Inspection Equipment

Abstract

To provide an inspection device capable of reducing a risk of errors in identification of a colored state of an inspection area, and to provide a cartridge.SOLUTION: An inspection device includes: a packing part for packing a cartridge; an illumination part having an emission end for emitting illumination light for illuminating an inspection area in which a colored state is changed according to whether an inspected substance is included in a specimen; and a detection part for optically detecting a colored state of an inspection area irradiated with illumination light. The cartridge includes a strip having an inspection area, and a case that houses the strip and forms an observation window for observing the inspection area from the outside on the surface. The emission end is disposed in a position separated from the observation window on the rear of the case. The detection part is disposed in a position that opposes the observation window in a surface side of the case. The illumination light is transmitted through the inside of the case from the rear of the case, reaches the inspection area while being diffused and reflected on an inner surface of the case, and lights the inspection area from a surface side.SELECTED DRAWING: Figure 10

Description

[Technical Field]

[0001] The technology of the present disclosure is Place Regarding. [Background technology]

[0002] Recently, immunochromatographic tests using immunochromatography have become popular. A cartridge is used in immunochromatographic tests. The cartridge includes a strip and a case for accommodating the strip.

[0003] A dissolving solution for a specimen, such as a nasal swab, which may contain a test substance, is applied to the strip. A labeled substance modified with a first binding substance that specifically binds to the test substance is immobilized in the area where the dissolving solution is applied. The dissolving solution spreads from the application area to one end of the strip by capillary action. A test area containing a second binding substance that specifically binds to the test substance to which the first binding substance has been bound is provided at the destination of the dissolving solution. An observation window is formed on the surface of the case to allow the test area to be observed from the outside.

[0004] If the individual who provided the specimen is infected with a viral infection or the like and the specimen contains a test substance, a line will appear in the test area indicating that the specimen is positive. Testing devices have been proposed that identify the presence or absence of this line and / or the coloring state of the test area, such as the degree of coloration of the line, by analyzing an image of the test area captured by an imaging element through an observation window (see, for example, Patent Document 1).

[0005] The inspection device described in Patent Document 1 includes an illumination unit that irradiates an inspection area with illumination light and an imaging element that captures an image of the inspection area illuminated with the illumination light through an observation window. The illumination unit is composed of a light source such as a light-emitting diode (LED) and a light guide that guides the illumination light emitted from the light source. The emission end of the light guide is located at a position corresponding to the inspection area on the back side of the cartridge case. The illumination light emitted from the emission end of the light guide passes through the case and the strip to reach the inspection area and illuminates the inspection area from the back side. The imaging element is located at a position facing the observation window on the front side of the case, which is the surface opposite the back side where the emission end of the light guide is located. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2002-267664 Summary of the Invention [Problem to be solved by the invention]

[0007] In the inspection device described in Patent Document 1, as mentioned above, the inspection area is illuminated from the back side. Therefore, if impurities are mixed inside the strip, the impurities may be reflected in the image captured by the imaging element, which may lead to incorrect identification.

[0008] It is also possible to arrange the exit end beside the image sensor and irradiate the inspection area with illumination light from an oblique direction, but even in this case, the illumination light may be eclipsed by the edge of the observation window, preventing a sufficient amount of illumination light from reaching the inspection area, which could result in incorrect identification.

[0009] One embodiment of the technique of the present disclosure is an inspection device capable of reducing the risk of erroneously identifying the color development state of an inspection area. Place provide. [Means for solving the problem]

[0010] The testing device disclosed herein is a testing device used for immunochromatographic testing using an immunochromatography method, and comprises: a loading section into which a cartridge is loaded, the cartridge having a strip provided with a testing area whose color state changes depending on whether or not the sample contains a test substance, and a case that houses the strip and has an observation window formed on its surface for observing the testing area from the outside; an illumination section having an emission end that emits illumination light to illuminate the testing area, the emission end of the illumination section being located at a position on the outer surface of the case away from the observation window; and a detection section that is located at a position opposite the observation window on the surface side of the case and optically detects the color state of the testing area irradiated with the illumination light, and the illumination section is configured so that the illumination light passes from the outer surface of the case into the interior of the case, reaches the testing area while being diffusely reflected on the inner surface of the case, and illuminates the testing area from the surface side.

[0011] The exit end is preferably disposed on the rear surface of the case, which is the surface opposite to the front surface on which the observation window is formed, at a position shifted in a direction along the short side of the case with respect to the inspection area.

[0012] There are two exit end portions, and the two exit end portions are preferably located at both ends of the short sides of the case that sandwich a position corresponding to the inspection region.

[0013] The emission end is preferably in contact with the outer surface of the case.

[0014] It is preferable to provide a suppression section that suppresses leakage of illumination light from the exit end to the surroundings.

[0015] The suppression portion is preferably an end that constitutes a part of the emission end portion and is a light-blocking elastic member having an end that elastically deforms when it comes into contact with the outer surface of the case.

[0016] The illumination unit preferably has a semiconductor light source that emits illumination light.

[0017] A cartridge to be loaded into the loading section of any of the above-described inspection devices, wherein the case is formed from a material that transmits illumination light incident from the outer surface to the interior and diffuses and reflects the transmitted illumination light on the inner surface.

[0018] The diffuse light transmittance of the material forming the case is preferably 0.1% or more and 50% or less for light of a specific wavelength when the transmission distance is 2 mm.

[0019] The diffuse light transmittance of the material forming the case is preferably 1% or more and 40% or less for light with a wavelength of 420 nm to 680 nm when the transmission distance is 2 mm. [Effects of the Invention]

[0020] According to the technology of the present disclosure, an inspection device capable of reducing the risk of erroneously identifying the color development state of an inspection area is provided. Place can be provided. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. [Figure 2] FIG. [Figure 3] FIG. 2 is a cutaway side view of the cartridge. [Figure 4] 10 is a cutaway side view of the cartridge showing a state in which a first pressing operation portion is pressed in. FIG. [Figure 5] 10 is a cutaway side view of the cartridge showing a state in which the second pressing operation portion is pressed in addition to the first pressing operation portion. FIG. [Figure 6] FIG. 1 is a diagram showing the procedure of an immunochromatographic test using a cartridge. [Figure 7] 10 is a graph showing the diffuse light transmittance of a translucent material forming the case. [Figure 8] FIG. [Figure 9] FIG. 2 is a cross-sectional view showing the inside of the inspection device. [Figure 10]FIG. 2 is a cross-sectional view showing the vicinity of the detection unit and the illumination unit. [Figure 11] FIG. [Figure 12] FIG. 2 is a block diagram showing a processing unit of a CPU of the inspection device. [Figure 13] FIG. 10 is a diagram showing a touch panel display on which a message indicating an identification result is displayed. [Figure 14] 10 is a flowchart showing a processing procedure of the inspection device. [Figure 15] 10 is a graph showing another example of the diffuse light transmittance of the translucent material forming the case. [Figure 16] FIG. 10 is a diagram showing a mode in which an inspection area is illuminated with illumination light from one illumination unit. [Figure 17] FIG. 10 is a diagram showing an example in which an illumination unit is arranged at a position shifted from the observation window. DETAILED DESCRIPTION OF THE INVENTION

[0022] First, the configuration of the cartridge 10 used in the immunochromatographic test by the immunochromatography method will be described.

[0023] As an example, as shown in Figures 1 and 2, a cartridge 10 is a single-use type used one for each sample, and has a case 11 in the shape of an elongated rectangular parallelepiped. The case 11 is made of a light-transmitting material. The case 11 is composed of a case body 12 and a cover member 13. The case body 12 is a box having a storage space surrounded by a base plate in the shape of an elongated rectangular plate and four side plates extending perpendicularly from the four sides of the base plate. A strip 14 having a test area L1 is stored in the storage space of the case body 12. The back surface of the bottom plate of the case body 12 is a back surface 15 of the case 11. The back surface 15 is an example of the "outer surface of the case" according to the technology of the present disclosure.

[0024] The cover member 13 has the same elongated rectangular plate shape as the bottom plate of the case body 12, and functions as a lid that covers the storage space of the case body 12. The surface of this cover member 13 is the surface 16 of the case 11. The surface 16 is also an example of the "outer surface of the case" according to the technology of the present disclosure. Note that the X and Y directions shown in the figure are directions along a horizontal plane and are perpendicular to each other. The X direction is the direction along the short side of the case 11, which is the so-called left-right direction. The Y direction is the direction along the long side of the case 11, which is the so-called front-back direction. The Z direction is the direction along the vertical direction and is perpendicular to the X and Y directions. The Z direction is the so-called up-down direction.

[0025] The cover member 13 is formed with a drip port 17 and an observation window 18. The cover member 13 is also provided with a first pressing operation portion 19 and a second pressing operation portion 20. The drip port 17, the observation window 18, the first pressing operation portion 19, and the second pressing operation portion 20 are integrally molded.

[0026] The drip port 17 is a round hole through which a sample dissolving solution (hereinafter simply referred to as dissolving solution) 72 (see FIG. 6) for the sample is dripped, and has a boss-like edge protruding from the surface 16. The drip port 17 is formed in the center of the cover member 13. The sample may be anything that can contain a test substance 73 (see FIG. 6), and is not particularly limited. The sample may be an individual subject of immunochromatographic testing, particularly an animal, or even a human biological sample, such as blood, serum, plasma, cerebrospinal fluid, tears, sweat, urine, feces, pus, nasal discharge, nasal swabs, throat swabs, nasal aspirates, or sputum, as well as organs, tissues, mucous membranes, and skin, or swabs containing these, or animals or plants themselves or their dried forms. Examples of test substances 73 include antigens, antibodies, proteins, and low-molecular-weight compounds.

[0027] The observation window 18 is a rectangular opening for externally observing the test area L1 etc. of the strip 14. The observation window 18 is formed between the drip port 17 and the second pressing operation part 20.

[0028] The first pressing operation unit 19 is provided at one end in the Y direction of the cover member 13. The first pressing operation unit 19 is pressed by the user when supplying a first reagent 48 (see FIG. 3) to the strip 14. The second pressing operation unit 20 is provided at the other end in the Y direction of the cover member 13 on the opposite side to the first pressing operation unit 19. The second pressing operation unit 20 is pressed by the user when supplying a second reagent 55 (see FIG. 3) to the strip 14.

[0029] The strip 14 has an overall elongated rectangular plate shape, and includes a carrier 30, a label holding pad 31, a liquid transfer pad 32, an absorbent pad 33, and a back adhesive sheet .

[0030] The carrier 30 is formed of a porous, insoluble material such as a nitrocellulose membrane. The label-retaining pad 31 is attached to the carrier 30 at a position opposite the drip port 17. The dissolving liquid 72 dropped into the drip port 17 is deposited on the label-retaining pad 31. In other words, the label-retaining pad 31 functions as a deposition area for the dissolving liquid 72.

[0031] The solution 72 applied to the label holding pad 31 penetrates the carrier 30 and spreads toward one end of the carrier 30 in the Y direction due to capillary action. The test region L1, control region L2, and color development region L3 are provided at one end of the carrier 30 in the Y direction where the solution 72 spreads. The test region L1, control region L2, and color development region L3 are strip-shaped regions extending from one end of the carrier 30 to the other end in the X direction. If the direction from the label holding pad 31 toward the test region L1, etc. is defined as the spreading direction of the solution 72 (see FIG. 3), the test region L1 is located at the most upstream side of the spreading direction, and the color development region L3 is located at the most downstream side of the spreading direction. The control region L2 is located between the test region L1 and the color development region L3. In other words, the control region L2 is located downstream of the test region L1 and upstream of the color development region L3. In Fig. 2, the test region L1, the control region L2, and the color-developing region L3 are hatched, but this hatching is done for the convenience of explanation and does not indicate that each region L1 to L3 is colored. The same applies to Figs. 3 to 5, 9, etc.

[0032] The liquid delivery pad 32 is attached to one end of the carrier 30 opposite to the other end where the test region L1, etc. are provided. The liquid delivery pad 32 is formed from a porous material similar to the carrier 30, etc., and delivers the first reagent 48 to the carrier 30 by capillary action.

[0033] The absorbent pad 33 is attached to one end of the carrier 30 where the test region L1 and the like are provided. The absorbent pad 33 is also made of a porous material. The absorbent pad 33 absorbs the solution 72, the first reagent 48, and the second reagent 55 that have been spread on the carrier 30. By actively absorbing the solution 72 and the like in this way, the speed at which the solution 72 and the like are spread is increased.

[0034] The back adhesive sheet 34 is a substrate with an adhesive surface, to which the carrier 30 is adhesively fixed. The back adhesive sheet 34, and therefore the strip 14, are placed on convex support bases 35 and 36 formed in the storage space of the case body 12. The support base 35 is provided in the center of the case body 12. The support base 36 is provided at one end of the case body 12 on the downstream side in the direction in which the dissolving liquid 72 is developed. The support bases 35 and 36 are the same height.

[0035] A convex support base 37 is also formed at the other end of the case body 12 on the upstream side in the direction of development of the dissolving liquid 72. The support base 37 is at the same height as the support bases 35 and 36. The liquid feed pad 32 is placed on the support base 37.

[0036] A concave first storage section 38 is formed in the support base 37. The first storage section 38 is provided at a position facing the other end of the liquid supply pad 32 opposite the one end attached to the carrier 30. A first reagent holding section 45 is stored in the first storage section 38.

[0037] The first reagent holding unit 45 is composed of a container 46 having an opening on one side and a seal 47 that liquid-tightly covers the opening of the container 46. The container 46 is made of, for example, a resin material. A first reagent 48 is stored inside the container 46. The seal 47 is, for example, an aluminum sheet, and can be easily broken with a sharp blade or the like. The first reagent holding unit 45 is housed in the first housing unit 38 with the seal 47 facing upward so that the seal 47 faces the other end of the liquid delivery pad 32.

[0038] A multifunctional member 49 is disposed on the upper part of the support base 36. The multifunctional member 49 is formed of a transparent resin material such as acrylic resin. The multifunctional member 49 is a member in which a second storage section 50 and a flow path forming section 51 are integrally provided. The second storage section 50 is a box with an open top, and a second reagent holding section 52 is stored inside. The flow path forming section 51 is a flat plate extending in the Y direction from the bottom of the second storage section 50. The flow path forming section 51 extends to just before the label holding pad 31 and covers the upper parts of the test region L1, control region L2, and color development region L3 of the carrier 30. A gap D is provided between the carrier 30 and the flow path forming section 51 (see FIG. 3). The gap D is, for example, in the range of 0.01 mm to 1 mm. By providing the gap D between the carrier 30 and the flow path forming section 51 in this manner, a flow path for the second reagent 55 is secured.

[0039] The second reagent holding unit 52 is composed of a container 53 having an opening on one side and a seal 54 that liquid-tightly covers the opening of the container 53. The container 53 is made of, for example, a resin material. A second reagent 55 is stored inside the container 53. The seal 54 is, for example, an aluminum sheet, and can be easily broken with a sharp blade or the like. The second reagent holding unit 52 is stored in the second storage unit 50 with the seal 54 facing downward so that it faces the strip 14.

[0040] 3, the first pressing operation unit 19 is provided with a first breaking protrusion 60. The second pressing operation unit 20 has an inner surface to which a second reagent holding unit 52 is attached. The second storage unit 50 has a bottom portion to which a second breaking protrusion 61 and a supply port 62 are provided. The first breaking protrusion 60 and the second breaking protrusion 61 have sharp tips.

[0041] As shown in FIG. 4 as an example, when the first pressing operation unit 19 is pressed, the first breaking protrusion 60 comes into contact with the other end of the liquid feed pad 32 and presses the other end of the liquid feed pad 32 toward the seal 47 of the first reagent holding unit 45. This pressing of the other end of the liquid feed pad 32 by the first breaking protrusion 60 breaks the seal 47, causing the other end of the liquid feed pad 32 to drop into the container 46 and become immersed in the first reagent 48. The first reagent 48 is developed from the other end of the liquid feed pad 32 toward the carrier 30 by capillary action. The first pressing operation unit 19 maintains its compressed state even after being compressed by the pressing operation. Therefore, the development of the first reagent 48 continues until substantially all of the first reagent 48 is absorbed into the liquid feed pad 32.

[0042] 5, when the second pressing operation unit 20 is pressed, the second reagent holding unit 52 moves downward within the second storage unit 50 and reaches the bottom of the second storage unit 50, where the second breaking protrusion 61 is located. The seal 54 of the second reagent holding unit 52 is then broken by the second breaking protrusion 61. The second reagent 55 stored in the second reagent holding unit 52 flows from the broken portion of the seal 54 to the supply port 62, and then flows through the flow path secured by the gap D (see FIG. 3) to be supplied to the carrier 30.

[0043] As an example, as shown in FIG. 6 , a labeling substance 70 is immobilized on a label holding pad 31. The labeling substance 70 is modified with a first binding substance 71. The first binding substance 71 specifically binds to an analyte 73 contained in a dissolution solution 72. In this embodiment, for example, gold colloid particles with a diameter of 50 nm (manufactured by BBI Solutions, product code: EM.GC50) are used as the labeling substance 70. Note that the labeling substance 70 is not limited to gold colloid particles, and may be metal sulfides used in immunochromatography or colored particles used in immunoagglutination reactions, among others. Metal colloids are particularly preferred. In addition to the above-mentioned gold colloids, examples of metal colloids include silver colloids, platinum colloids, iron colloids, aluminum hydroxide colloids, and composite colloids thereof. In particular, gold colloids are preferred because they are red and silver colloids are yellow at appropriate particle sizes, and of these, gold colloids are the most preferred.

[0044] For example, if test substance 73 is an antigen, first binding substance 71 is an antibody to the antigen, and if test substance 73 is an antibody, first binding substance 71 is an antigen to the antibody. If test substance 73 is a protein, a low molecular weight compound, or the like, first binding substance 71 is an aptamer to the protein, the low molecular weight compound, or the like.

[0045] Test area L1 contains a second binding substance 74. The second binding substance 74 specifically binds to the test substance 73 to which the first binding substance 71 is bound. This causes the test substance 73 to be captured in test area L1. When the test substance 73 is captured, the color density of test area L1 rises above a preset standard. When the color density of test area L1 rises above the standard, it is determined that the sample contains the test substance 73, i.e., the sample is positive.

[0046] Before the solution 72 is developed, the test area L1 is substantially the same color (e.g., white) as the carrier 30. When the solution 72 is developed and the developed solution 72 contains the test substance 73, that is, when the sample is positive, the color density of the test area L1 increases, and the test area L1 appears as a line. The test area L1 develops a black color due to amplified silver amplification, which will be described later.

[0047] The change in the color state of the test region L1 includes any of a color change, color development, and density change. A color change is a change from a first color different from the color of the carrier 30 to a second color. A color development is a change in the color of the carrier 30 to a different color due to the development of a color different from the color of the carrier 30. A density change is a change in the density of a color.

[0048] Like first binding substance 71, second binding substance 74 is, for example, an antibody against the antigen when test substance 73 is an antigen, or an antigen against the antibody when test substance 73 is an antibody. When test substance 73 is a protein, a low molecular weight compound, or the like, second binding substance 74 is an aptamer against the protein, low molecular weight compound, or the like. First binding substance 71 and second binding substance 74 may be the same or different. For example, when test substance 73 is influenza A virus or a biomarker thereof, first binding substance 71 and second binding substance 74 can be an anti-influenza A monoclonal antibody (manufactured by Medix Biochemica, product name: Anti-Influenza A SPT N-5 7307) that can be used.

[0049] The control region L2 contains a third binding substance 75. The third binding substance 75 specifically binds to the first binding substance 71. This causes the labeled substance 70 to be captured in the control region L2. Some labeled substances 70 have first binding substances 71 that do not bind to the test substance 73. Such labeled substances 70 reach the control region L2 without being captured in the test region L1, and are captured in the control region L2. When the labeled substance 70 is captured, the color density of the control region L2 increases to or above a preset standard. When the color density of the control region L2 increases to or above the standard, it is determined that the solution 72 has been sufficiently developed on the carrier 30, and the development of the solution 72 is complete.

[0050] Like the test region L1, the control region L2 is substantially the same color (e.g., white) as the carrier 30 before the dissolving solution 72 is developed. The control region L2 appears as a line due to an increase in color density when the labeled substance 70 is captured. The control region L2 also develops a black color due to being amplified by silver amplification, which will be described later.

[0051] The third binding substance 75 may be the test substance 73 itself, or may be a compound having a site recognized by the first binding substance 71. Examples of compounds having a site recognized by the first binding substance 71 include compounds in which a derivative of the test substance 73 is bound to a protein. For example, when the test substance 73 is influenza A virus or a biomarker thereof, an anti-mouse IgG antibody (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd., product name: anti-mouse IgG(H+L), rabbit F(ab')2, product code: 566-70621) can be used as the third binding substance 75.

[0052] The color-developing region L3 contains a substance (not shown) that changes color upon reaction with the first reagent 48. When the color-developing region L3 reacts with the first reagent 48 and develops color or changes color, it indicates that the first reagent 48 has spread to the color-developing region L3 and that it is time to start supplying the second reagent 55. For example, when a mixed aqueous solution of iron nitrate and citric acid (manufactured by FUJIFILM Wako Pure Chemical Industries, Ltd., product code: 038-06925) is used as the first reagent 48, it is preferable to form the color-developing region L3 with a color-developing reagent immobilization line in which Bromocresol Green (manufactured by FUJIFILM Wako Pure Chemical Industries, Ltd.) is immobilized in a strip shape. In this case, the color-developing region L3 is dark green before reacting with the first reagent 48 and changes color to orange upon arrival of the first reagent 48.

[0053] The first reagent 48 and the second reagent 55 are amplification solutions that react with each other to amplify the color development in the test region L1 and the control region L2. When a metal-based substance such as gold colloid particles is used as the labeled substance 70, as in this example, silver amplification is used as a method for amplifying the color development. The first reagent 48 and the second reagent 55 are amplification solutions used for silver amplification, for example. The reaction of the first reagent 48 and the second reagent 55 with the labeled substance 70 as a catalyst is the amplification reaction. The amplification reaction produces silver particles 76 that are relatively larger in particle size than the labeled substance 70.

[0054] More specifically, first reagent 48 is a solution of a reducing agent that reduces silver ions, and second reagent 55 is a solution of silver ions. When labeled substance 70 is brought into contact with the reducing agent in first reagent 48 and the silver ions in second reagent 55, silver particles 76 are generated. The silver particles 76 deposit on labeled substance 70, using labeled substance 70 as a nucleus. The silver particles 76 deposited on labeled substance 70 ultimately have a particle diameter several tens to several hundreds times larger than that of labeled substance 70. This amplifies the labeling signal emitted by labeled substance 70, and as a result, the color development in test region L1 and control region L2 is amplified.

[0055] The reducing agent of the first reagent 48 can be any inorganic or organic material or a mixture thereof, as long as it can reduce silver ions to silver. 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 an inorganic reducing agent, it is necessary to form a complex or reduce the oxidized ions, thereby removing or rendering them harmless. For example, Fe 2+ When using as a reducing agent, the oxide Fe is reduced using citric acid or ethylenediaminetetraacetic acid (EDTA). 3+ In this example, it is preferable to use such an inorganic reducing agent as the reducing agent, and more preferably Fe 2+ Metal salts of the formula are preferred.

[0056] Developing agents used in wet silver halide photographic light-sensitive materials (e.g., methyl gallate, hydroquinone, substituted hydroquinone, 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 as reducing agents.

[0057] 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-ascorbic acid or L-ascorbic acid (and their alkali metal salts) or isoascorbic acid (or its alkali metal salt) are particularly preferred, with sodium salts being preferred. Mixtures of these reducing agents can be used if necessary.

[0058] The second reagent 55 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.

[0059] The procedure for immunochromatographic testing using cartridge 10 will be described below with reference to Figure 6. Here, the case where the sample contains test substance 73, that is, the case where the sample is positive, will be described as an example. Note that back adhesive sheet 34 is not shown in Figure 6.

[0060] First, as shown in step ST1, a dissolution solution 72 is applied to the label retention pad 31. The test substance 73 in the dissolution solution 72 applied to the label retention pad 31 specifically binds to the first binding substance 71 that modifies the label substance 70 of the label retention pad 31. The dissolution solution 72 permeates from the label retention pad 31 into the carrier 30 and is spread by capillary action to the side (downstream side) of the test region L1, etc., as shown by arrow 80. A portion of the dissolution solution 72 is also spread to the side (upstream side) of the liquid delivery pad 32, as shown by arrow 81.

[0061] Next, as shown in step ST2, the first reagent 48 is supplied by pressing the first pressing operation unit 19. As shown by arrow 82, the first reagent 48 is supplied from the liquid supply pad 32 to the carrier 30 and is developed by capillary action toward the test region L1, etc. (downstream side).

[0062] Thereafter, as shown in step ST3, the development of the solution 72, the labeling substance 70, and the first reagent 48 progresses. The solution 72 and the labeling substance 70 developing from the label holding pad 31 are swept away by the first reagent 48 and developed toward the test region L1, etc. Then, as shown in step ST4, the first reagent 48 finally reaches the color-developing region L3. The color-developing region L3 reacts with the first reagent 48 and changes color. In this example, the color-developing region L3 is dark green before reacting with the first reagent 48, and changes color to orange upon reacting with the first reagent 48.

[0063] The test substance 73 that has reached the test region L1, more specifically, the labeled substance 70 that has bound to the test substance 73 via the first binding substance 71, is captured by the second binding substance 74 in the test region L1. This causes the color density in the test region L1 to rise above the reference level. On the other hand, the labeled substance 70 that has not bound to the test substance 73 passes through the test region L1 without being captured by the second binding substance 74, and is captured by the third binding substance 75 in the control region L2. This causes the color density in the control region L2 to rise above the reference level.

[0064] After the user presses the first pressing operation unit 19 to spread the first reagent 48, the user waits until the first reagent 48 reaches the color-forming region L3 and the color state of the color-forming region L3 changes (steps ST3 and ST4). When the user visually confirms through the observation window 18 that the color state of the color-forming region L3 has changed, the user presses the second pressing operation unit 20.

[0065] As shown in step ST5, pressing the second pressing operation unit 20 supplies the second reagent 55. As shown by arrow 83, the second reagent 55 is supplied to the carrier 30 from downstream of the color-developing region L3 and is developed toward the liquid-feeding pad 32 (upstream side). As shown in step ST6, the silver ions contained in the second reagent 55 and the reducing agent contained in the first reagent 48 generate silver particles 76 with the labeled substance 70 captured in the test region L1 and the control region L2 as nuclei. The silver particles 76 amplify the color development in the test region L1 and the control region L2. In this way, the cartridge 10 is configured to allow the user to visually determine whether the sample is positive or not without using the test device 100 (see FIG. 8).

[0066] As an example, as shown in FIG. 7, the diffuse light transmittance of the light-transmitting material forming the case 11 is 1% to 40% for visible light with wavelengths of 420 nm to 680 nm when the transmission distance is 2 mm.

[0067] Here, the diffuse light transmittance of a light-transmitting material is the proportion of diffuse components that diffuse within the light-transmitting material and exit the light-transmitting material, out of the incident light that enters the light-transmitting material. A portion of the incident light travels straight through the light-transmitting material. The proportion of this straight component that exits the light-transmitting material is called the "parallel light transmittance." The parallel light transmittance of the light-transmitting material forming the case 11 is, for example, 0.1% or less for visible light with a wavelength of 420 nm to 680 nm. In other words, in FIG. 7, the diffuse light transmittance in the wavelength range of 420 nm to 680 nm is at least 10% or more throughout the entire range, so a parallel light transmittance of 0.1% or less means that the majority of the light that passes through the light-transmitting material is diffuse components throughout the entire wavelength range of 420 nm to 680 nm.

[0068] Furthermore, the sum of the diffuse light transmittance and the parallel light transmittance is called the total light transmittance, which is the proportion of all light rays that pass through the light-transmitting material and are emitted out of the total light rays that enter the light-transmitting material from the light source.

[0069] As an example, the total light transmittance can be measured using an integrating sphere. As is well known, an integrating sphere is a hollow sphere whose inner surface is a reflective surface, and is a measuring instrument for spatially integrating the rectilinear and diffused components of light rays passing through a light-transmitting material by reflection from the inner surface. By measuring the amount of light integrated within the integrating sphere, the amount of light rays passing through the light-transmitting material can be measured.

[0070] The total light transmittance is measured while varying the wavelength of the light to be measured, for example, in a range of approximately 400 nm to 800 nm. On the other hand, the parallel light transmittance is measured by measuring only the linear component of the incident light that travels linearly through the translucent material without using an integrating sphere. For example, in a measuring device for measuring light intensity, the linear component can be measured by applying a mask to the light-receiving surface of the light-receiving unit so that only the linear component of the transmitted light is incident on the light-receiving unit. The parallel light transmittance is also measured while varying the wavelength of the light to be measured in a range of approximately 400 nm to 800 nm. The diffuse light transmittance is the value obtained by subtracting the parallel light transmittance from the total light transmittance measured in this manner. The graph shown in Figure 7 shows the diffuse light transmittance calculated in this manner. The transmission distance is the distance the incident light travels through the translucent material. For example, if the translucent material is plate-shaped, it is the thickness of the plate-shaped translucent material. A transmission distance of 2 mm means that the translucent material used to measure the total light transmittance is 2 mm thick. An example of the light-transmitting material is a resin material.

[0071] The light transmission characteristics shown in Fig. 7 are those of a resin material known as a milky white resin. If the resin material has the light transmission characteristics shown in Fig. 7, white light can be used as the illumination light LL (see Fig. 10) that illuminates the inspection area L1. Furthermore, green light with a center wavelength of approximately 550 nm or red light with a center wavelength of approximately 650 nm can also be used as the illumination light LL.

[0072] Next, the configuration of the testing device 100 that performs immunochromatographic testing will be described.

[0073] 8 and 9, an inspection device 100 includes a rectangular parallelepiped housing 101. Inside the housing 101, an L-shaped tray-shaped loading section 102 into which the cartridge 10 is loaded is provided.

[0074] A loading opening 103 for the cartridge 10 is formed on the front surface of the housing 101. An openable and closable lid 104 for covering the loading opening 103 is also attached to the front surface of the housing 101. Furthermore, a power switch 105 for the inspection device 100 is arranged on the front surface of the housing 101.

[0075] A touch panel display 106 is attached to the top surface of the housing 101. The touch panel display 106 accepts operational instructions, such as an instruction to start an immunochromatographic test (hereinafter referred to as a test start instruction), from the user. The touch panel display 106 also displays information such as an identification result 156 (see FIG. 12) of the color development state of the test area L1. The color development state of the test area L1 refers to the presence or absence of a line in the test area L1 and / or the degree of color development of the line.

[0076] The user opens the lid 104 to expose the loading opening 103, and loads the cartridge 10, which has completed the process of step ST6 shown in Fig. 6, into the loading section 102 via the loading opening 103. Thereafter, the user closes the lid 104 and operates the touch panel display 106 to input an instruction to start the test.

[0077] In FIG. 9, a detection unit 110 is provided within the housing 101. The detection unit 110 is disposed in a position facing the observation window 18 on the front surface 16 of the case 11. The detection unit 110 optically detects the color development states of the test area L1, the control area L2, and the color development area L3. Specifically, the detection unit 110 is a camera having an imaging lens 111 and an imaging element 112. The imaging lens 111 captures images of the test area L1, the control area L2, and the color development area L3 through the observation window 18. The imaging element 112 captures the image captured by the imaging lens 111. The imaging element 112 is a CCD (Charge Coupled Device) image sensor or a CMOS (Complementary Metal Oxide Semiconductor) image sensor.

[0078] An illumination unit 115 is also provided inside the housing 101. The illumination unit 115 is arranged on the back surface 15 side of the case 11, opposite the detection unit 110 across the loading unit 102. The position of the illumination unit 115 in the Y direction is the same as the observation window 18. The illumination unit 115 can move up and down along the Z direction between a set position indicated by a solid line, where it approaches the back surface 15 through a hole 116 formed in the bottom plate of the loading unit 102, and a retracted position indicated by a dashed line.

[0079] As an example, as shown in FIG. 10 , there are two illumination units 115. Each of the two illumination units 115 has an emission end 120. When the illumination unit 115 is moved to the set position, the two emission end parts 120 come into contact with the rear surface 15 of the case 11. The two emission end parts 120 are disposed at positions on the rear surface 15 of the case 11 away from the observation window 18. In other words, the two emission end parts 120 are disposed at positions offset from the detection unit 110. More specifically, the two emission end parts 120 are disposed at positions offset from the inspection area L1 on the rear surface 15 of the case 11 in the X direction, which is the direction along the short side of the case 11. Furthermore, the two emission end parts 120 are disposed at positions at both ends 122 of the short side of the case 11, sandwiching a position 121 corresponding to the inspection area L1.

[0080] Illumination light LL is emitted from the exit end 120. The case 11 transmits the illumination light LL incident from the back surface 15 of the case 11 into the interior. The case 11 is made of a material that diffusely reflects the transmitted illumination light LL from the inner surface 123 of the case main body 12 and the inner surface 124 of the cover member 13. Therefore, the illumination light LL emitted from the exit end 120 first transmits from the back surface 15 of the case 11 into the interior of the case 11. The illumination light LL that transmits into the interior of the case 11 is diffusely reflected from the inner surfaces 123 of the case main body 12 and the inner surface 124 of the cover member 13. The illumination light LL diffusely reflected from the inner surfaces 123 and 124 reaches the test region L1, the control region L2, and the color-development region L3, and illuminates the test region L1, the control region L2, and the color-development region L3 from the front surface 16 of the case 11. The inner surfaces 123 and 124 are examples of the "inner surface of the case" according to the technology disclosed herein.

[0081] 11, the illumination unit 115 has a cylindrical illumination unit body 130 and an elastic member 131. The illumination unit body 130 incorporates a light source 132 that emits illumination light LL and an exit window 133 that emits the illumination light LL to the outside as diffused light. The light source 132 is a semiconductor light source such as a light-emitting diode or a laser diode (LD: Laser Diode).

[0082] The elastic member 131 is fixed to the end of the illumination unit main body 130 on the exit window 133 side. The elastic member 131 is formed of a light-blocking material such as black rubber. One end 134 of the elastic member 131 constitutes a part of the exit end 120. The one end 134 of the elastic member 131 elastically deforms when the illumination unit 115 moves to the set position and comes into contact with the back surface 15 of the case 11. This causes the one end 134 of the elastic member 131 to tightly adhere to the back surface 15 of the case 11. In other words, the elastic member 131 functions as a suppression unit that suppresses leakage of illumination light LL from the exit end 120 to the surroundings.

[0083] 12, the inspection device 100 includes a storage 140, a memory 141, and a CPU (Central Processing Unit) 142. The storage 140, the memory 141, and the CPU 142 are connected to each other via a bus line 143. The storage 140, the memory 141, the CPU 142, and the bus line 143 constitute a computer.

[0084] The storage 140 is, for example, a hard disk drive or a solid state drive. The memory 141 is a work memory for the CPU 142 to execute processing. The CPU 142 loads a program stored in the storage 140 into the memory 141 and executes processing in accordance with the program. In this way, the CPU 142 comprehensively controls each part of the inspection device 100.

[0085] An operating program 145 is stored in the storage 140. The operating program 145 is an application program for causing a computer to function as the inspection device 100 of the present disclosure. In addition to the operating program 145, the storage 140 also stores information necessary for identifying the color development state of the inspection area L1.

[0086] When the operating program 145 is started, the CPU 142 functions as an instruction receiving unit 150, an illumination unit control unit 151, a detection unit control unit 152, an identification unit 153, and a display control unit 154 in cooperation with the memory 141 and the like.

[0087] The instruction receiving unit 150 receives various operation instructions from the user via the touch panel display 106. For example, the instruction receiving unit 150 receives an instruction to start an inspection. When the instruction receiving unit 150 receives an instruction to start an inspection, the instruction receiving unit 150 outputs a signal indicating this to the illumination unit control unit 151 and the detection unit control unit 152.

[0088] The illumination unit control unit 151 controls the operation of the illumination unit 115. The illumination unit control unit 151 moves the illumination unit 115 from the retracted position to the set position, and conversely moves the illumination unit 115 from the set position to the retracted position. The illumination unit control unit 151 also controls the turning on and off of the light source 132 of the illumination unit 115.

[0089] The detection unit control unit 152 controls the operation of the detection unit 110. The detection unit control unit 152 drives the image sensor 112 of the detection unit 110 to output an image 155 showing the inspection area L1 irradiated with the illumination light LL from the image sensor 112. The detection unit 110 outputs the image 155 to the recognition unit 153.

[0090] The discrimination unit 153 analyzes the image 155 from the detection unit 110 and discriminates the color development state of the inspection area L1. The discrimination unit 153 outputs a discrimination result 156 to the display control unit 154.

[0091] Display control unit 154 controls the display of various information on touch panel display 106. For example, display control unit 154 displays identification result 156 from identification unit 153 on touch panel display 106.

[0092] 13, the display control unit 154 displays a message 160 indicating the identification result 156 on the touch panel display 106. In FIG. 13, the case where the identification result 156 is positive for influenza A is illustrated.

[0093] Next, the operation of the above configuration will be described with reference to the flowchart shown in FIG. 14 as an example. First, a user performs steps ST1 to ST6 shown in FIG. 6. Then, the power switch 105 is operated to turn on the inspection device 100, and the operation program 145 is started. At this time, the illumination unit 115 is in the retracted position. When the operation program 145 is started, the CPU 142 of the inspection device 100 functions as an instruction receiving unit 150, an illumination unit control unit 151, a detection unit control unit 152, an identification unit 153, and a display control unit 154, as shown in FIG.

[0094] The user opens the lid 104, and the cartridge 10 that has completed the process of step ST6 shown in Fig. 6 is loaded into the loading section 102 through the loading opening 103 (step ST100). Thereafter, the user closes the lid 104.

[0095] Next, the user operates the touch panel display 106 to input an instruction to start the inspection. The instruction to start the inspection is received by the instruction receiving unit 150 (step ST110). Then, a signal indicating that the instruction to start the inspection has been received is output from the instruction receiving unit 150 to the illumination unit control unit 151 and the detection unit control unit 152.

[0096] Under the control of illumination unit control unit 151, illumination unit 115 is moved from the retracted position to the set position, whereby emission end portion 120, more specifically one end 134 of elastic member 131, comes into contact with rear surface 15 of case 11 (step ST120).

[0097] Thereafter, under the control of the illumination unit control unit 151, the light source 132 of the illumination unit 115 is driven, and illumination light LL is emitted from the emission end 120 (step ST130). As shown in Fig. 10, the illumination light LL emitted from the emission end 120 passes through the rear surface 15 of the case 11 into the interior of the case 11 (step ST140). The illumination light LL that has passed through the interior of the case 11 reaches the inspection area L1, etc. while being diffusely reflected by the inner surfaces 123 and 124 of the case 11, and illuminates the inspection area L1, etc. from the front surface 16 side (step ST150).

[0098] Next, under the control of the detection unit control unit 152, the imaging element 112 of the detection unit 110 is driven to capture an image of the inspection area L1, etc., irradiated with the illumination light LL (step ST160). The image 155 thus obtained is output from the detection unit 110 to the recognition unit 153. After the image 155 is captured, the detection unit control unit 152 turns off the light source 132, and the irradiation of the illumination light LL is stopped (step ST170).

[0099] The image 155 is analyzed in the discrimination unit 153, and the color development state of the inspection area L1 is discriminated (step ST180). The discrimination result 156 is output from the discrimination unit 153 to the display control unit 154.

[0100] 13, under the control of the display control unit 154, a message 160 indicating the identification result 156 is displayed on the touch panel display 106 (step ST190). This completes the immunochromatographic test for one cartridge 10.

[0101] As described above, the testing device 100 includes a loading section 102 into which the cartridge 10 is loaded, an illumination section 115 having an exit end 120 that emits illumination light LL to illuminate a test area L1, the color of which changes depending on whether or not the sample contains an analyte 73, and a detection section 110 that optically detects the color of the test area L1 illuminated by the illumination light LL. The cartridge 10 includes a strip 14 having the test area L1, and a case 11 that houses the strip 14 and has an observation window 18 formed on its surface 16 for external observation of the test area L1. The exit end 120 is located at a position spaced apart from the observation window 18 on the back surface 15 of the case 11. The detection section 110 is located opposite the observation window 18 on the surface 16 of the case 11.

[0102] The case 11 of the cartridge 10 is formed from a material that transmits the illumination light LL incident from the rear surface 15 into the interior and diffusely reflects the transmitted illumination light LL from the inner surfaces 123 and 124. Therefore, the illumination light LL transmits from the rear surface 15 of the case 11 into the interior of the case 11, is diffusely reflected from the inner surfaces 123 and 124 of the case 11, and reaches the inspection area L1, illuminating the inspection area L1 from the front surface 16 side.

[0103] With the above configuration, unlike the inspection device described in Patent Document 1, which illuminates the inspection area L1 from the back surface 15, there is no risk of impurities mixed inside the strip 14 being reflected in the image 155, resulting in an erroneous identification of the color state of the inspection area L1. Furthermore, unlike an embodiment in which the emission end 120 is disposed next to the detection unit 110 and illumination light LL is irradiated onto the inspection area L1 from an oblique direction, there is no risk of the illumination light LL being eclipsed by the edge of the observation window 18, preventing a sufficient amount of illumination light from reaching the inspection area L1, resulting in an erroneous identification of the color state of the inspection area L1. Therefore, it is possible to reduce the risk of an erroneous identification of the color state of the inspection area L1.

[0104] As shown in Figure 10, the exit end 120 is located on the back surface 15 of the case 11, which is the surface opposite to the front surface 16 on which the observation window 18 is formed, at a position shifted in the X direction, which is the direction along the short side of the case 11, relative to the inspection area L1.

[0105] The front surface 16 of the case 11 is provided with an observation window 18, a drip port 17, a first pressing operation unit 19, and a second pressing operation unit 20. In addition, a detection unit 110 is disposed on the front surface 16 side of the case 11. For this reason, there are many restrictions when arranging the output end 120 on the front surface 16 side of the case 11. However, in this example, the output end 120 is disposed on the back surface 15 side of the case 11 as described above, which provides greater flexibility than when the output end 120 is disposed on the front surface 16 side of the case 11.

[0106] 10, there are two exit ends 120, and the two exit ends 120 are arranged at both end portions 122 on the short sides of the case 11, sandwiching a position 121 corresponding to the inspection area L1. This makes it possible to reduce uneven irradiation of the illumination light LL onto the inspection area L1.

[0107] The exit end 120 is in contact with the rear surface 15 of the case 11. This makes it possible to minimize the amount of illumination light LL that does not penetrate into the inside of the case 11, thereby increasing the utilization efficiency of the illumination light LL.

[0108] As shown in FIG. 11 , an elastic member 131 is provided as a suppression unit that suppresses leakage of illumination light LL from the exit end 120 to the surroundings. The elastic member 131 has one end 134 that constitutes part of the exit end 120, and has one end 134 that elastically deforms when it comes into contact with the rear surface 15 of the case 11, and is made of a light-blocking material. Leakage of illumination light LL from the exit end 120 to the surroundings becomes noise when identifying the color development state of the inspection area L1. Therefore, by providing the elastic member 131 as a suppression unit, it is possible to further reduce the risk of erroneous identification of the color development state of the inspection area L1.

[0109] According to the elastic member 131, one end 134 is tightly attached to the rear surface 15 of the case 11 without any gaps. Therefore, it is possible to more effectively suppress leakage of the illumination light LL from the emission end 120 to the surroundings.

[0110] The light source 132 of the illumination unit 115 is a semiconductor light source. A semiconductor light source is smaller than a light source such as a xenon lamp. Therefore, using a semiconductor light source for the light source 132 can contribute to miniaturization of the inspection device 100.

[0111] 7, the diffuse light transmittance of the translucent material forming the case 11 is 1% or more and 40% or less for visible light with a wavelength of 420 nm to 680 nm when the transmission distance is 2 mm. This allows the use of various colors of light as the illumination light LL, such as white light, red light with a central wavelength of approximately 650 nm, or green light with a central wavelength of approximately 550 nm. Since the color options for the illumination light LL are increased, it is easy to select an appropriate color of illumination light LL that makes it easy to distinguish the color development state depending on the color developed by the inspection area L1, etc.

[0112] If the diffuse light transmittance of the translucent material forming the case 11 is less than 1%, the amount of illumination light LL is too small, making it impossible to ensure the amount of light necessary to identify the color development state of the inspection area L1, etc. On the other hand, if the diffuse light transmittance of the translucent material forming the case 11 is greater than 40%, much of the light is not diffusely reflected by the inner surfaces 123 and 124 of the case 11 and is instead emitted to the outside of the case 11. This light becomes leakage light that does not contribute to the illumination light LL of the inspection area L1, etc. The leakage light becomes unnecessary light that directly enters the detection unit 110 without passing through the inspection area L1, etc. As such, if the diffuse light transmittance exceeds 40%, the amount of unnecessary light due to leakage light increases. However, in this example, the diffuse light transmittance of the translucent material is 40% or less, so the unnecessary light due to leakage light can be reduced.

[0113] In this example, the parallel light transmittance of the light-transmitting material forming the case 11 is 0.1% or less. The lower the parallel light transmittance relative to the diffuse light transmittance, the better the light diffusion properties of the light-transmitting material. Furthermore, the lower the parallel light transmittance, the less illumination light LL, i.e., unwanted light, that travels straight through the inside of the case 11 and is emitted to the outside of the case 11. If the diffuse light transmittance of the light-transmitting material forming the case 11 is set to 40% or less and the parallel light transmittance is set to 0.1% or less, the light diffusion properties of the case 11 can be ensured while the unwanted light that travels straight through the inside of the case 11 and is emitted to the outside of the case 11 can be substantially eliminated, thereby further reducing the risk of erroneous identification of the color development state of the inspection area L1.

[0114] The light transmission characteristics of the light-transmitting material forming the case 11 are not limited to those shown in Fig. 7. For example, the light transmission characteristics shown in Fig. 15 may be used.

[0115] In Figure 15, the diffuse light transmittance of the translucent material forming the case 11 is 0.1% to 50% for light of at least a specific wavelength when the transmission distance is 2 mm. This specific wavelength is not particularly limited, but Figure 15 illustrates a case where the diffuse light transmittance is 0.1% to 50% for red light with a central wavelength of approximately 650 nm. An example of a translucent material having such light transmission characteristics is a resin material containing a large amount of red components. The wavelength of 650 nm is an example of the "specific wavelength" according to the technology of the present disclosure.

[0116] Thus, when a translucent material with a high diffuse light transmittance for red light is used, using red light as the illumination light LL can provide the amount of light necessary to identify the color development state of the inspection area L1, etc. Of course, since white light contains red wavelength components, it is also possible to combine such a translucent material with white illumination light LL. Since red light is irradiated onto the inspection area L1, for example, if the inspection area L1 develops a color other than red, it is easy to identify the color development state of the inspection area L1. Even for a translucent material having the light transmission characteristics shown in FIG. 15, a lower limit of the diffuse light transmittance of 0.1% or more is preferable because it ensures the amount of light necessary to identify the color development state of the inspection area L1, etc. Furthermore, an upper limit of the diffuse light transmittance of less than 50% can suppress unnecessary light due to leakage light.

[0117] Furthermore, when the diffuse light transmittance of the light-transmitting material forming case 11 is 0.1% or more and 50% or less for light of a specific wavelength, the parallel light transmittance for light of the specific wavelength is preferably 0.5% or less. By setting the parallel light transmittance to 0.5% or less, assuming that the diffuse light transmittance for light of the specific wavelength is within the above range, it is possible to ensure the light diffusion properties of case 11 while substantially eliminating unnecessary light that travels straight inside case 11 and is emitted to the outside of case 11, thereby further reducing the risk of erroneous identification of the color development state of inspection area L1.

[0118] 15 is just an example, and may be other than red light, such as green light with a central wavelength of approximately 550 nm. The specific wavelength may be selected appropriately depending on the color to be developed in the inspection area L1, etc.

[0119] 10, the two exit ends 120 are the exit ends 120 of the two illumination units 115, respectively, but this is not limiting. Two exit ends 120 may be prepared by connecting a light guide having one incident end and two exit ends 120 branching from the incident end to one illumination unit 115 having one light source 132.

[0120] 10, the two exit end portions 120 are arranged at both end portions 122 on the short side of the case 11, sandwiching a position 121 corresponding to the inspection area L1, but this is not limiting. As an example, as shown in FIG. 16, if the amount of illumination light LL irradiated onto the inspection area L1 or the like is sufficient, only one exit end portion 120 (illumination unit 115) may be used.

[0121] The number of output ends 120 is not limited to two or one, but may be three or more output ends 120.

[0122] The position of the illumination unit 115 in the Y direction does not necessarily have to be the same as the observation window 18. As an example, as shown in FIG. 17 , the position of the illumination unit 115 in the Y direction may be the same as the second pressing operation unit 20, but may be shifted in the Y direction from the observation window 18. The position of the illumination unit 115 is not particularly limited as long as the illumination light LL is diffusely reflected by the inner surfaces 123 and 124 of the case 11 and reaches the inspection area L1, etc. For this reason, the illumination unit 115 may be disposed on the front surface 16 of the case 11 instead of the back surface 15 of the case 11, and the illumination light LL may be incident on the inside of the case 11 from the front surface 16. Alternatively, the illumination unit 115 may be disposed on the side of the case 11, and the illumination light LL may be incident on the side of the case 11.

[0123] The emission end 120 does not have to be in contact with the rear surface 15 of the case 11. Furthermore, the suppression portion is not limited to the exemplified elastic member 131. It may be a simple light-blocking cap that does not have elasticity. As the suppression portion, a recess into which the emission end 120 fits may be provided on the rear surface 15 of the case 11.

[0124] To facilitate diffuse reflection of the illumination light LL, inner surfaces 123 and 124 of the case 11 may be textured or matte-finished. Conversely, it is preferable to smooth the back surface 15 of the case 11, onto which the illumination light LL is incident.

[0125] In the above embodiment, the user is responsible for pressing the first pressing operation unit 19 and the second pressing operation unit 20, but both pressing operations may be performed by the inspection device 100. In this case, the user only needs to perform the operation of dripping the solution 72 into the drip port 17. Alternatively, the user may be responsible for pressing the first pressing operation unit 19, and the inspection device 100 may be responsible for pressing the second pressing operation unit 20. In this case, the cartridge 10 may be loaded into the inspection device 100 so that the first pressing operation unit 19 is exposed to the outside, and after loading the cartridge 10 into the inspection device 100, the user may press the first pressing operation unit 19.

[0126] The light source 132 may be an EL (Electro-Luminescence) element. The detection unit 110 may be configured with a reflective photodiode.

[0127] In the above embodiment, the hardware structure of the processing unit that executes various processes can be any of the following processors: The various processors include the CPU 142, which is a general-purpose processor that executes software (operating program 145) and functions as various processing units, as well as programmable logic devices (PLDs), such as field programmable gate arrays (FPGAs), whose circuit configuration can be changed after manufacture, and / or dedicated electrical circuits, such as application specific integrated circuits (ASICs), which are processors with circuit configurations designed specifically for executing specific processes.

[0128] 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.

[0129] Examples of configuring multiple processing units with a single processor include, first, a form in which one processor is configured with a combination of one or more CPUs and software, and this processor functions as multiple processing units, as typified by client and server computers. Second, a form in which a processor is used to realize the functions of an entire system including multiple processing units with a single IC (Integrated Circuit) chip, as typified by System on Chip (SoC). In this way, various processing units are configured using one or more of the above-mentioned various processors as a hardware structure.

[0130] Furthermore, more specifically, the hardware structure of these various processors can be an electric circuit that combines circuit elements such as semiconductor elements.

[0131] The technology of the present disclosure can be appropriately combined with the various embodiments and / or various modified examples described above. Furthermore, it is not limited to the above embodiments, and various configurations can be adopted without departing from the spirit of the present disclosure. Furthermore, the technology of the present disclosure extends not only to programs but also to storage media that non-temporarily store programs.

[0132] The above-described description and illustrations are a detailed explanation of the parts related to the technology of the present disclosure and are merely an example of the technology of the present disclosure. For example, the above description of the configuration, functions, actions, and effects is an explanation of an example of the configuration, functions, actions, and effects of the parts related to the technology of the present disclosure. Therefore, it goes without saying that unnecessary parts may be deleted, new elements may be added, or replacements may be made to the above-described description and illustrations within the scope of the gist of the technology of the present disclosure. Furthermore, to avoid confusion and facilitate understanding of the parts related to the technology of the present disclosure, the above-described description and illustrations omit explanations of common technical knowledge that do not require particular explanation to enable the implementation of the technology of the present disclosure.

[0133] In this specification, "A and / or B" is synonymous with "at least one of A and B." In other words, "A and / or B" means that it may be only A, only B, or a combination of A and B. Furthermore, in this specification, the same concept as "A and / or B" is also applied when three or more things are expressed connected by "and / or."

[0134] 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. [Explanation of symbols]

[0135] 10 cartridges 11 cases 12 Case body 13 Cover member 14 Strip 15 Back of the case 16 Case surface 17 Drip nozzle 18 Observation window 19 First pressing operation unit 20 Second pressing operation unit 30 Carriers 31 Sign holding pad 32 Fluid transfer pad 33 Absorbent Pads 34 Back adhesive sheet 35~37 Support stand 38 First storage section 45 First reagent holding section 46, 53 container 47, 54 seals 48 Reagent 1 49 Multifunctional Components 50 Second storage section 51 Flow path forming section 52 Second reagent holding section 55 Second Reagent 60 First fracture protrusion 61 Second fracture protrusion 62 Supply port 70 Labeled substances 71 First binding substance 72 Lysis solution 73 Test substance 74 Second binding substance 75 Third binding substance 76 silver particles 80~83 Arrows 100 Inspection equipment 101 Case 102 Loading section 103 Loading port 104 Lid 105 Power switch 106 Touch Panel Display 110 Detection unit 111 Imaging lens 112 Image sensor 115 Lighting Department 116 holes 120 Output end 121 Position corresponding to inspection area 122 Both ends of the short side of the case sandwiching the position corresponding to the inspection area 123 Inside of the case body 124 Inner surface of cover member 130 Lighting unit body 131 Elastic member 132 Light source 133 Exit window 134 One end of elastic member 140 Storage 141 memory 142 CPU 143 Bus Line 145 Operating Program 150 Instruction Reception Department 151 Lighting unit control unit 152 Detection unit control unit 153 Identification Unit 154 Display control unit 155 images 156 Identification Results 160 Messages D Distance between the substrate and the flow channel forming part L1 inspection area L2 control region L3 coloring region LL illumination light ST1~ST6, ST100, ST110, ST120, ST130, ST140, ST150, ST160, ST170, ST180, ST190 steps

Claims

1. A testing device used in an immunochromatography test using an immunochromatography method, a strip having a test area whose color development state changes depending on whether or not a test substance is contained in a sample; a cartridge having a case in which the strip is housed and which has an observation window formed on its surface for observing the test area from the outside; a loading section into which the an illumination unit having an emission end portion that emits illumination light to illuminate the inspection area, the emission end portion being disposed on an outer surface of the case at a position separated from the observation window; a detection unit that is disposed at a position facing the observation window on the front surface of the case and that optically detects the color development state of the inspection area irradiated with the illumination light; a suppression unit that suppresses leakage of the illumination light from the exit end to the surroundings; Equipped with the illumination unit is configured such that the illumination light passes through an outer surface of a first material of the case into the interior of the case, is diffusely reflected by an inner surface of a second material of the case, and reaches the inspection area, thereby illuminating the inspection area from the surface side; the suppression portion is an end that constitutes a part of the emission end portion, and is a light-blocking elastic member having an end that elastically deforms when it comes into contact with the outer surface of the case. Inspection equipment.

2. A testing device used in an immunochromatographic test using an immunochromatography method, a strip having a test area whose color development state changes depending on whether or not a test substance is contained in a sample; a cartridge having a case in which the strip is housed and which has an observation window formed on its surface for observing the test area from the outside; a loading section into which the an illumination unit having two emission ends that emit illumination light to illuminate the inspection area, the emission ends being disposed at positions on the outer surface of the case that are spaced apart from the observation window; a detection unit that is disposed at a position facing the observation window on the front surface of the case and that optically detects the color development state of the inspection area irradiated with the illumination light; Equipped with the illumination unit is configured such that the illumination light passes through an outer surface of a first material of the case into the interior of the case, is diffusely reflected by an inner surface of a second material of the case, and reaches the inspection area, thereby illuminating the inspection area from the surface side; the exit end is disposed on a rear surface of the case, which is the surface opposite to the front surface on which the observation window is formed, at a position shifted in a direction along a short side of the case with respect to the inspection area, the two emission end portions are respectively disposed at both end positions of the short sides of the case, the position corresponding to the inspection area being sandwiched therebetween; Inspection equipment.

3. The inspection device according to claim 1, wherein the exit end is positioned on the back surface of the case, which is the surface opposite to the front surface on which the observation window is formed, at a position offset in a direction along the short side of the case relative to the inspection area.

4. There are two exit ends, The inspection device according to claim 3 , wherein the two exit end portions are disposed at both ends of a short side of the case, sandwiching a position corresponding to the inspection area.

5. The inspection device according to claim 1 , wherein the emission end is in contact with an outer surface of the case.

6. The inspection device according to claim 1 , wherein the illumination unit includes a semiconductor light source that emits the illumination light.

7. 7. The inspection device according to claim 1, wherein the first material has a diffuse light transmittance of 0.1% to 50% for light of a specific wavelength when the transmission distance is 2 mm.

8. 7. The inspection device according to claim 1, wherein the diffuse light transmittance of the first material is 1% or more and 40% or less for light with wavelengths of 420 nm to 680 nm when the transmission distance is 2 mm.

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