0110] The second reagent supply mechanism 118 is a mechanism for initiating the supply of the second reagent 46 to the carrier 2 from the second reagent holding section 45. Similar to the first reagent supply mechanism 116, the second reagent supply mechanism 118 also uses an actuator such as a solenoid. The second reagent supply mechanism 118 is positioned opposite the second pressed section 12 of the loaded reagent kit 100. The second reagent supply mechanism 118 is a pressing mechanism that applies pressure to the second pressed section 12 from the outside by pressing the second pressed section 12 of the reagent kit 100. When pressure is applied to the second pressed section 12 by the second reagent supply mechanism 118, the second reagent 46 is supplied from the second reagent holding section 45 to the carrier 2 through the aforementioned action. The second reagent supply mechanism 118 is not used in the third detection process, but only in the first and second detection processes.

[0111] In addition to the loading unit 112, the first reagent supply mechanism 116 and the second reagent supply mechanism 118, the detection device 110 also includes an imaging unit 114, a processor 120 and a memory 121 inside the frame 111. Figure 6 In the diagram, the processor 120 and memory 121 are shown outside the frame 111 of the detection device 110, but they are only schematic diagrams and are actually disposed inside the frame 111.

[0112] The imaging unit 114 captures an observation area including at least a detection area L1 and a control area L2, and outputs the observation image of the observation area to the processor 120. More preferably, the observation area includes a color rendering area L3.

[0113] The imaging unit 114 is, for example, an image sensor such as a CMOS (Complementary Metal Oxide Semiconductor) image sensor or a CCD (Charge Coupled Device) image sensor. The imaging unit 114 is, for example, positioned opposite the viewing window 18. The imaging unit 114 captures images of a pre-defined area centered on the viewing window 18 and including its periphery. The captured image by the imaging unit 114 includes a detection area L1, a control area L2, and a color development area L3, as well as an observation area 68 (see reference) exposed from the viewing window 18. Figure 8Furthermore, the captured images are output from the imaging unit 114 to the processor 120.

[0114] Furthermore, as an example, light sources 115, such as light-emitting diodes, are provided on both sides of the imaging unit 114 to illuminate the detection area L1, the control area L2, and the color rendering area L3 during imaging.

[0115] The processor 120 centrally controls all parts of the detection device 110. An example of the processor 120 is a CPU (Central Processing Unit) that performs various controls by executing programs. The CPU functions as a control unit including an imaging unit control unit 122, a color development state determination unit 123, a first reagent supply mechanism control unit 124, a second reagent supply mechanism control unit 125, a display control unit 126, an anomaly determination unit 127, and a timer 128. The memory 121 is an example of a memory connected to or built into the CPU of the processor 120. For example, the memory 121 stores control programs. The processor 120 implements this by executing the control programs through the CPU.

[0116] The shooting control unit 122 controls the shooting time of the shooting unit 114.

[0117] The first reagent supply mechanism control unit 124 controls the operation of the first reagent supply mechanism 116 to press the first pressed part 11.

[0118] The second reagent supply mechanism control unit 125 controls the operation of the second reagent supply mechanism 118 to press the second pressed part 12 according to the change in the color development state of the color development area L3.

[0119] The color development state determination unit 123 performs color development region determination processing, control region determination processing, and detection region determination processing based on the captured image obtained via the imaging unit 114. As described above, the imaging unit 114 outputs an captured image of an observation area 68 including a detection area L1, a control area L2, and a color development area L3. The color development state determination unit 123 performs each of the above-mentioned determination processes based on the captured image.

[0120] The color development region discrimination process is as follows: Based on the captured image, it is determined whether the color development state of the color development region L3 has changed. For example, the color changes from dark green before reacting with the first reagent 41 to orange. A change in the color development state indicates that the first reagent 41 has diffused into the color development region L3.

[0121] In addition, "change in color development state" includes any one of the following: a change from a first color different from the color of carrier 2 to another second color (i.e., color change), a change in the color of carrier 2 to another color through color development different from the color of carrier 2 (i.e., color development), or a change in the concentration of the color (i.e., concentration change).

[0122] When the color development state determination unit 123 determines that the color development state of the color development region L3 has changed, the processor 120 operates the second reagent supply mechanism 118 via the second reagent supply mechanism control unit 125.

[0123] The control region discrimination process determines whether the color development state of the control region L2 has changed based on the captured image. In this example, by capturing the marker substance 53 in the control region L2 or performing silver amplification after capture, lines appear in the control region L2, thus determining whether there are lines appearing in the control region L2. When the color development state discrimination unit 123 determines that the color development state of the control region L2 has changed, i.e., the control region L2 has appeared, the next step, the detection region discrimination process, is executed.

[0124] The detection area discrimination process determines whether there is a change in the color development state of the detection area L1 based on the captured image. In this example, by capturing the labeled substance 53 in the detection area L1 or performing silver amplification after capture, lines appear in the detection area L1. Therefore, the presence or absence of lines in the detection area L1 is used to determine whether there is a change in the color development state. When lines appear in the detection area L1, it indicates that the subject 50 is positive; when no lines appear, it indicates that the subject 50 is negative. The determination of whether there is a change in the color development state of the detection area L1 in this detection area discrimination process is equivalent to the primary determination of whether the subject 50 is positive or negative.

[0125] The anomaly determination unit 127 performs anomaly determination to determine whether there are any anomalies in the detection area image. Specifically, the anomaly determination unit 127 uses at least one of the following criteria for anomaly determination: the difference between relatively large and relatively small pixel values ​​in at least one column of the detection area image; the standard deviation of the pixel values ​​contained in at least one column of the detection area image; or the coefficient of variation based on the pixel values ​​of each column. The anomaly determination performed by the anomaly determination unit 127 can be performed before or after the main determination. The details of the anomaly determination method and process will be explained later.

[0126] The processor 120 determines the processing content involved in the main determination based on the result of the anomaly determination, i.e., whether or not an anomaly exists. The processing content involved in the main determination includes, for example, at least one of the following: whether to perform the main determination, and a method for indicating the determination result of the main determination. Specifically, for example, the processor 120 determines that if an anomaly is determined, the main determination will not be performed and the processing will end, and the main determination will only be performed if no anomaly is determined. Furthermore, for example, if an anomaly is determined, the processor 120 may retain the abnormal content and indicate the main determination result as the detection result, or may not indicate the main determination result but indicate a detection result of "determination failure". Furthermore, for example, the processor 120 determines that if no anomaly is determined, the determination result of the main determination will be directly indicated as the detection result. If an anomaly is determined, the processor 120 displays a detection result of "retained positive" or "determination failure" on the display 119 via the display control unit 126. If no anomaly is determined, the processor 120 displays a detection result such as "positive" on the display 119 via the display control unit 126.

[0127] In addition to storing the control program, the memory 121 also stores preset information that the processor 120 has set for performing various controls. This preset information includes information required by the color display state discrimination unit 123 to discern changes in the color display state. Examples of this preset information include a preset first setting time t1, a preset second setting time t2, and a preset number of times K, which will be described later. The first setting time t1 is the standby time from when the processor 120 determines that the color display state of color area L3 has not changed until it re-discriminates whether the color display state of color area L3 has changed. The second setting time t2 is the allowable time when the processor 120 repeatedly performs the discrimination of whether the color display state has changed when it determines that the color display state of color area L3 has not changed. Furthermore, the preset information also stores the judgment criteria for the processor 120 when performing anomaly judgments.

[0128] Here, for reference Figures 8-10 The method for determining anomalies by the anomaly determination unit 127 will be explained.

[0129] First, we will explain the anomalies that may occur in the image of the detection area. Figure 8 This diagram schematically illustrates the observation image 61 and the detection area image 62 obtained by cropping the observation area 68 from the captured image output by the imaging unit 114.

[0130] Image 61 is an image in which multiple pixels are arranged in a matrix-like two-dimensional arrangement. The detection region image 62 extracted from image 61 is also an image in which multiple pixels are arranged in a matrix-like two-dimensional arrangement. When the length direction of the carrier 2 is set as the X direction, and the length direction of the lines of the detection region L1 intersecting the X direction is set as the Y direction, the row direction refers to the X direction, and the column direction refers to the Y direction. For example... Figure 8 As an example, the detection area image 62 is composed of a matrix of pixels arranged in 8 rows and 6 columns. The processor 120 converts the signal value of each pixel in the captured image output by the imaging unit 114 into a digital pixel value of 0 to 255. Figure 8 In the detection area image 62, each pixel is labeled with its pixel value. The pixel value of the detection area image 62 corresponds, for example, to the brightness corresponding to the amount of light incident on each pixel. Therefore, in the detection area image 62, the higher the brightness, the larger the pixel value, and the lower the brightness, the smaller the pixel value. If the pixels of such a detection area image 62 are represented by optical density (hereinafter simply referred to as density), then the smaller the pixel value, the higher the pixel density, and the larger the pixel value, the lower the pixel density. Here, pixel values ​​and density values ​​can be converted using a pre-set conversion formula.

[0131] exist Figure 8 In the example observation image 61 shown, the lower region within the detection area L1 includes a locally high concentration region d (hereinafter referred to as high-concentration region d). When the test subject 50 is positive, the colorimetric concentration increases on average across almost the entire range of the detection area L1, thus displaying the same lines as the control area L2 in the observation image 61. In contrast, the locally generated high-concentration region d within the detection area L1 is presumed to be a region where the colorimetric concentration increases due to non-specific adsorption of the labeled substance. This high-concentration region d is an unnecessary contamination that can lead to misjudgment in the master determination. The high-concentration region d sometimes also shows an abnormally high concentration than the colorimetric concentration when the test subject 50 is positive. Such high-concentration regions d have small pixel values, for example, in Figure 8 In the detection region image 62 shown as an example, pixel values ​​below 130 are displayed. On the other hand, other parts of the detection region L1 display pixel values ​​between 185 and 208.

[0132] As mentioned above, Figure 8 Image 61 does not show the linear detection region L1, but it locally contains a high-concentration region d. In this case, if the main determination is performed with all pixels constituting the high-concentration region d included, even if the result is negative, it may be determined as positive due to the high-concentration region d. The anomaly determination unit 127 determines whether there are anomalies such as high-concentration regions d within this type of detection region L1 that could lead to a false determination by the main determination.

[0133] Next, the specific methods for anomaly detection will be explained. Figure 9middle, Figure 9 The observation image 74 shown in A and Figure 9 B (and) Figure 10 The observed images 75 shown are examples of observed images. Figure 9 C shows from Figure 9 The first detection region L1A of the observed image 74 of A and Figure 9 The shifting of pixel values ​​in the second detection region L1B of the observed image 75 of B, extracted from one pixel column respectively.

[0134] Figure 8 A schematic diagram of the observed image 61 is shown, but... Figure 9 For convenience, actual images of observation images 74 and 75 are shown instead of schematic diagrams. Figure 8 The observation image 61 and shown Figure 9 The common feature of the observation images 74 and 75 is that both are images of the observation area. However, the structures of the detection area L1, etc., differ between the observation area shown in observation image 61 and the observation areas shown in observation images 74 and 75. That is, Figure 8 The observed image 61 includes three regions: the detection region L1, the control region L2, and the color development region L3. In contrast, Figure 9 The observed images 74 and 75 include two detection regions, a first detection region L1A and a second detection region L1B, and a control region L2. That is, the kit shown here is used to detect the presence or absence of two analytes.

[0135] In kits used to detect the presence of two test substances, such as influenza A and influenza B, the two test substances are... Figure 9 A and Figure 9 In section B, detection area L1A is the detection area containing capture antibodies against influenza A, and detection area L1B is the detection area containing capture antibodies against influenza B. The width of detection area L1A, detection area L1B, and control area L2 in the X direction is, for example, 1 mm. These three areas are, for example, spaced 3 mm apart. Furthermore, when it is necessary to distinguish multiple detection areas L1, the symbols for detection areas L1 will be marked with subdivision symbols A or B; otherwise, they will be simply referred to as detection area L1.

[0136] exist Figure 9 In the example observation image 74 (A), the lines of the first detection region L1A are shown, but the lines of the second detection region L1B are not shown. On the other hand, in Figure 9In the observation image 75 shown in B, no lines are displayed in either the first detection area L1A or the second detection area L1B. However, a localized high-concentration area, equivalent to contamination, exists in the lower part of the second detection area L1B in the observation image 75. Thus, the presence of a localized high-concentration area in the detection area constitutes an abnormality in the detection area. The anomaly determination unit 127 determines whether such a detection area is abnormal, i.e., whether a locally generated high-concentration area exists.

[0137] As described above, observation images 74 and 75 are images in which multiple pixels are arranged in a matrix-like two-dimensional pattern. Figure 9 A represents the relationship between the pixel value of a pixel column 'a' in the detection region image of the first detection region L1A and the pixel position in the Y direction, and... Figure 9 The relationship between the pixel value of a pixel column b in the detection region image of the second detection region L1B and the pixel position in the Y direction is shown in the figure. Figure 9 C.

[0138] like Figure 9 As shown in C, the pixel values ​​of pixels in pixel column b of the abnormal second detection region L1B in observation image 75 vary greatly compared to the pixel values ​​of pixels in pixel column a of the abnormal first detection region L1A in observation image 74. When the subject 50 is positive and normal lines appear in detection region L1, as shown in pixel column a without abnormalities, the concentration of pixels in detection region L1 also increases, so the pixel values ​​of pixels arranged along the Y direction do not differ significantly. Similarly, when the subject 50 is negative and no lines appear in detection region L1, the concentration of pixels in detection region L1 does not change, so the pixel values ​​of pixels arranged along the Y direction do not differ significantly. On the other hand, local high-concentration areas caused by non-specific adsorption rarely occur in the Y direction as well. As shown in pixel column b with abnormalities, the variation in pixel values ​​(so-called pixel value deviation) of pixels arranged along the Y direction is greater compared to the case where no high-concentration areas occur.

[0139] Therefore, the magnitude of pixel value variation along the Y-direction in the detection region image can be used as a criterion to determine whether the detection region image has any abnormalities. As a measure of the magnitude of pixel value variation, examples include the amount of change in pixels within a pixel column, the standard deviation, and the coefficient of variation. Here, the amount of pixel variation refers to the difference between the relatively high and relatively low pixel values ​​in a pixel column, such as the difference between the maximum and minimum values. However, the amount of variation used as a criterion only needs to be the difference between the relatively high and relatively low pixel values ​​that is within an acceptable range for distinguishing between abnormal and normal conditions. For example, the difference between the second largest and second smallest pixel values, or the difference between the third largest and third smallest pixel values ​​in a pixel column, can be used as the amount of variation.

[0140] Table 1 shows Figure 9 The results shown in C are the calculation of the change (maximum value - minimum value), standard deviation, and coefficient of variation based on the pixel values ​​of the pixels constituting pixel column b in the abnormal detection area L1 and the pixels constituting pixel column a in the non-abnormal detection area.

[0141] [Table 1]

[0142] Change (maximum value - minimum value) 27 14 Standard deviation 10.3 4.4 coefficient of variation 7.1％ 3.0％

[0143] As shown in Table 1, in the case of pixel column b with anomalies, the standard deviation, variability, and coefficient of variation are larger compared to the case of pixel column a without anomalies. Therefore, at least one of the standard deviation, variability, and coefficient of variation is used as a criterion to determine whether there is an anomaly. For example, when using the standard deviation as a criterion, if the standard deviation is 8 or higher, it is considered an anomaly; if it is less than 8, it is considered normal. Similarly, when using the variability as a criterion, if it is 20 or higher, it is considered an anomaly; if it is less than 20, it is considered normal. When using the coefficient of variation as a criterion, if it is 5% or higher, it is considered an anomaly; if it is less than 5%, it is considered normal. Furthermore, when using both the standard deviation and the variability as criterion, for example, if the standard deviation is 8 or higher and the variability is 20 or higher, it is considered an anomaly; if the standard deviation is less than 8 or the variability is less than 20, it is considered normal. In addition, the value that serves as the criterion for determining whether there is an abnormality (hereinafter referred to as the criterion value TA) is a value that is appropriately determined based on the test substance, the type of reagent kit, and the testing device, and the preset value is stored in the memory 121 as setting information.

[0144] The above describes how, for the pixel values ​​of pixels contained in one column (one pixel column) within the detection region image representing detection region L1, at least one of the following—variance, standard deviation, and coefficient of variation—is used as a judgment criterion. As the pixel column used to calculate the judgment criterion, any one column within the detection region image can be extracted and used for anomaly detection. Regarding the extraction location, it is preferable to extract one column near the center in the X direction within the detection region image. This is because there are many cases where the difference between the presence and absence of anomalies is significant near the center. Furthermore, it is not limited to one column; the judgment criterion can be calculated separately for multiple columns within the detection region image. When the judgment criterion of all or more of the multiple columns satisfies the judgment benchmark value TA, an anomaly is determined.

[0145] Furthermore, the processor 120 can use at least one of the following criteria as a judgment index: the difference between the relatively large and relatively small representative values ​​of each row derived from multiple pixels in different columns of the same row within the detection region image; the standard deviation of the representative values ​​based on each row; and the coefficient of variation. For example, such as Figure 10As shown, multiple columns are extracted from the detection region image representing the second detection region L1B within the observation image 75, and the average value of the pixel values ​​of multiple pixels located in different columns of the same row is derived as the representative value. Figure 10 In this example, we extract 5 columns of pixels. Each column contains 15 rows of pixels. Figure 10 In this matrix, the values ​​shown for each pixel are called pixel values. The processor 120, for example, derives the average value of each row of five pixel columns and uses this average value as the representative value for each row. Figure 9 When calculating using pixel values ​​as an example, for instance, the representative value of the first row becomes (142+140+140+144+144) / 5=142. Treating the 15 rows of representative values ​​thus derived as one column, at least one of the following—variance, standard deviation, and coefficient of variation—is derived and used as the judgment criterion, similarly to the above.

[0146] Thus, by using at least one of the following criteria—the difference between the relatively large and relatively small representative values ​​derived from multiple pixels in different columns of the same row, the standard deviation of the representative values ​​of each row, and the coefficient of variation—as the criterion, noise suppression enables more accurate anomaly detection compared to using a specific column of the detection area to calculate the criterion.

[0147] The above anomaly determination is performed using the above method. Additionally, before determining whether there are any anomalies in the detection region image corresponding to detection region L1, the processor 120 needs to examine the observation images 74 and 75 (reference images). Figure 9 The detection region image is extracted from the image. The method for extracting the detection region is explained below.

[0148] Processor 120, for example, reads the position information of detection region L1 in the observation image, which is pre-stored as setting information in memory 121, determines the detection region L1 in observation images 74 and 75, and extracts the detection region image. The position information of detection region L1 is, for example, the distance from one end of the observation image.

[0149] As described above, the detection image can be easily extracted by extracting based on location information. On the other hand, due to individual differences in the kit 100, the position of the detection region L1 in the observation images 74 and 75 may sometimes be slightly misaligned. Therefore, when extracting the detection region L1 from the observation images 74 and 75 based solely on location information, there is a possibility of deviation from the actual detection region L1. Therefore, it is preferable to derive a distribution map of the row directions based on the representative values ​​of each column in the image 74 and 75, which is an image in which multiple pixels are arranged in a matrix in two dimensions, and to extract the detection region image corresponding to the detection region from the observation image based on the derived distribution map.

[0150] The following describes the method for extracting the detection region image using a distribution map. The processor 120 first derives representative values ​​for each column of the observed image. There are no particular limitations on the method for deriving the representative values; for example, the pixel values ​​of a specific row within that column can be used as representative values, or the average or median value of two or more pixels within that column can be used as representative values.

[0151] Processor 120 uses the derived representative values ​​to create a distribution map of pixel values ​​in the row direction (i.e., the X direction). Figure 11 This illustrates an example of a distribution plot created based on observed image 70. The distribution plot uses representative values ​​for each column, with the vertical axis representing pixel values ​​and the horizontal axis representing pixel positions in the X direction. Figure 9 A and Figure 9 Similar to observation images 74 and 75 shown in Figure B, observation image 70 is an observation image obtained using an influenza test kit that detects two test substances. Like observation images 74 and 75, observation image 70 includes two detection regions L1A and L1B and a control region L2.

[0152] exist Figure 11 In the observed image 70, the control region L2 is clearly shown as a line. Furthermore, although fainter than the control region L2, the first detection region L1A is also shown as a line. On the other hand, the second detection region L1B is not shown. Figure 11 In the distribution diagram shown, regions PA, PB, and PC correspond to the first detection region L1A, the second detection region L1B, and the control region L2, respectively.

[0153] Processor 120 extracts the detection region distribution map from the distribution map created using representative values. Specifically, processor 120 extracts the detection region distribution map from... Figure 11 The detection region distribution map PA corresponding to the first detection region L1A and the detection region distribution map PB corresponding to the second detection region L1B are extracted from the distribution map. Furthermore, when extracting the detection region distribution maps, the first detection region L1A and the second detection region L1B can be extracted by converting the pixel value distribution map into a concentration distribution map. High-concentration regions that appear as valleys in the pixel value distribution map represent peaks in the concentration distribution map; therefore, the first detection region L1A and the second detection region L1B can be extracted by extracting peaks from the concentration distribution map. For example, the processor 120 compares the position information of the first detection region L1A with... Figure 11The location of the valley in the detection area distribution map PA (or peak in the concentration distribution map) is used to determine the location of the first detection area L1A. Furthermore, the processor 120 extracts the detection area image from a specific location in the observation image 70. The location information of the first detection area L1A and the second detection area L1B in the observation image 70 is pre-stored in the memory 121 as setting information, for example. The setting information is, for example, the distance from one end of the observation image 70.

[0154] As described above, the processor 120 creates a pixel value distribution map (or density distribution map), and compares the location of the valley (or peak) corresponding to the detection region L1 extracted from the created distribution map with the location information of the detection region L1, thereby determining the location of the detection region L1 in the observed image. Therefore, compared to using only the location of the valley and the location information of the distribution map, the detection region distribution map of the detection region L1 can be extracted more accurately. Thus, by using the detection region image extracted from the observed images 74 and 75 with high positional accuracy for anomaly detection, the accuracy of anomaly detection can be improved.

[0155] Figure 12 The diagram shows the processing sequence of exception determination performed by the processor 120.

[0156] In the abnormality determination process, the processor 120 first extracts the observation area from the captured image output by the imaging unit 114, thereby obtaining the observation image 74 (or observation image 75) (process S61).

[0157] Next, the processor 120 extracts the detection region image from the acquired observation image 74 (or observation image 75) (step S62). The method for extracting the detection region image is as described above.

[0158] Processor 120 derives a decision criterion from the extracted detection region image (step S63). As described above, for example, processor 120 derives at least one of the following as a decision criterion: variation, standard deviation, and coefficient of variation, for the pixel values ​​of pixels contained in at least one column (one pixel column) within the detection region image. Alternatively, processor 120 derives at least one of the following as a decision criterion: the difference between the relatively large and relatively small representative values ​​of each row derived from multiple pixels in different columns of the same row within the detection region image, the standard deviation based on the representative values ​​of each row, and the coefficient of variation.

[0159] Processor 120 determines whether the derived judgment index is above or equal to a preset judgment reference value TA (step S64). If the judgment index is above or equal to the judgment reference value TA (step S64: Yes), processor 120 determines that there is an anomaly (step S65) and ends the anomaly judgment process. On the other hand, if the judgment index is below the judgment reference value TA (step S64: No), processor 120 determines that there is no anomaly (step S66) and ends the anomaly judgment process. The anomaly judgment process performed by processor 120 is as described above.

[0160] refer to Figure 13 and Figure 14 The immunochromatographic detection sequence using the detection device 110 of this embodiment will be described. Here, the first detection process, in which the supply of the first reagent 41 is performed by the user and the supply of the second reagent 46 is performed in the detection device 110, will be described.

[0161] (First testing procedure)

[0162] Figure 13 This is a diagram representing the first detection process.

[0163] First, the user adds the test sample 50 to the addition area of ​​the carrier 2 through the dropper 16 of the reagent kit 100 (step S11).

[0164] Next, the user presses the first pressed part 11 of the reagent kit 100 to start the supply of the first reagent 41 (process S12).

[0165] Afterwards, the user loads the reagent kit 100 into the loading section 112 of the powered-on detection device 110 (step S13).

[0166] Within the testing device 110, a test is performed on the filled reagent kit 100 (step S14).

[0167] Additionally, the time it takes for the first reagent 41 to fully diffuse on the carrier 2 after the first reagent 41 is supplied will vary depending on the kit, but it will take approximately 5 to 10 minutes. The time it takes for the filling part 112 to be filled after the user presses the first pressed part 11 will depend on the user's situation.

[0168] Figure 14 Shown by Figure 13 The detection device 110 shown performs a detailed detection process (step S14) for detection.

[0169] By filling the reagent kit 100 into the detection device 110, the detection in the detection device 110 ( Figure 13 The process begins with step S14.

[0170] like Figure 14 As shown, in the detection device 110, firstly, the processor 120 determines whether the color development state of the color development region L3 has changed (specifically, from dark green to orange) (step S21). Specifically, the processor 120 illuminates the observation area 68 exposed from the observation window 18 by turning on the light source 115, and in this state, the imaging unit 114 takes an image. Furthermore, the processor 120 acquires the captured image from the imaging unit 114 and determines the change in the color development state of the color development region L3 based on the acquired image. When it is determined that the color development state of the color development region L3 has changed, that is, when the color development region L3 changes from dark green to orange, it indicates that the first reagent 41 has reached the color development region L3 and its upstream detection region L1 and control region L2.

[0171] When the color development state of the color development region L3 changes (step S21: Yes), the processor 120 starts supplying the second reagent 46 by operating the second reagent supply mechanism 118 (step S22). In this embodiment, the processor 120 presses the second pressed portion 12 of the reagent kit 100 by the second reagent supply mechanism 118. When the second pressed portion 12 is pressed, it deforms in a way that it sinks into the second reagent holding portion 45. Through this deformation, the sheet-like component 48 of the second reagent holding portion 45 is pressed open by the protrusion 34, and the second reagent 46 is supplied onto the carrier 2.

[0172] On the other hand, if the color development state of the color development area L3 does not change (process S21: no), a determination is made as to whether it is within the second set time t2 (process S23).

[0173] Here, if the second set time t2 is exceeded (step S23: No), the processor 120 reports an error (step S26) and terminates the detection process. For example, the error is reported by displaying an error message on the display 119. Alternatively, as an error reporting method, in addition to displaying the error message on the display 119, the error message can also be reported by voice.

[0174] On the other hand, if it is within the second set time t2 (step S23: yes), then wait until the first set time t1 has elapsed (step S24). Figure 14 In process S24, it is represented as "t1 wait". The first set time t1 is, for example, about 30 seconds, and the second set time t2 is, for example, preset to 20 minutes, etc. After that, it returns to process S21, which determines whether the color development state of the color development area L3 has changed.

[0175] In step S22, after the second reagent supply mechanism 118 is activated to begin supplying the second reagent 46, the system remains idle until a preset third set time t3 has elapsed (step S27). Figure 14In process S27, it is represented as "t3 wait". The third set time t3 is, for example, about 3 minutes.

[0176] Next, the processor 120 determines whether lines appear within the control region L2 (step S28). Specifically, similar to step S21, the processor 120 causes the imaging unit 114 to capture images of the observation region 68 while the observation region 68 is illuminated. Furthermore, the processor 120 acquires the captured image from the imaging unit 114 and extracts an observation image 61 of the observation region 68 from the acquired image. The processor 120 then determines changes in the color development state of the control region L2 in the extracted observation image 61. For example, the processor 120 determines whether the color development concentration of the control region L2 reaches a concentration higher than a preset reference level; if the concentration is higher than the reference level, it determines that the control region L2 has appeared. When it is determined that the control region L2 has appeared, it indicates that the subject 50 has reached the control region L2 and its upstream detection region L1 and has undergone silver amplification.

[0177] In the determination of whether the control area L2 is visible in step S28, if the control area L2 is not visible (step S28: No), an error is reported (step S26) and the detection process ends. Additionally, if the control area L2 is not visible after the second reagent 46 has diffused, it may be because the test sample 50 was not added.

[0178] On the other hand, in the determination of whether the control area L2 is displayed (step S28), when the control area L2 is displayed (step S28: yes), the processor 120 performs a main determination with anomaly determination, and prompts the detection result based on the result of the main determination with anomaly determination (step S31).

[0179] In step S31, the processor 120 makes a primary determination as to whether the sample 50 is positive or negative. Specifically, the processor 120 determines whether the colorimetric concentration of the linear detection area L1 reaches or exceeds a preset baseline. If the concentration is above the baseline, the processor 120 determines that the detection area L1 has been visualized. If the detection area L1 is visualized, the sample 50 is determined to be positive; if the detection area L1 is not visualized, the sample 50 is determined to be negative. Furthermore, as an anomaly determination, the processor 120... Figure 12 The anomaly detection process is performed according to the shown sequence, and it is determined whether there is an anomaly in the detection area image. In step S31, the processor 120 can perform anomaly detection before or after the main detection process, which includes anomaly detection. Therefore, multiple processing sequences can be considered for step S31. The details of step S31 will be explained below. Furthermore, five processing sequences of step S31 are illustrated below, and for the purpose of distinguishing them, these five processing sequences will be referred to as Examples 1 to 5.

[0180] exist Figure 15 The first example shows an example of the processing sequence of step S31.

[0181] like Figure 15 As shown, in the first example of process S31, the processor 120 first performs the main determination of whether the subject 50 is positive or negative (process S71).

[0182] When the processor 120 determines the result of the main judgment to be negative (step S72: No), it does not perform an anomaly judgment but displays "negative" as the detection result on the display 119 and ends the process. Figure 14 The processor 120 performs an exception determination (S73) when the result of the main determination is positive (S72: Yes).

[0183] In the anomaly detection step S73, the processor 120 uses the detection region image extracted from the observation image obtained from the main detection step, according to... Figure 12 The exception handling sequence shown is used for exception detection.

[0184] If the processor 120 determines that an anomaly has occurred after performing an anomaly assessment (step S75: Yes), the processor 120 displays "partially positive" as the detection result on the display 119 (step S76), and then ends the process. Figure 14 The processing step S31 in the process. Here, "some retention" means retaining the abnormal content in the detection area image. That is, the display of "some retention of positive" makes the user aware that although it is positive in the main determination, there is a possibility of false positive due to the presence of abnormalities in the detection area L1.

[0185] Additionally, in step S76, as a test result, instead of displaying a partially positive result, an error message "Judgment Failure" can be displayed instead of a fully positive result. Furthermore, besides "Judgment Failure," a message indicating potential contamination within the test area can also be displayed. When a partially positive or partially negative test result is displayed, the user can visually assess whether the color development of the test area has changed to confirm whether it is positive or negative, or to determine if it should be retested.

[0186] On the other hand, if the processor 120 determines that there is no abnormality after performing the anomaly detection (step S75: No), it displays "positive" as the detection result on the display 119 (step S77) and ends the process. Figure 14 Processing step S31 in the process.

[0187] In the detection device 110, the processor 120 performs a main determination accompanied by anomaly determination, which is performed according to the above-described anomaly determination processing order. Specifically, the processor 120 performs anomaly determination by using at least one of the following criteria: the difference between the relatively large and relatively small pixel values ​​in at least one column of the detection area image, the standard deviation of the pixel values ​​in at least one column, and the coefficient of variation. Alternatively, the processor 120 performs anomaly determination by using at least one of the following criteria: the difference between the relatively large and relatively small representative values ​​derived from multiple pixels in different columns of the same row within the detection area image, the standard deviation of the representative values ​​in each row, and the coefficient of variation. Furthermore, the processor 120 determines the processing content involved in the main determination based on the presence or absence of anomalies. Therefore, it is possible to determine with high precision whether there are anomalies in the detection area L1, and based on the presence or absence of anomalies, determine the processing content involved in the main determination, thus providing a more reliable detection result.

[0188] In particular, in the first example of step S31 described above, the processor 120 first performs a main determination, and when the main determination result is positive, it performs an anomaly determination. Depending on whether there is an anomaly, the method of indicating the main determination result, which is part of the processing content involved in the main determination, differs. That is, when the main determination result is positive, if there is no anomaly, the main determination result is directly indicated as the detection result (in this case, "positive" is displayed on the display 119); if there is an anomaly, the abnormal content in the detection area image is retained as the indication of the main determination result (in this case, "somewhat reserved positive" is displayed on the display 119). Therefore, the user can be informed whether the reliability of the determination result is sufficiently high or whether there is a possibility of a false positive, thus improving the reliability of the detection result.

[0189] Figure 16 The second example of the processing sequence of step S31 is shown. Figure 16 In the middle, to and Figure 15 The same process is marked with the same process symbol and detailed descriptions are omitted in the first example shown.

[0190] In the second example of step S31, the subsequent processing when the processor 120 performs the main determination (step S71) and determines it to be negative (step S72: No) differs from the first example. In the second example, when the processor 120 performs the main determination (step S71) and determines it to be negative (step S72: No), an exception determination (step S81) is still performed. Moreover, when the processor 120 performs the exception determination in step S81 and determines that there is an exception (step S82: Yes), it displays "partially negative" on the display 119 (step S83), and the process ends. Figure 14 Processing step S31 in the process.

[0191] On the other hand, if the processor 120 determines that there is no abnormality in the abnormality determination of process S81 (process S82: No), it displays "negative" on the display 119 (process S84) and ends. Figure 14 Processing step S31 in the process.

[0192] exist Figure 16 In the second example shown, anomaly detection is also performed to determine whether there are any anomalies in the detection area image. Based on whether there are any anomalies, the processing content involved in the main determination is determined, thus enabling the suggestion of more reliable detection results.

[0193] Especially in Figure 16 In the second example shown, when the processor 120 determines that there is no abnormality (step S75: No and step S82: No), it directly presents the main determination result as the detection result (at this time, it displays "positive" or "negative" on the display 119). When the processor determines that there is an abnormality (step S75: Yes and step S82: Yes), it retains the abnormal content in the detection area image to present the main determination result (at this time, it displays "partially positive" or "partially negative" on the display 119). Therefore, it can indicate to the user whether the reliability of the determination result is sufficiently high or whether there is a possibility of a false positive, thereby improving the reliability of the detection result.

[0194] exist Figure 15 The first example shown and Figure 16 In the second example shown, the main decision is performed first, followed by the exception decision. However, in process S31, the exception decision can also be performed first, followed by the main decision. Figure 17 This is another example of the detailed processing sequence of process S31, showing the third example where an exception determination is performed first, followed by the main determination.

[0195] like Figure 17 As shown, in the third example, the processor 120 first performs an exception determination (step S91). The processor 120 follows... Figure 12 The exceptions are processed in the order shown.

[0196] Furthermore, when the processor 120 determines that there is an error in the error determination process (process S92: Yes), it does not perform the main determination but displays "Determination failure" on the display 119 (process S93) and ends the process. Figure 14 The process S31 in the process. At this time, a statement such as "There is contamination in the detection area, no main judgment will be performed" can be displayed on the display 119, either instead of the display of a defective judgment or together with the display of a defective judgment.

[0197] If the processor 120 determines that there is no abnormality in the abnormality determination (step S92: No), it performs the main determination (step S94). In addition, when performing the main determination after the abnormality determination, the observation image obtained in the abnormality determination step S91 is used.

[0198] When the processor 120 determines the result of the main determination to be positive (step S95: Yes), it displays "Positive" on the display 119 (step S96) and ends the process. Figure 14 The processing in step S31 is as follows. On the other hand, when the processor 120 determines the result of the main determination to be negative (step S95: No), it displays "negative" on the display 119 (step S97) and ends the process. Figure 14 Processing step S31 in the process.

[0199] exist Figure 17 In the third example shown, anomaly detection is performed, and the main determination is made only after confirming that there are no anomalies, thus improving the reliability of the detection results. Moreover, in the third example, when an anomaly is determined in the image of the detection area, the detection device 110 is no longer occupied and the detection ends, thus shortening the occupation time of the detection device 110.

[0200] like Figure 17 In the third example shown, when performing the main judgment after the anomaly judgment, the main judgment can still be performed even if the anomaly judgment determines that there is an anomaly. Figure 18 This is an example of the detailed processing sequence of process S31, showing the fourth case where an anomaly is first determined and identified as abnormal. Figure 18 In the middle, to and Figure 17 The third example shown uses the same process symbols for the same procedures and omits detailed descriptions.

[0201] like Figure 18 As shown, in the fourth example, the processor 120 performs an anomaly determination (step S91). Even if an anomaly is determined (step S92: Yes), the main determination is still performed (step S103). Furthermore, if the result of the main determination in step S103 is positive (step S105: Yes), the processor 120 displays "partially positive" on the display 119. On the other hand, if the result of the main determination in step S103 is negative (step S105: No), the processor 120 displays "negative" on the display 119. The other steps are the same as in the third example.

[0202] In addition, when the processor 120 performs the main determination of process S103 and the determination is positive (process S105: Yes), it can display an error message on the display 119 (at this time, the display 119 displays "determination failure") instead of displaying "somewhat positive" (process S106).

[0203] Figure 19 This is an example of the detailed processing sequence of process S31, showing the 5th case where an anomaly is first determined and identified as abnormal. Figure 19 In the text, the same process symbols are used for the same processes as in the 3rd or 4th examples, and detailed descriptions are omitted.

[0204] like Figure 19 As shown, in Example 5, the processor 120 performs an anomaly determination (step S91), and even if an anomaly is determined (step S92: yes), the main determination is still performed (step S103). Moreover, if the result of the main determination in step S103 is negative (step S105: no), the processor 120 displays "partially negative" on the display 119 (step S107). The other steps are the same as in Example 4.

[0205] and Figure 17 Similarly, in the third example shown, Figure 18 The fourth case shown and Figure 19 The fifth example shown also proceeds with the main judgment after confirming that there are no abnormalities through anomaly detection, thus improving the reliability of the detection results.

[0206] In addition, in the above examples 1 to 5, when the test results indicate poor judgment or some reservation, the user can visually confirm whether there are visible lines in the test area L1 or process it as a retest object.

[0207] In the above embodiments, the hardware structure of the processor 120, and consequently the imaging unit control unit 122, the color development state determination unit 123, the first reagent supply mechanism control unit 124, the second reagent supply mechanism control unit 125, the abnormality determination unit 127, and the display control unit 126, which perform various processes, can use various processors as shown below. As described above, in addition to a general-purpose processor, i.e., a CPU, which functions as various processing units executing software, various processors also include processors such as FPGAs (Field Programmable Gate Arrays) whose circuit structure can be changed after manufacturing, i.e., programmable logic devices (PLDs), and processors such as ASICs (Application Specific Integrated Circuits) with dedicated circuit structures designed for performing specific processes, i.e., dedicated electrical circuits.

[0208] A processing unit can consist of one of these various processors, or it can consist of a combination of two or more processors of the same or different types (e.g., a combination of multiple FPGAs and / or a combination of a CPU and an FPGA). Furthermore, multiple processing units can also be composed of a single processor.

[0209] As an example of a single processor comprising multiple processing units, one approach is to combine one or more CPUs and software to form a single processor, which then functions as multiple processing units. Another approach is exemplified by System-on-Chips (SoCs), which uses a single integrated circuit (IC) chip to implement the overall system functionality, including multiple processing units. Thus, various processing units utilize one or more of these different processors to form the hardware structure.

[0210] Moreover, the hardware structure of these various processors, more specifically, is capable of using circuits composed of combined semiconductor elements and other circuitry.

[0211] The invention relating to Japanese Patent Application No. 2021-050780, filed on March 24, 2021, is incorporated herein by reference in its entirety.

[0212] All documents, patent applications and technical standards described herein are incorporated herein by reference to the same extent as those specifically and separately described herein.

Claims

1. An immunochromatographic detection device, comprising: The filling section is detachably filled with a reagent kit, the reagent kit having a drop-in area for adding the test sample and a detection area whose color development state changes depending on whether the test sample is positive or negative; The imaging unit captures images of the detection area; as well as The processor determines whether the subject is positive or negative based on the detection area image captured by the imaging unit, i.e., the main determination. When the diffusion direction of the sample on the carrier is set as the row direction, and the direction intersecting the row direction is set as the column direction, the detection area is a linear region extending along the column direction. The detection region image is an image in which multiple pixels are arranged in a matrix-like two-dimensional pattern. The processor performs the following anomaly determination: determining whether the detection area image has an anomaly caused by contamination present in the detection area, and using at least one of the following criteria: the difference between the relatively large and relatively small pixel values ​​in at least one column of the detection area image, the standard deviation and coefficient of variation of the pixel values ​​in each column, or the difference between the relatively large and relatively small representative values ​​of each row derived from multiple pixels in different columns of the same row in the detection area image, and the standard deviation and coefficient of variation of the representative values ​​in each row. The processor determines whether to perform the main judgment and provides a prompting method for the main judgment result based on whether or not the exception exists.

2. The immunochromatographic detection device according to claim 1, wherein, The processor performs the main determination and displays the determination result when there is no exception; it does not perform the main determination when there is an exception.

3. The immunochromatographic detection device according to claim 2, wherein, When the processor does not perform the main determination, it will display a message indicating that the main determination will not be performed.

4. The immunochromatographic detection device according to claim 3, wherein, When the processor detects the anomaly, it indicates that there may be contaminated content in the detection area.

5. The immunochromatographic detection device according to claim 1, wherein, When there is no abnormality, the processor displays the determination result of the main determination. When there is an abnormality and the determination result of the main determination is positive, the processor retains the abnormal content of the detection area image to display the determination result of the main determination, or does not display the determination result of the main determination.

6. The immunochromatographic detection device according to claim 5, wherein, The processor performs the main determination and performs the anomaly determination when the determination result is positive.

7. The immunochromatographic detection device according to claim 1, wherein, When there is no abnormality, the processor displays the determination result of the main determination; when there is an abnormality, it retains the abnormal content of the detected area image to display the determination result of the main determination or does not display the determination result of the main determination.

8. The immunochromatographic detection apparatus according to any one of claims 1 to 7, wherein, The imaging unit is an image sensor that outputs an observation image including the observation area by capturing an observation area including the detection area. The observed image is an image in which multiple pixels are arranged in a matrix-like two-dimensional pattern. The processor derives a distribution map of the row direction based on the representative values ​​of each column in the observed image, and extracts the detection region image corresponding to the detection region from the observed image based on the derived distribution map.

Images