Immunochromatography test kit

Abstract

Compared to conventional immunochromatographic test kits, this kit reduces the amount of capture antibody used, providing a lower-cost immunochromatographic test kit. [Solution] The immunochromatographic test kit comprises a sample application section onto which the sample is dropped, a conjugate section on which a labeled antibody having the property of binding to the target substance in the sample is immobilized, and a detection section on which a capture antibody having the property of binding to the target substance is attached. The detection section is formed on a carrier and cannot be observed by visual inspection. The immunochromatographic test kit is designed to allow direct observation of the labeling substance of the labeled antibody bound to the target substance captured in the detection section using a microscope.

Description

Technical Field

[0001] The present invention relates to an immunochromatography test kit.

Background Art

[0002] Immunochromatography is currently being implemented in society as an aid for diagnosing various diseases, mainly influenza virus. Its principle utilizes antigen-antibody reactions and is widely used in the medical field due to its simplicity and effectiveness.

[0003] In conventional immunochromatography, the presence or absence of color development in the detection part of an immunochromatography test kit (also called a developing support or chromatographic medium) is visually observed. Specifically, when the detection target bound to the labeled antibody is captured by the capture antibody fixed on the detection part and sufficiently accumulated on the detection part, the color development derived from the labeled antibody is visually confirmed.

[0004] International Publication No. 2010 / 061772 (Patent Document 1) discloses an immunochromatography test kit in which the detection part is formed with a size of several millimeters or more that can be visually determined.

Prior Art Documents

Patent Documents

[0005] [[ID=3*]]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] In the conventional immunochromatography test kit as described above, since the color development derived from the labeled antibody is visually confirmed, it is necessary to provide a sufficient area to avoid misjudgment. As a result, the area of the detection part is several millimeters. 2As described above, a certain number of capture antibodies must be immobilized on the detection unit to capture the antigen, making it difficult to reduce the amount of expensive capture antibodies used and thus hindering cost reduction.

[0007] The main objective of the present invention is to provide an immunochromatographic test kit that can reduce the amount of capture antibody used and is low-cost compared to conventional immunochromatographic test kits. [Means for solving the problem]

[0008] The immunochromatographic test kit according to the present invention comprises a sample application section onto which a sample is dropped, a conjugate section on which a labeled antibody having the property of binding to a target substance in the sample is immobilized, and a detection section on which a capture antibody having the property of binding to a target substance is attached. The detection section is formed on a carrier and is not observable by visual inspection. The immunochromatographic test kit is designed to allow direct observation of the labeling substance of the labeled antibody bound to the target substance captured in the detection section using a microscope. [Effects of the Invention]

[0009] According to the present invention, the amount of capture antibody used can be reduced compared to conventional immunochromatographic test kits, and a low-cost immunochromatographic test kit can be provided. [Brief explanation of the drawing]

[0010] [Figure 1] This is a perspective view of the immunochromatographic test kit according to Embodiment 1. [Figure 2] Figure 1 is a partially enlarged plan view of the detection section of the immunochromatographic test kit shown. [Figure 3] This is a magnified view of a portion of the detection unit to illustrate its width. [Figure 4] This is a partially enlarged cross-sectional view taken from arrow IV-IV in Figure 2. [Figure 5] This is a flowchart of the manufacturing method for the immunochromatographic test kit according to Embodiment 1. [Figure 6]It is a perspective view of a coating device used in a method for manufacturing an immunochromatographic test kit according to Embodiment 1. [Figure 7] It is a front view of the coating unit of the coating device shown in FIG. 6. [Figure 8] It is a side view of the coating unit of the coating device shown in FIG. 6. [Figure 9] It is a front view for explaining the operation of the coating unit of the coating device shown in FIG. 6. [Figure 10] It is a front view for explaining the operation of the coating unit of the coating device shown in FIG. 6. [Figure 11] It is a partially enlarged plan view showing a modified example of the detection unit shown in FIG. 2. [Figure 12] It is a partially enlarged plan view showing another modified example of the detection unit shown in FIG. 2. [Figure 13] It is a partially enlarged plan view of the detection unit of the immunochromatographic test kit according to Embodiment 2. [Figure 14] It is a partially enlarged plan view showing a modified example of the detection unit shown in FIG. 13. [Figure 15] It is a partially enlarged plan view showing another modified example of the detection unit shown in FIG. 13. [Figure 16] It is a partially enlarged plan view showing still another modified example of the detection unit shown in FIG. 13. [Figure 17] It is a perspective view of an immunochromatographic test kit according to Embodiment 3. [Figure 18] It is a perspective view of an immunochromatographic test kit according to Embodiment 4. [Figure 19] It is an electron microscope image obtained by observing the detection unit 3 of Example 1 using an electron microscope. [Figure 20] It is an electron microscope image obtained by observing the detection unit 3 of Example 2 using an electron microscope. [Figure 21] In Example 2, it is an electron microscope image obtained by observing the detection unit 3 before the auxiliary liquid is dropped using an electron microscope. [Figure 22]This is an electron microscope image obtained by observing the detection unit 3 after the auxiliary liquid was dropped in Example 2.

Mode for Carrying Out the Invention

[0011] Hereinafter, an embodiment as an example of the present invention will be described with reference to the drawings. In the following drawings, the same or corresponding parts are denoted by the same reference numerals, and the description thereof will not be repeated.

[0012] (Embodiment 1) <Immunochromatographic Test Kit> As shown in FIGS. 1 to 2, the immunochromatographic test kit 100 according to Embodiment 1 mainly includes a specimen dropping part 1, a conjugate part 2, a detection area t including a plurality of detection units 3, a control area c including a control part 4, and an absorption part 5. As shown in FIGS. 1 and 2, the specimen dropping part 1, the conjugate part 2, the detection area t, the control area c, and the absorption part 5 are arranged in the above-described order along the development direction D.

[0013] The specimen dropping part 1 is a part where a specimen is dropped. The specimen dropping part 1 is formed of a porous member such as a glass fiber pad, a cellulose fiber pad, and a polyester pad.

[0014] The conjugate portion 2 is the portion on which a labeled antibody, which has the property of binding to the target substance in the sample, is immobilized. The labeled antibody is a conjugate of an antibody that specifically recognizes and binds to the first part (first epitope) of the target substance and a labeling substance. The antibody can be arbitrarily selected depending on the target substance. The labeling substance can be arbitrarily selected from labeling substances used in conventional immunochromatography. The labeling substance includes, for example, at least one selected from the group consisting of metal nanoparticles (metal fine particles), latex fine particles, organic polymer fine particles, inorganic fine particles, and chromogenic fine particles such as liposomes containing a chromogenic agent. The labeling substance includes, for example, at least one selected from the group consisting of precious metal nanoparticles such as gold nanoparticles, platinum nanoparticles, platinum-gold nanoparticles, and silver nanoparticles, titanium nanoparticles, iron nanoparticles, nickel nanoparticles, and cadmium nanoparticles as metal nanoparticles. The above metal nanoparticles may be colloidal metal nanoparticles with a particle size of 1 nm or more and 100 nm or less. The conjugate portion 2 is prepared, for example, by applying a suspension containing a labeled antibody to a porous material such as a fiberglass pad, a cellulose fiber pad, or a polyester pad, and then drying it.

[0015] The detection region t is positioned in the unfolding direction D on the opposite side of the sample application area 1 from the conjugate portion 2. The detection region t is formed on a carrier 6 made of a porous material. The detection region t includes a plurality of detection units 3. Each detection unit 3 is connected to the sample application area 1 via the conjugate portion 2. Each detection unit 3 is positioned in the unfolding direction D on the opposite side of the sample application area 1 from the conjugate portion 2. Each detection unit 3 is a portion on which a capture antibody, which has the property of binding to the target substance, is fixed. The capture antibody is an antibody that specifically recognizes and binds to a second portion (second epitope) of the target substance that is different from the first portion described above. From a different perspective, the capture antibody has the property of binding to the target substance that is bound to a labeling substance. The capture antibody can be arbitrarily selected depending on the target substance.

[0016] As shown in Figure 2, the external shape of each detection unit 3 is dot-shaped. The dot width of each detection unit 3 is the smallest size observable by the naked eye, or a size that is not observable by the naked eye but observable by a microscope. The dot width of each detection unit 3 is, for example, less than 1 mm. Preferably, the dot width of each detection unit 3 is equivalent to the field of view of an electron microscope or the like, which can directly observe labeled substances with a size of 1 μm or less that bind to the labeled antibody. The dot width of each detection unit 3 is, for example, 100 μm or less.

[0017] The width of the detection unit 3 is measured as follows. First, a sample containing a sufficient amount of the target substance is dropped onto the sample dropper 1 to induce an antigen-antibody reaction on the immunochromatographic test kit 100. Next, an electron microscope image of the detection unit 3 is acquired according to the test method described later. In the case where the detection unit 3 includes the bottom surface 7A of the recess 7, as in the immunochromatographic test kit 100 according to this embodiment 1, the electron microscope image acquired with focus on the bottom surface 7A is used. Next, the outline of the region where the labeled antibody is observed in the image is identified as the outline of the detection unit 3. Next, the width of the outline of the detection unit 3 is measured. As shown in Figure 3, if the outline of the region where the labeled antibody is observed is wavy inward and outward, the diameter D1 of the circumscribed circle CC and the diameter D2 of the inscribed circle IC of the outline are calculated by image processing, and the midpoint between diameter D1 and diameter D2 is defined as the width of the outline of the detection unit 3.

[0018] The detection units 3 shown in Figure 2 are spaced apart from each other in a direction that intersects (e.g., orthogonal to) the deployment direction D. The detection units 3 are arranged one-dimensionally in a direction that intersects (e.g., orthogonal to) the deployment direction D. The distance between two adjacent detection units 3 is, for example, less than 1 mm.

[0019] The external shape of each detection unit 3 is not particularly limited as long as it is dot-shaped, but for example, it is circular. However, the external shape of each detection unit 3 may also be elliptical, square, or rectangular.

[0020] As shown in Figure 4, a plurality of recesses 7 are formed in the detection region t of the carrier 6. Each recess 7 is recessed relative to the upper surface of the carrier 6. Each recess 7 has a bottom surface 7A and a wall surface 7B connecting the bottom surface 7A and the upper surface of the carrier 6, and the opening of the upper surface 6A and the bottom surface 7A are dot-shaped. In the cross-section shown in Figure 4, the bottom surface 7A and the wall surface 7B form an obtuse angle. In other words, the cross-sectional shape of each recess 7 shown in Figure 4 has a tapered shape such that the distance between the opposing wall surfaces 7B narrows as it approaches the bottom surface 7A, but the diameter of the opening of the upper surface 6A and the diameter of the bottom surface 7A may be the same. The width of the bottom surface 7A of each recess 7 is the smallest size that can be confirmed by visual observation, for example, less than 1 mm. Preferably, the width of the bottom surface 7A of each recess 7 is equivalent to the field of view of an electron microscope or the like that can directly observe labeled substances with a size of 1 μm or less that bind to the labeled antibody. For example, the dot width of each base surface 7A is 100 μm or less. The depth of each base surface 7A is greater than the depth of focus of the electron microscope. The depth of each base surface 7A is, for example, 10 μm or more.

[0021] The planar external shape of each base surface 7A is, for example, circular. However, the planar external shape of each base surface 7A may also be elliptical, square, or rectangular.

[0022] Each detection unit 3 includes the bottom surface 7A of each recess 7. Each detection unit 3 is formed in each recess 7 of the carrier 6. Each detection unit 3 and each recess 7 are formed simultaneously in the carrier 6, for example. The method for simultaneously forming the detection units 3 and recesses 7 in the carrier 6 will be described in detail in the manufacturing method of the immunochromatographic test kit described later.

[0023] The control region c is positioned on the opposite side of the conjugate portion 2 from the detection region t in the unfolding direction D. The control region C includes a control portion 4. The control portion 4 is the portion to which the control antibody that binds to the labeled antibody is fixed. The external shape of the control portion 4 can be any shape, for example, a line.

[0024] The control unit 4 is formed on the carrier 6. In the deployment direction D, the control unit 4 is positioned on the opposite side of the conjugate unit 2 from the detection unit 3.

[0025] Note that in Figures 1 and 2, for ease of explanation, the detection region t and control region c are shown with dashed lines. In actual immunochromatographic test kits, for example, these dashed lines are not shown.

[0026] The absorbent section 5 is the part that absorbs excess sample after deployment. The absorbent section 5 is formed from a porous material such as a glass fiber pad, a cellulose fiber pad, or a polyester pad. In the deployment direction D, the absorbent section 5 is positioned on the opposite side of the detection area t from the control area c.

[0027] The external shape of the carrier 6 is rectangular. The carrier 6 has a longitudinal direction along the unfolding direction D and a transverse direction perpendicular to the unfolding direction D. The material constituting the carrier 6 can be any porous material, but includes, for example, nitrocellulose and polyvinylidene fluoride (PVDF) at least one of the above. In other words, in the immunochromatographic test kit 100 according to Embodiment 1, the multiple detection units 3 and control units 4 are formed on porous members separate from the porous members constituting the sample application unit 1, the conjugate unit 2, and the absorption unit 5. The porous member constituting the sample application unit 1 is, for example, bonded to the porous member constituting the conjugate unit 2. Each porous member constituting the conjugate unit 2 and the absorption unit 5 is, for example, bonded to each porous member constituting the carrier 6.

[0028] The sample application section 1, conjugate section 2, detection section 3, control section 4, absorption section 5, and carrier 6 may be fixed to a substrate (also called a backing sheet) (not shown) using an adhesive or adhesive sheet. The carrier 6 may be a thin film formed on the substrate.

[0029] <Testing method using an immunochromatographic test kit> In the testing method using an immunochromatographic test kit, the detection unit 3 after the antigen-antibody reaction on the immunochromatographic test kit is observed using an electron microscope. The antigen-antibody reaction on the immunochromatographic test kit is described below.

[0030] First, the sample is dropped into the sample dropper 1. The dropped sample flows along the expansion direction D due to capillary action. The target substance in the sample binds to the labeled antibody in the conjugate section 2. The conjugate of the target substance and the labeled antibody moves along the expansion direction D along the expansion direction D due to capillary action, along with the labeled antibody that is not bound to the target substance. The target substance bound to the labeled antibody binds to the capture antibody in the detection section 3. As a result, the labeled antibody bound to the target substance accumulates in the detection section 3. The labeled substance bound to the labeled antibody in the detection section 3 is directly observed using an electron microscope. Furthermore, the labeled antibody that is not bound to the target substance binds to the control antibody in the control section 4. As a result, the labeled antibody that is not bound to the target substance is captured in the control section 4. The labeled substance bound to the labeled antibody in the control section 4 is directly observed using an electron microscope. Any excess sample that flows downstream of the control section 4 in the expansion direction D is absorbed into the absorption section 5.

[0031] The testing method using an immunochromatographic test kit is performed, for example, using the following procedure. First, the sample is dropped into sample application area 1, and after the specified time has elapsed, the auxiliary solution is dropped.

[0032] The auxiliary solution has conductivity and / or the property of polymerizing to form a film, which contributes to image clarity under electron microscope measurement conditions, preventing the generation of static charge and heat. The auxiliary solution contains, as essential components, glycerin and glycerin substitutes; polysorbates such as polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 80, polysorbate 85, and polysorbate substitutes, and at least one compound selected from these; and as optional components, at least one compound selected from monosaccharides, disaccharides, salts, and buffers.

[0033] Next, the detection unit 3 is observed using an electron microscope. Specifically, first, the carrier 6 is set in the chamber of the electron microscope. Next, the detection unit 3 is searched for while observing the upper surface of the carrier 6. In the immunochromatography test kit 100, a focus shift caused by the distance between the upper surface and the bottom surface 7A of the carrier 6 is observed in the electron microscope image (bright-field image). Therefore, by checking for the presence or absence of a focus shift, the recess 7 can be searched in the microscope image, and thus the detection unit 3 can be easily searched in the image. Subsequently, by focusing the image on the bottom surface 7A, the focus of the image can be adjusted to the detection unit 3. Next, an electron microscope image is taken, and the number of labeled substances in the image is measured. Since the outlines of the labeled substances can be clearly identified in the electron microscope image, the number of labeled substances in the image can be measured. If the number of measured labeled substances exceeds a predetermined judgment criterion, it is determined that the target substance is present in the sample (i.e., "positive").

[0034] The above observations and measurements are performed similarly for multiple detection units 3, for example. In this case, the average, maximum, and minimum values ​​of the number of labeled substances in the same field of view of each detection unit 3 are calculated, and one of these calculated values ​​is used as the evaluation value. If the evaluation value exceeds a predetermined judgment criterion, it is determined to be "positive".

[0035] <Manufacturing method for immunochromatographic test kits> Next, an example of a method for manufacturing the immunochromatographic test kit 100 will be described. As shown in Figure 5, the method for manufacturing the immunochromatographic test kit 100 comprises the steps of preparing a carrier 6 (S1) and forming a plurality of detection units 3 on the prepared carrier 6 (S2).

[0036] In the process of preparing the carrier 6, either a carrier 6 with a control portion 4 formed on its upper surface, or a carrier 6 without a control portion 4 formed on its upper surface, is prepared.

[0037] In the process of forming multiple detection units 3, the captured antibody is applied in a dot pattern to the upper surface of the carrier 6 using a coating needle 21 (see Figure 10) that holds the captured antibody at its tip. The diameter of the tip of the coating needle 21 (hereinafter referred to as the tip diameter) is less than 1 mm. In this process, a recess 7 is formed in the carrier 6 using the coating needle 21, and at the same time, the captured antibody is applied to the bottom surface 7A of the recess 7. In other words, the coating needle 21 that holds the captured antibody at its tip is pressed further into the carrier 6 after contacting the upper surface of the carrier 6. The coating apparatus shown in Figures 6 to 10 is used in this process. The configuration of the coating apparatus will be described later.

[0038] In this way, a carrier 6 including multiple detection units 3 is formed. If a control unit 4 is formed on the carrier 6, a conjugate unit 2 and an absorption unit 5 are connected to the carrier 6, and a sample application unit 1 is further connected to the conjugate unit 2 to manufacture an immunochromatographic test kit 100. If a control unit 4 is not formed on the carrier 6, a control unit 4 is formed on the carrier 6. Subsequently, a conjugate unit 2 and an absorption unit 5 are connected to the carrier, and a sample application unit 1 is further connected to the conjugate unit 2 to manufacture an immunochromatographic test kit 100. In the manufacturing method of the immunochromatographic test kit 100, each of the sample application unit 1, conjugate unit 2, control unit 4, and absorption unit 5 can be formed in the same way as those in conventional immunochromatographic test kits.

[0039] <Configuration of the coating device> Next, an example of a coating apparatus used to form multiple detection units 3 in the manufacturing method of the immunochromatographic test kit 100 will be described.

[0040] As shown in Figure 6, the coating apparatus according to Embodiment 1 mainly comprises an X-axis table 11, a Y-axis table 12, a Z-axis table 13, a coating mechanism 14, an observation optical system 15, a CCD camera 16, and a control unit. The X-axis table 11, Y-axis table 12, Z-axis table 13, coating mechanism 14, observation optical system 15, and CCD camera 16 are located, for example, inside the processing chamber. The control unit includes an operation panel 17, a monitor 18, and a control computer 19. The operation panel 17, monitor 18, and control computer 19 are located, for example, outside the processing chamber.

[0041] The Y-axis table 12 is movable in the Y-axis direction and can accommodate the carrier 6. For example, a guide rail extending along the Y-axis direction is fixed to the bottom of the processing chamber. A guide section movable along the guide rail is connected to the lower surface of the Y-axis table 12. The upper surface of the Y-axis table 12 is a mounting surface for accommodating the carrier 6. A structure spanning the Y-axis table 12 in the X-axis direction is fixed to the bottom of the processing chamber.

[0042] The X-axis table 11 is positioned on a structure that straddles the Y-axis table 12 in the X-axis direction. A movable body, to which the Z-axis table 13 is connected, is mounted on the X-axis table 11 so as to be movable in the X-axis direction. The movable body is movable in the X-axis direction, for example, using a ball screw. The X-axis table 11 is fixed to the bottom surface of the processing chamber via the above structure. Therefore, the Y-axis table 12 is movable in the Y-axis direction relative to the X-axis table 11.

[0043] A Z-axis table 13 is installed on the mobile body connected to the X-axis table 11, as described above. An observation optical system 15 and a coating mechanism 14 are connected to the Z-axis table 13. The observation optical system 15 is for observing the coating position on the carrier 6. A CCD camera converts the observed image into an electrical signal. The Z-axis table 13 holds these observation optical system 15 and coating mechanism 14 so that they can move in the Z-axis direction.

[0044] The operation panel 17, monitor 18, and control computer 19 are used to control the Y-axis table 12, X-axis table 11, Z-axis table 13, observation optical system 15, and coating mechanism 14. The operation panel 17 is used to input commands to the control computer 19. The monitor 18 displays image data converted by the CCD camera 16 described above, as well as output data from the control computer 19.

[0045] <Configuration of coating mechanism 14> Next, the detailed configuration of the coating mechanism 14 shown in Figure 6 will be described. As shown in Figures 7 and 8, the coating mechanism 14 mainly includes a servo motor 41, a frame 42, a cam 43, a bearing 44, a cam connecting plate 45, a movable part 46, a coating needle holder 20, a coating needle 21 held in the coating needle holder 20, and a coating material container 22. The servo motor 41 is installed so that its rotation axis extends in the direction along the Z-axis direction shown in Figure 6. The servo motor 41 is held by the frame 42. A cam 43 is connected to the rotation axis of the servo motor 41. The cam 43 is rotatable about the rotation axis of the servo motor 41.

[0046] The cam 43 includes a central part connected to the rotation axis of the servo motor 41 and a flange part connected to one end of the central part. The upper surface of the flange part (the surface on the servo motor 41 side) is a cam surface. This cam surface is formed in an annular shape along the outer circumference of the central part and is also formed in a slope shape so that the distance from the bottom surface of the flange part varies. Specifically, the cam surface includes an upper flat region with the longest distance from the bottom surface of the flange part, a lower flat region with the shortest distance from the bottom surface of the flange part, and a slope region connecting the upper flat region and the lower flat region. The upper flat region is spaced apart from the lower flat region in the circumferential direction with respect to the rotation axis.

[0047] The bearing 44 has an outer ring positioned to contact the cam surface of the cam 43 and an inner ring connected to the cam connecting plate 45. As shown in Figure 7, the bearing 44 is positioned in a specific direction (to the right of the servo motor 41) when viewed from the cam 43. The bearing 44 is biased to the cam surface of the cam 43 by a spring 50, which will be described later. Therefore, when the cam 43 rotates, the bearing 44 is held in a state where the outer circumferential surface of the outer ring is in contact with the cam surface. The cam connecting plate 45 has one end connected to the inner ring of the bearing 44 and the other end fixed to the movable part 46. The coating needle holder fixing part 47 and the coating needle holder housing part 48 are connected to the movable part 46.

[0048] A fixing pin 51 is installed on the frame 42. A fixing pin 52 is installed on the movable part 46. One end of the spring 50 is connected to the fixing pin 51, and the other end of the spring 50 is connected to the fixing pin 52. Due to the spring 50, the movable part 46 is subjected to a tensile force directed toward the coating material container 22. This tensile force from the spring 50 also acts on the bearing 44 via the movable part 46 and the cam connecting plate 45. Due to this tensile force from the spring 50, the bearing 44 maintains a state of being pressed against the cam surface of the cam 43.

[0049] The movable part 46, the coating needle holder fixing part 47, and the coating needle holder storage part 48 are connected to a linear guide 49 installed on the frame 42. The linear guide 49 is positioned to extend in the Z-axis direction. Therefore, the movable part 46, the coating needle holder fixing part 47, and the coating needle holder storage part 48 are movable along the Z-axis direction.

[0050] The coating needle holder 20 is housed in the coating needle holder storage section 48. The coating needle holder 20 includes a coating needle 21. The coating needle 21 is positioned to protrude from the coating needle holder 20 at the lower surface of the coating needle holder 20. The extension direction of the coating needle 21 is along the direction of gravity (the Z-axis direction in Figure 6). The shape of the tip of the coating needle 21 is, for example, a frustoconical shape. The tip diameter of the coating needle 21 in the radial direction with respect to the central axis is less than 1 mm. Preferably, the tip diameter of the coating needle 21 is 100 μm or less.

[0051] A coating material container 22 is positioned below the coating needle holder 20. Inside the coating material container 22, a space for storing the coating material 70 is formed. As shown in Figures 9 and 10, first and second holes are formed at the bottom and top of the coating material container 22, connecting the space to the outside. The shape of the first and second holes can be any shape, but for example, they are circular. The first and second holes are arranged to overlap in the direction in which the coating needle 21 extends. The coating material 70 contains a capture antibody.

[0052] The coating needle holder 20 and the coating needle 21 move up and down relative to the coating material container 22 as the coating needle holder housing 48 moves in the Z-axis direction. This switches between a first state in which the tip of the coating needle 21 is immersed in the coating material 70 stored in the coating material container 22, and a second state in which the tip of the coating needle 21 protrudes downward from the bottom surface of the coating material container 22 through a hole formed in the bottom of the coating material container 22.

[0053] <Operation of the coating device> Next, the operation of the coating apparatus in the process of forming multiple detection units 3 in the manufacturing method of the immunochromatographic test kit will be described. First, the carrier 6 is mounted on the Y-axis table 12. Next, the tip of the coating needle 21 is immersed in the coating material 70 stored in the coating material container 22, which is the first state described above. Next, the X-axis table 11 and the Y-axis table 12 are operated to position the carrier 6 in the X-axis and Y-axis directions so that the area where the first detection unit 3 is to be formed is positioned directly below the coating mechanism 14. Next, the Z-axis table 13 is operated to lower the Z-axis table 13 and the coating mechanism 14 by a distance d in the Z-axis direction so that when the coating needle is in the second state described above, the tip of the coating needle 21 is pushed below the upper surface of the carrier 6.

[0054] Next, the servo motor 41 of the coating mechanism 14 is operated to switch from the first state to the second state. Specifically, by operating the servo motor 41, the rotation axis of the servo motor 41 is rotated, which in turn rotates the cam 43. As a result, the height of the cam surface of the cam 43 changes in the Z-axis direction, and the position of the bearing 44 in contact with the cam surface in the Z-axis direction also changes in accordance with the rotation of the drive shaft of the servo motor 41. In accordance with the change in the position of the bearing 44 in the Z-axis direction, the movable part 46, the coating needle holder fixing part 47, the coating needle holder housing part 48, and the coating needle holder 20 held in the coating needle holder housing part 48 also move in the Z-axis direction. As a result, by operating the servo motor 41, the coating needle 21 moves in the Z-axis direction, and the first state shown in Figure 9 and the second state shown in Figure 10 are switched. In the coating mechanism 14 described above, the rotational motion of the servo motor 41 can be converted into motion (up and down) of the coating needle 21 in the Z-axis direction, so that the coating needle 21 can be moved quickly and accurately in the Z-axis direction.

[0055] In the first state shown in Figure 9, the coating needle 21 is positioned as far upward as possible within its range of motion. At this time, the tip of the coating needle 21 is immersed in the coating material 70 held in the coating material container 22. In the first state, the outer ring of the bearing 44 is in contact with the upper flat region of the cam surface of the cam 43.

[0056] In the second state shown in Figure 10, the coating needle 21 is positioned at its lowest point within its range of motion. At this time, the coating material containing the capture antibody is held at the tip of the coating needle 21. Specifically, the coating material containing the capture antibody is held at the end face and side surface of the tip of the coating needle 21. The tip of the coating needle 21 protrudes downward from the bottom surface of the coating material container 22 through a hole formed in the bottom of the coating material container 22 and is pushed below the upper surface of the carrier 6.

[0057] In this way, by operating the servo motor 41 to switch from the first state to the second state, a recess 7 is formed in the carrier 6, and at the same time, the captured antibody is coated on the bottom surface 7A of the recess 7. Next, the servo motor 41 is operated to switch from the second state to the first state.

[0058] Furthermore, after operating only the X-axis table 11 and Y-axis table 12 to position the area where the second detection unit 3 should be formed directly below the coating mechanism 14, the Z-axis table 13 is lowered by a distance d, and then the servo motor 41 of the coating mechanism 14 is operated to switch from the first state to the second state. After switching again from the second state to the first state, the Z-axis table 13 is raised by a distance d.

[0059] By repeatedly performing the above operation in succession, multiple detection units 3 are formed on the upper surface of the carrier 6. <Effects and Effects> The effects of the immunochromatographic test kit 100 according to Embodiment 1 will be explained in comparison with a conventional immunochromatographic test kit (hereinafter simply referred to as Comparative Example 1). In Comparative Example 1, the detection unit is formed on a flat surface, and the color development in the detection unit derived from the labeled antibody is provided to be visually confirmed. Therefore, in Comparative Example 1, the detection unit area is not large enough (for example, several mm) to prevent misjudgments by visual inspection. 2 The above requirements were necessary, and it was difficult to reduce the amount of expensive capture antibody immobilized on the detection unit. As a result, it was difficult to reduce manufacturing costs in Comparative Example 1.

[0060] In contrast, in the immunochromatographic test kit 100, the dot width of each detection unit 3 can be reduced to less than 1 mm by reducing the tip diameter of the coating needle 21. In other words, in the immunochromatographic test kit 100, the area of ​​each detection unit 3 can be made smaller than that of each detection unit in Comparative Example 1, so the amount of capture antibody fixed to each detection unit 3 can be reduced compared to the amount of capture antibody fixed to each detection unit in Comparative Example 1. As a result, the manufacturing cost of the immunochromatographic test kit 100 can be reduced compared to the manufacturing cost of Comparative Example 1.

[0061] Furthermore, according to the immunochromatographic test kit 100, the detection unit 3 can be confirmed using an electron microscope, and the number of labeled antibodies captured by the detection unit 3 in the electron microscope image can be measured to quantitatively evaluate the target substances in the sample.

[0062] Furthermore, if the detection area formed on a flat surface is miniaturized, as in Comparative Example 1, it becomes necessary to magnify the detection area with a microscope, for example, to confirm the labeled antibody. However, it is difficult to locate and align the minute detection area with a microscope. As a countermeasure, one could consider placing a marker on the kit and positioning the detection area at a predetermined distance from that marker. However, in this case, equipment for setting the marker is required separately from the equipment for forming the detection area, and the process is increased, making it difficult to reduce manufacturing cycle time and thus difficult to lower costs.

[0063] In contrast, in the immunochromatographic inspection kit 100 described above, multiple recesses 7 are formed in the carrier 6, and each detection unit 3 includes the bottom surface 7A of one of the recesses 7. Therefore, when directly confirming the labeled substance on the detection unit 3 using an electron microscope, the focus shift caused by the distance between the top surface and the bottom surface 7A of the carrier 6 can be confirmed in the electron microscope image, and this focus shift can be used to search for the recesses 7 in the electron microscope image. As a result, in the immunochromatographic inspection kit 100, each detection unit 3 can be miniaturized compared to Comparative Example 1.

[0064] Furthermore, by focusing the image on the bottom surface 7A, the focus of the image can be easily aligned with the detection unit 3. In other words, the immunochromatographic inspection kit 100 can reduce the time required to search for the detection unit 3 compared to the case where each detection unit 3 does not include the bottom surface 7A of one recess 7.

[0065] Furthermore, unlike Comparative Example 1, the immunochromatographic inspection kit 100 does not require a separate marker to be used when searching for the detection unit 3, and there is no need to prepare equipment for setting the marker separately from the equipment for forming the detection unit. In addition, since the recess 7 can be formed simultaneously with the detection unit 3 in the immunochromatographic inspection kit 100, the manufacturing cycle can be reduced compared to the case in Comparative Example 1 where a marker is set.

[0066] In the immunochromatographic test kit 100 described above, the width of each detection unit can be made extremely small, less than 100 μm. In such an immunochromatographic test kit 100, the amount of capture antibody immobilized on each detection unit 3 is significantly reduced compared to the amount of capture antibody immobilized on each detection unit in Comparative Example 1. Therefore, the manufacturing cost of the immunochromatographic test kit 100 can be significantly reduced compared to the manufacturing cost of Comparative Example 1.

[0067] The above-described immunochromatographic test kit 100 is equipped with multiple detection units 3. Compared to an immunochromatographic test kit equipped with only one detection unit 3, such an immunochromatographic test kit 100 allows for the confirmation of the labeled substances of multiple detection units 3 in the electron microscope image, thereby improving the reliability of the test results.

[0068] In the immunochromatographic test kit 100 described above, the multiple detection units 3 are arranged one-dimensionally with respect to the deployment direction D. Compared to immunochromatographic test kits in which the multiple detection units 3 are randomly arranged, this type of immunochromatographic test kit 100 allows the target substance to flow efficiently to all of the detection units 3 and bind to the capture antibody, thus providing stable test results.

[0069] In the immunochromatographic test kit 100 described above, the shortest distance between two adjacent detection units 3 is less than 1 mm. In such an immunochromatographic test kit 100, multiple detection units 3 can be observed even within a relatively small field of view compared to an immunochromatographic test kit in which the shortest distance is 1 mm or more, and each detection unit 3 can be easily searched.

[0070] The effects and advantages of the manufacturing method of the immunochromatographic test kit 100 according to Embodiment 1 will be explained in comparison with a manufacturing method in which each detection unit 3 is formed using a dispenser (hereinafter simply referred to as Comparative Example 2) and a manufacturing method in which each detection unit 3 is formed using an inkjet method (hereinafter simply referred to as Comparative Example 3).

[0071] In Comparative Examples 2 and 3, in order to form the detection unit 3 at a minute size, it is necessary to reduce the opening width of the dispenser or nozzle tip. However, when a high-viscosity coating material 70 is used, the coating material 70 cannot be dispensed, which may cause clogging. In Comparative Example 3, in a method that uses a piezoelectric element or the like to instantaneously increase the pressure inside the container and dispense the liquid material containing the captured antibody, the high discharge pressure causes the liquid material to spread easily upon impact with the carrier 6, resulting in problems such as unstable shape of the detection unit 3.

[0072] In contrast, in the manufacturing method of the immunochromatographic test kit 100, in order to form a minute detection unit 3, the tip diameter of the coating needle 21 can be reduced, so clogging like that seen in Comparative Examples 2 and 2 does not occur, regardless of viscosity. Furthermore, in the above manufacturing method, the position of the tip of the coating needle 21 in the Z-axis direction relative to the upper surface of the carrier 6 can be precisely controlled by the Z-axis table 13, so that variations in the size of the detection unit 3 can be reduced, and the immunochromatographic test kit 100 can be manufactured stably.

[0073] Furthermore, in Comparative Example 2, it is difficult to stably form detection units 3 with a dot width of less than 1 mm for coating droplets, and especially difficult to stably form detection units 3 with a dot width of less than 100 μm.

[0074] In contrast, the manufacturing method for the immunochromatographic test kit 100 uses a coating needle 21, so that the planar outer shape of each detection unit 3 is dot-shaped and the width of each detection unit 3 is less than 1 mm can be easily and stably manufactured.

[0075] Furthermore, in the manufacturing method of the immunochromatographic test kit 100, a recess 7 is formed in the carrier 6 using the coating needle 21, and at the same time, the capture antibody is coated on the bottom surface 7A of the recess 7. Therefore, the formation of the detection unit 3, including the bottom surface 7A of one recess 7, and the coating of the capture antibody can be performed in a single operation. As a result, there is no increase in cycle time associated with the formation of the detection unit 3, and manufacturing costs do not increase.

[0076] <Example 1> The immunochromatographic test kit 100 according to Embodiment 1 can be modified in the following ways.

[0077] The detection region t only needs to include at least one detection unit 3. In the immunochromatographic test kit 100, each detection unit 3 has a similar configuration to the others, but is not limited to this. In the immunochromatographic test kit 100, the concentration of the capture antibody immobilized in each detection unit 3 is constant, but the concentrations of the capture antibodies immobilized in each detection unit 3 may be different. For example, the concentration of the capture antibody may gradually decrease from one side to the other in a direction perpendicular to the deployment direction D. Alternatively, a set of patterns consisting of multiple detection units 3 with different capture antibody concentrations may be arranged side by side. Such multiple detection units 3 can be easily formed by using multiple coating mechanisms 14 in which the concentrations of capture antibodies in the coating material stored in the coating material container 22 are different.

[0078] Furthermore, at least one of the following may differ: the planar external shape of each detection unit 3, the dot width of each detection unit 3, the distance between two adjacent detection units 3, the planar external shape of the bottom surface 7A of each recess 7, the maximum width of each bottom surface 7A, and the depth of each bottom surface 7A. Such multiple detection units 3 can be easily formed by using multiple types of coating needles 21 or by using multiple types of coating conditions.

[0079] In the immunochromatographic test kit 100, multiple recesses 7 are formed in the detection region t of the carrier 6, and one detection unit 3 includes the bottom surface 7A of one of the recesses 7, but this is not limited to this configuration.

[0080] Each detection unit 3 may include the entire bottom surface 7A of each recess 7 and at least a portion of the wall surface 7B. Alternatively, each detection unit 3 may include the entire bottom surface 7A and wall surface 7B of each recess 7. Furthermore, each detection unit 3 may include the entire bottom surface 7A and wall surface 7B of each recess 7, as well as an annular region of the upper surface of the carrier 6 that is connected to the wall surface 7B.

[0081] The multiple detection units 3 may include at least one detection unit 3 shown in Figure 4 and at least one detection unit 3 shown in Figure 11. The multiple detection units 3 shown in Figure 11 include only the upper surface of the carrier 6. Such detection units 3 can be easily formed in the above manufacturing method by the tip of the coating needle 21 or the coating material 70 attached to the tip contacting the upper surface of the carrier 6 and then moving upward without being pushed downward. Furthermore, all of the detection units 3 may be configured as the detection units 3 shown in Figure 11. In other words, multiple recesses 7 do not need to be formed in the detection region t of the carrier 6.

[0082] As shown in Figure 12, in the immunochromatographic test kit 100, multiple detection units 3 may be arranged at intervals in the deployment direction D. The distance between two adjacent detection units 3 in the deployment direction D is equal to, for example, the distance between two adjacent detection units 3 in a direction perpendicular to the deployment direction D.

[0083] In the manufacturing method of the immunochromatographic test kit 100, one coating needle 21 is used to form multiple detection units 3, but multiple coating needles 21 may be used to form multiple detection units 3. In other words, the coating device may include multiple coating mechanisms 14.

[0084] Furthermore, in order to further improve the accuracy of the coating process of the coating material 70 by the coating needle 21, the movement speed of the coating needle 21 in the Z-axis direction may be changed according to the position of the coating needle 21. For example, when switching from the first state to the second state, the movement speed of the coating needle 21 is reduced just before the second state is realized. The reduction in the movement speed of the coating needle 21 is achieved by reducing the rotation speed of the servo motor 41.

[0085] By performing this control, the movement speed of the coating needle 21 is sufficiently small when it comes into contact with the carrier 6, so that the contact time between the tip of the coating needle 21 or the coating material 70 attached to the tip and the carrier 6 can be increased. As a result, the amount of capture antibody coated on the carrier 6 can be increased and its concentration can be raised, thus making the antigen-antibody reaction with the target substance more stable.

[0086] In the immunochromatographic test kit 100, the sample application portion 1 and the conjugate portion 2 may be formed on a single porous material separate from the carrier 6. In the immunochromatographic test kit 100, the conjugate portion 2 may be formed on the carrier 6, and the sample application portion 1 may be formed on a porous material separate from the carrier 6. In the immunochromatographic test kit 100, the absorption portion 5 may be formed on the carrier 6.

[0087] (Embodiment 2) The immunochromatographic test kit 101 according to Embodiment 2 has basically the same configuration and provides the same effects as the immunochromatographic test kit 100 according to Embodiment 1, but differs from the immunochromatographic test kit 100 in that, as shown in Figure 13, the plurality of detection units 3 include a first detection unit 3A and a second detection unit 3B.

[0088] The first detection unit 3A has a first capture antibody immobilized on it that has the property of binding to a first type of target substance. The second detection unit 3B has a second capture antibody immobilized on it that has the property of binding to a second type of target substance that is different from the first type of target substance.

[0089] As shown in Figure 13, the plurality of detection units 3 include, for example, a plurality of first detection units 3A and a plurality of second detection units 3B. The plurality of first detection units 3A are spaced apart from each other in a direction perpendicular to the deployment direction D. The plurality of first detection units 3A are arranged, for example, in one dimension. The plurality of second detection units 3B are spaced apart from each other in a direction perpendicular to the deployment direction D. The plurality of second detection units 3B are arranged, for example, in one dimension.

[0090] Multiple first detection units 3A and multiple second detection units 3B are arranged at intervals in a direction perpendicular to the deployment direction D. The shortest distance between a first detection unit 3A and a second detection unit 3B is longer than the shortest distance between two adjacent first detection units 3A and the shortest distance between two adjacent second detection units 3B. Multiple first detection units 3A and multiple second detection units 3B are arranged, for example, in a one-dimensional manner as a whole.

[0091] Each of the first detection unit 3A and the second detection unit 3B has the same configuration as each detection unit 3 in Embodiment 1. The dot width of the first detection unit 3A is, for example, equal to the dot width of the second detection unit 3B. However, the dot width of the first detection unit 3A may be narrower or wider than, for example, the dot width of the second detection unit 3B.

[0092] The detection region t is divided into a first detection region t1, where multiple first detection units 3A are arranged, and a second detection region t2, where multiple second detection units 3B are arranged. The first detection region t1 and the second detection region t2 are arranged in a direction perpendicular to the deployment direction D.

[0093] Each first detection unit 3A includes the bottom surface 7A of each recess 7. Each second detection unit 3B includes the bottom surface 7A of each recess 7.

[0094] According to the immunochromatographic test kit 101 of Embodiment 2, two types of target substances can be detected from a single sample by immunochromatography.

[0095] The immunochromatographic test kit 101 can be manufactured in the same manner as the immunochromatographic test kit according to Embodiment 1. Preferably, the coating apparatus comprises a first coating mechanism 14 for forming a first detection unit 3A by coating a first capture antibody onto a carrier 6, and a second coating mechanism 14 for forming a second detection unit 3B by coating a second capture antibody onto the carrier 6. The first coating mechanism 14 includes a first coating needle 21 and a first coating material container 22 in which coating material containing the first capture antibody is stored. The second coating mechanism 14 includes a second coating needle 21 and a second coating material container 22 in which coating material containing the second capture antibody is stored.

[0096] In the manufacturing method of the immunochromatographic test kit 101, the first coating needle 21 holds a first capture antibody at its tip. The second coating needle 21 holds a second capture antibody at its tip. In the step of forming multiple detection units 3, the first detection unit 3A is formed by coating the first capture antibody onto the first region of the carrier 6 using the first coating needle 21. Furthermore, the second detection unit 3B is formed by coating the second capture antibody onto the second region of the carrier 6 using the second coating needle 21.

[0097] By manufacturing the immunochromatographic test kit 101 using such a coating apparatus, the manufacturing time can be reduced compared to manufacturing the immunochromatographic test kit 101 using a single coating apparatus equipped with only one coating mechanism 14, and the manufacturing cost can be reduced compared to manufacturing the immunochromatographic test kit 101 using multiple coating apparatuses equipped with only one coating mechanism 14.

[0098] <Modification 2> The immunochromatographic test kit 101 according to Embodiment 2 can also be modified in the same way as the immunochromatographic test kit 100 according to Embodiment 1.

[0099] Furthermore, the immunochromatographic test kit 101 can be modified in the following ways. The multiple first detection units 3A and the multiple second detection units 3B may be arranged alternately.

[0100] As shown in Figures 14 to 16, the multiple detection units 3 may further include multiple third detection units 3C in addition to the first detection unit 3A and the second detection unit 3B. Each third detection unit 3C has a third capture antibody immobilized on it that has the property of binding to a third type of detectable substance that is different from the first type of detectable substance and the second type of detectable substance.

[0101] As shown in Figure 14, each of the multiple first detection units 3A, multiple second detection units 3B, and multiple third detection units 3C are arranged alternately, one at a time, in a direction perpendicular to the deployment direction D.

[0102] As shown in Figure 15, each of the multiple first detection units 3A, multiple second detection units 3B, and multiple third detection units 3C are arranged alternately in groups of multiples in a direction perpendicular to the deployment direction D, for example. In this case, the distance between two adjacent first detection units 3A and the distance between two adjacent second detection units 3B is shorter than, for example, the distance between adjacent first detection units 3A and second detection units 3B. The distance between two adjacent second detection units 3B and the distance between two adjacent third detection units 3C is shorter than, for example, the distance between adjacent second detection units 3B and third detection units 3C.

[0103] As shown in Figure 16, each of the multiple first detection units 3A, multiple second detection units 3B, and multiple third detection units 3C are arranged one-dimensionally, for example, in the deployment direction D. Furthermore, each of the multiple first detection units 3A, multiple second detection units 3B, and multiple third detection units 3C are arranged alternately one by one in a direction perpendicular to the deployment direction D. The distance between adjacent first detection units 3A and second detection units 3B in the direction perpendicular to the deployment direction D is longer, for example, the distance between two adjacent first detection units 3A and the distance between two adjacent second detection units 3B in the deployment direction D. The distance between adjacent second detection units 3B and third detection units 3C in the direction perpendicular to the deployment direction D is longer, for example, the distance between two adjacent second detection units 3B and the distance between two adjacent third detection units 3C in the deployment direction D.

[0104] In the modified examples shown in Figures 14 to 16, in a set of first detection units 3A, second detection unit 3B, and third detection unit 3C, at least one of the following may differ from one another: the planar shape of each detection unit 3, the dot width of each detection unit 3, the distance between two adjacent detection units 3, the planar shape of the bottom surface 7A of each recess 7, the maximum width of each bottom surface 7A, and the depth of each bottom surface 7A.

[0105] For example, the dot width of the second detection unit 3B may be narrower than the dot width of the first detection unit 3A and wider than the dot width of the third detection unit 3C. The maximum width of the bottom surface 7A included in the second detection unit 3B may be narrower than the maximum width of the bottom surface 7A included in the first detection unit 3A and wider than the maximum width of the bottom surface 7A included in the third detection unit 3C.

[0106] The external shape of the second detection unit 3B may be rectangular, and the external shapes of each detection unit 3 of the first detection unit 3A and the third detection unit 3C may be circular.

[0107] The depth of the bottom surface 7A included in the second detection unit 3B may be shallower than the maximum width of the bottom surface 7A included in the first detection unit 3A, and deeper than the maximum width of the bottom surface 7A included in the third detection unit 3C.

[0108] The distance between the first detection unit 3A and the second detection unit 3B may be longer than the distance between the second detection unit 3B and the third detection unit 3C, and the distance between the third detection unit 3C and the first detection unit 3A.

[0109] Such first detection unit 3A, second detection unit 3B, and third detection unit 3C can be easily formed by using multiple types of coating needles 21 or by using multiple types of coating conditions.

[0110] In this way, the first detection unit 3A, the second detection unit 3B, and the third detection unit 3C can be easily identified within a single field of view.

[0111] (Embodiment 3) The immunochromatographic test kit 102 according to Embodiment 3 has basically the same configuration and provides the same effects as the immunochromatographic test kit 100 according to Embodiment 1, but differs from the immunochromatographic test kit 100 in that the sample application section 1 and the conjugate section 2 are formed on the carrier 6. In other words, in the immunochromatographic test kit 102, the sample application section 1, the conjugate section 2, the multiple detection sections 3, and the control section 4 are formed on the upper surface of a single porous member (one carrier 6).

[0112] In the immunochromatographic test kit 102 shown in Figure 17, the absorbent portion 5 is also formed on the carrier 6.

[0113] The sample application area 1 is the region on the carrier 6 where the sample is dropped, and is located on one side in the deployment direction D. The conjugate area 2 is the region on the upper surface of the carrier 6 where the labeled antibody is coated, and is located between the sample application area 1 and the detection area t in the deployment direction D. The absorption area 5 is the region on the carrier 6 where excess sample is absorbed, and is located on the other side in the deployment direction D relative to the control area C.

[0114] According to the immunochromatographic inspection kit 102, the number of parts has been reduced compared to the immunochromatographic inspection kit 100, so the manufacturing cost of the immunochromatographic inspection kit 102 may be lower compared to the manufacturing cost of the immunochromatographic inspection kit 100.

[0115] <Variation 3> The immunochromatographic test kit 102 according to Embodiment 3 can also be modified in the same way as the immunochromatographic test kit 100 according to Embodiment 1 and the immunochromatographic test kit 101 according to Embodiment 2.

[0116] (Embodiment 4) The immunochromatographic inspection kit 103 according to Embodiment 4 has basically the same configuration and provides the same effects as the immunochromatographic inspection kit 100 according to Embodiment 1, but differs from the immunochromatographic inspection kit 100 in that, as shown in Figure 18, it is configured as a connected body in which multiple immunochromatographic inspection kits 100A to 100C are linked in a direction perpendicular to the deployment direction D. The target substances for detection of each of the immunochromatographic inspection kits 100A to 100C are different from each other.

[0117] Each of the immunochromatographic test kits 100A to 100C can be fixed to each other by any method, for example, by adhesive.

[0118] According to the immunochromatographic test kit 103 of Embodiment 4, three types of target substances can be detected by immunochromatography using a single immunochromatographic test kit 103 configured as a linked unit.

[0119] (Example 1) In this example, we will describe the results observed using an electron microscope on the detection unit 3 of the immunochromatographic test kit 100.

[0120] <Sample> The carrier 6 was made of a porous material consisting of nitrocellulose. Each detection unit 3 was formed using a coating needle 21 having a frustoconical tip shape and a tip diameter of 50 μm, so as to include the bottom surface 7A of the recess 7.

[0121] <Observation Method> Figure 19 is a microscopic image obtained by observing the detection unit 3 of the above sample using a microscope.

[0122] As shown in Figure 19, in the microscope image, a difference is created between the background and the detection unit 3 due to the focus shift caused by the recess 7, so the bottom surface 7A of the recess 7 can be easily explored, and the minute detection unit 3 including the bottom surface 7A can be easily explored.

[0123] (Example 2) This example describes the results of immunochromatography performed using immunochromatography test kit 100.

[0124] <Sample> The sample application section 1 and the conjugate section 2 were made of glass fiber pads. The carrier 6 was made of a porous material made of nitrocellulose. Each detection section 3 was formed using a coating needle 21 having a frustoconical tip shape and a tip diameter of 50 μm, so as to include the bottom surface 7A of the recess 7.

[0125] <Testing Method> The testing method was equivalent to that of the immunochromatographic test kit described above.

[0126] Figure 20 is an electron microscope image obtained by observing the detection unit 3 of the above sample using an electron microscope.

[0127] As shown in Figure 20, the electron microscope image produces a contrast of light and dark due to the recess 7, making it easy to locate the bottom surface 7A of the recess 7, and thus easy to locate the minute detection area 3 including the bottom surface 7A.

[0128] Furthermore, Figure 21 is an electron microscope image of the detection unit 3 before the auxiliary solution is added, and Figure 22 is an electron microscope image of the detection unit 3 after the auxiliary solution has been added.

[0129] In the image shown in Figure 22, it was confirmed that the image edges are clearer compared to the image shown in Figure 21.

[0130] The embodiments and examples disclosed herein should be considered in all respects to be illustrative and not restrictive. The scope of the present invention is indicated by the claims rather than the foregoing description and is intended to include all modifications within the meaning and scope of the claims. [Explanation of symbols]

[0131] 1 Sample application section, 2 Conjugate section, 3 Detection section, 3A First detection section, 3B Second detection section, 3C Third detection section, 4 Control section, 5 Absorption section, 6 Carrier, 7 Recess, 7A Bottom surface, 7B Wall surface, 11 X-axis table, 12 Y-axis table, 13 Z-axis table, 14 Coating mechanism, 15 Observation optics, 16 Camera, 17 Operation panel, 18 Monitor, 19 Control computer, 20 Coating needle holder, 21 Coating needle, 22 Coating material container, 41 Servo motor, 42 Stand, 43 Cam, 44 Bearing, 45 Cam connecting plate, 46 Movable part, 47 Coating needle holder fixing part, 48 Coating needle holder storage part, 49 Linear guide, 50 Spring, 51, 52 Fixing pin, 70 Coating materials, 100, 100A, 100C, 101, 102, 103 immunochromatographic test kits.

Claims

[Claim 1] The sample application area where the sample is dispensed, A conjugate portion on which a labeled antibody having the property of binding to the target substance in the sample is immobilized, The system comprises a detection unit to which a capture antibody having the property of binding to the object to be detected is attached, The detection unit is formed on a carrier and is not observable by visual inspection. An immunochromatographic test kit is provided to allow direct observation, using a microscope, of the labeling substance of the labeled antibody that is bound to the object to be detected, which has been captured in the detection unit.

Images