Inspection cartridge

Abstract

This test cartridge, which is detachably loaded in an immunochromatographic test device, is provided with: a carrier having a test area in which a coloring state thereof changes according to whether a sample is positive or negative; a case in which the carrier is housed; and an opening provided in the case for observation of an observation area LA that includes the test area, the opening being illuminated by a light source in the immunochromatographic test device, at least a portion of an inner peripheral wall 18A of the opening being a processed surface that is subjected to a surface roughening treatment and is at an angle of 50° or greater with respect to the surface of the observation area LA.

Description

[Technical Field]

[0001] The technology of the present disclosure relates to a testing cartridge. [Background technology]

[0002] Japanese Patent Application Laid-Open Publication No. 2013-238543 (hereinafter referred to as "JP Patent Application Laid-Open Publication No. 2013-238543") describes a test device (referred to as a test strip in the publication) for testing whether a sample is positive or negative, i.e., whether the sample contains a test substance, using immunochromatography. Such a test device is also called a test cartridge. The test cartridge includes a carrier having a test area for testing whether the sample is positive or negative, and a case for accommodating the carrier. An antibody that reacts with the test substance is fixed to the test area, and the color of the test area changes when the antibody reacts with the test substance. The case is formed with an opening for externally observing the color of the test area. Summary of the Invention [Problem to be solved by the invention]

[0003] In the testing cartridge disclosed in JP 2013-238543 A, the sidewall of the opening is a tapered, inclined surface. When the testing cartridge is loaded into the testing device, a detection unit that detects light reflected from the testing area is disposed directly opposite the opening. A light source is disposed to the side of the detection unit and is positioned diagonally above the opening. Light from the light source is irradiated onto the opening from diagonally above.

[0004] In the testing cartridge disclosed in JP 2013-238543 A, the angle of the inclined surface of the sidewall of the opening is approximately 45° with respect to the surface of the testing area, and an anti-reflection layer is formed on the inclined surface. First, by making the sidewall an inclined surface, light is made to easily enter the testing area. Second, by forming an anti-reflection layer on the inclined surface, unnecessary light reflected by the sidewall is prevented from entering the detection unit.

[0005] When the detection unit is positioned directly opposite the opening as described in JP 2013-238543 A, light must be irradiated from an oblique direction toward the opening. When light is irradiated from an oblique direction like this, there is a problem that the light intensity distribution in the observation area is likely to be uneven due to differences in the distance from the light source within the observation area, including the inspection area and its surrounding area, and light vignetting around the opening. The configuration of the inspection cartridge described in JP 2013-238543 A was not sufficient to solve these problems.

[0006] Taking the above facts into consideration, the technology disclosed herein provides an inspection cartridge that, compared to conventional techniques, makes it easier to uniformly distribute the light intensity in the observation area, including the inspection area and its surrounding area, when illuminating the opening. [Means for solving the problem]

[0007] The testing cartridge of the present disclosure is a testing cartridge that is removably loaded into an immunochromatographic testing device, and comprises a carrier having a testing area whose color state changes depending on whether the sample is positive or negative, a case in which the carrier is housed, and an opening provided in the case for observing an observation area including the testing area, the opening being illuminated by a light source within the immunochromatographic testing device, and at least a portion of the inner wall of the opening has an angle of 50° or more with respect to the surface of the observation area and is a processed surface that has been roughened.

[0008] In the testing cartridge of the present disclosure, the angle is preferably in the range of 70° or more and 90° or less.

[0009] In the testing cartridge of the present disclosure, it is preferable that the opening be rectangular, and the processed surface be formed on a wall surface of the inner circumferential wall that extends in the longitudinal direction.

[0010] In the testing cartridge of the present disclosure, the testing region is a linear testing line, and the testing line is preferably arranged along a direction intersecting the longitudinal direction.

[0011] In the testing cartridge of the present disclosure, the processed surface is preferably formed over the entire circumference of the inner peripheral wall.

[0012] In the inspection cartridge of the present disclosure, among the parameters that define the surface roughness of the processed surface, the arithmetic mean height Sa is preferably 100 μm or less.

[0013] In the testing cartridge of the present disclosure, the surface roughening treatment is preferably a graining treatment.

[0014] In the testing cartridge of the present disclosure, the opening is rectangular, and when the opening width in the direction along the surface of the observation area and the direction of the short side of the opening is D and the height of the inner wall in the direction perpendicular to the opening width is H, it is preferable that 0.5D≦H≦1.5D.

[0015] In the testing cartridge of the present disclosure, when the inner wall of the opening is the first inner wall, the opening may have a second inner wall that rises in a direction away from the surface along an intersecting direction that intersects with the surface of the observation area.

[0016] In the testing cartridge of the present disclosure, a flat portion extending in a direction along the surface of the observation area is provided around the opening, and the second inner wall may rise from the edge of the flat portion opposite the opening.

[0017] In the testing cartridge of the present disclosure, when the inner circumferential wall of the opening is the first inner circumferential wall, the second inner circumferential wall may rise from the edge of the first inner circumferential wall.

[0018] In the testing cartridge of the present disclosure, at least a portion of the second inner circumferential wall is preferably subjected to a surface roughening treatment.

[0019] In the testing cartridge of the present disclosure, the second inner circumferential wall may be inclined at an angle smaller than the angle of the first inner circumferential wall.

[0020] In the testing cartridge of the present disclosure, a convex structure is provided around the opening in a direction away from the surface of the observation area, and it is preferable that at least a portion of the outer wall of the structure is subjected to a roughening treatment. [Effects of the Invention]

[0021] According to the testing cartridge of the present disclosure, when the opening is illuminated, it is easier to make the light intensity distribution of the observation area, including the testing area and its surrounding area, uniform compared to conventional methods. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a perspective view of a testing cartridge according to the present disclosure. [Figure 2] FIG. 1 is an exploded perspective view of a testing cartridge according to the present disclosure. [Figure 3] FIG. 3A is a cross-sectional view showing a state in which a first pressing operation portion is operated in a testing cartridge according to the present disclosure, and FIG. 3B is a cross-sectional view showing a state in which the first pressing operation portion and the second pressing operation portion are operated. [Figure 4] 1 is a side view showing the positional relationship between a test strip, a multifunctional member, a first reagent holding portion, and a second reagent holding portion in a testing cartridge according to the present disclosure. FIG. [Figure 5] FIG. 1 is an explanatory diagram of immunochromatography. [Figure 6] 1 is a perspective view showing the appearance of an immunochromatographic testing device into which a testing cartridge according to the present disclosure is loaded. [Figure 7] 1 is a partially cutaway side view showing the positional relationship between a light source and an observation window in a testing device in a state where a testing cartridge according to the present disclosure is loaded. FIG. [Figure 8] FIG. 2 is a perspective view showing an observation window of the testing cartridge according to the present disclosure. [Figure 9] 1 is a top view showing an observation window of a testing cartridge according to the present disclosure. FIG. [Figure 10] 1 is a cross-sectional view showing an observation window of a testing cartridge according to the present disclosure. [Figure 11] 10 is a cross-sectional view showing an example of light incident from a light source on an observation area of ​​the testing cartridge according to the present disclosure. FIG. [Figure 12] 10 is a cross-sectional view showing another example of light incident from a light source on an observation area of ​​the testing cartridge according to the present disclosure. FIG. [Figure 13] 10A and 10B are cross-sectional views showing an example of incident light on an inner peripheral wall of an observation window of the testing cartridge according to the present disclosure and reflected light from the inner peripheral wall. [Figure 14] FIG. 10 is a cross-sectional view showing a comparative example. [Figure 15] 10 is a cross-sectional view showing an example of the relationship between the width and height of an observation window of an inspection cartridge according to the present disclosure. FIG. [Figure 16] 10A and 10B are cross-sectional views showing modified examples of the angle of the inner peripheral wall of the observation window of the testing cartridge according to the present disclosure. [Figure 17] FIG. 17 is a cross-sectional view showing a state in which the angle of incidence of light is changed in the modified example shown in FIG. [Figure 18] 10 is a cross-sectional view showing a modified example in which a first inner peripheral wall and a second inner peripheral wall are formed as inner peripheral walls of an observation window of the testing cartridge according to the present disclosure. FIG. [Figure 19] 10 is a cross-sectional view showing an example of incident light and reflected light in a modified example in which a first inner circumferential wall and a second inner circumferential wall are formed as the inner circumferential wall. FIG. [Figure 20] FIG. 10 is a cross-sectional view showing a modified example in which the angle of the second inner circumferential wall is changed. [Figure 21] FIG. 10 is a cross-sectional view showing a modified example in which the angles of the first inner circumferential wall and the second inner circumferential wall are changed. [Figure 22] FIG. 10 is a cross-sectional view showing a modified example in which a flat portion is provided between the first inner circumferential wall and the second inner circumferential wall. [Figure 23] 10 is a cross-sectional view showing a modified example in which an observation region of the testing cartridge according to the present disclosure receives transmitted light. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0023] Hereinafter, a testing cartridge according to an embodiment of the present invention will be described with reference to the drawings. Components indicated by the same reference numerals in the various drawings are the same components. However, unless otherwise specified in the specification, each component is not limited to one, and multiple components may be present.

[0024] Furthermore, the description of the same components and symbols in each drawing may be omitted. Note that the present invention is not limited to the following embodiments, and may be implemented by making appropriate modifications, such as omitting components or replacing them with different components, within the scope of the object of the present invention.

[0025] The directions indicated by arrows X and Y in each drawing are directions along the horizontal plane and are perpendicular to each other. The direction indicated by arrow Z is a direction along the vertical direction (up and down). The directions indicated by arrows X, Y, and Z in each drawing are assumed to be the same.

[0026] <Overview of the testing cartridge> Fig. 1 is an external view of a cartridge 100, which is a testing cartridge according to one embodiment, and Fig. 2 is an exploded perspective view of the cartridge 100. Fig. 3 is a view showing a state in which a first pressing operation unit 11 and a second pressing operation unit 12 provided on the cartridge 100 have been operated. Fig. 4 is a view showing the main components housed inside the cartridge 100.

[0027] The cartridge 100 is a single-use type that is used one for each sample to be tested. As shown in Figure 2, 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.

[0028] 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).

[0029] 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.

[0030] The cartridge 100 has a configuration that allows a user to visually confirm whether a sample is positive or negative. Such a cartridge 100 is also called an immunochromatographic test tool or an immunochromatographic test kit.

[0031] As shown in FIGS. 1 and 2, the cartridge 100 includes, for example, a case 9 composed of a case main body 20 and a cover member 10. The case 9 is formed of, for example, a resin material. The case main body 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 main body 20, thereby covering the opening of the case main body 20. The case 9 has an elongated shape overall to match the elongated shape of the test strip 1.

[0032] In this example, a drip port 16, an observation window 18, a first pressing operation unit 11, and a second pressing operation unit 12 are provided at the top of the case 9, which is made up of a cover member 10. As an example, these units are integrally molded with the cover member 10. The drip port 16 is an opening for dripping a sample into the case 9. A boss is provided on the edge of the drip port 16, pointing upward.

[0033] (observation window) The observation window 18 is an opening for observing the test region L1 from the outside, and in this example, the size of the observation window 18 is such that in addition to the test region L1, the control region L2 and color development region L3, which will be described later, can also be observed. The area of ​​the carrier 2 that includes the test region L1, control region L2, color development region L3, and their surrounding areas and can be observed through the observation window 18 is referred to as the observation region LA. The user can check the observation region LA through the observation window 18. The user can confirm whether the sample is positive or negative by observing the color development state of the test region L1 within the observation region LA.

[0034] The cartridge 100 of this example is characterized by the observation window 18, as shown in Figures 8 and 9 described below. The characteristics of the observation window 18 will be explained after explaining the basic structure and basic usage of the cartridge 100.

[0035] (First pressing operation unit, second pressing operation unit) 2 and 3, the first pressing operation unit 11 is an operation unit that is operated to supply the first reagent 41 in the first reagent holding unit 40 to the carrier 2. The second pressing operation unit 12 is an operation unit that is operated to supply the second reagent 46 in the second reagent holding unit 45 to the carrier 2. As will be described later, the first reagent 41 and the second reagent 46 are amplification liquids that amplify the color development in the test region L1 when the sample is positive.

[0036] As shown in FIG. 3A , when a pressing force is applied from the outside as an external force to the first pressing operation unit 11 due to a pressing operation by a user or the like, the first pressing operation unit 11 is deformed. As shown in FIG. 2 , for example, the first pressing operation unit 11 has a quadrangular pyramid shape. 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 inside of the case 9, as shown in FIG. 3A . When the first pressing operation unit 11 is deformed in this manner, a pressing force is applied to the first reagent holding unit 40 inside the case 9. The first reagent holding unit 40 is deformed by the pressing force applied through the first pressing operation unit 11. Due to this deformation, the first reagent 41 held in the first reagent holding unit 40 is supplied to the test strip 1.

[0037] Furthermore, the first pressing operation unit 11 is configured to maintain the deformed state after being deformed by pressing, so that when the first pressing operation unit 11 is pressed, the supply of the first reagent 41 to the test strip 1 continues.

[0038] Similarly, as shown in FIG. 3B , when a pressing force is applied from the outside as an external force to the second pressing operation unit 12, the second pressing operation unit 12 is deformed. As shown in FIG. 2 , the second pressing operation unit 12 of this example also has a quadrangular pyramid shape, similar to the first pressing operation unit 11. 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 inside of the case 9, as shown in FIG. 3B . When the second pressing operation unit 12 deforms in this manner, a pressing force is applied to the second reagent holding unit 45 inside the case 9. The second reagent holding unit 45 is deformed by the pressing force applied through the second pressing operation unit 12. This deformation causes the second reagent 46 held in the second reagent holding unit 45 to be supplied to the test strip 1. The second pressing operation unit 12 of this example has an abutting portion 12b on the inside of the case 9 that abuts against the second reagent holding unit 40.

[0039] (First reagent holding section) 2 and 3, the case body 20 accommodates a test strip 1 including a carrier 2 along the longitudinal direction. As shown in FIGS. 3 and 4, a first reagent holding section 40 is disposed on one end side of the case body 20 in the longitudinal direction (the upstream side as shown in FIG. 4). A first container 24 having a recessed shape that matches the shape of the first reagent holding section 40 is formed in the portion of the case body 20 where the first reagent holding section 40 is disposed. One end of the test strip 1 is disposed above the first reagent holding section 40 when it is accommodated in the first container 24.

[0040] 3 and 4, 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 that covers 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 placed in the first storage unit 24 with the sheet member 43 facing upward.

[0041] The pressing force applied from the first pressing operation unit 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 break. When the sheet member 43 is broken, the first reagent 41 is supplied to the test strip 1. Note that the first pressing operation unit 11 in this example is provided with a protrusion 11b that comes into contact with the sheet member 43. The protrusion 11b has, for example, an elongated shape that extends longitudinally in the width direction of the test strip 1 and has a pointed tip that points toward the sheet member 43, so as to make it easier to break the sheet member 43.

[0042] (Multifunctional components) 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 main body 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 test strip 1.

[0043] Furthermore, 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 at a position facing the test region L1, etc. in the longitudinal direction of the test strip 1, with a gap between it and the test strip 1. The flow path forming section 35 forms a flow path between it and the test strip 1, which allows the second reagent 46 flowing out of the second storage section 32 toward the test region L1, etc. The flow path forming section 35 is also disposed between the observation window 18 and the test region L1, etc. of the test strip 1. 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.

[0044] (Second reagent holding section) 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.

[0045] The pressing force applied from the second pressing operation unit 12 to the second reagent holding unit 45 acts in a direction that presses the second reagent holding unit 45 downward, thereby pressing the sheet member 48 against the protrusion 34. The sheet member 48 is broken by being pressed against the protrusion 34. By breaking the sheet member 48, the second reagent 46 is supplied to the test strip 1 through the flow path formed by the opening 33 at the bottom of the second storage unit 32 and the flow path forming unit 35.

[0046] As shown in FIG. 4, a gap (clearance) C 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 C 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 C 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.

[0047] An absorbent pad 6, which will be described later, is disposed at the downstream end of the test strip 1. As shown in FIG. 2, a support section 22 is formed in the case body 20 at a position opposite the absorbent pad 6, for supporting the end of the test strip 1 including 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 body 20 also has a support section 21 formed therein for supporting the center of the test strip 1.

[0048] <Test strips> 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.

[0049] (Carrier) 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 a spotting region where the sample is applied from a drop port 16. 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 develops on the carrier 2.

[0050] 2 to 4 show the test region L1, control region L2, and color-developing region L3 as lines, but these do not always appear. As will be described in detail later, before the sample 50 (see FIG. 5), first reagent 41 (see FIGS. 3 and 4), and second reagent 46 (see FIGS. 3 and 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. The color of the test region L1 is amplified by silver amplification, which will be described later, and the test region L1 turns black.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] (Carrier-label-holding pad) 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 port 16 (see Figure 3) of the cover member 10. Therefore, the specimen 50 is dripped onto the label-retaining pad 3 from the drip port 16. Therefore, the label-retaining pad 3 corresponds to a deposition area where the specimen 50 is deposited.

[0055] 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.

[0056] (Carrier-Testing Area) As shown in Figure 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, capturing the analyte 51, 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, causing the color density in the test region L1 to rise above a preset standard. 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.

[0057] (Carrier-control region) 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.

[0058] (carrier-coloring region) 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.

[0059] (binding substance) 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, such as an antibody against the antigen if the test substance is an antigen, an antigen against the antibody if the test substance is an antibody, or an aptamer against the protein, low molecular weight compound, etc. if the test substance is a protein, low molecular weight compound, etc.

[0060] Second binding substance 56, which is immobilized in test region L1 and specifically binds to test substance 51, is a substance that specifically binds to the test substance, such as an antibody for the antigen if the test substance is an antigen, an antigen for the antibody if the test substance is an antibody, or an aptamer for the protein, low molecular weight compound, etc. if the test substance is a protein, low molecular weight compound, etc. First binding substance 52 and second binding substance 56 may be the same or different.

[0061] 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.

[0062] For example, when the test substance 51 is influenza A virus or its biomarker, 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.

[0063] (liquid transfer pad) 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 retention pad 3). As shown in FIG. 3A, when the first pressing operation unit 11 is pressed, one end of the liquid delivery pad 4 is immersed in the first reagent retention unit 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.

[0064] (absorbent pad) 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.

[0065] <Amplification solution> In this embodiment, the first reagent 41 and the second reagent 46 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 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 solutions used for 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 that are relatively larger in particle size than the labeled substance 53.

[0066] 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, with the labeled substance 53 serving 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.

[0067] (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. 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.

[0068] 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.

[0069] 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.

[0070] (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.

[0071] <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.

[0072] First, a sample 50 is spotted on the label holding pad 3, which is a 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.

[0073] 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.

[0074] 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).

[0075] 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.

[0076] 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.

[0077] 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).

[0078] <Immunochromatography testing device> As described above, the cartridge 100 allows the user to check the color state of the test area L1 by visually checking the observation window 18. Furthermore, the cartridge 100 also allows the color state of the test area L1 to be checked using an immunochromatographic test device 110 (hereinafter simply referred to as test device 110) as shown in Fig. 6. The test device 110 detects the color state of the test area L1 of the loaded cartridge 100, determines whether the sample is positive or negative based on the detected color state, and displays the determination result.

[0079] 6, the inspection device 110 includes a housing 111, which includes a cartridge 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 cartridge loading section 112, the opening / closing lid 112a is closed. The inspection is performed with the opening / closing lid 112a closed.

[0080] As an example, the cartridge 100 is loaded into the testing device 110 of this example in a state where the sample has been deposited on the carrier 2 and the supply of the first reagent 41 and the second reagent 46 to the carrier 2 has begun. That is, in this example, before loading the cartridge 100 into the testing device 110, the user performs a pressing operation on the first pressing operation unit 11 and the second pressing operation unit 12. This places the cartridge 100 in the state shown in FIG. 3B , and the cartridge 100 is loaded into the testing device 110 in this state. The testing device 110 detects the color development state of the testing region L1 of the loaded cartridge 100 and displays a determination result of whether the sample is positive or negative. When testing multiple samples, one cartridge 100 for each sample is loaded into the testing device 110.

[0081] 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. The monitor 119 displays the determination results, error messages, and the like. The monitor 119 is, for example, a touch panel monitor, and displays various operation screens. The user can input operation instructions, such as an instruction to start processing and a selection of an inspection procedure, through the operation screen.

[0082] As shown in FIGS. 7 and 8, the inspection device 110 includes a detection unit 114 and an illumination unit 115.

[0083] (Detection unit) The detector 114 optically detects the color development states of the test area L1, the control area L2, and the color development area L3, and outputs a detection signal representing the color development state to a processor (not shown). The detector 114 is, for example, an image sensor such as a CMOS (Complementary Metal Oxide Semiconductor) image sensor or a CCD (Charge Coupled Device) image sensor, and captures an image of the observation area LA, which includes the test area L1, the control area L2, and the color development area L3. The detector 114 in this example outputs the captured image including the observation area LA as a detection signal to the processor.

[0084] When the cartridge 100 is loaded into the inspection device 110, the detection unit 114 is disposed at a position directly facing the observation area LA of the cartridge 100. The directly facing position is a position facing the observation area LA, and more specifically, the directly facing position is a position in front of the observation window 18 that exposes the observation area LA, where the imaging surface of the detection unit 114 faces the surface of the observation area LA in a parallel orientation.

[0085] (Lighting Department) The illumination unit 115 is an example of a light source that illuminates the observation area LA. The illumination unit 115 has, for example, a semiconductor light source such as a light-emitting diode as a light-emitting element (not shown) that emits illumination light. An illumination window (not shown) that emits the illumination light is provided at one end of the illumination unit 115, and the light-emitting element is disposed inside the illumination window. There are, for example, two illumination units 115, which are disposed on both sides of the detection unit 114. More specifically, they are disposed symmetrically in the X direction with respect to the illumination unit 115. Because the detection unit 114 is disposed directly opposite the observation area LA, the two illumination units 115 disposed on both sides of the detection unit 114 irradiate the observation area LA with illumination light from an oblique direction. The observation area LA is exposed through an observation window 18, which is an opening. The illumination units 115 illuminate the observation area LA through the observation window 18.

[0086] The detection unit 114 captures an image of the observation area LA illuminated by the illumination unit 115. The processor acquires the captured image from the detection unit 114 and crops an observation image corresponding to the observation area LA from the acquired captured image. The processor then detects the color development state of the test area L1 based on the observation image, thereby determining whether the sample is positive or negative.

[0087] (Inspection mode) The testing device 110 has two selectable testing modes. In the first mode, the user presses both the first pressing operation unit 11 and the second pressing operation unit 12, and then loads the cartridge 100 into the testing device 110. In the second mode, the user presses only the first pressing operation unit 11 to load the cartridge 100 into the testing device 110, and the second pressing operation unit 12 is operated by an internal mechanism of the testing device 110. Regardless of which mode is selected, the detection unit 114 captures an image of the observation area LA in a state in which the second pressing operation unit 12 has been operated and the second reagent 46 has been supplied.

[0088] <Observation window> 9, the observation window 18 has a rectangular shape with its short side in the X direction and its long side in the Y direction. The Y direction is the longitudinal direction of the cartridge 100, so the observation window 18 has a rectangular shape with its longitudinal direction (Y direction) aligned with the longitudinal direction of the cartridge 100. The illumination unit 115 illuminates the observation area LA from the X direction, which intersects with the Y direction, which is the longitudinal direction of the observation window 18.

[0089] In the observation area LA, the test area L1, the control area L2, and the color-developing area L3 are arranged along a direction intersecting the longitudinal direction of the observation window 18 (X direction).

[0090] As shown in Figure 10, in the observation window 18, two inner peripheral walls 18A along the longitudinal direction and two inner peripheral walls 18B along the lateral direction (X direction) are formed to be inclined with respect to the surface of the observation region LA on the carrier 2. The inclination angle θ1 is 50° or more. Note that the "inclination angle θ1" is an angle based on the surface of the observation region LA, and is 0° when parallel to the surface of the observation region LA and 90° when perpendicular. "Inclined" includes an angle perpendicular to the surface of the observation region LA.

[0091] The inner peripheral walls 18A, 18B are machined surfaces that have been subjected to a roughening process (see the hatched areas in FIG. 8). That is, the inner peripheral wall of the observation window 18 is roughened over the entire periphery. This machined surface is formed by, for example, a texturing process, and the surface roughness is set to an arithmetic mean height Sa of 100 μm or less, which is one of the parameters related to surface roughness defined by the international standard (ISO 25178).

[0092] As shown in Figure 10, when the opening width in the direction along the surface of the observation area LA on the carrier 2 and in the short side direction (X direction) of the observation window 18 is D and the height of the inner wall 18A in the direction perpendicular to the opening width (Z direction) is H, 0.5D≦H≦1.5D is satisfied.

[0093] <Actions and Effects> 3, the cartridge 100 of the present disclosure includes a test strip 1 having a carrier 2 with a test area L1, and a case 9 that houses the test strip 1. The cartridge 100 also includes an observation window 18 that is provided in the case 9 and serves as an opening for observing the test area L1, and is illuminated by an illumination unit 115, which is an example of a light source, within the testing device 110, as shown in FIGS.

[0094] 10, at least a portion of the inner peripheral wall of the observation window 18 (in this embodiment, inner peripheral walls 18A and 18B) has an inclination angle θ1 of 50° or more relative to the surface of the observation area LA having the inspection area L1 on the carrier 2. Furthermore, the inner peripheral walls 18A and 18B are processed surfaces that have been subjected to a surface roughening treatment.

[0095] With this configuration, it is possible to provide a cartridge 100 that, when the observation window 18 is illuminated, makes it easier to uniformize the light intensity distribution in the observation area LA, which includes the inspection area L1 and its surrounding area, compared to conventional cartridges.

[0096] 7 and 8, the inspection device 110 is provided with a detection unit 114 that optically detects the color development state of the inspection area L1, in addition to an illumination unit 115 that is an example of a light source that illuminates the observation window 18. Therefore, the more non-uniform the light intensity distribution of the illumination light in the observation area LA, which includes the inspection area L1 and its surrounding area, the higher the possibility of erroneous detection.

[0097] Here, if the illumination unit 115 can be placed in a position directly facing the observation area LA including the inspection area L1, like the detection unit 114, it is possible to irradiate the observation area LA with illumination light from the front. In this case, the distance from the illumination unit 115 becomes relatively uniform throughout the entire observation area LA, making it easier to ensure uniformity in the light intensity distribution.

[0098] 7 and 8, however, it is highly necessary to place the detection unit 114 in a position directly opposite the observation area LA, and in that case, the illumination unit 115 must be placed to the side of the detection unit 114. Therefore, illumination light is irradiated from an oblique direction rather than from the front of the observation area LA.

[0099] In this case, compared to when the illumination unit 115 is placed in a directly opposite position, the distance from the illumination unit 115 is more likely to be uneven depending on the location of the observation area LA, and part of the observation area LA is more likely to be in shadow due to vignetting of the illumination light around the observation window 18. In this case, the light intensity distribution in the observation area LA is more likely to be non-uniform.

[0100] 11, consider a case where the observation window 18 is illuminated by an illumination unit 115 disposed diagonally above and to the right of the observation window 18. In this case, there is a difference in distance from the illumination unit 115 between the right and left sides of the observation area LA, which tends to result in a non-uniform light intensity distribution. That is, the distance D2 from the illumination unit 115 to the left portion of the observation area LA is longer than the distance D1 to the right portion, so the left portion appears darker.

[0101] 12, because the illumination light is incident from diagonally above to the right, it is likely that the illumination light will be directly incident on the observation area LAL located on the left side of the observation window 18 without being vignetted, but because there is a possibility that the illumination light will be vignetted around the right side of the observation window 18, the amount of illumination light that directly incidents on the observation area LAR located on the right side of the observation window 18 is relatively small, and it is likely to be shaded. In this way, when illumination light is irradiated onto the observation window 18 from an oblique direction, the light amount distribution within the observation area LA is likely to be non-uniform.

[0102] 11 and 12 are positioned differently within the inspection device 110 than the illumination unit 115 shown in FIG. 8, but these are merely examples of the position of the illumination unit 115. Within the inspection device 110, the illumination unit 115 can be positioned in various positions. For example, if the planar dimensions of the detection unit 114 are large, the illumination unit 115 may be positioned farther away from the observation window 18 than if the planar dimensions are small. Furthermore, if the vertical dimensions of the inner area of ​​the inspection device 110 are small, the illumination unit 115 may be positioned at a lower position.

[0103] According to the cartridge 100 of the present disclosure, as shown in FIG. 13, at least a portion of the inner wall 18A of the observation window 18 has an inclination angle θ1 of 50° or more relative to the surface of the observation area LA, making it easier to reflect illumination light incident on the inner wall 18A of the observation window 18 from an oblique direction toward the observation area LA compared to when the angle θ1 is less than 50°.

[0104] For example, illumination light directed toward the observation window 18 from diagonally above to the right is incident on the inner circumferential wall 18A on the left side of the observation window 18, as shown by the straight line K1. If the angle θ1 of the processed surface of the inner circumferential wall 18A is 50° or more, the incident illumination light is more likely to be reflected toward the right side of the observation area LA, as shown by the arrow K2, than if the angle θ1 is less than 50°. This makes it possible to increase the amount of light on the right side of the observation area LA.

[0105] Furthermore, since at least a portion of the inner circumferential wall 18A is roughened, the scattering of reflected light is greater than when the inner circumferential wall 18A is not roughened. As a result, the light scattering effect reduces non-uniformity in the light intensity distribution caused by differences in distance from the illumination unit 115 (see FIG. 11).

[0106] In addition, when the illumination unit 115 is a light-emitting element such as a light-emitting diode, it emits divergent light that spreads radially from a light-emitting point as a base point. In FIG. 13, the axis passing through the center of the divergent light beam is indicated by a line K1 as the central axis of the beam. Furthermore, arrow K2 is an arrow drawn symmetrically with line K1, with the normal N of the inner circumferential wall 18A as the "axis of symmetry," and indicates an example of the direction of reflected light, which is scattered light. Furthermore, arrows K3 and K4 indicate other examples of the direction of reflected light. In this way, the reflected light from the inner circumferential wall 18A is diffused in various directions. This mechanism of diffusing reflected light makes it easier to uniform the light intensity distribution in the observation area LA compared to conventional methods.

[0107] Here, of the reflected light from the inner wall 18A of the observation window 18, the reflected light that goes directly to the detection unit 114 (see Figures 7 and 8) without passing through the observation area LA does not contain information about the observation area LA, and therefore is unnecessary light that becomes noise for the detection unit 114.

[0108] In this embodiment, the inclination angle θ1 of the inner peripheral wall 18A of the observation window 18 is 50° or more, and therefore, compared to when the inclination angle θ1 is less than 50°, the amount of illumination light reflected by the inner peripheral wall 18A that is reflected toward the observation area LA is greater. This makes it possible to relatively reduce unnecessary light that is directed directly toward the detection unit 114. Because unnecessary light that becomes noise is reduced, more accurate inspection is possible.

[0109] 14 shows an inner circumferential wall 180A as a comparative example in which the angle θ1 with respect to the surface of the observation region LA is less than 50°, for example, 45°. In this example, the reflected light of the incident light indicated by the line K1, which is reflected at an angle symmetrical to the line K1 with the normal line N of the inner circumferential wall 18A as the axis of symmetry, is directed upward rather than toward the observation region LA. When the angle θ1 with respect to the surface of the observation region LA is less than 50°, as in this inner circumferential wall 180A, it is more difficult to reduce the unnecessary light that directly heads toward the detection unit 114 than when the angle θ1 is 50° or more.

[0110] Furthermore, according to the cartridge 100 of the present disclosure, the observation window 18 is rectangular, as shown in FIG. 9 . Of the inner circumferential walls 18A and 18B, at least the inner circumferential wall 18A extending in the longitudinal direction has a roughened surface (note that in this example, the inner circumferential wall 18B also has a roughened surface). When the observation window 18 is rectangular, the illumination unit 115 is often disposed so that the illumination direction intersects with the longitudinal direction (Y direction) along which the opening is wide in order to ensure a sufficient amount of incident light. For example, in this embodiment, as shown in FIG. 8 , the illumination unit 115 is disposed so as to illuminate the observation window 18 from a direction (X direction) perpendicular to the longitudinal direction of the observation window 18. Therefore, if a roughened surface is formed on the inner circumferential wall 18A, which is a wall surface extending in the longitudinal direction, it is highly effective in suppressing non-uniformity in the light intensity distribution.

[0111] In addition, in the cartridge 100 of the present disclosure, the roughened processed surface is also formed on the inner wall 18B extending in the short direction, and the processed surface is formed around the entire inner wall of the observation window 18, which is an example of an opening (in this example, both inner walls 18A and 18B).

[0112] If only a specific wall surface, for example, inner circumferential wall 18A, is roughened, it is difficult to obtain a scattering effect for light reflected from the other wall surface, inner circumferential wall 18B. However, if the entire inner circumferential wall of observation window 18 is roughened as in the present disclosure, the area of ​​the wall surface from which a scattering effect can be obtained is increased, thereby improving the scattering effect for reflected light.

[0113] For example, when the observation window 18 is rectangular as in this embodiment, the illumination light incident on the inner peripheral wall 18B extending in the short direction as well as the inner peripheral wall 18A extending in the longitudinal direction can be scattered. A portion of the light scattered by the inner peripheral wall 18B is irradiated onto the observation area LA. This makes it easy to suppress non-uniformity in the light intensity distribution across the entire surface of the observation area LA.

[0114] In this embodiment, the processed surface is formed around the entire periphery of the inner peripheral wall of the observation window 18, but the embodiment of the present disclosure is not limited to this. For example, the processed surface may be formed only on the entire inner peripheral wall 18A. Furthermore, the processed surface may be formed only on the position of the inner peripheral wall 18A that overlaps with the inspection region L1 and the surrounding area of ​​that position.

[0115] Furthermore, in the cartridge 100 of the present disclosure, a linear inspection area L1 is arranged along a direction (X direction) intersecting the longitudinal direction of the observation window 18. Therefore, in the direction in which the inspection area L1 extends, it is possible to obtain the effect of suppressing non-uniformity in the light intensity distribution caused by the processed surface formed on the inner circumferential wall 18A extending in the longitudinal direction.

[0116] That is, by forming a processed surface on the inner peripheral wall 18A extending in the longitudinal direction, i.e., the Y direction, the non-uniformity of the light intensity distribution in the X direction of the observation area LA can be suppressed, making it easier to uniformly illuminate the inspection area L1.

[0117] Furthermore, the surface roughness of the processed surface of the cartridge 100 of the present disclosure is set to an arithmetic mean height Sa of 100 μm or less, which is one of the parameters related to surface roughness defined by the international standard (ISO 25178). This makes it easier for reflected light to diffuse over a wide angle compared to when the arithmetic mean height Sa is greater than 100 μm, thereby improving the effect of suppressing non-uniformity in the light intensity distribution.

[0118] Furthermore, in the cartridge 100 of the present disclosure, the processed surface is roughened by applying a embossing process, which results in higher durability of the roughened surface compared to, for example, a case where a roughened sheet material is attached.

[0119] Note that the roughening treatment in the present disclosure includes roughening by forming regular or irregular irregularities, as well as attaching a roughened sheet material, etc. Examples of regular irregularities include irregularities with a sawtooth cross section and a regular pitch, and irregularities formed by arranging multiple circular or rectangular protrusions two-dimensionally at regular intervals.

[0120] Examples of irregular asperities include chemical etching and embossing by sandblasting. Furthermore, the mold used to form cover member 10 of case 9 may be roughened by etching or sandblasting. If the mold is roughened, the asperities of the mold are transferred to cover member 10.

[0121] 10, in the cartridge 100 of the present disclosure, the height H of the inner circumferential wall 18A of the observation window 18 is set to be 0.5 or more times the opening width D in the direction along the surface of the observation area LA and in the short side direction of the observation window 18. This increases the area that can reflect light compared to when the height H of the inner circumferential wall 18A is less than 0.5 times the opening width D of the observation window 18 (an example of an opening) as shown in FIG. 15, and therefore increases the scattering effect of light incident on the observation window 18 due to reflection by the inner circumferential wall.

[0122] Specifically, when the height H of the inner circumferential wall 18A is set to be "at least" 0.5 times the opening width D of the observation window 18, the light indicated by the straight line K5 is incident on the inner circumferential wall 18A and reflected toward the observation area LA as indicated by the arrow K6. On the other hand, when the height H of the inner circumferential wall 18A is set to be "less than" 0.5 times the opening width D of the observation window 18, the light indicated by the straight line K5 is not incident on the inner circumferential wall 18A, but is incident on the upper surface of the cover member 10 and reflected upward as indicated by the arrow K7.

[0123] Furthermore, in the cartridge 100 of the present disclosure, the height H of the inner circumferential wall 18A is set to be 1.5 times or less the opening width D of the observation window 18. This makes it less likely for the inner circumferential wall 18A to block the illumination light compared to when the height H of the inner circumferential wall 18A is greater than 1.5 times the opening width D of the observation window 18, and therefore the illumination light is more likely to enter the observation area LA.

[0124] Specifically, when the height H of the inner circumferential wall 18A is "less than" 1.5 times the opening width D of the observation window 18, the light indicated by the arrow K8 enters the observation area LA. On the other hand, when the height H of the inner circumferential wall 18A is "greater than" 1.5 times the opening width D of the observation window 18, the light indicated by the arrow K8 does not enter the observation area LA, but enters the upper surface of the cover member 10 and is reflected upward as indicated by the arrow K9.

[0125] 1, 2, and 8, the cartridge 100 of the present disclosure has a structure that is convex in a direction away from the surface of the observation area LA around the observation window 18. An example of such a structure is a boss that forms a drip port 16 for dripping a sample onto the test strip 1 arranged inside the cartridge 100. Another example is a pressing portion (e.g., a second pressing operation portion 12) for spreading an amplification liquid on the test strip 1.

[0126] In the cartridge 100, at least a portion of the outer circumferential wall of these structures may be roughened. By roughening such a portion, a portion of the scattered light reflected by the outer circumferential wall can be made to enter the observation area LA. This increases the amount of light in the observation area LA.

[0127] 10 and 13, in the cartridge 100 of the present disclosure, the angle θ1 of the inner circumferential wall 18A relative to the surface of the observation area LA is set to 50° or more. It is more preferable that this inclination angle θ1 be set to 70° or more and 90° or less. When the inclination angle θ1 is less than 70°, the amount of light reflected toward the observation area LA is reduced compared to when the inclination angle θ1 is 70° or more. Furthermore, when the inclination angle θ1 is greater than 90°, it becomes more difficult for light to enter the observation window 18, and therefore the amount of light entering the observation area LA is reduced.

[0128] As an example of the inclination angle θ1 within the range of 70° to 90°, FIG. 16 shows an example in which the inclination angle θ1 is approximately 90°. Increasing the angle θ1 within the range of 70° to 90° in this way makes it easier for light incident on the observation window 18 to be reflected downward. This makes it possible to further suppress non-uniformity in the light intensity distribution in the observation area LA. Note that when molding the cover member 10 using a mold by injection molding or the like, a draft angle is required for the mold, so strictly speaking, the inclination angle θ1 is slightly smaller than 90°.

[0129] As shown in FIG. 17, the larger the tilt angle θ1, the smaller the incident angle of light from the illumination unit 115 toward the observation window 18. As with the tilt angle θ1, the incident angle is an angle where 0° is parallel to the surface of the observation area LA and 90° is perpendicular. If the incident angle is made smaller, the position of the illumination unit 115 can be lowered. This allows the inspection device 110 for loading the cartridge 100 to be made smaller. The tilt angle θ1 is set taking these multiple factors into consideration.

[0130] Furthermore, when the cartridge 100 is loaded into the inspection device 110, the relative positional relationship between the illumination unit 115 and the observation window 18 is preferably as follows.

[0131] That is, as shown in FIG. 13, it is preferable that a straight line K1 indicating the central axis of the divergent light beam emitted from the illumination unit 115 (see FIGS. 7 and 8) and a normal N to the inner peripheral wall 18A of the observation window 18 satisfy the following relationship:

[0132] When the angle between the surface of the observation area LA in the test strip 1 and the straight line K1 is defined as the first angle α, and the angle between the surface of the observation area LA and the normal N of the inner wall 18A is defined as the second angle β, the conditions that β<α and α are 90° or less are satisfied.

[0133] If the inspection device 110 is used in which the illumination unit 115 is arranged so as to satisfy this condition, it is easy to increase the amount of light reflected from the inner circumferential wall 18A that travels toward the observation area LA.

[0134] (Modification of inner peripheral wall) The shape of the inner peripheral wall can be modified as follows: In the example shown in Fig. 18, when the inner peripheral wall 18A is the first inner peripheral wall, an inner peripheral wall 18C is formed around the observation window 18 as a second inner peripheral wall that rises in a direction away from the surface of the observation area LA along an intersecting direction that intersects with the surface of the observation area LA. This inner peripheral wall 18C rises from the edge of the inner peripheral wall 18A.

[0135] In this embodiment, a recess is formed in a part of the cover member 10, sagging toward the interior where the test strip 1 is placed, and the observation window 18 is formed at the bottom of the recess. Because a recess is formed, the inner peripheral wall of the recess becomes the inner peripheral wall 18C. By forming a recess, it is easy to bring the observation window 18 close to the observation area LA, even when the maximum thickness of the cover member 10 is large. Because the observation window 18 can be brought close to the observation area LA, it is possible to efficiently allow the amount of light incident on the observation window 18 to enter the observation area LA, compared to when the observation window 18 and the observation area LA are far apart.

[0136] Furthermore, it is preferable that at least a portion of the inner circumferential wall 18C be roughened, similar to the inner circumferential wall 18A. This allows the light reflected from the inner circumferential wall 18C to be diffused, as shown by arrows K10 in Fig. 19. This makes it easier to achieve a uniform light intensity distribution compared to when the inner circumferential wall 18C is not roughened.

[0137] Furthermore, when forming inner wall 18C as the second inner wall, as shown in Figures 19 and 20, it is preferable that the inclination angle θ2 of inner wall 18C relative to the surface of observation area LA is smaller than the inclination angle θ1 of inner wall 18A relative to the surface of observation area LA.

[0138] 20, light reflected by inner circumferential wall 18C is more likely to be directed upward than light reflected by inner circumferential wall 18A. Therefore, light reflected by inner circumferential wall 18C is not only incident on observation area LA as indicated by arrow K11, but is also more likely to be incident on inner circumferential wall 18A as indicated by arrow K12. Because light enters observation area LA via various paths, including light passing through two reflective surfaces of inner circumferential wall 18C and inner circumferential wall 18A, a synergistic effect can be obtained with the light scattering effect of inner circumferential wall 18A.

[0139] As shown in FIG. 21, for example, the inclination angle θ2 of the inner circumferential wall 18C relative to the surface of the observation region LA may be set to be larger than the inclination angle θ1 of the inner circumferential wall 18A relative to the surface of the observation region LA.

[0140] Furthermore, when forming inner peripheral wall 18C as the second inner peripheral wall, a flat portion 18D may be provided between inner peripheral wall 18A and inner peripheral wall 18C, as shown in Fig. 22. Flat portion 18D is a flat portion that is provided around the observation window 18 and extends in a direction along the surface of observation area LA. Inner peripheral wall 18C rises from the edge of flat portion 18D on the side opposite to observation window 18. By providing such a flat portion, the thickness of the portion around observation window 18 can be reduced even if the entire thickness of cover member 10 is large.

[0141] Furthermore, although the inspection device into which the cartridge 100 of the present disclosure is loaded has the illumination unit 115 disposed above the cartridge 100, the embodiment of the present disclosure is not limited to this. For example, the illumination unit 115, which is an example of a light source, may be disposed below the cartridge 100 as shown in FIG.

[0142] When the observation area LA is illuminated from the illumination unit 115 below the cartridge 100 in this manner, the observation area LA is illuminated by transmitted light that has passed through the case body 20 and the test strip 1. Even in this case, the transmitted light is reflected by the inner circumferential wall 18A, and the reflected light is diffused, so that the observation area LA can be illuminated with scattered light.

[0143] When the observation area LA is illuminated from the illumination unit 115 below the cartridge 100, it is preferable that the portion of the inner surface of the cover member 10 that faces the test strip 1 also be a roughened processed surface, which can enhance the scattering effect when transmitted light is reflected.

[0144] In addition, in the cartridge 100 of the present disclosure, the test region L1, the control region L2, and the color-developing region L3 are formed in the observation region LA, but the embodiment of the present disclosure is not limited to this. As long as at least the test region L1 is formed in the observation region LA, the light scattering effect of the inner circumferential wall 18A can be utilized.

[0145] Furthermore, in the above embodiment, the cartridge 100 was described as an example in which the color development state of the inspection area L1 can be visually confirmed. However, the technology of the present disclosure can also be applied to cartridges in which the color development state of the inspection area cannot be visually confirmed. For example, such cartridges include fluorescent cartridges in which the inspection area emits fluorescence when irradiated with excitation light. In fluorescent cartridges, the color development state of the inspection area cannot be visually confirmed when excitation light is not irradiated. However, even when excitation light is used to illuminate the inspection area, the light intensity distribution of the excitation light affects the color development state of the fluorescence in the inspection area. Therefore, the technology of the present disclosure is also effective for such cartridges.

[0146] The present disclosure is not limited to the above embodiments, and can be implemented by making appropriate modifications, such as omitting configurations or replacing them with different configurations, within the scope that does not deviate from the spirit of the present disclosure.

[0147] The disclosure of Japanese Patent Application No. 2021-054135, filed on March 26, 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. A test cartridge that is detachably loaded into an immunochromatographic testing device, a carrier having a test area whose color development state changes depending on whether the sample is positive or negative; a case in which the carrier is housed; an opening provided in the case for observing an observation area including the test area, the opening being illuminated by a light source within the immunochromatographic test device; It is equipped with At least a part of the inner peripheral wall of the opening has an angle of 50° or more with respect to the surface of the observation area, and is a processed surface that has been subjected to a roughening treatment.

2. 2. The testing cartridge according to claim 1, wherein the angle is in the range of 70 degrees to 90 degrees.

3. The opening is rectangular, 3. The testing cartridge according to claim 1, wherein the processed surface is formed on a wall surface of the inner circumferential wall that extends in the longitudinal direction.

4. the inspection area is a linear inspection line, The inspection cartridge according to claim 3 , wherein the inspection line is arranged along a direction intersecting the longitudinal direction.

5. 5. The testing cartridge according to claim 1, wherein the processed surface is formed over the entire circumference of the inner peripheral wall.

6. 6. The inspection cartridge according to claim 1, wherein the arithmetic mean height Sa of the processed surface, which is one of the parameters defining the surface roughness, is 100 μm or less.

7. 7. The inspection cartridge according to claim 1, wherein the surface roughening treatment is a graining treatment.

8. The opening is rectangular, When the opening width in the direction along the surface of the observation area and in the direction of the short side of the opening is D and the height of the inner wall in the direction perpendicular to the opening width is H, 0.5D≦H≦1.5D The testing cartridge according to any one of claims 1 to 7, wherein

9. In the case where the inner peripheral wall of the opening is a first inner peripheral wall, a second inner peripheral wall extending in a direction intersecting the surface of the observation area and rising in a direction away from the surface, around the opening; The testing cartridge according to any one of claims 1 to 8.

10. a flat surface portion extending in a direction along the surface of the observation area is provided around the opening, The testing cartridge according to claim 9 , wherein the second inner peripheral wall rises from an edge of the flat portion opposite to the opening.

11. In the case where the inner peripheral wall of the opening is a first inner peripheral wall, The testing cartridge according to claim 9 , wherein the second inner circumferential wall rises from an edge of the first inner circumferential wall.

12. 12. The inspection cartridge according to claim 9, wherein at least a portion of the second inner circumferential wall is subjected to the surface roughening treatment.

13. 13. The testing cartridge according to claim 9, wherein the second inner circumferential wall is inclined at an angle smaller than the angle of the first inner circumferential wall.

14. a convex structure is provided around the opening in a direction away from the surface of the observation area, The testing cartridge according to any one of claims 1 to 13, wherein at least a part of the outer peripheral wall of the structure is subjected to the surface roughening treatment.

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