Immunochromatography testing device

Abstract

According to the present invention, a testing device comprises: a loading unit into which a cartridge can be removably loaded, the cartridge comprising a support that has a test area and a spotting area onto which a sample is to be spotted; an imaging unit that captures an image of the test area; and a processor that performs a principal determination on the basis of the test area image captured by the imaging unit, the principal determination being a determination of whether the sample is positive or negative. The test area image is a two-dimensional matrix of pixels, and the processor performs abnormality determination that determines whether there is an abnormality in the test area image using, as a determination index, at least one of the difference between a relatively large pixel value and a relatively small pixel value for at least one column of the test area image and a standard deviation and a coefficient of variation that are based on the pixel values for each column. The processor determines processing details for the principal determination on the basis of whether there is an abnormality.

Description

[Technical Field]

[0001] The present disclosure relates to an immunochromatographic testing device. [Background technology]

[0002] Among immunoassay methods, immunochromatography is widely used because it is easy to operate and allows for rapid test determination.

[0003] The immunochromatographic method uses an immunochromatographic carrier equipped with a test area where an antibody that specifically binds to the antigen, the test substance, is immobilized. When a labeled antibody that specifically binds to the antigen is spread on the immunochromatographic carrier together with a sample containing the antigen, the antigen binds to the antibody immobilized in the test area, and the labeled substance is captured via the antigen. The test area develops color due to the labeled substance captured in the test area, and if the color density in the test area is equal to or greater than the reference value, the result is determined to be positive.

[0004] Japanese Patent Application Laid-Open Publication No. 2009-115470 discloses a testing device that optically analyzes the color development state of a test area on an immunochromatographic carrier. The testing device includes a sensor that optically detects the reaction state and a measurement unit that determines whether a result is positive or negative based on the detection results. In Japanese Patent Application Laid-Open Publication No. 2009-115470, the presence or absence of degradation of the immunochromatographic carrier is determined before the determination in order to prevent erroneous determinations due to deterioration of the immunochromatographic carrier. In this case, the amount of change in brightness in a predetermined area on the immunochromatographic carrier is measured while the sample is being developed, and if the change is greater than a predetermined standard value, the immunochromatographic carrier is determined to be degraded. This prevents erroneous determinations due to deterioration of the immunochromatographic carrier. Summary of the Invention [Problem to be solved by the invention]

[0005] In testing devices, in addition to erroneous determinations due to deterioration of the immunochromatographic carrier, color development due to nonspecific adsorption of labeled substances in the test area or near the test area can sometimes result in a positive determination even when the result is actually negative. Such erroneous determinations due to nonspecific adsorption of labeled substances undermine the reliability of immunochromatographic testing. It is desirable for testing devices to provide more reliable results than ever before.

[0006] The present disclosure has been made in consideration of the above circumstances, and has an object to provide an immunochromatographic testing device that can present more reliable determination results than conventional devices. [Means for solving the problem]

[0007] The immunochromatographic testing device of the present disclosure comprises: a loading section in which a cartridge having a carrier having a spotting area where a sample is spotted and a test area where a color development state changes depending on whether the sample is positive or negative is detachably loaded; an imaging unit that images the inspection area; a processor for making a primary determination of whether the sample is positive or negative based on the inspection area image of the inspection area captured by the imaging unit; When the direction in which the specimen is developed on the carrier is defined as a row direction and the direction intersecting the row direction is defined as a column direction, the test region is a linear region extending along the column direction, The inspection area image is an image in which a plurality of pixels are arranged two-dimensionally in a matrix form, the processor performs an abnormality determination for determining whether or not there is an abnormality in the inspection area image, using at least one of the difference between a relatively large pixel value and a relatively small pixel value in at least one column in the inspection area image, the standard deviation and the coefficient of variation based on the pixel values ​​of each column, or the difference between a relatively large representative value and a relatively small representative value among representative values ​​of each row derived based on a plurality of pixels existing in the same row but different columns in the inspection area image, and the standard deviation and the coefficient of variation based on the representative values ​​of each row as a determination index; The processing contents for the main determination are determined based on the presence or absence of an abnormality.

[0008] In the immunochromatographic testing device of the present disclosure, the processing content may include either a decision as to whether or not to perform a main determination, and a method for presenting the main determination result.

[0009] In the immunochromatographic testing device of the present disclosure, the processor can perform a main judgment and present the judgment result of the main judgment when no abnormality is found, and can not perform the main judgment when an abnormality is found.

[0010] In the immunochromatographic testing device of the present disclosure, when the main determination is not to be performed, the processor preferably presents a message to the effect that the main determination will not be performed.

[0011] In the immunochromatographic testing device of the present disclosure, if an abnormality is detected, the processor may indicate that there may be contamination in the testing area.

[0012] In the immunochromatographic testing device of the present disclosure, the processor presents the judgment result of the main judgment if no abnormality is found, and if an abnormality is found and the judgment result of the main judgment is positive, the processor may present the judgment result of the main judgment with a reservation that there is an abnormality in the test area image, or may not present the judgment result of the judgment.

[0013] In the immunochromatographic testing device of the present disclosure, the processor may perform a main determination and, if the determination result is positive, perform an abnormality determination.

[0014] In the immunochromatographic testing device of the present disclosure, the processor may present the judgment result of the main judgment if no abnormality is found, and may present the judgment result of the main judgment with a reservation that there is an abnormality in the test area image if an abnormality is found, or may not present the judgment result.

[0015] In the immunochromatographic testing device disclosed herein, the imaging unit is an image sensor that captures an imaging area that includes the testing area, thereby outputting an observation image that includes the observation area, and the observation image is an image in which a plurality of pixels are arranged two-dimensionally in a matrix, and the processor may derive a row-direction profile based on a representative value of each column in the observation image, and extract an examination area image that corresponds to the testing area from the observation image based on the derived profile. [Effects of the Invention]

[0016] The immunochromatographic testing device of the present disclosure can provide determination results that are more reliable than conventional ones. [Brief explanation of the drawings]

[0017] [Figure 1] 1 is a perspective view showing the appearance of an immunochromatographic testing device according to a first embodiment. [Figure 2] FIG. [Figure 3] FIG. [Figure 4] 3 is a diagram showing the positional relationship between a test strip, a multifunctional member, a first reagent container, and a second reagent container within a cartridge. FIG. [Figure 5] FIG. 1 is an explanatory diagram of immunochromatography. [Figure 6] FIG. 2 is a partially cutaway side view of the inspection device with a cartridge loaded therein. [Figure 7] FIG. 10 is a partially cutaway side view of the testing device in a state where a cartridge is loaded and a second reagent supply mechanism is in operation. [Figure 8] 3A and 3B are diagrams schematically showing an observation image and an inspection area image. [Figure 9] 9A and 9B are captured images, and FIG. 9C is a diagram showing the displacement of pixel values ​​in one pixel column extracted from each of the first inspection area L1A in FIG. 9A and the second inspection area L1B in FIG. 9B. [Figure 10] FIG. 10 is an explanatory diagram of data processing for deriving a determination index for abnormality determination. [Figure 11] FIG. 10 is an explanatory diagram of a method for extracting an inspection area image. [Figure 12] FIG. 10 is a diagram showing a procedure for determining an abnormality. [Figure 13] FIG. 10 is a diagram showing a first inspection flow. [Figure 14] FIG. 1 is a diagram showing a test flow performed by an immunochromatographic testing device. [Figure 15] FIG. 10 is a diagram showing a first example of a detailed processing procedure of a main determination accompanied by an abnormality determination. [Figure 16] FIG. 10 is a diagram showing a second example of a detailed processing procedure of a main determination accompanied by an abnormality determination. [Figure 17] FIG. 10 is a diagram illustrating a third example of a detailed processing procedure of a main determination accompanied by an abnormality determination. [Figure 18] FIG. 10 is a diagram illustrating a fourth example of a detailed processing procedure of a main determination accompanied by an abnormality determination. [Figure 19] FIG. 10 is a diagram illustrating a fifth example of detailed processing procedures of a main determination accompanied by an abnormality determination. DETAILED DESCRIPTION OF THE INVENTION

[0018] An embodiment of the immunochromatographic testing device of the present disclosure will be described with reference to the drawings.

[0019] Fig. 1 is a perspective view showing the appearance of an immunochromatographic testing device 110 (hereinafter simply referred to as testing device 110) according to a first embodiment. Fig. 2 is an external view of a cartridge 100 to be attached to testing device 110, and Fig. 3 is an exploded perspective view of cartridge 100. Fig. 4 is a diagram showing the positional relationship of the main components housed inside cartridge 100.

[0020] The cartridge 100 is a single-use type that is used one for each sample to be tested. As shown in Figure 3, the cartridge 100 contains a test strip 1 including an immunochromatographic carrier 2 (hereinafter referred to as carrier 2). The carrier 2 is provided with a test region L1, and the color development state changes depending on whether the sample contains a test substance or not, i.e., whether the sample is positive or negative.

[0021] The specimen may be any sample that may contain the test substance, and is not particularly limited. Examples of specimens include biological samples, particularly body fluids such as animal (especially human) blood, serum, plasma, cerebrospinal fluid, tears, sweat, urine, pus, nasal discharge, nasal swabs, pharyngeal swabs, nasal aspirates, or sputum, or liquid samples containing excrement, organs, tissues, mucous membranes, and skin, or swabs containing these, or animals or plants themselves or their dried forms. Examples of test substances include antigens, antibodies, proteins, and low-molecular-weight compounds.

[0022] In this example, a cartridge 100 with a sample applied thereto is loaded into the testing device 110. The testing device 110 then detects the color development state of the testing area L1 of the loaded cartridge 100, determines whether the sample is positive or negative, and presents the test result. In the following, the determination of whether the sample is positive or negative is referred to as the main determination. When testing multiple samples, one cartridge 100 for each sample is loaded into the testing device 110.

[0023] In the following description, cartridge 100 will be described on the assumption that it is loaded into testing device 110, but cartridge 100 in this example has a configuration that allows a user to visually confirm whether a sample is positive or negative without using testing device 110. Such a cartridge 100 is also called an immunochromatographic testing tool or an immunochromatographic testing kit.

[0024] 1, the inspection device 110 includes a housing 111, which includes a loading section 112 into which the cartridge 100 is detachably loaded. As an example, the front of the housing 111 is provided with an opening for inserting the cartridge 100 into the housing 111, and an opening / closing lid 112a for opening and closing this opening. When loading the cartridge 100, the opening / closing lid 112a is opened, and the cartridge 100 is inserted into the housing 111. Once the cartridge 100 is loaded into the loading section 112, the opening / closing lid 112a is closed. The inspection is performed with the opening / closing lid 112a closed.

[0025] A power switch 113 is provided on the front surface of the housing 111, and a monitor 119 is provided on the top surface of the housing 111. Test results, error messages, and the like are displayed on the monitor 119. The monitor 119 is, for example, a touch panel monitor, and various operation screens are displayed on the monitor 119. The user can input operation instructions, such as an instruction to start processing and a selection of an inspection procedure, via the operation screen.

[0026] As shown in FIGS. 2 and 3 , the cartridge 100 includes, for example, a housing 9 composed of a case member 20 and a cover member 10. The housing 9 is formed of, for example, a resin material. The case member 20 has an opening formed at the top, and accommodates the test strip 1 as well as a first reagent holding portion 40 and a second reagent holding portion 45 inside. The cover member 10 is attached to the opening of the case member 20, thereby covering the opening of the case member 20. The housing 9 has an elongated shape overall to match the elongated shape of the test strip 1.

[0027] In this example, a drip port 16, an observation window 18, a first pressed portion 11, and a second pressed portion 12 are provided at the top of the housing 9, which is formed by the cover member 10. As an example, these portions are integrally molded with the cover member 10. The drip port 16 is an opening for dripping a sample into the housing 9. A boss is provided on the edge of the drip port 16, facing upward. The observation window 18 is a window for observing the test region L1 from the outside, and is formed of a transparent member, as an example. In this example, the size of the observation window 18 is such that in addition to the test region L1, a control region L2 and a color-developing region L3, which will be described later, can also be observed.

[0028] The first pressed portion 11 is an operating portion that is operated to supply the first reagent 41 (see FIG. 4) in the first reagent holding portion 40 to the carrier 2. The second pressed portion 12 is an operating portion that is operated to supply the second reagent 46 in the second reagent holding portion 45 to the carrier 2. As will be described later, the first reagent 41 and the second reagent 46 are amplification agents that amplify the color development in the test region L1 when the sample 50 is positive.

[0029] When a pressing force is applied to the first pressure-receiving portion 11 from the outside as an external force, the first pressure-receiving portion 11 is deformed. As an example, the first pressure-receiving portion 11 has a quadrangular pyramid shape, and when a pressing force is applied from above to a region including the apex of the quadrangular pyramid, the apex of the quadrangular pyramid is deformed so that it sinks into the housing 9. When the first pressure-receiving portion 11 is deformed in this manner, a pressing force is applied to the first reagent holding portion 40 inside the housing 9. The first reagent holding portion 40 is deformed by the pressing force applied through the first pressure-receiving portion 11. Due to this deformation, the first reagent 41 held in the first reagent holding portion 40 is supplied to the test strip 1.

[0030] Furthermore, it is preferable that the first pressed portion 11 maintains its deformed state after being deformed by pressing. The reason for this is as follows: As will be described later, the testing device 110 of this example can be loaded with a cartridge 100 in which the first pressed portion 11 has been pressed in advance by the user. If the first pressed portion 11 is pressed by the user before loading into the testing device 110, it is easier to continue supplying the first reagent 41 if the deformation of the first pressed portion 11 is maintained even after the user releases their hand.

[0031] Similarly, when a pressing force is applied to the second pressed portion 12 from the outside as an external force, the second pressed portion 12 is deformed. Like the first pressed portion 11, the second pressed portion 12 in this example also has a quadrangular pyramid shape, and when a pressing force is applied from above to a region including the apex of the quadrangular pyramid, the apex of the quadrangular pyramid is deformed so that it sinks into the housing 9. When the second pressed portion 12 is deformed in this manner, a pressing force is applied to the second reagent holding portion 45 inside the housing 9. The second reagent holding portion 45 is deformed by the pressing force applied through the second pressed portion 12. Due to this deformation, the second reagent 46 held in the second reagent holding portion 45 is supplied to the test strip 1. The second pressed portion 12 in this example is provided with an abutting portion 12b that abuts against the second reagent holding portion 45 (see FIGS. 6 and 7).

[0032] The testing device 110 of this example is capable of selecting from a plurality of testing flows, as will be described later. When selecting a testing flow in which the testing device 110 supplies the second reagent 46 from among the testing flows selectable by the testing device 110, the second pressable portion 12 is pressed by an internal mechanism of the testing device 110. Therefore, it is sufficient that the second pressable portion 12 can be pressed by the internal mechanism. When selecting a testing flow in which the cartridge 100 is loaded into the testing device 110 after the first reagent 41 and the second reagent 46 have been supplied, it is preferable that the cartridge 100 is configured so that the second pressable portion 12 can also be pressed by the user.

[0033] As shown in Figures 3 and 4, a test strip 1 including a carrier 2 is housed in the case member 20 along the longitudinal direction. A first reagent holding section 40 is arranged in the case member 20 at one end side in the longitudinal direction (the upstream side as shown in Figure 4). A first container section 24 having a recessed shape that matches the shape of the first reagent holding section 40 is formed in the case member 20 at the portion where the first reagent holding section 40 is arranged. One end of the test strip 1 is located above the first reagent holding section 40 when housed in the first container section 24.

[0034] The first reagent holding unit 40 holds a first reagent 41. The first reagent holding unit 40 is made of, for example, a resin material and is configured with a container 42 having an opening on one side and a rupturable sheet member 43 covering the opening of the container 42. The container 42 is filled with the first reagent 41, and the opening of the container 42 is sealed with the sheet member 43. The first reagent holding unit 40 is disposed in the first storage unit 24 with the sheet member 43 facing upward. The pressing force applied by the first pressed portion 11 is transmitted to the sheet member 43 of the first reagent holding unit 40 via the end of the test strip 1, causing the sheet member 43 to rupture (see FIGS. 6 and 7). The rupture of the sheet member 43 allows the first reagent 41 to be supplied to the test strip 1. In this example, the first pressed portion 11 is provided with a protrusion 11b that abuts against the sheet member 43 (see FIGS. 6 and 7). The protrusions 11b have, for example, an elongated shape extending longitudinally in the width direction of the test strip 1 and a pointed tip toward the sheet member 43 so as to easily break the sheet member 43.

[0035] The cartridge 100 also includes a multifunctional member 30 that has the function of accommodating a second reagent holding portion 45. The multifunctional member 30 is disposed on the other end side (the downstream side in FIG. 4 ) of the case member 20 and above the test strip 1. The multifunctional member 30 is a member in which a second storage portion 32 and a flow path forming portion 35 are integrally formed. The second storage portion 32 is a portion that accommodates the second reagent holding portion 45. The second storage portion 32 has a box-like shape with an open top. As shown in FIG. 4 , the bottom of the second storage portion 32 is formed with a protrusion 34 for breaking a sheet member 48 (described later) of the second reagent holding portion 45, and an opening 33 for allowing the second reagent 46 flowing out of the second reagent holding portion 45 to flow toward the carrier 2.

[0036] The flow path forming section 35 is provided adjacent to the second storage section 32 toward the upstream side. The flow path forming section 35 is flat and disposed in a position facing the test region L1, etc. in the longitudinal direction of the carrier 2, with a gap between it and the carrier 2. The flow path forming section 35 forms a flow path between itself and the carrier 2, which allows the second reagent 46 flowing out of the second storage section 32 toward the test region L1, etc. In this way, the flow path forming section 35 is disposed between the observation window 18 and the test region L1, etc. of the carrier 2. For this reason, the flow path forming section 35 is formed of a transparent member, so that the test region L1, etc. can be observed through the observation window 18.

[0037] The second reagent holding unit 45 holds a second reagent 46. The second reagent holding unit 45 is made of, for example, a resin material and is composed of a container 47 having an opening on one side, and a breakable sheet member 48 that covers the opening of the container 47. The container 47 is filled with the second reagent 46, and the opening of the container 47 is sealed with the sheet member 48. The second reagent holding unit 45 is placed in the second storage unit 32 with the sheet member 48 facing downward. This causes the sheet member 48 to face the protrusion 34 in the second storage unit 32.

[0038] The pressing force applied from the second pressed portion 12 to the second reagent holding portion 45 acts in a direction pressing the second reagent holding portion 45 downward, thereby pressing the sheet member 48 against the protrusion 34. When the sheet member 48 is pressed against the protrusion 34, the sheet member 48 is broken (see FIGS. 6 and 7). When the sheet member 48 is broken, the second reagent 46 is supplied to the carrier 2 through the flow path formed by the opening 33 at the bottom of the second storage portion 32 and the flow path forming portion 35.

[0039] As shown in FIG. 4, a gap (clearance) 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 member 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 out from the opening 33 at the bottom of the second storage section 32 toward the carrier 2, and the flowed-out second reagent 46 flows through the flow path formed by the gap D and reaches at least above the test region L1. The second reagent 46 that has reached the test region L1 permeates from the flow path into the test region L1.

[0040] An absorbent pad 6, which will be described later, is disposed at the downstream end of the test strip 1. A support section 22 that supports the end of the test strip 1 including the absorbent pad 6 is formed in the case member 20 at a position facing the absorbent pad 6. A second housing section 32 of the multifunctional member 30 is disposed above the absorbent pad 6. The support section 22 also supports the multifunctional member 30 via the absorbent pad 6. The case member 20 also has a support section 21 that supports the center of the test strip 1.

[0041] The test strip 1 includes a carrier 2, a liquid delivery pad 4, and an absorbent pad 6. The carrier 2 is fixed and supported on a back adhesive sheet 7.

[0042] The carrier 2 is a porous, insoluble carrier for developing the sample, and includes a test region L1, a control region L2, and a color-developing region L3. The carrier 2 also includes a label-retaining pad 3. The label-retaining pad 3 forms the spotting region where the sample is applied. When the direction from the spotting region toward the test region L1 is considered the downstream side of the carrier 2, the color-developing region L3 is located downstream of the test region L1. In this example, the test region L1, the control region L2, and the color-developing region L3 are each linear regions extending in a direction perpendicular to the direction in which the sample is developed on the carrier 2.

[0043] Although the test region L1, control region L2, and color-developing region L3 are shown as lines, they are not always visible. As will be described in detail later, before the sample 50 (see FIG. 5), first reagent 41 (see FIG. 4), and second reagent 46 (see FIG. 4) are developed, the colors of the test region L1 and control region L2 are nearly the same as the color of the carrier 2 (e.g., white), and therefore the test region L1 and control region L2 cannot be clearly seen at this stage. The test region L1 appears as a line when the sample 50 is developed, and if the developed sample 50 is positive, the color density increases. This makes the test region L1 visible. The color of the test region L1 is amplified by silver amplification, which will be described later, and the test region L1 turns black.

[0044] When the sample 50 is developed, the color density of the control region L2 increases, and the control region L2 appears as a line. This makes the control region L2 visible. The color of the control region L2 is also amplified by silver, so the control region L2 also turns black.

[0045] On the other hand, only color-developing region L3 appears as a blackish dark green (hereinafter referred to as dark green) line and is visible even before the first reagent 41 is developed. However, once the first reagent 41 is developed, color-developing region L3 changes color from dark green to orange, and appears as an orange line.

[0046] For example, a porous material such as a nitrocellulose membrane can be used as the carrier 2. The back adhesive sheet 7 to which the carrier 2 is fixed is a sheet-like substrate whose surface to which the carrier 2 is attached is an adhesive surface.

[0047] As shown in Figure 5, a labeling substance 53 is immobilized on the label-retaining pad 3. The labeling substance 53 is modified with a first binding substance 52 that specifically binds to an analyte 51 contained in a specimen 50. The label-retaining pad 3 is fixed on the carrier 2 at a position facing the drip opening 16 of the cover member 10. Therefore, the specimen 50 is dripped onto the label-retaining pad 3 from the drip opening 16. Therefore, the label-retaining pad 3 corresponds to a deposition area where the specimen 50 is deposited.

[0048] The label holding pad 3 is fixed at approximately the center position in the longitudinal direction of the carrier 2. For example, gold colloid particles (EM.GC50, manufactured by BBI) with a diameter of 50 nm can be used as the labeling substance 53. The labeling substance 53 is not limited to gold colloids; metal sulfides that can be used in ordinary chromatography, colored particles used in immune agglutination reactions, etc. can also be used, with metal colloids being particularly preferred. Metal colloids include gold colloids, silver colloids, platinum colloids, iron colloids, aluminum hydroxide colloids, and composite colloids of these. Gold colloids are particularly preferred because they are red and silver colloids are yellow at appropriate particle sizes, with gold colloids being the most preferred.

[0049] As shown in FIG. 5 , the test region L1 contains a second binding substance 56 that specifically binds to the analyte 51 and captures the analyte 51. When the second binding substance 56 binds to the analyte 51 in the test region L1, the analyte 51 is captured, and the first binding substance 52 and labeled substance 53 bound to the analyte 51 are also captured. If the specimen 50 contains the analyte 51, the analyte 51 and labeled substance 53 are captured in the test region L1, and the color density of the test region L1 increases to a predetermined standard or higher. The test region L1 is a region for confirming the presence or absence of the analyte 51 based on a labeled signal from the labeled substance 53 captured via the analyte 51. Note that the number of analyte 51 detected with one cartridge 100 is not limited to one, and a plurality of test regions L1 may be provided to simultaneously detect multiple different analytes 51. When the multiple test areas L1 include, for example, a first test area L1A and a second test area L1B (see Figure 9), the first test area L1A contains a second binding substance 56 that specifically binds to a first test substance 51, and the second test area L1B contains a second binding substance 56 that specifically binds to a second test substance 51 different from the first test substance 51.

[0050] The control region L2 contains a third binding substance 58 that specifically binds to the first binding substance 52 and captures the labeled substance 53 via the first binding substance 52. When a sample 50 is deposited on the label holding pad 3, the labeled substance 53 modified with the first binding substance 52 and not bound to the analyte 51 also develops within the carrier 2 toward the test region L1 along with the sample 50. The labeled substance 53 not bound to the analyte 51 passes through the test region L1 without being captured in the test region L1. The labeled substance 53 that has passed through the test region L1 is captured in the control region L2 via the first binding substance 52 as a result of the first binding substance 52 binding to the third binding substance 58. The capture of the labeled substance 53 in the control region L2 causes the color density of the control region L2 to increase above a predetermined standard. The control region L2 is a region for confirming the completion of the development of the sample 50 based on a label signal from the labeled substance 53 captured via the first binding substance 52. Therefore, the control region L2 is sometimes called a confirmation region.

[0051] The first binding substance 52 that modifies the labeling substance 53 and specifically binds to the test substance 51 is a substance that specifically binds to the test substance 51, such as, for example, an antibody against the antigen if the test substance 51 is an antigen, an antigen against the antibody if the test substance 51 is an antibody, or an aptamer against the protein, low molecular weight compound, etc. if the test substance 51 is a protein, low molecular weight compound, etc.

[0052] The second binding substance 56 that is immobilized in the test region L1 and that specifically binds to the test substance 51 is, for example, an antibody for the antigen if the test substance 51 is an antigen, an antigen for the antibody if the test substance 51 is an antibody, or an aptamer for the protein, low molecular weight compound, etc. if the test substance 51 is a protein, low molecular weight compound, etc. The first binding substance 52 and the second binding substance 56 may be the same or different.

[0053] The third binding substance 58 that specifically binds to the first binding substance 52 may be the test substance 51 itself, or a compound having a site recognized by the first binding substance 52, such as a compound in which a derivative of the test substance 51 is bound to a protein.

[0054] For example, when the test substance 51 is influenza A virus or a biomarker thereof, an anti-influenza A monoclonal antibody (Anti-Influenza A SPTN-5 7307, manufactured by Medix Biochemica) can be used as the first binding substance 52 and the second binding substance 56, and an anti-mouse IgG antibody (anti-mouse IgG(H+L), rabbit F(ab')2, product number 566-70621, manufactured by Wako Pure Chemical Industries, Ltd.) can be used as the third binding substance 58.

[0055] The color-developing region L3 contains a substance that changes color upon reaction with the first reagent 41. The color-developing region L3 reacts with the first reagent 41 to develop color or change color, indicating that the first reagent 41 has spread to that region. For example, when a mixed aqueous solution of iron nitrate and citric acid (manufactured by Wako Pure Chemical Industries, Ltd., 038-06925) is used as the first reagent 41, a preferred embodiment is one in which the color-developing region L3 is formed by a color-reagent immobilization line in which bromocresol green (manufactured by Wako Pure Chemical Industries, Ltd.) is immobilized in a linear fashion. This embodiment is the embodiment of the color-developing region L3 in this example. As described above, the color-developing region L3 in this example is dark green before reacting with the first reagent 41 and changes to orange when the first reagent 41 reaches the color-developing region L3. The color-developing region L3 is sometimes called an amplification indicator region because the change in color state indicates the timing at which the first reagent 41 is developed and the second reagent 46 is supplied.

[0056] The liquid delivery pad 4 is disposed in contact with one end of the carrier 2, and delivers the first reagent 41 to the carrier 2 from the upstream side of the spotting area (formed by the label holding pad 3). When the first pressed portion 11 is pressed, one end of the liquid delivery pad 4 is immersed in the first reagent holding portion 40. The liquid delivery pad 4 is formed from a porous material, absorbs the first reagent 41, and delivers the absorbed first reagent 41 to the carrier 2 by capillary action.

[0057] The absorbent pad 6 is disposed in contact with the other end of the carrier 2, and absorbs the specimen 50, the first reagent 41, and the second reagent 46 developed on the carrier 2. The absorbent pad 6 is also formed of a porous material.

[0058] In this embodiment, the first reagent 41 and the second reagent 46 are amplification agents that react with each other to amplify the color development in the test region L1 and the control region L2. When a metal-based labeled substance such as gold colloid is used as the labeled substance 53, as in this example, silver amplification is used, for example, as a method for amplifying the labeled signal of the labeled substance 53. The first reagent 41 and the second reagent 46 are amplification agents used in silver amplification, for example, and the reaction of the first reagent 41 and the second reagent 46 with the labeled substance 53 as a catalyst is an amplification reaction. The amplification reaction produces silver particles 60 (see FIG. 5) that are relatively larger in particle size than the labeled substance 53.

[0059] More specifically, in this example, the first reagent 41 is a reducing agent that reduces silver ions, and the second reagent 46 is silver ions. When the first reagent 41, which is a reducing agent, and the second reagent 46, which is silver ions, are brought into contact with the labeled substance 53, silver particles 60 (see FIG. 5) are generated, and the generated silver particles 60 deposit on the labeled substance 53, using the labeled substance 53 as a nucleus. The deposition of the silver particles on the labeled substance 53 generates silver particles 60 (see FIG. 5) that are larger in particle size than the labeled substance 53. This amplifies the labeled signal emitted by the labeled substance 53, and as a result, the color development of the labeled substance 53 is amplified in the test region L1 and the control region L2.

[0060] (First Reagent) The reducing agent in the first reagent 41 can be any inorganic or organic material or mixture thereof, as long as it can reduce the silver ions used in the second reagent 46 to silver. The inorganic reducing agent is Fe 2+ , V 2+ Or Ti 3+ Preferred examples of reducing metal salts and reducing metal complex salts are those whose valence can be changed by metal ions such as Fe. When using inorganic reducing agents, it is necessary to form a complex or reduce the oxidized ions, thereby removing or rendering them harmless. For example, Fe 2+ In systems using ethylenediaminetetraacetic acid (EDTA) as a reducing agent, the oxide Fe is reduced using citric acid or EDTA (ethylenediaminetetraacetic acid). 3+ In this system, it is preferable to use such an inorganic reducing agent, and more preferably Fe 2+ Metal salts of the formula are preferred.

[0061] Developing agents used in wet silver halide photographic light-sensitive materials (e.g., methyl gallate, hydroquinone, substituted hydroquinones, 3-pyrazolidones, p-aminophenols, p-phenylenediamines, hindered phenols, amidoximes, azines, catechols, pyrogallols, ascorbic acid (or its derivatives), and leuco dyes), as well as other materials obvious to those skilled in the art, such as those described in U.S. Pat. No. 6,020,117, can also be used.

[0062] Ascorbic acid reducing agents are also preferred as reducing agents. Useful ascorbic acid reducing agents include ascorbic acid, analogs, isomers, and derivatives thereof. Examples of preferred ascorbic acid reducing agents include D- or L-ascorbic acid and its sugar derivatives (e.g., γ-lactoascorbic acid, glucoascorbic acid, fucoascorbic acid, glucoheptoascorbic acid, and maltoascorbic acid), sodium ascorbic acid, potassium ascorbic acid, isoascorbic acid (or L-erythroascorbic acid), salts thereof (e.g., alkali metal salts, ammonium salts, or salts known in the art), enediol-type ascorbic acid, enaminol-type ascorbic acid, and thioenol-type ascorbic acid. D, L, or D,L-ascorbic acid (and its alkali metal salts) or isoascorbic acid (or its alkali metal salts) are particularly preferred, with sodium salts being the preferred salts. Mixtures of these reducing agents can be used if necessary.

[0063] (Second reagent) The solution containing silver ions used as the second reagent 46 is preferably one in which a silver ion-containing compound is dissolved in a solvent. The silver ion-containing compound can be an organic silver salt, an inorganic silver salt, or a silver complex. Preferably, it is an inorganic silver salt or a silver complex. As the inorganic silver salt, a silver ion-containing compound that is highly soluble in a solvent such as water can be used, such as silver nitrate, silver acetate, silver lactate, silver butyrate, or silver thiosulfate. Silver nitrate is particularly preferred. As the silver complex, a silver complex coordinated with a ligand having a water-soluble group such as a hydroxyl group or a sulfonic acid group is preferred, such as silver hydroxythioether.

[0064] <Immunochromatography> The immunochromatography method will be described with reference to Fig. 5. Here, the description will be given on the assumption that the specimen 50 contains the test substance 51, that is, the specimen 50 is positive.

[0065] First, a sample 50 is spotted onto the label holding pad 3, which is the spotting area (step S1). The test substance 51 in the sample 50 spotted on the label holding pad 3 specifically binds to a first binding substance 52 that modifies a label substance 53 contained in the label holding pad 3. The sample 50 is developed downstream from the label holding pad 3 within the carrier 2 due to capillary action in the carrier 2. Some of the sample 50 is also developed upstream. Arrow S indicates the state of the sample 50 as it is being developed.

[0066] Next, the first reagent 41 is supplied (step S2). The first reagent 41 is supplied from the liquid supply pad 4 side. The first reagent 41 is supplied to the carrier 2 via the liquid supply pad 4 and developed downstream.

[0067] Thereafter, the process waits until the first reagent 41 is developed downstream (steps S3-S4). "Wait" in Fig. 5 means waiting. The first reagent 41 is gradually developed downstream, and the specimen 50 and the labeled substance 53 modified with the first binding substance 52 that are being developed from the label holding pad 3 are developed downstream as if pushed by the first reagent 41 (step S3).

[0068] The analyte 51 in the specimen 50 that has developed downstream and reached the test region L1 is captured by the second binding substance 56 in the test region L1. That is, the labeled substance 53 is captured in the test region L1 via the analyte 51 and the first binding substance 52. On the other hand, the labeled substance 53 that has not bound to the analyte 51 passes through the test region L1 without being captured, and is captured by the third binding substance 58 in the control region L2.

[0069] As the development of the first reagent 41 progresses and the first reagent 41 reaches the color-developing region L3 (step S4), the color-developing region L3 reacts with the first reagent 41 and changes color. In this example, the color-developing region L3 is dark green before reacting with the first reagent 41, and changes color to orange upon reacting with the first reagent 41.

[0070] After the first reagent 41 has been sufficiently developed, 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 color-developing region L3 and is developed upstream. Here, the first reagent 41 is a first amplification liquid containing a reducing agent that reduces silver ions, and the second reagent 46 is a second amplification liquid containing silver ions. The first amplification liquid and the second amplification liquid react with each other to produce silver particles 60 using gold colloid particles, which are the labeling substance 53, as a catalyst. This amplifies the labeling signal (step S6).

[0071] 6 and 7 are partially cutaway side views of the inspection device 110 in a state where the cartridge 100 is loaded. The configuration and function of the inspection device 110 will be described below with reference to FIGS.

[0072] The testing device 110 of this example can select from the following three testing flows: a first testing flow, a second testing flow, and a third testing flow. In any of the first to third testing flows, the specimen 50 must be applied to the carrier 2 of the cartridge 100 before loading.

[0073] The first testing flow is a flow for testing the cartridge 100 in a state where, before loading, application of the sample 50 and supply of the first reagent 41 have started. In the case of the first testing flow, after loading the cartridge into the testing device 110, of the first reagent 41 and the second reagent 46, only supply of the second reagent 46 to the carrier 2 is performed by the testing device 110.

[0074] The second testing flow is a flow for testing the cartridge 100 to which only the sample 50 has been applied before loading. In the case of the second testing flow, after the cartridge is loaded into the testing device 110, both the first reagent 41 and the second reagent 46 are supplied to the carrier 2 by the testing device 110.

[0075] The third testing flow is a flow for testing the cartridge 100 in a state where, before loading, application of the sample 50, supply of the first reagent 41, and supply of the second reagent 46 have already started. In the case of the third testing flow, after loading the cartridge into the testing device 110, the first reagent 41 and the second reagent 46 are not supplied to the testing device 110.

[0076] In the following, the configuration of the inspection device 110 will be described, and then the first inspection flow will be described.

[0077] (Configuration of inspection device 110) As shown in FIGS. 6 and 7 , the testing device 110 has, as its internal mechanisms, a first reagent supply mechanism 116 and a second reagent supply mechanism 118. The first reagent supply mechanism 116 is a mechanism for starting the supply of the first reagent 41 from the first reagent holding unit 40 to the carrier 2. The first reagent supply mechanism 116 uses an actuator such as a solenoid that includes an electromagnet and a plunger that is movable relative to the electromagnet. For example, as the plunger moves, the plunger comes into contact with the first pressed portion 11 and presses the first pressed portion 11. The first reagent supply mechanism 116 is disposed in a position facing the first pressed portion 11 of the loaded cartridge 100.

[0078] The first reagent supply mechanism 116 is a pressing mechanism that applies a pressing force to the first pressed portion 11 of the cartridge 100 from the outside by pressing the first pressed portion 11. When the first reagent supply mechanism 116 applies a pressing force to the first pressed portion 11, the first reagent 41 is supplied from the first reagent holding portion 40 to the carrier 2 by the above-mentioned action. The first reagent supply mechanism 116 is not used in the first and third testing flows, and is used only in the second testing flow.

[0079] The second reagent supply mechanism 118 is a mechanism for starting the supply of the second reagent 46 from the second reagent holding portion 45 to the carrier 2. Like 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 disposed at a position facing the second pressure-receiving portion 12 of the loaded cartridge 100. The second reagent supply mechanism 118 is a pressing mechanism that applies a pressing force to the second pressure-receiving portion 12 from the outside by pressing the second pressure-receiving portion 12 of the cartridge 100. When the second reagent supply mechanism 118 applies a pressing force to the second pressure-receiving portion 12, the second reagent 46 is supplied from the second reagent holding portion 45 to the carrier 2 by the above-mentioned action. The second reagent supply mechanism 118 is not used in the third testing flow, and is used only in the first and second testing flows.

[0080] The testing device 110 includes, in addition to a loading unit 112, a first reagent supply mechanism 116, and a second reagent supply mechanism 118, an imaging unit 114, a processor 120, and a memory 121 within a housing 111. In FIG. 6, the processor 120 and the memory 121 are shown outside the housing 111 of the testing device 110, but this is a schematic diagram and they are actually arranged within the housing 111.

[0081] The imaging section 114 captures an image of the observation area including at least the test area L1 and the control area L2, and outputs the observation image of the observation area to the processor 120. It is more preferable that the observation area includes a color-developing area L3.

[0082] The imaging unit 114 is 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 disposed, for example, at a position facing the observation window 18. The imaging unit 114 captures an image of a predetermined range centered on the observation window 18 and including its surroundings. The captured image captured by the imaging unit 114 includes the observation region 68 (see FIG. 8 ) exposed through the observation window 18, such as the test region L1, the control region L2, and the color-developing region L3. The captured image is then output from the imaging unit 114 to the processor 120.

[0083] As an example, light sources 115 such as light emitting diodes are provided on both sides of the imaging unit 114 to illuminate the test area L1, the control area L2, and the color-developing area L3 during imaging.

[0084] The processor 120 comprehensively controls each unit of the inspection device 110. An example of the processor 120 is a CPU (Central Processing Unit) that performs various controls by executing a program. By executing the program, the CPU functions as a control unit having 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 abnormality determination unit 127, and a timer 128. The memory 121 is an example of a memory connected to or built into the CPU as the processor 120. For example, a control program is stored in the memory 121. The processor 120 is realized by the CPU executing the control program.

[0085] The image capturing unit control unit 122 controls the image capturing timing of the image capturing unit 114 .

[0086] The first reagent supply mechanism control section 124 controls the first reagent supply mechanism 116 to operate and press the first pressed section 11.

[0087] The second reagent supply mechanism control section 125 controls the second reagent supply mechanism 118 to operate and press the second pressed section 12 based on the change in the coloring state of the coloring region L3.

[0088] The coloring state determination unit 123 executes a coloring region determination process, a control region determination process, and an inspection region determination process based on the captured image acquired via the imaging unit 114. As described above, the imaging unit 114 outputs a captured image of the observation region 68, which includes the inspection region L1, the control region L2, and the coloring region L3. The coloring state determination unit 123 executes each of the above determination processes based on the captured image.

[0089] The color region determination process is a process for determining, based on the captured image, whether or not the color state of the color region L3 has changed, for example, from the dark green color before the reaction with the first reagent 41 to orange. A "yes" change in the color state means that the first reagent 41 has spread to the color region L3.

[0090] In addition, "change in color state" includes any of the following: a change from a first color different from the color of carrier 2 to a different second color (i.e., discoloration); a change in the color of carrier 2 to a different color due to the development of a color different from carrier 2 (i.e., color development); and a change in the color density (i.e., density change).

[0091] The processor 120 operates the second reagent supply mechanism 118 via the second reagent supply mechanism control unit 125 when the coloring state determination unit 123 determines that the coloring state of the coloring region L3 has changed.

[0092] The control area discrimination process is a process for discriminating whether or not there is a change in the color development state of the control area L2 based on the captured image. In this example, a line appears in the control area L2 when the labeling substance 53 is captured in the control area L2 or when the captured labeling substance 53 is amplified by silver after capture, and the presence or absence of the line development in the control area L2 is discriminated. If the color development state discriminator 123 determines that the color development state of the control area L2 has changed, i.e., that there is development in the control area L2, the next process, the test area discrimination process, is executed.

[0093] The test area discrimination process is a process for discriminating whether or not there is a change in the color development state of the test area L1 based on the captured image. In this example, a line appears in the test area L1 when the labeling substance 53 is captured in the test area L1 or when silver is amplified after capture, and therefore, whether or not there is a line in the test area L1 is discriminated as whether or not there is a change in the color development state. If a line appears in the test area L1, it means that the specimen 50 is positive, and if no line appears, it means that the specimen 50 is negative. The discrimination of whether or not there is a change in the color development state of the test area L1 in this test area discrimination process corresponds to the main determination of whether the specimen 50 is positive or negative.

[0094] The abnormality determination unit 127 performs an abnormality determination to determine whether or not there is an abnormality in the inspection area image. Specifically, the abnormality determination unit 127 performs the abnormality determination using at least one of the following as a determination index: a difference in pixel values ​​between a relatively large pixel value and a relatively small pixel value in at least one column in the inspection area image; a standard deviation of pixel values ​​of pixels included in at least one column in the inspection area image; or a coefficient of variation based on pixel values ​​of each column. The abnormality determination by the abnormality determination unit 127 may be performed before or after the main determination. Details of the method and process of the abnormality determination will be described later.

[0095] The processor 120 determines the processing content related to the main judgment based on the result of the abnormality judgment, i.e., the presence or absence of an abnormality. The processing content related to the main judgment includes, for example, at least one of whether to perform the main judgment and the direction of presentation of the main judgment result of the main judgment. Specifically, for example, if the processor 120 determines that an abnormality is present, the processor 120 terminates the processing without performing the main judgment, and determines that the main judgment is to be performed only if the processor 120 determines that an abnormality is not present. Furthermore, for example, if the processor 120 determines that an abnormality is present, the processor 120 presents the main judgment result as the test result with a reservation indicating that an abnormality is present, or presents a test result indicating a bad judgment without presenting the main judgment result. Furthermore, for example, if the processor 120 determines that no abnormality is present, the processor 120 determines that the main judgment result is to be presented as the test result as is. If the processor 120 determines that an abnormality is present, the processor 120 displays the test result as a "positive with reservation" or a "bad judgment" on the monitor 119 via the display control unit 126. Furthermore, if the processor 120 determines that there is no abnormality, it displays the test result such as "positive" on the monitor 119 via the display control unit 126.

[0096] The memory 121 stores not only a control program but also setting information that is preset so that the processor 120 can perform various controls. The setting information stores information required by the coloring state determination unit 123 to determine a change in the coloring state. Examples of the setting information include a first setting time t1, a second setting time t2, and a preset number of times K, which will be described later. The first setting time t1 is the waiting time until the processor 120 determines again whether or not there has been a change in the coloring state of the coloring region L3 if it determines that there has been no change in the coloring state of the coloring region L3. The second setting time t2 is the allowable time for the processor 120 to repeat the determination of whether or not there has been a change in the coloring state if it determines that there has been no change in the coloring state of the coloring region L3. The setting information also stores criteria for the processor 120 to determine whether or not there has been an abnormality.

[0097] Here, a method of abnormality determination by the abnormality determination unit 127 will be described with reference to FIGS.

[0098] First, an abnormality that may occur in the inspection area image will be described. Fig. 8 is a diagram schematically showing an observation image 61 and an inspection area image 62 acquired by cutting out an observation area 68 from a captured image output by the imaging unit 114.

[0099] The observation image 61 is an image in which a plurality of pixels are arranged two-dimensionally in a matrix, and the inspection area image 62 extracted from the observation image 61 is also an image in which a plurality of pixels are arranged two-dimensionally in a matrix. If the length direction of the carrier 2 is the X direction, which intersects with the X direction, and the length direction of the line of the inspection area L1 is the Y direction, the row direction refers to the X direction and the column direction refers to the Y direction. As shown in FIG. 8 as an example, the inspection area image 62 is composed of pixels arranged in a matrix of 8 rows and 6 columns. The processor 120 converts the signal value of each pixel of the captured image output by the imaging unit 114 into a digital pixel value ranging from 0 to 255. In FIG. 8, each pixel of the inspection area image 62 is indicated by its pixel value. The pixel value of the inspection area image 62 corresponds to, for example, the luminance corresponding to the amount of light incident on each pixel. Therefore, in the inspection area image 62, the higher the luminance, the larger the pixel value, and the lower the luminance, the smaller the pixel value. If the pixels of such an inspection area image 62 are expressed in terms of optical density (hereinafter simply referred to as density), the smaller the pixel value, the higher the density, and the larger the pixel value, the lower the density. Here, pixel values ​​and density values ​​can be converted using a preset conversion formula.

[0100] In the example observation image 61 shown in FIG. 8, the lower region of the test region L1 contains a region d with a locally high density (hereinafter referred to as a high-density region d). If the sample 50 is positive, the color density increases on average across almost the entire test region L1, resulting in the appearance of a line similar to that in the control region L2 of the observation image 61. In contrast, the high-density region d occurring partially within the test region L1 is presumed to be a region where the color density has increased due to nonspecific adsorption of the labeling substance. Such a high-density region d is an unnecessary stain that may induce an erroneous determination in the main judgment. The high-density region d may exhibit a density abnormally higher than the color density when the sample 50 is positive. Such a high-density region d has a small pixel value; for example, in the test region image 62 shown as an example in FIG. 8, it exhibits a pixel value of 130 or less. On the other hand, the other parts of the test region L1 exhibit pixel values ​​of 185 to 208.

[0101] As described above, the linear inspection area L1 is not expressed in the image 61 in Figure 8, but it does include a high-density area d. In such a case, if the main judgment is performed in a state that includes all of the pixels that make up the high-density area d, the high-density area d may result in a positive judgment despite the actual result being negative. The abnormality judgment unit 127 judges the presence or absence of an abnormality such as the high-density area d, which may cause an erroneous judgment in the main judgment, in such an inspection area L1.

[0102] Next, a specific method for determining an abnormality will be described. In Fig. 9, an observed image 74 shown in Fig. 9A and an observed image 75 shown in Fig. 9B (and Fig. 10) are each an example of an observed image, and Fig. 9C shows the displacement of pixel values ​​in one pixel column extracted from a first inspection region L1A of the observed image 74 in Fig. 9A and a second inspection region L1B of the observed image 75 in Fig. 9B.

[0103] While the observation image 61 is shown as a schematic diagram in FIG. 8, the observation images 74 and 75 in FIG. 9 are shown as actual images rather than as schematic diagrams for convenience. The observation image 61 shown in FIG. 8 and the observation images 74 and 75 shown in FIG. 9 are similar in that they are both images of the observation region. However, the configuration of the test region L1 and other elements is different between the observation region shown in the observation image 61 and the observation region shown in the observation images 74 and 75. That is, the observation image 61 shown in FIG. 8 includes three regions: the test region L1, the control region L2, and the color-developing region L3, whereas the observation images 74 and 75 shown in FIG. 9 include two regions: the first test region L1A and the second test region L1B, and the control region L2. That is, the cartridge shown here is a cartridge for testing for the presence or absence of two types of test substances.

[0104] In a cartridge for testing for the presence or absence of two types of test substances, the two types of test substances are, for example, influenza type A and influenza type B. In Figures 9A and 9B, the first test region L1A is a test region containing a capture antibody for influenza type A, and the second test region L1B is a test region containing a capture antibody for influenza type B. The width of the first test region L1A, the second test region L1B, and the control region L2 in the X direction is, for example, 1 mm, and the three regions, first test region L1A, second test region L1B, and control region L3, are arranged, for example, at intervals of 3 mm. Note that, below, when it is necessary to distinguish between multiple test regions L1, a subcode A or B will be added to the reference symbol for test region L1, and when there is no need to distinguish between them, they will simply be referred to as test region L1.

[0105] In the example observation image 74 shown in FIG. 9A, a line appears in the first inspection region L1A, but a line does not appear in the second inspection region L1B. On the other hand, in the observation image 75 shown in FIG. 9B, no line appears in either the first inspection region L1A or the second inspection region L1B, but there is a localized high-density area corresponding to a stain at the bottom of the second inspection region L1B in the observation image 75. When a localized high-density area appears in the inspection region, this indicates that an abnormality exists in the inspection region. The abnormality determination unit 127 determines whether or not there is an abnormality in the inspection region, i.e., whether or not there is a localized high-density area.

[0106] As described above, the observed image 74 and the observed image 75 are images in which a plurality of pixels are arranged two-dimensionally in a matrix. The relationship between the pixel values ​​of one pixel row a in the inspection area image showing the first inspection area L1A in Fig. 9A and the pixel positions in the Y direction, and the relationship between the pixel values ​​of one pixel row b in the inspection area image showing the second inspection area L1B in Fig. 9B and the pixel positions in the Y direction are shown in Fig. 9C.

[0107] As shown in FIG. 9C , the pixel values ​​of pixels included in pixel row b of the second inspection region L1B, which contains an abnormality in the observation image 75, fluctuate more than the pixel values ​​of pixels included in pixel row a of the first inspection region L1A, which contains no abnormality in the observation image 74. When the specimen 50 is positive and a normal line appears in the inspection region L1, the density of pixels in the inspection region L1 increases uniformly, as shown in pixel row a without an abnormality, and there is no significant difference in the pixel values ​​of pixels aligned in the Y direction. Similarly, when the specimen 50 is negative and no line appears in the inspection region L1, the density of pixels in the inspection region L1 does not change, and there is no significant difference in the pixel values ​​of pixels aligned in the Y direction. On the other hand, because localized high-density areas caused by nonspecific adsorption rarely occur uniformly in the Y direction, the fluctuation in pixel values ​​of pixels aligned in the Y direction (i.e., pixel value variation) is greater, as shown in pixel row b with an abnormality, than when no high-density areas exist.

[0108] Therefore, it is possible to determine whether or not an abnormality exists in the inspection area image using the magnitude of variation in pixel values ​​of pixels aligned in the Y direction in the inspection area image as a determination index. Examples of measures for measuring the magnitude of variation in pixel values ​​include the amount of pixel change in a pixel row, standard deviation, and coefficient of variation. Here, the amount of pixel change is the difference between a relatively high pixel value and a relatively low pixel value in the pixel row, and an example is the difference between the maximum and minimum values. However, the amount of change used as the determination index may be any difference between a relatively high pixel value and a relatively low pixel value within a range in which a difference sufficient to distinguish between the presence and absence of an abnormality is recognized. For example, the amount of change may be the difference between the second-largest and second-smallest pixel values ​​in the pixel row, or the difference between the third-largest and third-smallest pixel values.

[0109] Table 1 shows the results of calculating the amount of change (maximum value - minimum value), standard deviation, and coefficient of variation based on the pixel values ​​of the pixels that make up pixel row b in the inspection area L1 with an abnormality shown in Figure 9C and the pixels that make up pixel row a in the inspection area without an abnormality.

[0110] [Table 1]

[0111] As shown in Table 1, pixel row b, which has an abnormality, has a larger standard deviation, change amount, and coefficient of variation than pixel row a, which has no abnormality. Therefore, the presence or absence of an abnormality is determined using at least one of the standard deviation, change amount, and coefficient of variation as a determination index. As an example, when the standard deviation is used as the determination index, if the standard deviation is, for example, 8 or more, it is determined that there is an abnormality, and if it is less than 8, it is determined that there is no abnormality. When the change amount is used as the determination index, for example, it is determined that there is an abnormality if it is 20 or more, and if it is less than 20, it is determined that there is no abnormality. When the coefficient of variation is used as the determination index, for example, it is determined that there is an abnormality if it is 5% or more, and if it is less than 5%, it is determined that there is no abnormality. When the standard deviation and change amount are used as the determination index, for example, if the standard deviation is 8 or more and the change amount is 20 or more, it is determined that there is an abnormality, and if the standard deviation is less than 8 or the change amount is less than 20, it is determined that there is no abnormality. The numerical value that serves as the criterion for determining whether or not there is an abnormality (hereinafter referred to as the judgment criterion value TA) is a value that is appropriately determined depending on the test substance in question, the type of cartridge, the testing device, etc., and the preset value is stored in memory 121 as setting information.

[0112] As described above, at least one of the amount of change, standard deviation, and coefficient of variation for pixel values ​​of pixels included in one column (one pixel column) in the inspection area image representing the inspection area L1 is used as the judgment index. An arbitrary column may be extracted from the inspection area image as the pixel column used to calculate the judgment index, and the extracted column may be used for abnormality judgment. The extraction position is preferably a column near the center in the X direction of the inspection area image. This is because the difference between the presence and absence of an abnormality is often more pronounced near the center. Furthermore, the number of columns is not limited to one, and judgment indices may be calculated for multiple columns in the inspection area image, and an abnormality may be judged to exist if the judgment indices for all or a majority of the columns satisfy the judgment reference value TA.

[0113] Furthermore, the processor 120 may use, as the judgment index, at least one of the difference between a relatively large representative value and a relatively small representative value among the representative values ​​of each row derived based on multiple pixels existing in the same row but different columns in the inspection area image, and the standard deviation and the coefficient of variation based on the representative values ​​of each row. For example, as shown in FIG. 10, multiple columns are extracted from the inspection area image showing the second inspection area L1B in the observation image 75, and the average pixel value of multiple pixels existing in the same row but different columns is derived as the representative value. In FIG. 10, as an example, five pixel columns are extracted. Each column includes 15 rows of pixels. In FIG. 10, the numerical values ​​shown in each pixel of the pixels arranged in a matrix are pixel values. For example, the processor 120 derives the average value for each row of the five pixel columns and uses this average value as the representative value for each row. Using the example pixel values ​​in FIG. 9, for example, the representative value for the first row is (142 + 140 + 144 + 144) / 5 = 142. The representative values ​​for the 15 rows thus derived are regarded as one column, and at least one of the amount of change, standard deviation, and coefficient of variation is derived in the same manner as above and used as a judgment index.

[0114] In this way, by using at least one of the difference between a relatively large representative value and a relatively small representative value among the representative values ​​of each row derived based on multiple pixels existing in different columns in the same row, and the standard deviation and the coefficient of variation based on the representative values ​​of each row as the judgment index, it is possible to suppress noise and perform more accurate abnormality judgment compared to when the judgment index is obtained using a specific column in the inspection area.

[0115] The abnormality determination is performed by the above method. Note that, before determining whether or not there is an abnormality in the inspection area image corresponding to the inspection area L1, the processor 120 needs to extract the inspection area image from the observation images 74, 75 (see FIG. 9). The method for extracting the inspection area will be described below.

[0116] The processor 120 reads, for example, position information of the inspection area L1 in the observation image stored in advance in the memory 121 as setting information, identifies the inspection area L1 in the observation images 74 and 75, and extracts the inspection area image. The position information of the inspection area L1 is, for example, the distance from one end of the observation image.

[0117] As described above, extraction based on position information makes it possible to easily extract a detection image. However, due to individual differences in the cartridge 100, the position of the inspection area L1 in the observation images 74, 75 may be slightly misaligned. Therefore, when the inspection area L1 is extracted from the observation images 74, 75 based only on position information, a positional deviation from the actual inspection area L1 may occur. Therefore, it is preferable to derive a row-direction profile based on a representative value of each column in the observation images 74, 75, which are images in which a plurality of pixels are arranged two-dimensionally in a matrix, and to extract an inspection area image corresponding to the inspection area from the observation images based on the derived profile.

[0118] A method for extracting a detection area image using a profile will be described below. Processor 120 first derives a representative value for each column of the observed image. The method for deriving the representative value is not particularly limited. For example, for each column, the pixel value of a specific row included in that column may be used as the representative value, or the average or median of the pixel values ​​of two or more pixels included in that column may be used as the representative value.

[0119] The processor 120 creates a profile of pixel values ​​in the row direction (i.e., the X direction) using the derived representative values. FIG. 11 shows an example of a profile created from the observed image 70. In the profile using the representative values ​​of each column, the vertical axis represents the pixel value and the horizontal axis represents the pixel position in the X direction. The observed image 70, like the observed images 74 and 75 shown in FIGS. 9A and 9B, is an observed image obtained when an influenza test cartridge for testing two types of test substances is used. Like the observed images 74 and 75, the observed image 70 includes two test areas L1A and L1B and a control area L2.

[0120] In the observation image 70 shown in Figure 11, the control region L2 is clearly expressed as a line. The first inspection region L1A is also expressed as a line, though it is thinner than the control region L2. On the other hand, the second inspection region L1B is not expressed. The PA, PB, and PC regions in the profile shown in Figure 11 correspond to the first inspection region L1A, second inspection region L1B, and control region L2, respectively.

[0121] The processor 120 extracts an inspection region profile from the profile created using the representative values. Specifically, the processor 120 extracts an inspection region profile PA corresponding to the first inspection region L1A and an inspection region profile PB corresponding to the second inspection region L1B from the profile of FIG. 11. When extracting the inspection region profiles, the pixel value profile may be converted into a density profile, and then the first inspection region L1A and the second inspection region L1B may be extracted. High-density areas that form valleys in the pixel value profile represent peaks in the density profile. Therefore, the first inspection region L1A and the second inspection region L1B can be extracted by extracting the peaks from the density profile. For example, the processor 120 identifies the position of the first inspection region L1A by comparing the position information of the first inspection region L1A with the valley position (or peak position in the case of a density profile) of the inspection region profile PA shown in FIG. 11. The processor 120 then extracts an inspection region image from the identified position from the observed image 70. Position information of the first inspection region L1A and the second inspection region L1B in the observation image 70 is stored in advance as setting information in the memory 121. The setting information is, for example, the distance from one end of the observation image 70.

[0122] As described above, the processor 120 creates a profile (or density profile) of pixel values ​​and identifies the position of the inspection area L1 in the observation image by comparing the position of the valley (or peak) corresponding to the inspection area L1 extracted from the created profile with the position information of the inspection area L1. Therefore, the inspection area profile of the inspection area L1 can be extracted more accurately than when only one of the valley position and the position information of the profile is used. In this way, an abnormality determination is performed using an inspection area image extracted with high positional accuracy from the observation images 74 and 75, thereby improving the accuracy of the abnormality determination.

[0123] FIG. 12 shows the procedure for the abnormality determination performed by the processor 120.

[0124] In the procedure for determining an abnormality, the processor 120 first obtains the observed image 74 (or the observed image 75) by cutting out an observation area from the captured image output by the imaging unit 114 (step S61).

[0125] Next, the processor 120 extracts an inspection area image from the acquired observation image 74 (or observation image 75) (step S62). The method for extracting the inspection area image is as described above.

[0126] The processor 120 derives a determination index from the extracted inspection area image (step S63). As described above, for example, the processor 120 derives at least one of the amount of change, standard deviation, and coefficient of variation for pixel values ​​of pixels included in at least one column (one pixel column) in the inspection area image as the determination index. Alternatively, the processor 120 derives at least one of the difference between a relatively large representative value and a relatively small representative value among representative values ​​of each row derived based on multiple pixels existing in the same row but different columns in the inspection area image, or the standard deviation and coefficient of variation based on the representative values ​​of each row as the determination index.

[0127] The processor 120 determines whether the derived judgment index is equal to or greater than a preset judgment reference value TA (step S64). If the judgment index is equal to or greater than the judgment reference value TA (step S64: Yes), the processor 120 determines that an abnormality exists (step S65) and ends the abnormality judgment process. On the other hand, if the judgment index is less than the judgment reference value TA (step S64: No), the processor 120 determines that no abnormality exists (step S66) and ends the abnormality judgment process. The processing procedure for abnormality judgment by the processor 120 is as described above.

[0128] The procedure for immunochromatographic testing using the testing device 110 of this embodiment will be described with reference to Figures 13 and 14. Here, a first testing flow will be described in which the first reagent 41 is supplied by the user and the second reagent 46 is supplied by the testing device 110.

[0129] (First inspection flow) FIG. 13 is a diagram showing the first inspection flow. First, the user drips the specimen 50 onto the spotting area of ​​the carrier 2 from the drip port 16 of the cartridge 100 (step S11).

[0130] Next, the user presses the first pressed portion 11 of the cartridge 100 to start supplying the first reagent 41 (step S12).

[0131] Thereafter, the user loads the cartridge 100 into the loading section 112 of the inspection device 110, which is in a powered-on state (step S13).

[0132] In the inspection device 110, an inspection is carried out on the loaded cartridge 100 (step S14).

[0133] The time required for the first reagent 41 to fully develop the carrier 2 after the supply of the first reagent 41 begins varies for each cartridge, but generally takes about 5 to 10 minutes. The time required for the first reagent 41 to be loaded into the loading section 112 after the user presses the first pressed section 11 may be determined according to the user's convenience.

[0134] FIG. 14 shows a detailed inspection flow of the inspection performed by the inspection device 110 shown in FIG. 13 (step S14). When the cartridge 100 is loaded into the inspection device 110, inspection in the inspection device 110 (step S14 in FIG. 13) begins.

[0135] 14, in the testing device 110, the processor 120 first determines whether the color state of the color-producing region L3 has changed (specifically, from dark green to orange) (step S21). Specifically, the processor 120 turns on the light source 115 to illuminate the observation region 68 exposed through the observation window 18, and causes the imaging unit 114 to capture an image in this state. The processor 120 then acquires the captured image from the imaging unit 114 and determines whether the color state of the color-producing region L3 has changed from dark green to orange. If it is determined that the color state of the color-producing region L3 has changed, that is, if the color-producing region L3 has changed from dark green to orange, this means that the first reagent 41 has reached the color-producing region L3 and the test region L1 and control region L2 located upstream of it.

[0136] If the coloring state of the coloring region L3 has changed (step S21: Yes), the processor 120 activates the second reagent supply mechanism 118 to start supplying the second reagent 46 (step S22). In this embodiment, the processor 120 causes the second reagent supply mechanism 118 to press the second pressed portion 12 of the cartridge 100. When the second pressed portion 12 is pressed, the second pressed portion 12 is deformed so as to sink toward the second reagent holding portion 45. Due to this deformation, the sheet member 48 of the second reagent holding portion 45 is pressed against the protrusion 34 and breaks, and the second reagent 46 is supplied onto the carrier 2.

[0137] On the other hand, if the coloring state of the coloring region L3 has not changed (step S21: No), it is determined whether the time is within the second set time t2 (step S23).

[0138] Here, if the second set time t2 has been exceeded (step S23: No), the processor 120 notifies the user of an error (step S26) and ends the inspection flow. For example, the error is notified by displaying an error message on the monitor 119. Note that, as a method of notifying the user of an error, in addition to displaying the error message on the monitor 119, the error message may also be notified by voice.

[0139] On the other hand, if the time is within the second set time t2 (step S23: Yes), the process waits until the first set time t1 has elapsed (step S24). In step S24 of FIG. 14, this is indicated 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. Thereafter, the process returns to step S21, where it is determined whether the coloring state of the coloring region L3 has changed.

[0140] In step S22, the second reagent supply mechanism 118 is operated to start supplying the second reagent 46, and then the system waits until a preset third set time t3 has elapsed (step S27). In step S27 of Fig. 14, this is indicated as "t3 wait." The third set time t3 is, for example, about 3 minutes.

[0141] The processor 120 then determines whether a line has appeared in the control region L2 (step S28). Specifically, the processor 120, similar to step S21, causes the imaging unit 114 to capture an image of the observation region 68 while illuminating the observation region 68. The processor 120 then acquires the captured image from the imaging unit 114 and cuts out an observation image 61 of the observation region 68 from the acquired image. The processor 120 then determines a change in the color development state of the control region L2 in the cut-out observation image 61. For example, the processor 120 determines whether the color development density of the control region L2 has reached a density equal to or greater than a predetermined reference density, and if the density is equal to or greater than the reference density, determines that the control region L2 has appeared. If it is determined that the control region L2 has appeared, this means that the specimen 50 has reached the control region L2 and the test region L1 upstream thereof, and that silver has been amplified.

[0142] In determining whether the control region L2 is expressed in step S28, if the control region L2 is not expressed (step S28: No), an error is reported (step S26), and the test flow ends. Note that if the control region L2 is not expressed after the second reagent 46 is developed, there is a possibility that the specimen 50 has not been deposited.

[0143] On the other hand, in determining whether or not the control region L2 is expressed (step S28), if the control region L2 is expressed (step S28: Yes), the processor 120 performs a main judgment including an abnormality judgment and presents the test results based on the results of the main judgment including an abnormality judgment (step S31).

[0144] In step S31, the processor 120 performs a main determination of whether the specimen 50 is positive or negative. Specifically, the processor 120 determines whether the color density of the linear test area L1 reaches a predetermined standard or higher, and if the color density is equal to or higher than the standard, determines that the test area L1 is expressed. If the test area L1 is determined to be expressed, the specimen 50 is determined to be positive. If the test area L1 is determined to be not expressed, the specimen 50 is determined to be negative. Furthermore, as an abnormality determination, the processor 120 performs processing according to the abnormality determination processing procedure shown in FIG. 12 to determine the presence or absence of an abnormality in the test area image. In step S31, in a main determination involving an abnormality determination, the processor 120 may perform the abnormality determination before or after the main determination. Therefore, multiple processing procedures are possible for the processing procedure of step S31. Step S31 will be described in detail below. In the following, five examples of the processing procedure of step S31 will be given, and in order to distinguish between them, the five processing procedures will be referred to as a first example to a fifth example.

[0145] FIG. 15 shows a first example of the processing procedure of step S31.

[0146] As shown in FIG. 15, in a first example of step S31, the processor 120 first makes a main determination as to whether the sample 50 is positive or negative (step S71).

[0147] If the processor 120 determines that the result of the main judgment is negative (step S72: No), it displays "negative" as the test result on the monitor 119 without making an abnormality judgment, and ends the processing of step S31 in Fig. 14. On the other hand, if the processor 120 determines that the result of the main judgment is positive (step S72: Yes), it makes an abnormality judgment (step S73).

[0148] In the abnormality determination step S73, the processor 120 performs abnormality determination according to the abnormality determination processing procedure shown in FIG. 12, using the inspection area image extracted from the observation image acquired in the main determination step.

[0149] When the processor 120 determines that an abnormality is present as a result of the abnormality determination (step S75: Yes), the processor 120 displays "Positive with reservation" as the test result on the monitor 119 (step S76), and ends the processing of step S31 in Fig. 14. Here, "with reservation" means that a reservation has been made to indicate that there is an abnormality in the inspection area image. In other words, the display of "Positive with reservation" is intended to make the user aware that although the main determination is positive, there is a possibility of a false positive due to the presence of an abnormality in the inspection area L1.

[0150] In step S76, instead of displaying a test result of positive with a reservation, an error message of "bad judgment" may be displayed without displaying the test result. Also, in addition to "bad judgment," it may be indicated that there may be dirt in the test area. When a test result of positive with a reservation or bad judgment is displayed, the user can visually determine whether the test area is colored or not to confirm whether it is positive or negative, or can decide to perform a retest.

[0151] On the other hand, if the processor 120 determines that there is no abnormality as a result of the abnormality determination (step S75: No), it displays "positive" as the test result on the monitor 119 (step S77) and ends the processing of step S31 in Figure 14.

[0152] In the inspection device 110, the processor 120 performs a main judgment involving an anomaly judgment according to the above-described anomaly judgment processing procedure. Specifically, the processor 120 performs an anomaly judgment using, as a judgment index, the difference between a relatively large pixel value and a relatively small pixel value in at least one column in the inspection area image, and at least one of the standard deviation and the coefficient of variation based on the pixel values ​​of at least one column. Alternatively, the processor 120 performs an anomaly judgment using, as a judgment index, the difference between a relatively large representative value and a relatively small representative value among representative values ​​of each row derived based on multiple pixels existing in the same row but different columns in the inspection area image, and at least one of the standard deviation and the coefficient of variation based on the representative values ​​of each row. The processor 120 then determines the processing details for the main judgment based on the presence or absence of an anomaly. Therefore, the presence or absence of an anomaly in the inspection area L1 can be determined with high accuracy, and the processing details for the main judgment are determined based on the presence or absence of an anomaly, thereby providing more reliable inspection results.

[0153] In particular, in the first example of step S31 described above, the processor 120 first performs a main judgment, and if the judgment result of the main judgment is positive, performs an abnormality judgment, and the method of presenting the main judgment result as processing content related to the main judgment is changed based on the presence or absence of an abnormality. That is, when the main judgment result is positive, if there is no abnormality, the judgment result of the main judgment is presented as the test result as is (here, "positive" is displayed on the monitor 119), and if there is an abnormality, the judgment result of the main judgment is presented with a reservation indicating that there is an abnormality in the inspection area image (here, "positive with reservation" is displayed on the monitor 119). This makes it possible to present to the user whether the judgment result is sufficiently reliable or whether it may be a false positive, thereby increasing the reliability of the test results.

[0154] Fig. 16 shows a second example of the processing procedure of step S31. In Fig. 16, the same steps as those in the first example shown in Fig. 15 are denoted by the same step reference numerals, and detailed explanations thereof will be omitted.

[0155] The second example of step S31 differs from the second example in the processing that follows when the processor 120 makes a main determination (step S71) and determines that the result is negative (step S72: No). In the second example, even when the processor 120 makes a main determination (step S71) and determines that the result is negative (step S72: No), it still performs an abnormality determination (step S81). Then, when the processor 120 determines that there is an abnormality as a result of the abnormality determination in step S81 (step S82: Yes), it displays "Negative with reservation" on the monitor 119 (step S83) and ends the processing of step S31 in FIG. 14.

[0156] On the other hand, if the processor 120 determines that there is no abnormality as a result of the abnormality determination in step S81 (step S82: No), it displays "Negative" on the monitor 119 (step S84) and ends the processing of step S31 in FIG.

[0157] In the second example shown in Figure 16, an abnormality judgment is also performed to determine whether or not there is an abnormality in the inspection area image, and the processing content related to the main judgment is determined based on the presence or absence of an abnormality, so that more reliable inspection results can be presented.

[0158] 16, in particular, if the processor 120 determines that there is no abnormality (step S75: No and step S82: No), it presents the determination result of the main determination as the test result as is (here, it displays "positive" or "negative" on the monitor 119), and if it determines that there is an abnormality (step S75: Yes and step S82: Yes), it presents the determination result of the main determination with a reservation to the effect that there is an abnormality in the test area image (here, it displays "positive with reservation" or "negative with reservation" on the monitor 119). This makes it possible to present to the user whether the test result is sufficiently reliable or whether there is a possibility of a false positive, thereby increasing the reliability of the test result.

[0159] In the first example shown in Fig. 15 and the second example shown in Fig. 16, the main judgment is performed first, and then the abnormality judgment is performed. However, in step S31, the abnormality judgment may be performed first, and the main judgment may be performed later. Fig. 17 shows yet another example of the detailed processing procedure of step S31, and shows a third example in which the abnormality judgment is performed first and the main judgment is performed later.

[0160] 17, in the third example, the processor 120 first performs an abnormality determination (step S91). The processor 120 performs processing in accordance with the abnormality determination processing procedure shown in FIG.

[0161] Then, when the processor 120 determines that there is an abnormality in the abnormality determination (step S92: Yes), it displays "bad determination" on the monitor 119 without performing the main determination (step S93), and ends the processing of step S31 in Fig. 14. At this time, instead of or together with the display of "bad determination," it may be possible to display an explanation such as "There is dirt in the inspection area, so no main determination was made" on the monitor 119.

[0162] When the processor 120 determines that there is no abnormality in the abnormality determination (step S92: No), it performs a main determination (step S94). Note that when the main determination is performed after the abnormality determination, the observed image acquired in the abnormality determination step S91 is used.

[0163] If the processor 120 determines that the result of the main judgment is positive (step S95: Yes), it displays "positive" on the monitor 119 (step S96) and ends the processing of step S31 in Fig. 14. On the other hand, if the processor 120 determines that the result of the main judgment is negative (step S95: No), it displays "negative" on the monitor 119 (step S97) and ends the processing of step S31 in Fig. 14.

[0164] 17, an abnormality determination is performed, and after confirming that there is no abnormality, a main determination is performed, thereby improving the reliability of the inspection results. Furthermore, in the third example, if it is determined that there is an abnormality in the inspection area image, the inspection is terminated without further occupying the inspection device 110, thereby reducing the occupancy time of the inspection device 110.

[0165] As in the third example shown in Fig. 17, when the main judgment is made after the abnormality judgment, the main judgment may be made even if the abnormality judgment determines that an abnormality exists. Fig. 18 is an example showing the detailed processing procedure of step S31, and shows a fourth example where the abnormality judgment is made first and then determines that an abnormality exists. In Fig. 18, the same steps as in the third example shown in Fig. 17 are assigned the same step symbols, and detailed explanations will be omitted.

[0166] 18, in the fourth example, the processor 120 performs an abnormality determination (step S91), and even if it determines that an abnormality is present (step S92: Yes), it performs a main determination (step S103). Then, if the processor 120 determines that the result of the main determination in step S103 is positive (step S105: Yes), it displays "Positive with reservations" on the monitor 119. On the other hand, if the processor 120 determines that the result of the main determination in step S103 is negative (step S105: No), it displays "Negative" on the monitor 119. The other steps are the same as in the third example.

[0167] In addition, if the processor 120 judges the result of the main judgment in step S103 to be positive (step S105: Yes), instead of displaying "Positive with reservations" on the monitor 119, it may display an error message (here, display "Poor judgment" on the monitor 119) (step S106).

[0168] Fig. 19 shows an example of the detailed processing procedure of step S31, and shows a fifth example in which an abnormality determination is first performed and it is determined that an abnormality exists. In Fig. 19, the same steps as those in the third or fourth example are given the same step reference numerals, and detailed explanations thereof will be omitted.

[0169] 19, in the fifth example, the processor 120 performs an abnormality determination (step S91), and even if it determines that an abnormality is present (step S92: Yes), it performs a main determination (step S103). Then, if the result of the main determination in step S103 is determined to be negative (step S105: No), the processor 120 displays "Negative with reservation" on the monitor 119 (step S107). The other steps are the same as in the fourth example.

[0170] In the fourth example shown in FIG. 18 and the fifth example shown in FIG. 19, similarly to the third example shown in FIG. 17, the main judgment is made after confirming that there is no abnormality by abnormality judgment, thereby improving the reliability of the inspection results.

[0171] In the above-mentioned first to fifth examples, if the test result is a poor judgment or a judgment result with reservations, the user can visually check whether or not a line has appeared in the test area L1, or can take measures such as processing the test area L1 as a target for retesting.

[0172] In the above embodiment, the following various processors can be used as the hardware structure of the processing unit that executes various processes, such as the processor 120 and its internal components, such as the detection unit control unit 122, color development state determination unit 123, first reagent supply mechanism control unit 124, second reagent supply mechanism control unit 125, abnormality determination unit 127, and display control unit 126. As described above, the various processors include a CPU, which is a general-purpose processor that executes software to function as various processing units, as well as dedicated electrical circuits, such as a programmable logic device (PLD), a processor whose circuit configuration can be changed after manufacture, such as an FPGA (Field Programmable Gate Array), and an ASIC (Application Specific Integrated Circuit), which is a processor having a circuit configuration designed specifically for executing specific processes.

[0173] A single processing unit may be configured with one of these various processors, or may be configured with 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). Also, multiple processing units may be configured with a single processor.

[0174] An example of configuring multiple processing units with one processor is a form in which one processor is configured by combining one or more CPUs and software, and this processor functions as multiple processing units. Secondly, there is a form in which a processor is used that realizes the functions of the entire system including multiple processing units with a single IC (Integrated Circuit) chip, as typified by a System on Chip (SoC). In this way, various processing units are configured using one or more of the above various processors as a hardware structure.

[0175] Furthermore, more specifically, the hardware structure of these various processors can be an electric circuit that combines circuit elements such as semiconductor elements.

[0176] The disclosure of Japanese Patent Application No. 2021-050780, filed on March 24, 2021, is incorporated herein by reference in its entirety. All publications, patent applications, and technical standards mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent application, or technical standard was specifically and individually indicated to be incorporated by reference.

Claims

1. An immunochromatography testing device, a loading section in which a cartridge having a carrier having a spotting area where a sample is spotted and a test area where a color development state changes depending on whether the sample is positive or negative is removably loaded; an imaging unit that images the inspection area; a processor that performs a primary determination of whether the sample is positive or negative based on the inspection area image of the inspection area captured by the imaging unit, When a direction in which the specimen is developed on the carrier is defined as a row direction and a direction intersecting the row direction is defined as a column direction, the test region is a linear region extending along the column direction, the inspection area image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix, the processor performs an abnormality determination for determining the presence or absence of an abnormality in the inspection area image, using 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 inspection area image, a standard deviation and a coefficient of variation based on the pixel values ​​of each column, or a difference between a relatively large representative value and a relatively small representative value among representative values ​​of each row derived based on a plurality of pixels existing in the same row but different columns in the inspection area image, and a standard deviation and a coefficient of variation based on the representative values ​​of each row as a determination index; The immunochromatographic testing device determines the processing details related to the main judgment based on the presence or absence of the abnormality.

2. The immunochromatographic testing device according to claim 1 , wherein the processing content includes either a decision as to whether or not to perform the main judgment and a method for presenting the judgment result of the main judgment.

3. The immunochromatographic testing device according to claim 2 , wherein the processor performs the main judgment and presents the judgment result of the main judgment when the abnormality is not present, and does not perform the main judgment when the abnormality is present.

4. The immunochromatographic testing device according to claim 3 , wherein, when the main determination is not to be performed, the processor displays a message to the effect that the main determination will not be performed.

5. The immunochromatographic testing device according to claim 3 or 4, wherein the processor indicates, when the abnormality is detected, that there is a possibility that the testing area is soiled.

6. 3. The immunochromatographic testing device according to claim 2, wherein the processor presents a judgment result of the main judgment when the abnormality is not present, and presents the judgment result of the main judgment with a reservation that there is an abnormality in the test area image when the abnormality is present and the judgment result of the main judgment is positive, or does not present the judgment result of the main judgment.

7. The immunochromatographic testing device according to claim 6 , wherein the processor performs the main determination and, if the determination result is positive, performs the abnormality determination.

8. 3. The immunochromatographic testing device according to claim 2, wherein the processor presents a determination result of the main determination when the abnormality is not present, and presents a determination result of the main determination with a reservation that the inspection area image contains an abnormality when the abnormality is present, or does not present a determination result of the main determination.

9. the imaging unit is an image sensor that captures an image of an observation area including the inspection area, and outputs an observation image including the observation area, the observed image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix, 9. The immunochromatographic testing device according to claim 1, wherein the processor derives the row-direction profile based on a representative value of each column in the observation image, and extracts the test area image corresponding to the test area from the observation image based on the derived profile.

Images