Immuno-chromatographic assay kit

Abstract

An immunochromatographic assay kit (100) includes a sample dropping portion (1) for dropping a sample, a coupling portion (2) for fixing a labeled antibody having a property of binding to a detection target in the sample, and at least one detection portion (3) for fixing a capture antibody having a property of binding to the detection target. The sample dropping portion (1), the coupling portion (2), and the plurality of detection portions (3) are formed on a porous member. An outer shape of each detection portion (3) is punctiform.

Description

Technical Field

[0001] This invention relates to an immunochromatographic assay kit. Background Technology

[0002] Immunochromatography is currently used as a diagnostic aid for various diseases, primarily influenza. The principle of immunochromatography is based on antigen-antibody reactions, and due to its simplicity and effectiveness, it is widely used in medical practice.

[0003] In existing immunochromatography, the presence of color development in the detection zone of the immunochromatographic assay kit (also known as the developing support or chromatographic medium) is visually observed. Specifically, color development originating from the labeled antibody is visually examined when the detection target bound to the labeled antibody is captured by the capture antibody immobilized in the detection zone and accumulates sufficiently in the detection zone.

[0004] WO 2010 / 061772 (Patent Document 1) discloses an immunochromatographic assay kit in which the detection part is formed in a size greater than or equal to a few millimeters, the size of which can be determined visually. Reference List Patent documents

[0005] Patent Document 1: WO2010 / 061772 Summary of the Invention Technical issues

[0006] In existing immunochromatographic assay kits as described above, since the color development derived from labeled antibodies is visually detectable, sufficient area is required to prevent false detections. As a result, the area of ​​the detection zone is greater than or equal to several millimeters. 2 Therefore, a large amount of capture antibodies, greater than or equal to a certain level, needs to be immobilized on the detection unit to capture the antigen, making it difficult to reduce the amount of expensive capture antibodies used and to lower costs.

[0007] The main objective of this invention is to provide a low-cost immunochromatographic assay kit that, compared to existing immunochromatographic assay kits, can suppress the amount of capture antibody required. Technical means used to solve technical problems

[0008] An immunochromatographic assay kit according to one embodiment of the present invention includes: a sample dispensing portion for dispensing a sample; a coupling portion for immobilizing a labeled antibody having the property of binding to a detection target in the sample; and at least one detection portion for attaching a capture antibody having the property of binding to the detection target. The sample dispensing portion, the coupling portion, and the at least one detection portion are formed on a porous member. The capture antibody having the property of binding to the detection target is immobilized on the at least one detection portion. The at least one detection portion is dot-shaped.

[0009] In the immunochromatographic assay kit according to this embodiment, at least one recess may be formed in the porous member. At least one detection section includes the bottom surface of at least one recess.

[0010] An immunochromatographic assay kit according to another embodiment of the present invention includes: a sample dropper for sample drop; a coupling portion for attachment of a labeled antibody having the property of binding to a detection target in the sample; and at least one detection portion for attachment of a capture antibody having the property of binding to the detection target. The sample dropper, coupling portion, and at least one detection portion are formed on a porous member. At least one recess is formed in the porous member. The at least one detection portion includes the bottom surface of the at least one recess.

[0011] In the immunochromatographic assay kits according to one embodiment and another embodiment, preferably, the width of at least one detection portion is less than 1 mm.

[0012] In the immunochromatographic assay kit according to one embodiment and another embodiment, the outer diameter of at least one detection part may be less than or equal to 100 μm.

[0013] In the immunochromatographic assay kit according to this embodiment, at least one detection unit may be multiple detection units.

[0014] In an immunochromatographic assay kit according to another embodiment, at least one detection zone may be multiple detection zones, and at least one recess may be multiple recesses. Each of the multiple detection zones includes the bottom surface of one of the multiple recesses.

[0015] In an immunochromatographic assay kit according to one embodiment and another embodiment, multiple detection units can be arranged in a one-dimensional or two-dimensional manner.

[0016] In an immunochromatographic assay kit according to one embodiment and another embodiment, the shortest distance between two adjacent detection zones among a plurality of detection zones can be less than 1 mm.

[0017] In an immunochromatographic assay kit according to one embodiment and another embodiment, a plurality of detection units may include a first detection unit and a second detection unit, wherein the first detection unit is fitted with a first capture antibody having the property of binding to a first type of detection target, and the second detection unit is fitted with a second capture antibody having the property of binding to a second type of detection target.

[0018] In an immunochromatographic assay kit according to one embodiment and another embodiment, the sample drop portion, the coupling portion, and at least one detection portion can be formed on a single porous component.

[0019] In an immunochromatographic assay kit according to one embodiment and another embodiment, the sample drop portion, the coupling portion and at least one detection portion may be formed on a plurality of porous components. Invention Effects

[0020] According to the present invention, a low-cost immunochromatographic assay kit can be provided that reduces the amount of capture antibody used compared to existing immunochromatographic assay kits. Attached Figure Description

[0021] Figure 1 This is a perspective view showing the immunochromatographic assay kit according to the first embodiment. Figure 2 It is shown Figure 1 A magnified top view of the detection section of the immunochromatographic assay kit. Figure 3 This is a magnified view showing the width of the detection section. Figure 4 From Figure 2 The arrows I, VI, and V in the diagram show a magnified sectional view of the area. Figure 5 This is a flowchart illustrating a method for manufacturing the immunochromatographic assay kit of the first embodiment. Figure 6 This is a perspective view showing the coating apparatus used in the method for manufacturing the immunochromatographic assay kit of the first embodiment. Figure 7 It is shown Figure 6 A front view of the coating unit of the coating apparatus. Figure 8 It is shown Figure 6 A side view of the coating unit of the coating apparatus. Figure 9 It is shown Figure 6 A front view of the operation of the coating unit in the coating apparatus. Figure 10 It is shown Figure 6 A front view of the operation of the coating unit in the coating apparatus. Figure 11 It is shown Figure 2 A magnified top view of a modified detection section. Figure 12 It is shown Figure 2 A partially enlarged top view of another variant of the detection unit. Figure 13 This is a partially enlarged top view showing the detection section of the immunochromatographic assay kit according to the second embodiment. Figure 14 It is shown Figure 13 A magnified top view of a modified detection section. Figure 15 It is shown Figure 13 A partially enlarged top view of another variant of the detection unit. Figure 16 It is shown Figure 13 A magnified top view of another variant of the detection section. Figure 17 This is a perspective view showing the immunochromatographic assay kit according to the third embodiment. Figure 18 This is a perspective view showing the immunochromatographic assay kit according to the fourth embodiment. Figure 19 The electron microscope image is obtained by observing the detection unit 3 of the first example using an electron microscope. Figure 20 The electron microscope image is obtained by observing the detection unit 3 of the second example using an electron microscope. Figure 21 The electron microscope image is obtained in the second example by observing the detection unit 3 before the auxiliary liquid is dropped using an electron microscope. Figure 22 The electron microscope image is obtained in the second example by observing the detection unit 3 after the auxiliary material is dropped using an electron microscope. Detailed Implementation

[0022] Referring to the accompanying drawings, embodiments exemplified by the present invention will be described below. In the following drawings, the same or corresponding parts are indicated by the same reference numerals, and repeated descriptions will be omitted.

[0023] (First Implementation) <Immunochromatographic assay kit> like Figure 1 and Figure 2As shown, the immunochromatographic assay kit 100 according to the first embodiment mainly includes: a sample dropper 1; a coupling part 2; a detection region t including multiple detection parts 3; a control region c including a control part 4; and an absorption part 5. Figure 1 and Figure 2 As shown, the sample droplet 1, coupling part 2, detection area t, control area c, and absorption part 5 are arranged in the order described above along the unfolding direction D.

[0024] The sample drop section 1 is the part for the sample to be dropped. The sample drop section 1 is formed of a porous component such as a glass fiber pad, a cellulose fiber pad, and a polyester pad.

[0025] The coupling section 2 is a portion for immobilizing a labeled antibody having the property of binding to the detection target in the sample. The labeled antibody is a conjugate of an antibody that specifically recognizes and binds to a first part (first epitope) of the detection target and a labeling substance. The antibody can be arbitrarily selected according to the detection target. The labeling substance can be arbitrarily selected from labeling substances used in existing immunochromatography. For example, the labeling substance includes at least one selected from the group consisting of metal nanoparticles (metal microparticles), latex microparticles, organic polymer microparticles, inorganic microparticles, and colored microparticles such as liposomes containing colorants. For example, as metal nanoparticles, the labeling substance includes at least one selected from the group consisting of noble metal nanoparticles such as gold nanoparticles, platinum nanoparticles, platinum nanoparticles, and silver nanoparticles, titanium nanoparticles, iron nanoparticles, nickel nanoparticles, and cadmium nanoparticles. The metal nanoparticles can be colloidal metal nanoparticles with a particle size greater than or equal to 1 nm and less than or equal to 100 nm. For example, the coupling section 2 is adjusted by coating a suspension containing the labeled antibody onto a porous component such as a glass fiber pad, cellulose fiber pad, or polyester pad and drying the porous component.

[0026] The detection region t is positioned opposite the coupling portion 2 on the sample dropper 1 in the unfolding direction D. The detection region t is formed on a carrier 6 including a porous component. The detection region t includes multiple detection portions 3. Each detection portion 3 is connected to the sample dropper 1 via the coupling portion 2. Each detection portion 3 is positioned opposite the coupling portion 2 on the sample dropper 1 in the unfolding direction D. Each detection portion is a portion immobilized with a capture antibody having the property of binding to the detection target. The capture antibody is an antibody that specifically recognizes and binds to a second portion (second epitope) that is different from the first portion of the detection target. From different perspectives, the capture antibody has the property of binding to the analytical target bound to the labeled substance. The capture antibody can be arbitrarily selected according to the detection target.

[0027] like Figure 2As shown, the planar shape of each detection part 3 is dot-shaped. The width of each dot of each detection part 3 is the smallest size that can be observed visually, or a size that cannot be observed visually but can be observed with a microscope. For example, the width of each dot of each detection part 3 is less than 1 mm. Preferably, the width of each dot of each detection part 3 is equal to the field of view of an electron microscope, in which labeled material with a size of less than or equal to 1 μm bound to the labeled antibody can be directly observed. For example, the width of each dot of each detection part 3 is less than or equal to 100 μm.

[0028] The width of the detection section 3 is measured as follows. First, a sample containing sufficient detection targets is dropped onto the sample dropper 1, and an antigen-antibody reaction is generated on the immunochromatographic assay kit 100. Then, an electron microscope image of the detection section 3 is obtained according to the assay method described later. As with the immunochromatographic assay kit 100 of the first embodiment, when the detection section 3 includes the bottom surface 7A of the recess 7, an electron microscope image obtained by focusing on the bottom surface 7A is used. Then, the shape of the region where the labeled antibody is observed in the image is designated as the shape of the detection section 3. Then, the width of the shape of the detection section 3 is measured. Figure 3 As shown, when the outline of the region labeled with the antibody is observed to be wavy along the inside and outside, the diameter D1 of the outer circle CC and the diameter D2 of the inner circle IC of the outline are calculated by image processing, and the midpoint between the diameter D1 and the diameter D2 is defined as the width of the outline of the detection unit 3.

[0029] Figure 2 The detection units 3 are arranged at intervals in a direction intersecting (e.g., orthogonal) to the unfolding direction D. Each detection unit 3 is arranged in a one-dimensional manner in a direction intersecting (e.g., orthogonal) to the unfolding direction D. For example, the distance between two adjacent detection units 3 is less than 1 mm.

[0030] There are no particular restrictions on the planar shape of each detection unit 3, as long as the detection unit 3 is point-shaped, such as having a circle. The planar shape of each detection unit 3 can be elliptical, square, rectangular, etc.

[0031] like Figure 4 As shown, multiple recesses 7 are formed in the detection area 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 to the upper surface of the carrier 6, and the openings of the upper surface 6A and the bottom surface 7A are dot-shaped. Figure 4 In the cross-section, the bottom surface 7A and the wall surface 7B form an obtuse angle. In other words, Figure 4Each recess 7 has a tapered cross-sectional shape, in which the spacing between opposite wall surfaces 7B narrows towards the bottom surface 7A, but the opening diameter of the upper surface 6A can be equal to the diameter of the bottom surface 7A. The width of the bottom surface 7A of each recess 7 is the smallest dimension that can be visually inspected, for example, less than 1 mm. Preferably, it is desirable that the width of the bottom surface 7A of each recess 7 is equal to the field of view of an electron microscope, in which labeled material bound to labeled antibodies with a size less than or equal to 1 μm can be directly observed. For example, the dot width of each bottom surface 7A is less than or equal to 100 μm. The depth of each bottom surface 7A is deeper than the focal depth of an electron microscope. For example, the depth of each bottom surface 7A is greater than or equal to 10 μm.

[0032] For example, the planar shape of each bottom surface 7A is circular. The planar shape of each bottom surface 7A can be elliptical, square, rectangular, etc.

[0033] Each detection portion 3 includes a bottom surface 7A of each recess 7. Each detection portion 3 is formed in each recess 7 of the carrier 6. For example, the detection portion 3 and the recess 7 are formed simultaneously on the carrier 6. The method of simultaneously forming the detection portion 3 and the recess 7 on the carrier 6 will be described in detail later in the section on methods for manufacturing immunochromatographic assay kits.

[0034] The control region c is positioned opposite the detection region t in the unfolding direction D, on the opposite side of the coupling portion 2. The control region c includes a control portion 4. The control portion 4 is a portion for immobilizing the control antibody that binds to the labeled antibody. The planar shape of the control portion 4 can be any shape, for example, a linear shape.

[0035] The control unit 4 is formed on the carrier 6. The control unit 4 is disposed on the opposite side of the coupling unit 2 in the unfolding direction D relative to the detection unit 3.

[0036] exist Figure 1 and Figure 2 In the diagram, for ease of description, the ranges of the detection region t and the control region c are represented by dashed lines. In actual immunochromatographic assay kits, dashed lines are not shown, for example.

[0037] The absorption section 5 is the part that absorbs the remaining sample after unfolding. The absorption section 5 is formed of a porous component such as a glass fiber pad, cellulose fiber pad, or polyester pad. The absorption section 5 is positioned on the opposite side of the detection area t relative to the control area c in the unfolding direction D.

[0038] The carrier 6 has a rectangular planar shape. The carrier 6 has a longitudinal direction along the unfolding direction D and a transverse direction orthogonal to the unfolding direction D. The material constituting the carrier 6 can be any porous material, including at least one of nitrocellulose and polyvinylidene fluoride (PVDF). That is, in the immunochromatographic assay kit 100 of the first embodiment, a plurality of detection sections 3 and a plurality of control sections 4 are formed on a porous member separate from the porous members constituting the sample drop section 1, the coupling section 2, and the absorption section 5. For example, the porous member constituting the sample drop section 1 is bonded to the porous member constituting the coupling section 2. For example, each porous member constituting the coupling section 2 and the absorption section 5 is bonded to each porous member constituting the carrier 6.

[0039] The sample drop section 1, coupling section 2, detection section 3, control section 4, absorption section 5, and carrier 6 can be fixed to the substrate (also called backing sheet) (not shown) using adhesives or adhesive sheets. The carrier 6 can be a thin film formed on the substrate.

[0040] <Testing methods using immunochromatographic assay kits> In the assay method using an immunochromatographic assay kit, the detection section 3 of the immunochromatographic assay kit after the antigen-antibody reaction is observed using an electron microscope. The antigen-antibody reaction on the immunochromatographic assay kit will be described below.

[0041] First, the sample is dropped into the sample dropper 1. Due to capillary action, the dropped sample flows along the spreading direction D. The detection target in the sample binds to the labeled antibody in the coupling section 2. The conjugate of the detection target and the labeled antibody, along with the labeled antibody not bound to the detection target, moves along the spreading direction D due to capillary action. The detection target bound to the labeled antibody binds to the capture antibody in the detection section 3. Therefore, the labeled antibody bound to the detection target accumulates in the detection section 3. The labeled material bound to the labeled antibody in the detection section 3 is directly observed using an electron microscope. Furthermore, the labeled antibody not bound to the detection target binds to the control antibody in the control section 4. Therefore, the labeled antibody not bound to the detection target is captured by the control section 4. The labeled material bound to the labeled antibody in the control section 4 is directly observed using an electron microscope. Excess sample flowing downstream of the control section 4 in the spreading direction D is absorbed by the absorption section 5.

[0042] For example, the testing method using an immunochromatographic assay kit is performed through the following procedure. First, after the sample is dropped into the sample dropper 1, the auxiliary liquid is dropped after a specified time.

[0043] The auxiliary liquid possesses conductivity that contributes to image clarity under electron microscopy measurement conditions, prevents charging and heating, and / or forms a film through polymerization. The auxiliary liquid comprises: glycerol and glycerol substitutes; at least one compound selected from polysorbates such as polysorbate-20, polysorbate-40, polysorbate-60, polysorbate-65, polysorbate-80, and polysorbate-85, and polysorbate substitutes, as an essential component; and at least one compound selected from monosaccharides, disaccharides, salts, and buffer solutions as an optional component.

[0044] Subsequently, the detection section 3 is observed using an electron microscope. Specifically, first, the carrier 6 is placed in the chamber of the electron microscope. Then, the detection section 3 is searched while observing the upper surface of the carrier 6. In the immunochromatographic assay kit 100, defocus caused by the distance between the upper surface and the bottom surface 7A of the carrier 6 is observed in the electron microscope micrograph (bright field image). Thus, by checking for the presence of defocus, the recess 7 can be searched in the micrograph image, thereby making it easy to search for the detection section 3 in the image. Thereafter, by focusing the image onto the bottom surface 7A, the image can be focused onto the detection section 3. Subsequently, an electron microscope image is captured, and the amount of labeled substance in the image is measured. The outline of the labeled substance can be clearly identified in the electron microscope image, thereby allowing the amount of labeled substance in the image to be measured. When the measured amount of labeled substance exceeds a predetermined standard, it is determined that the detection target exists in the sample (i.e., "positive").

[0045] For example, observation and calculation are performed on multiple detection units 3 in a similar manner. In this case, for example, the average, maximum, minimum, etc. of the amount of labeled material in the same field of view of each detection unit 3 are calculated, any one of these calculated values ​​is set as an evaluation value, and when the evaluation value exceeds a predetermined judgment criterion, the amount of labeled material is judged as "positive".

[0046] <Methods for Manufacturing Immunochromatographic Assay Kits> The following describes an example of a method for manufacturing an immunochromatographic assay kit 100. Figure 5 As shown, the method for manufacturing the immunochromatographic assay kit 100 includes a step (S1) of preparing a carrier 6 and a step (S2) of forming a plurality of detection sections 3 on the prepared carrier 6.

[0047] In the process of preparing the carrier 6, 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.

[0048] In the process of forming multiple detection sections 3, a coating needle 21 is used to hold the captured antibody at its tip (see...). Figure 10The capture antibody is dotted onto the upper surface of the carrier 6. The diameter of the tip of the coating needle 21 (hereinafter referred to as the tip diameter) is less than 1 mm. In this step, the coating needle 21 is used to form a recess 7 on the carrier 6, and simultaneously, the capture antibody is coated onto the bottom surface 7A of the recess 7. That is, the coating needle 21, which holds the capture antibody at its tip, is further pushed into the carrier 6 after contacting the upper surface of the carrier 6. In this step, using Figures 6 to 10 The coating apparatus is described below. The structure of the coating apparatus will be described later.

[0049] In this manner, a carrier 6 comprising multiple detection sections 3 is formed. When a control section 4 is formed on the carrier 6, a coupling section 2 and an absorption section 5 are connected to the carrier 6, and a sample drop section 1 is connected to the coupling section 2, thereby manufacturing an immunochromatographic assay kit 100. When the control section 4 is not formed on the carrier 6, the control section 4 is formed on the carrier 6. Then, the coupling section 2 and the absorption section 5 are connected to the carrier, and the sample drop section 1 is further connected to the coupling section 2, thereby manufacturing an immunochromatographic assay kit 100. In the method for manufacturing the immunochromatographic assay kit 100, each of the sample drop section 1, the coupling section 2, the control section 4, and the absorption section 5 can be formed in the same manner as in existing immunochromatographic assay kits.

[0050] <Structure of the Coating Apparatus> The following will describe an example of a coating apparatus for forming a plurality of detection sections 3 in a method for manufacturing an immunochromatographic assay kit 100.

[0051] like Figure 6 As shown, the coating apparatus of the first embodiment mainly includes an X-axis stage 11, a Y-axis stage 12, a Z-axis stage 13, a coating mechanism 14, an observation optical system 15, a CCD camera 16, and a control unit. For example, the X-axis stage 11, Y-axis stage 12, Z-axis stage 13, coating mechanism 14, observation optical system 15, and CCD camera 16 are disposed inside the processing chamber. The control unit includes an operation panel 17, a monitor 18, and a control computer 19. For example, the operation panel 17, monitor 18, and control computer 19 are disposed outside the processing chamber.

[0052] The Y-axis stage 12 is movable in the Y-axis direction, and the carrier 6 can be mounted on the Y-axis stage. For example, a guide rail extending along the Y-axis direction is fixed to the bottom of the processing chamber. A guide portion movable along the guide rail is connected to the lower surface of the Y-axis stage 12. The upper surface of the Y-axis stage 12 is a mounting surface for mounting the carrier 6. A structure spanning the Y-axis stage 12 in the X-axis direction is fixed to the bottom of the processing chamber.

[0053] The X-axis stage 11 is mounted on a structure that spans the Y-axis stage 12 in the X-axis direction. A movable body connected to the Z-axis stage 13 is mounted on the X-axis stage 11 so that it can move in the X-axis direction. The movable body can move in the X-axis direction using, for example, a ball screw. The X-axis stage 11 is fixed to the bottom surface of the processing chamber by this structure. For this purpose, the Y-axis stage 12, as described above, can move relative to the X-axis stage 11 in the Y-axis direction.

[0054] The Z-axis stage 13 is mounted on a movable body connected to the X-axis stage 11 as described above. An observation optics system 15 and a coating mechanism 14 are connected to the Z-axis stage 13. The observation optics system 15 is used to observe the coating position on the carrier 6. A CCD camera converts the observed image into an electrical signal. The Z-axis stage 13 holds the observation optics system 15 and the coating mechanism 14 so that they can move in the Z-axis direction.

[0055] The control panel 17, monitor 18, and control computer 19 are used to control the Y-axis stage 12, X-axis stage 11, Z-axis stage 13, observation optical system 15, and coating mechanism 14. The control panel 17 is used to input commands to the control computer 19. The monitor 18 displays image data converted by the CCD camera 16 as described above and output data from the control computer 19.

[0056] <Construction of Coating Mechanism 14> The following will describe Figure 6 The detailed structure of the coating mechanism 14 is shown below. Figure 7 and Figure 8 As shown, 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 by the coating needle holder 20, and a coating material container 22. The servo motor 41 causes the rotating shaft to rotate... Figure 6 The servo motor 41 is mounted in a manner extending along the Z-axis. The servo motor 41 is held on the frame 42. A cam 43 is connected to the rotation axis of the servo motor 41. The cam 43 can rotate about the rotation axis of the servo motor 41.

[0057] The cam 43 includes a central portion connected to the rotation shaft of the servo motor 41 and a flange portion connected to one end of the central portion. The upper surface of the flange portion (the surface on the side of the servo motor 41) is a cam surface. The cam surface is formed in an annular shape along the outer periphery of the central portion and is also formed in a sloping shape, causing the distance from the bottom surface of the flange portion to vary. Specifically, the cam surface includes: an upper flat region with the longest distance from the bottom surface of the flange portion; a lower flat region with the shortest distance from the bottom surface of the flange portion; and an inclined region connecting the upper flat region and the lower flat region. The upper flat region is arranged to be spaced apart from the lower flat region in the circumferential direction relative to the rotation shaft.

[0058] The bearing 44 includes an outer ring configured to contact the cam surface of the cam 43 and an inner ring connected to the cam connecting plate 45. For example... Figure 7 As shown, viewed from cam 43, bearing 44 is positioned in a specific direction (to the right of servo motor 41). Bearing 44 is biased to the cam surface of cam 43 by spring 50, described later. Therefore, as cam 43 rotates, bearing 44 is held in contact with the cam surface while the outer peripheral surface of its outer ring contacts the cam surface. One end of cam connecting plate 45 is connected to the inner ring of bearing 44, and the other end is fixed to movable part 46. Coating needle holder fixing part 47 and coating needle holder receiving part 48 are connected to movable part 46.

[0059] A retaining pin 51 is mounted on the frame 42. A retaining pin 52 is mounted in the movable part 46. One end of a spring 50 is connected to the retaining pin 51, and the other end of the spring 50 is connected to the retaining pin 52. The movable part 46 is under tension towards the coating material container 22 via the spring 50. The tension of the spring 50 acts on the bearing 44 through the movable part 46 and the cam connecting plate 45. This tension of the spring 50 keeps the bearing 44 pressed against the cam surface of the cam 43.

[0060] The movable part 46, the coating needle holder fixing part 47, and the coating needle holder receiving part 48 are connected to the linear guide 49 mounted on the frame 42. The linear guide 49 is configured to extend in the Z-axis direction. Therefore, the movable part 46, the coating needle holder fixing part 47, and the coating needle holder receiving part 48 can move along the Z-axis direction.

[0061] A coating needle holder 20 is housed in a coating needle holder receiving portion 48. The coating needle holder 20 includes a coating needle 21. The coating needle 21 is configured to protrude from the coating needle holder 20 on the lower surface of the coating needle holder 20. The extending direction of the coating needle 21 is along the direction of gravity. Figure 6(Z-axis direction). For example, the tip of the coating needle 21 is truncated conical. The tip diameter of the coating needle 21 in the radial direction relative to the central axis is less than 1 mm. Preferably, the tip diameter of the coating needle 21 is less than or equal to 100 μm.

[0062] The coating material container 22 is positioned below the coating needle holder 20. A space for storing coating material 70 is formed inside the coating material container 22. Figure 9 and Figure 10 As shown, a first hole and a second hole connecting the aforementioned space to the outside are formed at the bottom and top of the coating material container 22. Each of the first and second holes can be of any shape, and for example, circular. The first and second holes are arranged to overlap each other in the extending direction of the coating needle 21. The coating material 70 contains capture antibodies.

[0063] As the coating needle holder accommodating portion 48 moves in the Z-axis direction, the coating needle holder 20 and the coating needle 21 move vertically relative to the coating material container 22. This switches between a first state where 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 where the tip passes through a hole formed in the bottom of the coating material container 22 and protrudes downward from the bottom surface of the container.

[0064] <Operation of the Coating Device> The operation of the coating apparatus in the process of forming multiple detection sections 3 in a method for manufacturing an immunochromatographic assay kit will be described below. First, the carrier 6 is mounted on the Y-axis stage 12. Then, a first state is achieved where the tip of the coating needle 21 is immersed in the coating material 70 stored in the coating material container 22. Next, the X-axis stage 11 and the Y-axis stage 12 are operated to position the carrier 6 in the X-axis and Y-axis directions, such that the area where the detection section 3 is to be formed is positioned directly below the coating mechanism 14. Then, the Z-axis stage 13 is operated to lower the distance d between the Z-axis stage 13 and the coating mechanism 14 in the Z-axis direction, such that when the coating needle is in the second state, the tip of the coating needle 21 is pushed downwards below the upper surface of the carrier 6.

[0065] Subsequently, the servo motor 41 of the coating mechanism 14 is switched from the first state to the second state. Specifically, the servo motor 41 is operated to rotate the cam 43, thereby rotating the rotation shaft of the servo motor 41. As a result, the height of the cam surface of the cam 43 in the Z-axis direction changes, causing the position of the bearing 44, which contacts the cam surface in the Z-axis direction, to also change with the rotation of the drive shaft of the servo motor 41. According to 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 receiving part 48, and the coating needle holder 20 held by the coating needle holder receiving 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 Figure 9 The first state and Figure 10 The second state is switched. In the coating mechanism 14, the rotational motion of the servo motor 41 can be converted into the motion (vertical motion) of the coating needle 21 in the Z-axis direction, so that the coating needle 21 can move quickly and accurately in the Z-axis direction.

[0066] exist Figure 9 In the first state, the coating needle 21 is positioned at the uppermost position within its movable range. 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 contacts the upper flat area of ​​the cam surface of the cam 43.

[0067] exist Figure 10 In the second state, the coating needle 21 is positioned at its lowest point within its movable range. 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 on the end and side surfaces of the tip of the coating needle 21. The tip of the coating needle 21 passes through a hole formed in the bottom of the coating material container 22, protrudes downward from the bottom surface of the coating material container, and is pushed downward below the upper surface of the carrier 6.

[0068] As described above, when the servo motor 41 is operated to switch from the first state to the second state, a recess 7 is formed in the carrier 6, and simultaneously, the capture antibody is coated on the bottom surface 7A of the recess 7. Subsequently, the servo motor 41 is operated to switch from the second state to the first state.

[0069] Furthermore, after operating only the X-axis stage 11 and Y-axis stage 12 to position the area where the secondary forming detection unit 3 is located directly below the coating mechanism 14, the Z-axis stage 13 descends 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. Furthermore, after switching from the second state to the first state, the Z-axis stage 13 rises a distance d.

[0070] By continuously repeating the above operation, multiple detection units 3 are formed on the upper surface of the carrier 6. <Beneficial Effects> The beneficial effects of the immunochromatographic assay kit 100 of the first embodiment will be described by comparing it with existing immunochromatographic assay kits (hereinafter referred to as the first comparative example). In the first comparative example, the detection zone is formed on a flat plane and is configured such that the color development from the antibody-derived detection zone is visually detectable. Therefore, in the first comparative example, the detection zone needs to have a sufficient area (e.g., greater than or equal to a few mm). 2 This is to prevent erroneous judgments by visual means, and it is difficult to reduce the amount of expensive capture antibodies fixed to the detection unit. As a result, in the first comparative example, it is difficult to reduce manufacturing costs.

[0071] On the other hand, in the immunochromatographic assay kit 100, by reducing the tip diameter of the coating needle 21, the spot width of each detection zone 3 can be less than 1 mm. That is, in the immunochromatographic assay kit 100, compared to the area of ​​each detection zone in the first comparative example, the area of ​​each detection zone 3 can be reduced, and compared to the amount of capture antibody immobilized in each detection zone 3 in the first comparative example, the amount of capture antibody immobilized in each detection zone 3 can be reduced. As a result, the manufacturing cost of the immunochromatographic assay kit 100 can be reduced compared to the manufacturing cost of the first comparative example.

[0072] Furthermore, according to the immunochromatographic assay kit 100, the detection unit 3 is examined using an electron microscope, and the number of labeled antibodies captured by the detection unit 3 in the electron microscope image is measured, thereby quantitatively assessing the detection target in the sample.

[0073] Furthermore, when the detection portion formed on a flat plane is miniaturized as in the first comparative example, it is necessary to examine the labeled antibody by magnifying the detection portion with a microscope or similar device. However, it is difficult to search for and align the miniaturized detection portion with a microscope. As a countermeasure, a method for setting a label on a kit and placing the detection portion at a predetermined distance from the label can be conceived. However, in this case, a separate device for setting the label is required in addition to the device for forming the detection portion, and the number of steps increases, making it impossible to reduce the manufacturing cycle time and difficult to reduce costs.

[0074] On the other hand, in the immunochromatographic assay kit 100, a plurality of recesses 7 are formed in the carrier 6, and each detection zone 3 includes a bottom surface 7A of a recess. Therefore, when the labeled material on the detection zone 3 is directly examined using an electron microscope, the defocus caused by the distance between the upper surface and the bottom surface 7A of the carrier 6 can be examined in the electron microscope image, allowing the recesses 7 to be searched in the electron microscope image using defocus. As a result, in the immunochromatographic assay kit 100, each detection zone 3 can be miniaturized compared to the first comparative example. For example, in the immunochromatographic assay kit 100, by reducing the tip diameter of the coating needle 21, the dot width of each detection zone 3 can be less than 1 mm. That is, in the immunochromatographic assay kit 100, the area of ​​each detection zone 3 can be reduced compared to the area of ​​each detection zone in the first comparative example, and the amount of capture antibody immobilized in each detection zone 3 can be reduced compared to the amount of capture antibody immobilized in each detection zone 3 in the first comparative example. As a result, the manufacturing cost of the immunochromatographic assay kit 100 can be reduced compared to the manufacturing cost of the first comparative example.

[0075] Furthermore, by focusing the image onto the bottom surface 7A, the image can be easily focused onto the detection unit 3. That is, in the immunochromatographic assay kit 100, compared to the case where each detection unit 3 does not include a recess 7 on the bottom surface 7A, the time required to search for the detection unit 3 can be shortened.

[0076] Furthermore, unlike the first comparative example, in the immunochromatographic assay kit 100, it is not necessary to separately set a mark for the detection section 3, nor is it necessary to provide a separate device for setting the mark in addition to the device for forming the detection section. Moreover, in the immunochromatographic assay kit 100, the recess 7 can be formed simultaneously with the detection section 3, thereby reducing the manufacturing cycle time compared to the case where a mark is set in the first comparative example.

[0077] In the immunochromatographic assay kit 100, the width of each detection zone can be reduced to less than or equal to 100 μm. In such an immunochromatographic assay kit 100, the amount of capture antibody immobilized in each detection zone 3 is significantly reduced compared to the amount of capture antibody immobilized in each detection zone of the first comparative example, thereby greatly reducing the manufacturing cost of the immunochromatographic assay kit 100 compared to the manufacturing cost of the first comparative example.

[0078] The immunochromatographic assay kit 100 includes multiple detection units 3. In this immunochromatographic assay kit 100, compared to an immunochromatographic assay kit that includes only one detection unit 3, the labeled substances of multiple detection units can be examined in an electron microscope image, thereby improving the reliability of the test results.

[0079] In the immunochromatographic assay kit 100, multiple detection units 3 are arranged in a one-dimensional manner relative to the unfolding direction D. In such an immunochromatographic assay kit 100, compared to an immunochromatographic assay kit with multiple detection units 3 randomly arranged, the detection target effectively flows to all detection units 3 and binds to the capture antibody, thereby obtaining stable test results.

[0080] In the immunochromatographic assay kit 100, the shortest distance between any two adjacent detection zones 3 is less than 1 mm. In this immunochromatographic assay kit 100, compared to immunochromatographic assay kits with a shortest distance greater than or equal to 1 mm, multiple detection zones 3 can be observed even in a relatively small field of view, thus making it easy to search for each detection zone 3.

[0081] The effects of the method for manufacturing the immunochromatographic assay kit 100 of the first embodiment are described by comparing it with a manufacturing method that uses a dispenser to form each detection unit 3 (hereinafter referred to as the second comparative example) and a manufacturing method that uses an inkjet method to form each detection unit 3 (hereinafter referred to as the third comparative example).

[0082] In the second and third comparative examples, in order to form the detection section 3 with its minute size, it is necessary to reduce the opening width of the tip of the dispenser or nozzle. However, when using a coating material 70 with high viscosity, the coating material 70 cannot be discharged, and clogging may occur. In the third comparative example, in the method of discharging the liquid material containing the capture antibody by instantaneously increasing the pressure in the container using a piezoelectric element or the like, the discharge pressure is high, resulting in the problem that the liquid material may diffuse when it falls onto the carrier 6 and the shape of the detection section 3 may be unstable.

[0083] On the other hand, in the method for manufacturing the immunochromatographic assay kit 100, in order to form the tiny detection part 3, it is only necessary to reduce the tip diameter of the coating needle 21 so that clogging as seen in the second comparative example will not occur regardless of viscosity. Furthermore, in the above manufacturing method, since the position of the tip of the coating needle 21 relative to the upper surface of the carrier 6 in the Z-axis direction can be precisely controlled by the Z-axis stage 13, the size variation of the detection part 3 can be reduced, and the immunochromatographic assay kit 100 can be manufactured stably.

[0084] Furthermore, in the second comparative example, it was difficult to stably form a detection part 3 with a dot width of less than 1 mm in order to coat the droplets, and in particular, it was difficult to stably form a detection part with a dot width of less than 100 μm.

[0085] On the other hand, in the method for manufacturing the immunochromatographic assay kit 100, since the coating needle 21 is used, the immunochromatographic assay kit 100 in which the planar shape of each detection part 3 is dot-shaped and the width of each detection part is less than 1 mm can be easily and stably manufactured.

[0086] Furthermore, in the method for manufacturing the immunochromatographic assay kit 100, while forming a recess 7 in the carrier 6 using a coating needle 21, a capture antibody is coated onto the bottom surface 7A of the recess 7. This allows for the formation of a detection section 3 including a bottom surface 7A of a recess 7 and the coating of the capture antibody in a single operation. Therefore, the cycle time does not increase due to the formation of the detection section 3, and the manufacturing cost does not increase.

[0087] <First Variation> The immunochromatographic assay kit 100 of the first embodiment can be modified as follows.

[0088] The detection area t may include at least one detection unit 3. In the immunochromatographic assay kit 100, the detection units 3 have the same structure, but the present invention is not limited thereto. In the immunochromatographic assay kit 100, the concentration of the capture antibody immobilized in each detection unit 3 is constant, but the concentration of the capture antibody immobilized in each detection unit 3 can be different from each other. For example, the concentration of the capture antibody can be set to gradually decrease from one side to the other in a direction orthogonal to the unfolding direction D. Furthermore, a pattern consisting of multiple detection units 3 with different concentrations of capture antibodies can be arranged side by side. Multiple detection units 3 can be easily formed using multiple coating mechanisms 14 with different concentrations of capture antibodies stored in the coating material container 22.

[0089] Furthermore, at least one of the following can be different from each other: the planar shape of each detection part 3, the dot width of each detection part, the distance between two adjacent detection parts 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. Such a plurality of detection parts 3 can be easily formed using various coating needles 21 or various coating conditions.

[0090] In the immunochromatographic assay kit 100, a plurality of recesses 7 are formed in the detection region t of the carrier 6, and a detection part 3 includes the bottom surface 7A of a recess 7, but the present invention is not limited thereto.

[0091] Each detection section 3 may include at least a portion of the entire bottom surface 7A and wall surface 7B of each recess 7. Furthermore, each detection section 3 may include the entire bottom surface 7A and wall surface 7B of each recess 7, as well as an annular region continuous with the wall surface 7B of the upper surface of the carrier 6.

[0092] Multiple detection units 3 may include Figure 4 At least one detection unit and Figure 11 At least one detection unit in it. Figure 11 The multiple detection units 3 in the carrier 6 only include the upper surface of the carrier 6. In the above manufacturing method, the tip of the coating needle 21 or the coating material 70 attached to the tip contacts the upper surface of the carrier 6 and then moves upward without being pushed downward, thereby easily forming the detection units 3. Furthermore, all detection units 3 can be configured as follows: Figure 11 The detection section 3 in the carrier 6. That is, multiple recesses 7 may not be formed in the detection area t of the carrier 6.

[0093] like Figure 12 As shown, in the immunochromatographic assay kit 100, multiple detection units 3 can be arranged at intervals along the unfolding direction D. For example, the distance between two adjacent detection units in the unfolding direction D is equal to the distance between adjacent detection units 3 in a direction orthogonal to the unfolding direction D.

[0094] In the method for manufacturing the immunochromatographic assay kit 100, a single coating needle 21 is used to form multiple detection zones 3, but multiple coating needles 21 can be used to form multiple detection zones 3. In other words, the coating apparatus may include multiple coating mechanisms 14.

[0095] Furthermore, to further improve the accuracy of the coating needle 21 in the coating process of the coating material 70, the moving speed of the coating needle 21 in the Z-axis direction can be changed according to the position of the coating needle 21. For example, when switching from the first state to the second state, the moving speed of the coating needle 21 is reduced before implementing the second state. The reduction in the moving speed of the coating needle 21 is achieved by reducing the rotational speed of the servo motor 41.

[0096] By implementing such control, the movement speed of the coating needle 21 is sufficiently low when it contacts the carrier 6, thereby prolonging the contact time between the coating needle 21 or the tip of the coating material 70 attached to the tip and the carrier 6. Consequently, the amount and concentration of the capture antibody coated on the carrier 6 are increased, thereby further stabilizing the antigen-antibody reaction with the target antigen.

[0097] In the immunochromatographic assay kit 100, the sample drop portion 1 and the coupling portion 2 can be formed on a single porous component separate from the carrier 6. In the immunochromatographic assay kit 100, the coupling portion 2 can be formed on the carrier 6, and the sample drop portion 1 can be formed on a porous component separate from the carrier 6. In the immunochromatographic assay kit 100, the absorption portion 5 can be formed on the carrier 6.

[0098] (Second Implementation) The immunochromatographic assay kit 101 according to the second embodiment has a structure substantially similar to that of the immunochromatographic assay kit 100 according to the first embodiment, and exhibits similar effects, but differs from the immunochromatographic assay kit 100 in that, as Figure 13 As shown, the plurality of detection units 3 include a first detection unit 3A and a second detection unit 3B.

[0099] A first capture antibody, having the property of binding to a first type of detection target, is immobilized on a first detection unit 3A. A second capture antibody, having the property of binding to a second type of detection target different from the first type of detection target, is immobilized on a second detection unit 3B.

[0100] like Figure 13 As shown, for example, the plurality of detection units 3 include a plurality of first detection units 3A and a plurality of second detection units 3B. The plurality of first detection units 3A are arranged at intervals in a direction orthogonal to the unfolding direction D. For example, the plurality of first detection units 3A are arranged in a one-dimensional manner. The plurality of second detection units 3B are arranged at intervals in a direction orthogonal to the unfolding direction D. For example, the plurality of second detection units 3B are arranged in a one-dimensional manner.

[0101] Multiple first detection units 3A and multiple second detection units 3B are arranged at intervals in a direction orthogonal to the unfolding 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. For example, the multiple first detection units 3A and multiple second detection units 3B are arranged in a one-dimensional manner.

[0102] Each of the first detection unit 3A and the second detection unit 3B has the same structure as each detection unit 3 in the first embodiment. For example, the dot width of the first detection unit 3A is equal to the dot width of the second detection unit 3B. For example, the dot width of the first detection unit 3A may be narrower or wider than the dot width of the second detection unit 3B.

[0103] Within the detection area t, the area where multiple first detection units 3A are arranged is designated as the first detection area t1, and the area where multiple second detection units 3B are arranged is designated as the second detection area t2. The first detection area t1 and the second detection area t2 are arranged side by side in a direction orthogonal to the deployment direction D.

[0104] Each first detection unit 3A includes a bottom surface 7A of each recess 7. Each second detection unit 3B includes a bottom surface 7A of each recess 7.

[0105] According to the immunochromatographic assay kit 101 of the second embodiment, two types of detection targets can be detected from a single sample by immunochromatography.

[0106] The immunochromatographic assay kit 101 can be manufactured in the same manner as the immunochromatographic assay kit of the first embodiment. Preferably, the coating apparatus includes: a first coating mechanism 14 for forming a first detection section 3A by coating a first capture antibody onto a carrier 6; and a second coating mechanism 14 for forming a second detection section 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.

[0107] In the method for manufacturing an immunochromatographic assay kit 101, a first coating needle 21 holds a first capture antibody at its tip. A second coating needle 21 holds a second capture antibody at its tip. In the step of forming a plurality of detection zones 3, a first detection zone 3A is formed by coating the first capture antibody onto a first region of a carrier 6 using the first coating needle 21. Furthermore, a second detection zone 3B is formed by coating the second capture antibody onto a second region of the carrier 6 using the second coating needle 21.

[0108] When such a coating apparatus is used to manufacture the immunochromatographic assay kit 101, the number of manufacturing hours can be reduced compared to the case where a single coating apparatus including only one coating mechanism 14 is used to manufacture the immunochromatographic assay kit 101, and the manufacturing cost can be reduced compared to the case where multiple coating apparatuses including only one coating mechanism 14 are used to manufacture the immunochromatographic assay kit 101.

[0109] <Second Variation> The immunochromatographic assay kit 101 of the second embodiment can also be a variant similar to the immunochromatographic assay kit 100 of the first embodiment.

[0110] In addition, the immunochromatographic assay kit 101 can be modified in the following ways. Each of the plurality of first detection units 3A and the plurality of second detection units 3B can be arranged alternately.

[0111] like Figures 14 to 16 As shown, in addition to the first detection unit 3A and the second detection unit 3B, the plurality of detection units 3 may also include a plurality of third detection units 3C. A third capture antibody having the property of binding to a third type of detection target that is different from the first type of detection target and the second type of detection target is immobilized on each third detection unit 3C.

[0112] like Figure 14 As shown, multiple first detection units 3A, multiple second detection units 3B, and multiple third detection units 3C are arranged one after another alternately in a direction orthogonal to the unfolding direction D.

[0113] like Figure 15 As shown, a plurality of first detection units 3A, a plurality of second detection units 3B, and a plurality of third detection units 3C are arranged alternately, for example, in a direction orthogonal to the unfolding direction D. In this case, for example, the distance between two adjacent first detection units 3A and the distance between two adjacent second detection units 3B are shorter than the distance between adjacent first detection units 3A and second detection units 3B. For example, the distance between two adjacent second detection units 3B and the distance between two adjacent third detection units 3C are shorter than the distance between adjacent second detection units 3B and third detection units 3C.

[0114] like Figure 16 As shown, for example, each of the plurality of first detection units 3A, the plurality of second detection units 3B, and the plurality of third detection units 3C is arranged in a one-dimensional manner in the unfolding direction D. Furthermore, the plurality of first detection units 3A, the plurality of second detection units 3B, and the plurality of third detection units 3C are arranged alternately one after another in a direction orthogonal to the unfolding direction D. For example, the distance between adjacent first detection units 3A and second detection units 3B in a direction orthogonal to the unfolding direction D is longer than the distance between two adjacent first detection units 3A and two adjacent second detection units 3B in the unfolding direction D. For example, the distance between adjacent second detection units 3B and third detection units 3C in a direction orthogonal to the unfolding direction D is longer than the distance between two adjacent second detection units 3B and two adjacent third detection units 3C in the unfolding direction D.

[0115] exist Figures 14 to 16In the variant shown, in a set of first detection units 3A, second detection units 3B and third detection units 3C, at least one of the following can be different from each other: the planar shape of each detection unit 3, the dot width of each detection unit, 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.

[0116] 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.

[0117] The planar shape of the second detection unit 3B can be rectangular, while the planar shape of each detection unit 3 of the first detection unit 3A and the third detection unit 3C can be circular.

[0118] 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 included in the third detection unit 3C.

[0119] The distance between the first detection unit 3A and the second detection unit 3B can 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.

[0120] The first detection section 3A, the second detection section 3B, and the third detection section 3C can be easily formed using a variety of coating needles 21 or by using a variety of coating conditions.

[0121] 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.

[0122] (Third Implementation) The immunochromatographic assay kit 102 according to the third embodiment has a structure substantially similar to that of the immunochromatographic assay kit 100 according to the first embodiment, and exhibits similar effects. However, the difference from the immunochromatographic assay kit 100 is that the sample drop portion 1 and the coupling portion 2 are formed on the carrier 6. That is, in the immunochromatographic assay kit 102, the sample drop portion 1, the coupling portion 2, the plurality of detection portions 3, and the control portion 4 are formed on the upper surface of a single porous member (a carrier 6).

[0123] exist Figure 17 In the immunochromatographic assay kit 102, the absorption portion 5 is also formed on the carrier 6.

[0124] The sample drop section 1 is the area where the sample is dropped onto the carrier 6, and is positioned on one side in the spreading direction D. The coupling section 2 is the area where the labeled antibody is coated on the upper surface of the carrier 6, and is positioned between the sample drop section 1 and the detection area t in the spreading direction D. The absorption section 5 is the area where the remaining sample is absorbed in the carrier 6, and is positioned on the other side in the spreading direction D relative to the control area C.

[0125] According to the immunochromatographic assay kit 102, the number of parts is reduced compared to the immunochromatographic assay kit 100. Therefore, the manufacturing cost of the immunochromatographic assay kit 102 can be reduced compared to the manufacturing cost of the kit for immunochromatographic analysis.

[0126] <Third Variation> The immunochromatographic assay kit 102 of the third embodiment can also be a variant similar to the immunochromatographic assay kit 100 of the first embodiment and the immunochromatographic assay kit 101 of the second embodiment.

[0127] (Fourth Implementation) The immunochromatographic assay kit 103 according to the fourth embodiment has a structure substantially similar to that of the immunochromatographic assay kit 100 according to the first embodiment, and exhibits similar effects, but differs from the immunochromatographic assay kit 100 in that, as Figure 18 As shown, multiple immunochromatographic assay kits 100A to 100C are configured as connectors linked in a direction orthogonal to the unfolding direction D. The detection targets of immunochromatographic assay kits 100A to 100C are different from each other.

[0128] Each of the immunochromatographic assay kits 100A to 100C can be fixed by any method, such as binding with each other.

[0129] According to the fourth embodiment of the immunochromatographic assay kit 103, three types of detection targets can be detected by immunochromatography using an immunochromatographic assay kit 103 configured as a linker.

[0130] (Example 1) In Example 1, the observation results of electron microscopy using the detection section 3 of the immunochromatographic assay kit 100 will be described.

[0131] <Sample> The carrier 6 is a porous component made of nitrocellulose. Each detection part 3 is formed into a bottom surface 7A including a recess 7 using a coating needle 21 with a truncated cone shape at the tip and a tip diameter of 50 μm.

[0132] <Observation Methods> Figure 19The microscopic image is obtained by observing the detection part 3 of the sample using a microscope.

[0133] like Figure 19 As shown, in the microscopic image, due to the defocus caused by the recess 7, a difference is generated between the background and the detection unit 3. Therefore, the bottom surface 7A of the recess 7 can be easily searched, and the tiny detection unit 3 including the bottom surface 7A can be easily searched.

[0134] (Example 2) In Example 2, the immunochromatographic results using Immunochromatographic Assay Kit 100 will be described.

[0135] <Sample> The sample drop section 1 and coupling section 2 are glass fiber pads. The carrier 6 is a porous component made of nitrocellulose. Each detection section 3 is formed into a bottom surface 7A including a recess 7 using a coating needle 21 with a truncated cone shape at the tip and a tip diameter of 50 μm.

[0136] <Testing Methods> This testing method is equivalent to the testing method of the immunochromatographic assay kit described above.

[0137] Figure 20 The electron microscope image is obtained by observing the detection section 3 of the sample using an electron microscope.

[0138] like Figure 20 As shown, due to the contrast between light and dark caused by the recess 7 in the electron microscope image, the bottom surface 7A of the recess 7 can be easily searched, and the tiny detection part 3 including the bottom surface 7A can be easily searched.

[0139] Figure 21 This is an electron microscope image of the detection unit 3 before the auxiliary liquid is dropped. Figure 22 This is an electron microscope image of the detection unit 3 after the auxiliary liquid has been dripped.

[0140] exist Figure 22 In the image, with Figure 21 Compared to the image in the middle, the edges of the image are checked for clarity.

[0141] It should be understood that the disclosed embodiments and examples are exemplary in all respects and not restrictive. The scope of the invention is not limited by the description above, but by the claims, and it is intended that all variations with the equivalent meaning and scope of the claims be included in the invention. List of reference numerals

[0142] 1: Sample drop section; 2: Coupling 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 stage; 12: Y-axis stage; 13: Z-axis stage; 14: Coating mechanism; 15: Observation optical system; 16: Camera; 17: Operation panel; 18: Monitor; 19: Control computer; 20: 21: Coating needle holder; 22: Coating material container; 41: Servo motor; 42: Frame; 43: Cam; 44: Bearing; 45: Cam connecting plate; 46: Movable part; 47: Coating needle holder fixing part; 48: Coating needle holder receiving part; 49: Linear guide; 50: Spring; 51, 52: Fixing pin; 70: Coating material; 100, 100A, 100C, 101, 102, 103: Immunochromatographic assay kit.

Claims

1. An immunochromatographic assay kit, comprising: The sample dripping section is used for sample dripping. A coupling section, wherein a labeled antibody having the property of binding to a detection target in the sample is attached; and The detection area includes at least one detection section for attaching a capture antibody having the property of binding to the detection target. The sample drop portion, the coupling portion, and the at least one detection portion are formed on the porous component. In the detection area of ​​the porous component, at least one recess is formed that is recessed relative to the upper surface of the porous component. The at least one recess has a bottom surface and a wall surface that connects the bottom surface to the upper surface of the porous member. The bottom surface is dotted, and the cross-sectional shape of the concave portion is conical. The at least one detection section includes the bottom surface of the at least one recess.

2. The immunochromatographic assay kit as described in claim 1, characterized in that, The width of at least one detection part is less than 1 mm.

3. The immunochromatographic assay kit as described in claim 1 or 2, characterized in that, The width of at least one detection unit is less than or equal to 100 μm.

4. The immunochromatographic assay kit as described in claim 1 or 2, characterized in that, The at least one detection unit may be a plurality of detection units.

5. The immunochromatographic assay kit as described in claim 1 or 2, characterized in that, The at least one detection unit may be multiple detection units. The at least one recess is a plurality of recesses. Each of the plurality of detection units includes the bottom surface of one of the plurality of recesses.

6. The immunochromatographic assay kit as described in claim 4, characterized in that, The multiple detection units are arranged in a one-dimensional or two-dimensional manner.

7. The immunochromatographic assay kit as described in claim 4, characterized in that, The shortest distance between two adjacent detection units in the plurality of detection units is less than 1 mm.

8. The immunochromatographic assay kit as described in claim 4, characterized in that, The plurality of detection units include a first detection unit and a second detection unit, wherein the first detection unit is fitted with a first capture antibody having the property of binding to the detection target of a first type, and the second detection unit is fitted with a second capture antibody having the property of binding to the detection target of a second type.

9. The immunochromatographic assay kit as described in claim 1 or 2, characterized in that, The sample drop portion, the coupling portion, and the at least one detection portion are formed on a single porous component.

10. The immunochromatographic assay kit as described in claim 1 or 2, characterized in that, The sample drop portion, the coupling portion, and the at least one detection portion are formed on the plurality of porous components.

Images