JP2022074912A - Immunochromatographic test kit - Google Patents

Abstract

To provide an immunochromatographic test kit which features reduced production cost compared with conventional immunochromatographic test kits.SOLUTION: An immunochromatographic test kit is provided, comprising a sample-dropping section where a sample is dropped, a conjugate section having adhered thereto a capture antibody having a property to bind to a detention target in the sample, and a plurality of detection sections 3 having adhered thereto the capture antibody having the property to bind to the detection target. The sample-dropping section, the conjugate section, and the plurality of detection sections 3 are formed on a porous member. Each detection section 3 has a dotted outer shape. Each detection section 3 has a width less than 1 mm.SELECTED DRAWING: Figure 2

Description

The present invention relates to an immunochromatographic test kit.

Immunochromatography is currently socially implemented as a diagnostic aid for various diseases centered on influenza virus. The principle uses the antigen-antibody reaction and is widely used in the medical field because of its simplicity and effectiveness.

In conventional immunochromatography, the presence or absence of color development in the detection unit of an immunochromatography test kit (also referred to as a development support or a chromatograph medium) is visually observed. Specifically, when the detection target bound to the labeled antibody is captured by the capture antibody immobilized on the detection unit and sufficiently accumulated on the detection unit, the color development derived from the labeled antibody is visually confirmed. ..

International Publication No. 2010/061772 (Patent Document 1) discloses an immunochromatographic test kit in which the detection unit is formed to have a size of several mm or more that can be visually determined.

International Publication No. 2010/061772

In the conventional immunochromatographic 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 so as not to make an erroneous judgment, and as a result, the area of the detection unit is several. It is mm ² or more. Therefore, it is necessary to fix a large number of capture antibodies above a certain level to the detection unit to capture the antigen, and it is difficult to reduce the amount of expensive capture antibody used, and it is difficult to reduce the cost.

A main object of the present invention is to provide an immunochromatographic test kit that can reduce the amount of a capture antibody used as compared with a conventional immunochromatographic test kit and is low in cost.

The immunochromatographic test kit according to the present invention has a sample dropping portion on which a sample is dropped, a conjugate portion on which a labeled antibody having a property of binding to a detection target in the sample is fixed, and a property of binding to the detection target. It is provided with at least one detection unit to which the capture antibody having the above is attached. The sample dropping portion, the conjugate portion, and at least one detection portion are formed on the porous member. A capture antibody having a property of binding to a detection target is immobilized on at least one detection unit. The outer shape of at least one detection unit is dot-shaped. The width of at least one detector is less than 1 mm.

In the above-mentioned immunochromatographic test kit, at least one recess may be formed in the porous member. The at least one detector includes the bottom surface of at least one recess.

In the above-mentioned immunochromatographic test kit, the outer diameter of at least one detection unit may be 100 μm or less.

In the above-mentioned immunochromatographic test kit, at least one detection unit may be a plurality of detection units.

In the above-mentioned immunochromatographic test kit, a plurality of detection units may be arranged one-dimensionally or two-dimensionally.

In the above-mentioned immunochromatographic test kit, the shortest distance between two adjacent detection units among a plurality of detection units may be less than 1 mm.

In the above-mentioned immunochromatographic test kit, the plurality of detection units bind to the first detection unit in which the first capture antibody having the property of binding to the first type detection target is immobilized, and to the second type detection target. It may have a second detection unit to which a second capture antibody having a property is fixed.

In the above-mentioned immunochromatographic test kit, the sample dropping part, the conjugate part, and at least one detection part may be formed on a single porous member.

In the above-mentioned immunochromatographic test kit, the sample dropping part, the conjugate part, and at least one detection part may be formed on a plurality of porous members.

According to the present invention, the amount of the capture antibody used can be suppressed as compared with the conventional immunochromatographic test kit, and a low-cost immunochromatographic test kit can be provided.

FIG. 3 is a perspective view of an immunochromatographic test kit according to the first embodiment. It is a partially enlarged plan view of the detection part of the inner flow test kit shown in FIG. 1. It is a partially enlarged view for demonstrating the width of the detection part. It is a partially enlarged sectional view seen from the arrow IV-IV in FIG. It is a flowchart of the manufacturing method of the immunochromatography test kit which concerns on Embodiment 1. FIG. FIG. 3 is a perspective view of a coating device used in the method for manufacturing an immunochromatographic test kit according to the first embodiment. It is a front view of the coating unit of the coating apparatus shown in FIG. It is a side view of the coating unit of the coating apparatus shown in FIG. It is a front view explaining the operation of the coating unit of the coating apparatus shown in FIG. It is a front view explaining the operation of the coating unit of the coating apparatus shown in FIG. It is a partially enlarged plan view which shows the modification of the detection part shown in FIG. It is a partially enlarged plan view which shows the other modification of the detection part shown in FIG. It is a partially enlarged plan view of the detection part of the inner flow test kit which concerns on Embodiment 2. FIG. It is a partially enlarged plan view which shows the modification of the detection part shown in FIG. It is a partially enlarged plan view which shows the other modification of the detection part shown in FIG. FIG. 3 is a partially enlarged plan view showing still another modification of the detection unit shown in FIG. FIG. 3 is a perspective view of an immunochromatographic test kit according to a third embodiment. FIG. 3 is a perspective view of an immunochromatographic test kit according to a fourth embodiment. It is an electron microscope image obtained by observing the detection part 3 of Example 1 using an electron microscope. It is an electron microscope image obtained by observing the detection part 3 of Example 2 using an electron microscope. In Example 2, it is an electron microscope image obtained by observing the detection part 3 before the auxiliary liquid is dropped using an electron microscope. In Example 2, it is an electron microscope image obtained by observing the detection unit 3 after the auxiliary liquid was dropped by using an electron microscope.

Hereinafter, embodiments of the present invention as an example will be described with reference to the drawings. In the following drawings, the same or corresponding parts shall be given the same reference number, and the description thereof shall not be repeated.

(Embodiment 1)
<Immunochromatographic test kit>
As shown in FIGS. 1 to 2, the laterl flow test kit 100 according to the first embodiment has a sample dropping section 1, a conjugate section 2, a detection region t including a plurality of detection sections 3, and a control including a control section 4. It mainly includes a region c and an absorption unit 5. As shown in FIGS. 1 and 2, the sample dropping unit 1, the conjugate unit 2, the detection region t, the control region c, and the absorption unit 5 are arranged side by side in the above-mentioned order along the development direction D. ..

The sample dropping section 1 is a portion where a sample is dropped. The sample dropping portion 1 is formed of a porous member such as a glass fiber pad, a cellulose fiber pad, and a polyester pad.

The conjugate section 2 is a portion to which a labeled antibody having a property of binding to a detection target in a sample is immobilized. The labeled antibody is a conjugate of an antibody and a labeling substance that specifically recognizes and binds to the first portion (first epitope) of the detection target. The antibody can be arbitrarily selected depending on the object to be detected. The labeling substance can be arbitrarily selected from the labeling substances used in conventional immunochromatography. The labeling substance includes, for example, at least one selected from the group consisting of colored fine particles such as metal nanoparticles (metal fine particles), latex fine particles, organic polymer fine particles, inorganic fine particles, and liposomes containing a coloring agent. Labeling substances are, for example, from gold nanoparticles, platinum nanoparticles, noble metal nanoparticles such as platinum-gold nanoparticles, silver nanoparticles, titanium nanoparticles, iron nanoparticles, nickel nanoparticles, and cadmium nanoparticles as metal nanoparticles. Includes at least one selected from the group of The metal nanoparticles may be colloidal metal nanoparticles having a particle size of 1 nm or more and 100 nm or less. The conjugate portion 2 is adjusted by applying, for example, a suspension containing a labeled antibody to a porous member such as a glass fiber pad, a cellulose fiber pad, and a polyester pad, and then drying the suspension.

The detection region t is arranged in the deployment direction D on the side opposite to the sample dropping portion 1 with respect to the conjugate portion 2. The detection region t is formed on the carrier 6 made of a porous member. The detection area t includes a plurality of detection units 3. Each detection unit 3 is connected to the sample dropping unit 1 via the conjugate unit 2. Each detection unit 3 is arranged on the side opposite to the sample dropping unit 1 with respect to the conjugate unit 2 in the deployment direction D. Each detection unit 3 is a portion to which a capture antibody having a property of binding to a detection target is fixed. The capture antibody is an antibody that specifically recognizes and binds to a second portion (second epitope) different from the first portion of the detection target. From a different point of view, the capture antibody has the property of binding to the test object bound to the labeling substance. The capture antibody can be arbitrarily selected depending on the object to be detected.

As shown in FIG. 2, the out-of-plane shape of each detection unit 3 is dot-shaped. The dot width of each detection unit 3 is the minimum size that can be visually observed, or the size that cannot be visually observed and can be observed with 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 that can directly observe the labeled substance having a size of 1 μm or less that binds to the labeled antibody. The dot width of each detection unit 3 is, for example, 100 μm or less.

The width of the detection unit 3 is measured as follows. First, a sample containing a sufficient detection target is dropped onto the sample dropping section 1 to express 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 inspection method described later. When the detection unit 3 includes the bottom surface 7A of the recess 7 as in the immunochromatographic test kit 100 according to the first embodiment, the electron microscope image acquired after focusing on the bottom surface 7A is used. Be done. Next, the outer shape of the region where the labeled antibody is observed in the image is specified as the outer shape of the detection unit 3. Next, the width of the outer shape of the detection unit 3 is measured. As shown in FIG. 3, when the outer line of the region where the labeled antibody is observed is wavy inward and outward, the diameter D1 of the circumscribed circle CC of the outer line and the inscribed circle IC of the outer line are obtained by image processing. The diameter D2 of the above is calculated, and the intermediate value between the diameter D1 and the diameter D2 is defined as the width of the outer shape of the detection unit 3.

The detection units 3 shown in FIG. 2 are arranged at intervals from each other in a direction intersecting (for example, orthogonal to) the deployment direction D. Each detection unit 3 is one-dimensionally arranged in a direction intersecting (for example, orthogonal to) the development direction D. The distance between two adjacent detection units 3 is, for example, less than 1 mm.

The non-planar shape of each detection unit 3 is not particularly limited as long as it is a dot shape, but is, for example, a circular shape. The out-of-plane shape of each detection unit 3 may be an elliptical shape, a square shape, a rectangular shape, or the like.

As shown in FIG. 4, a plurality of recesses 7 are formed in the detection region t of the carrier 6. Each recess 7 is recessed with respect 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 FIG. 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 FIG. 4 has a tapered shape such that the distance between the facing wall surfaces 7B becomes narrower as it approaches the bottom surface 7A, but the opening diameter and the bottom surface of the top surface 6A. The diameters of 7A may be the same. The width of the bottom surface 7A of each recess 7 is the minimum size that can be visually confirmed, 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 directly observes a labeling substance having a size of 1 μm or less that binds to the labeled antibody. For example, the dot width of each bottom surface 7A is 100 μm or less. The depth of each bottom surface 7A is deeper than the depth of focus of the electron microscope. The depth of each bottom surface 7A is, for example, 10 μm or more.

The out-of-plane shape of each bottom surface 7A is, for example, a circular shape. The non-planar shape of each bottom surface 7A may be an elliptical shape, a square shape, a rectangular shape, or the like.

Each detection unit 3 includes a 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 simultaneously formed on, for example, the carrier 6. The method of simultaneously forming the detection unit 3 and the recess 7 on the carrier 6 will be described in detail in the method for manufacturing an immunochromatographic test kit described later.

The control region c is arranged on the side opposite to the conjugate portion 2 with respect to the detection region t in the deployment direction D. The control area C includes the control unit 4. The control unit 4 is a portion to which the control antibody that binds to the labeled antibody is fixed. The non-planar shape of the control unit 4 may be any shape, for example, a line shape.

The control portion 4 is formed on the carrier 6. The control unit 4 is arranged on the side opposite to the conjugate unit 2 with respect to the detection unit 3 in the deployment direction D.

In FIGS. 1 and 2, for convenience of explanation, each range of the detection area t and the control area c is shown by a broken line. In an actual lateral flow test kit, for example, the above broken line is not shown.

The absorption unit 5 is a portion that absorbs a surplus sample or the like after development. The absorbing portion 5 is formed of a porous member such as a glass fiber pad, a cellulose fiber pad, and a polyester pad. The absorption unit 5 is arranged on the side opposite to the detection region t with respect to the control region c in the deployment direction D.

The out-of-plane shape of the carrier 6 is rectangular. The carrier 6 has a longitudinal direction along the deployment direction D and a lateral direction orthogonal to the deployment direction D. The material constituting the carrier 6 may be any porous material, and includes, for example, at least one of nitrocellulose and polyvinylidene fluoride (PVDF). That is, in the immunochromatographic test kit 100 according to the first embodiment, the plurality of detection units 3 and the control unit 4 are separate from the porous members constituting the sample dropping unit 1, the conjugate unit 2, and the absorption unit 5. It is formed on a porous member. The porous member constituting the sample dropping portion 1 is adhered to, for example, the porous member constituting the conjugate portion 2. Each of the porous members constituting the conjugate portion 2 and the absorption portion 5 is adhered to, for example, each of the porous members constituting the carrier 6.

The sample dropping unit 1, the conjugate unit 2, the detection unit 3, the control unit 4, the absorption unit 5, and the carrier 6 use an adhesive or an adhesive sheet on a base material (also referred to as a backing sheet) (not shown). It may be fixed. The carrier 6 may be a thin film formed on the substrate.

<Inspection method using an immunochromatographic test kit>
In the inspection method using the immunochromatographic test kit, the detection unit 3 after the antigen-antibody reaction on the immunochromatographic test kit is observed using an electron microscope. Hereinafter, the antigen-antibody reaction on the immunochromatographic test kit will be described.

First, the sample is dropped on the sample dropping section 1. The dropped sample flows along the development direction D due to the capillary phenomenon. The detection target in the sample binds to the labeled antibody at the conjugate portion 2. The conjugate of the detection target and the labeled antibody moves along the development direction D together with the labeled antibody that is not bound to the detection target due to the capillary phenomenon. The detection target bound to the labeled antibody binds to the capture antibody in the detection unit 3. As a result, the labeled antibody bound to the detection target is accumulated in the detection unit 3. The labeled substance bound to the labeled antibody in the detection unit 3 is directly observed using an electron microscope. Further, the labeled antibody that is not bound to the detection target binds to the control antibody in the control unit 4. As a result, the labeled antibody that is not bound to the detection target is captured by the control unit 4. The labeled substance bound to the labeled antibody in the control unit 4 is directly observed using an electron microscope. The surplus sample that has flowed downstream of the control unit 4 in the deployment direction D is absorbed by the absorption unit 5.

The inspection method using the immunochromatographic inspection kit is performed by, for example, the following procedure.
First, the sample is dropped onto the sample dropping section 1, and after a lapse of a designated time, the auxiliary liquid is dropped.

The auxiliary liquid has conductivity of preventing the generation of charge and heat, which contributes to the sharpness of the image, and / or the property of forming a film by polymerization under the measurement conditions of an electron microscope. The auxiliary solution contains glycerin and a glycerin substitute as essential components; 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 optional component, it contains at least one compound selected from monosaccharides, disaccharides, salts, and a buffer solution.

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 while observing the upper surface of the carrier 6. In the immunochromatographic test kit 100, a focus shift due to the distance between the upper surface and the bottom surface 7A of the carrier 6 is observed in a microscope image (bright field image) of an electron microscope. Therefore, since the recess 7 can be searched for in the microscope image by confirming the presence or absence of the out-of-focus, the detection unit 3 can be easily searched in the image. After that, by focusing the image on the bottom surface 7A, the image can be focused on the detection unit 3. Next, an electron microscope image is taken and the number of labeled substances in the image is measured. Since the contour of the labeling substance can be clearly identified in the electron microscope image, the number of labeling substances in the image can be measured. If the measured number of labeled substances exceeds a predetermined criterion, it is determined that the detection target is present in the sample (that is, “positive”).

The observation and measurement are performed in the same manner for, for example, a plurality of detection units 3. In this case, for example, the average value, the maximum value, the minimum value, etc. of the number of labeled substances in the same field of view of each detection unit 3 are calculated, and any one of these calculated values is used as an evaluation value. If the evaluation value exceeds a predetermined judgment standard, it is judged as "positive".

<Manufacturing method of immunochromatographic test kit>
Next, an example of a method for manufacturing the immunochromatographic test kit 100 will be described. As shown in FIG. 5, the method for producing an immunochromatographic test kit 100 includes a step of preparing a carrier 6 (S1) and a step of forming a plurality of detection units 3 on the prepared carrier 6 (S2).

In the step of preparing the carrier 6, the carrier 6 having the control portion 4 formed on the upper surface or the carrier 6 having the control portion 4 not formed on the upper surface is prepared.

In the step of forming the plurality of detection units 3, the capture antibody is applied in dots on the upper surface of the carrier 6 by using the coating needle 21 (see FIG. 10) holding the capture antibody at the tip portion. 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 concave portion 7 is formed on the carrier 6 by using the coating needle 21, and at the same time, the capture antibody is applied to the bottom surface 7A of the concave portion 7. That is, the coating needle 21 holding the capture antibody at the tip thereof is further pushed into the carrier 6 after coming into contact with the upper surface of the carrier 6. In this step, the coating apparatus shown in FIGS. 6 to 10 is used. The configuration of the coating device will be described later.

In this way, the carrier 6 including the plurality of detection units 3 is formed. When the control unit 4 is formed on the carrier 6, the conjugate unit 2 and the absorption unit 5 are connected to the carrier 6, and the sample dropping unit 1 is connected to the conjugate unit 2, thereby connecting the immunochromatographic test kit. 100 is manufactured. When the control unit 4 is not formed on the carrier 6, the control unit 4 is formed on the carrier 6. After that, the conjugate section 2 and the absorption section 5 are connected to the carrier, and the sample dropping section 1 is further connected to the conjugate section 2, whereby the immunochromatographic test kit 100 is manufactured. In the method for producing the immunochromatographic test kit 100, each of the sample dropping section 1, the conjugate section 2, the control section 4, and the absorbing section 5 can be formed in the same manner as those in the conventional immunochromatographic test kit.

<Structure of coating device>
Next, an example of a coating device used for forming a plurality of detection units 3 in the method for manufacturing the immunochromatographic test kit 100 will be described.

As shown in FIG. 6, the coating apparatus according to the first embodiment includes 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. Mainly prepare. The X-axis table 11, the Y-axis table 12, the Z-axis table 13, the coating mechanism 14, the observation optical system 15, and the CCD camera 16 are arranged, 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, the monitor 18, and the control computer 19 are arranged, for example, outside the processing room.

The Y-axis table 12 is movable in the Y-axis direction and can mount 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 portion 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 on which the carrier 6 is mounted. A structure straddling the Y-axis table 12 in the X-axis direction is fixed to the bottom of the processing chamber.

The X-axis table 11 is arranged on a structure installed so as to straddle the Y-axis table 12 in the X-axis direction. On the X-axis table 11, a moving body to which the Z-axis table 13 is connected is installed so as to be movable in the X-axis direction. The moving body can be moved in the X-axis direction by using, for example, 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 described above can be moved in the Y-axis direction with respect to the X-axis table 11.

A Z-axis table 13 is installed on the moving body connected to the X-axis table 11 as described above. The observation optical system 15 and the 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. The CCD camera converts the observed image into an electrical signal. The Z-axis table 13 holds the observation optical system 15 and the coating mechanism 14 so as to be movable in the Z-axis direction.

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

<Structure of coating mechanism 14>
Next, the detailed configuration of the coating mechanism 14 shown in FIG. 6 will be described. As shown in FIGS. 7 and 8, the coating mechanism 14 is held by the servomotor 41, the gantry 42, the cam 43, the bearing 44, the cam connecting plate 45, the movable portion 46, the coating needle holder 20, and the coating needle holder 20. It mainly contains the coated needle 21 and the coated material container 22. The servomotor 41 is installed so that the rotation axis extends in the direction along the Z-axis direction shown in FIG. The servomotor 41 is held on the gantry 42. A cam 43 is connected to the rotating shaft of the servomotor 41. The cam 43 is rotatable about the rotation axis of the servomotor 41.

The cam 43 includes a central portion connected to the rotation shaft of the servomotor 41 and a flange portion connected to one end of the central portion. The upper surface of the flange portion (the surface on the servo motor 41 side) is a cam surface. The cam surface is formed in an annular shape along the outer periphery of the central portion, and is formed in a slope shape so that the distance from the bottom surface of the flange portion varies. Specifically, the cam surface is formed between the upper end flat region having the longest distance from the bottom surface of the flange portion, the lower end flat region having the shortest distance from the bottom surface of the flange portion, and the upper end flat region and the lower end flat region. Includes a slope area to connect with. The upper end flat region is arranged at a distance from the lower end flat region in the circumferential direction with respect to the rotation axis.

The bearing 44 has an outer ring arranged so as to be in contact with the cam surface of the cam 43, and an inner ring connected to the cam connecting plate 45. As shown in FIG. 7, the bearing 44 is arranged in a specific direction (on the right side of the servomotor 41) when viewed from the cam 43. The bearing 44 is urged to the cam surface of the cam 43 by a spring 50 described later. Therefore, when the cam 43 rotates, the bearing 44 is held in a state where the outer peripheral 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 portion 46. The coating needle holder fixing portion 47 and the coating needle holder accommodating portion 48 are connected to the movable portion 46.

A fixing pin 51 is installed on the gantry 42. A fixing pin 52 is installed on the movable portion 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 portion 46 is in a state of receiving a tensile force toward the coating material container 22 side. Further, the tensile force of the spring 50 acts on the bearing 44 via the movable portion 46 and the cam connecting plate 45. The bearing 44 is maintained in a state of being pressed against the cam surface of the cam 43 by the tensile force of the spring 50.

The movable portion 46, the coating needle holder fixing portion 47, and the coating needle holder accommodating portion 48 are connected to the linear guide 49 installed on the gantry 42. The linear guide 49 is arranged so as to extend in the Z-axis direction. Therefore, the movable portion 46, the coating needle holder fixing portion 47, and the coating needle holder accommodating portion 48 are movable along the Z-axis direction.

The coating needle holder 20 is housed in the coating needle holder storage unit 48. The coating needle holder 20 includes a coating needle 21. The coating needle 21 is arranged so as 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 gravity direction (Z-axis direction in FIG. 6). The shape of the tip of the coating needle 21 is, for example, a truncated cone shape. The tip diameter in the radial direction with respect to the central axis of the coating needle 21 is less than 1 mm. Preferably, the tip diameter of the coating needle 21 is 100 μm or less.

A coating material container 22 is arranged below the coating needle holder 20. A space for storing the coating material 70 is formed inside the coating material container 22. As shown in FIGS. 9 and 10, a first hole and a second hole connecting the space and the outside are formed in the bottom and the top of the coating material container 22. The shape of the first hole and the second hole may be any shape, but is, for example, a circular shape. The first hole and the second hole are provided so as to overlap each other in the extending direction of the coating needle 21. The coating material 70 contains a capture antibody.

The coating needle holder 20 and the coating needle 21 move up and down with respect to the coating material container 22 as the coating needle holder accommodating portion 48 moves in the Z-axis direction. As a result, the tip of the coating needle 21 passes through the first state of being immersed in the coating material 70 stored in the coating material container 22 and the hole formed in the bottom of the coating material container 22, and the coating material container 22 The second state, which protrudes downward from the bottom surface of the, is switched.

<Operation of coating device>
Next, the operation of the coating device in the step of forming a plurality of detection units 3 in the method for manufacturing an 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 to be in the first state. Next, the X-axis table 11 and the Y-axis table 12 are operated so that the carrier 6 is arranged in the X-axis direction and the Y-axis so that the region where the detection unit 3 is to be formed is arranged directly under the coating mechanism 14. Position in the direction. Next, the Z-axis table 13 is operated so that the tip of the coating needle 21 is pushed downward from the upper surface of the carrier 6 when the coating needle is in the second state. The mechanism 14 is lowered by a distance d in the Z-axis direction.

Next, the servomotor 41 of the coating mechanism 14 is operated to switch from the first state to the second state. Specifically, by operating the servomotor 41, the rotation shaft of the servomotor 41 is rotated to rotate the cam 43. As a result, since the height of the cam surface of the cam 43 changes in the Z-axis direction, the position of the bearing 44 in contact with the cam surface in the Z-axis direction also changes according to the rotation of the drive shaft of the servomotor 41. do. Depending on the position change of the bearing 44 in the Z-axis direction, the movable portion 46, the coating needle holder fixing portion 47, the coating needle holder storage portion 48, and the coating needle holder 20 held in the coating needle holder storage portion 48 are also Z. Move in the axial direction. As a result, by operating the servomotor 41, the coating needle 21 moves in the Z-axis direction, and the first state shown in FIG. 9 and the second state shown in FIG. 10 are switched. In the coating mechanism 14, the rotational movement of the servomotor 41 can be converted into a movement (vertical movement) 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. can.

In the first state shown in FIG. 9, the coating needle 21 is placed at the top of 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 end flat region of the cam surface of the cam 43.

In the second state shown in FIG. 10, the coating needle 21 is arranged at the lowest position in 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, a coating material containing a capture antibody is held on the end face and the side surface of the tip end portion 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 and protrudes downward from the bottom surface of the coating material container 22 and is pushed downward from the upper surface of the carrier 6.

In this way, by operating the servomotor 41 to switch from the first state to the second state, the recess 7 is formed in the carrier 6, and at the same time, the capture antibody is applied to the bottom surface 7A of the recess 7. Next, the servomotor 41 is operated to switch from the second state to the first state.

Further, after operating only the X-axis table 11 and the Y-axis table 12 to arrange a region to form the second detection unit 3 directly under the coating mechanism 14, the Z-axis table 13 is lowered by a distance d. , The servomotor 41 of the coating mechanism 14 is operated to switch from the first state to the second state. Further, after switching from the second state to the first state, the Z-axis table 13 is raised by the distance d.

By continuously repeating the above operation, a plurality of detection units 3 are formed on the upper surface of the carrier 6.
<Action effect>
The operation and effect of the immunochromatographic test kit 100 according to the first embodiment will be described in comparison with a conventional immunochromatographic test kit (hereinafter, simply referred to as Comparative Example 1). Comparative Example 1 is provided so that the detection unit is formed on a flat flat surface and the color development in the detection unit derived from the labeled antibody can be visually confirmed. Therefore, in Comparative Example 1, a sufficient area of the detection unit (for example, several mm ² or more) is required so as not to make an erroneous judgment by visual determination, and the amount of expensive capture antibody fixed to the detection unit is reduced. It was difficult to do. As a result, in Comparative Example 1, it was difficult to reduce the manufacturing cost.

On the other hand, in the laterl flow test kit 100, the dot width of each detection unit 3 can be made less than 1 mm by reducing the tip diameter of the coating needle 21. That is, in the immunochromatographic test kit 100, the area of each detection unit 3 can be made smaller than the area of each detection unit of Comparative Example 1, so that the amount of the captured antibody fixed to each detection unit 3 is the comparative example. It can be reduced as compared with the amount of the capture antibody fixed to each detection unit of 1. As a result, the manufacturing cost of the immunochromatographic test kit 100 can be reduced as compared with the manufacturing cost of Comparative Example 1.

Further, according to the immunochromatographic test kit 100, the detection unit 3 is confirmed by using an electron microscope, and the number of labeled antibodies captured by the detection unit 3 in the electron microscope image is measured to detect the target in the sample. You can evaluate things quantitatively.

Further, when the detection unit formed on a flat flat surface is miniaturized as in Comparative Example 1, it is necessary to magnify the detection unit with a microscope or the like to confirm the labeled antibody, but the detection unit is minute with a microscope. It is difficult to search for and align the detector. As a countermeasure, a method of providing a mark on the kit and providing a detection unit at a predetermined distance from the mark can be considered. However, in this case, equipment for providing a mark is required separately from the equipment for forming the detection unit, and the number of processes is increased, so that the manufacturing tact cannot be reduced and it is difficult to reduce the cost.

On the other hand, in the above-mentioned immunochromatographic test kit 100, a plurality of recesses 7 are formed in the carrier 6, and each detection unit 3 includes a bottom surface 7A of one recess 7. Therefore, when the labeled substance on the detection unit 3 is directly confirmed using an electron microscope, the focus shift due to the distance between the upper surface and the bottom surface 7A of the carrier 6 can be confirmed in the microscope image of the electron microscope. The recess 7 can be searched for in the microscope image of the electron microscope by utilizing the out-of-focus. As a result, in the later flow test kit 100, each detection unit 3 can be miniaturized as compared with Comparative Example 1.

Further, by focusing the image on the bottom surface 7A, the image can be easily focused on the detection unit 3. That is, in the lateral flow test kit 100, the time required for searching for the detection unit 3 can be shortened as compared with the case where each detection unit 3 does not include the bottom surface 7A of one recess 7.

Further, unlike the comparative example 1, it is not necessary to separately provide a mark to be used when searching for the detection unit 3, and it is necessary to prepare a facility for providing the mark separately from the equipment for forming the detection unit in the immunochromatographic test kit 100. not. Further, in the lateral flow test kit 100, since the recess 7 can be formed at the same time as the detection unit 3, the manufacturing tact can be reduced as compared with the case where the mark is provided in Comparative Example 1.

In the above-mentioned immunochromatographic test kit 100, the width of each detection unit can be as small as 100 μm or less. In such an immunochromatographic test kit 100, the amount of the capture antibody fixed to each detection unit 3 is significantly reduced as compared with the amount of the capture antibody fixed to each detection unit of Comparative Example 1, and therefore, the immunochromatographic test kit 100 The manufacturing cost of 100 can be significantly reduced as compared with the manufacturing cost of Comparative Example 1.

The above-mentioned immunochromatographic test kit 100 includes a plurality of detection units 3. In such an immunochromatographic test kit 100, as compared with an immunochromatographic test kit having only one detection unit 3, the labeled substances of a plurality of detection units 3 can be confirmed in the electron microscope image, so that the reliability of the test result is improved. ..

In the above-mentioned immunochromatographic test kit 100, the plurality of detection units 3 are arranged one-dimensionally with respect to the development direction D. In such an immunochromatographic test kit 100, as compared with an immunochromatographic test kit in which a plurality of detection units 3 are randomly arranged, the detection target efficiently flows to all the detection units 3 and binds to the capture antibody. Stable test results can be obtained.

In the above-mentioned Lateral Flow Test Kit 100, the shortest distance between two adjacent detection units among the plurality of detection units 3 is less than 1 mm. In such an immunochromatographic test kit 100, a plurality of detection units 3 can be observed even in a relatively small field of view as compared with an immunochromatographic test kit having a shortest distance of 1 mm or more, so that each detection unit 3 can be easily searched. Can be done.

The operation and effect of the manufacturing method of the immunochromatographic test kit 100 according to the first embodiment is obtained by a manufacturing method in which each detection unit 3 is formed by using a dispenser (hereinafter, simply referred to as Comparative Example 2), and each detection unit 3 is subjected to an inkjet method. This will be described in comparison with the manufacturing method for forming (hereinafter, simply referred to as Comparative Example 3).

In Comparative Examples 2 and 3, in order to form the detection unit 3 with a minute size, it is necessary to reduce the opening width of the tip of the dispenser or the nozzle. However, when the high-viscosity coating material 70 is used, the coating material 70 cannot be discharged, and clogging may occur. Further, in Comparative Example 3, in the method of instantaneously increasing the pressure inside the container using a piezo element or the like to discharge the liquid material containing the capture antibody, the liquid material landed on the carrier 6 because the discharge pressure was high. Sometimes it spreads easily, and there is a problem that the shape of the detection unit 3 is not stable.

On the other hand, in the method for manufacturing the immunochromatographic test kit 100, the tip diameter of the coating needle 21 may be reduced in order to form the minute detection unit 3, and therefore, regardless of the viscosity, Comparative Examples 2 and 2 No such clogging occurs. Further, in the above manufacturing method, since the position of the tip of the coating needle 21 in the Z-axis direction with respect to the upper surface of the carrier 6 can be precisely controlled by the Z-axis table 13, the variation in the size of the detection unit 3 can be reduced, and the immunochromatographic test can be performed. The kit 100 can be stably manufactured.

Further, in Comparative Example 2, in order to apply the droplet, the detection unit 3 having a dot width of less than 1 mm is stably formed, and in particular, the detection unit 3 having a dot width of less than 100 μm is stably formed. It is difficult.

On the other hand, in the manufacturing method of the immunochromatographic test kit 100, since the coating needle 21 is used, the out-of-plane shape of each detection unit 3 is dot-shaped, and the width of each detection unit 3 is less than 1 mm. 100 can be easily and stably manufactured.

Further, in the method for manufacturing the immunochromatographic test kit 100, the recess 7 is formed on the carrier 6 by using the coating needle 21, and at the same time, the capture antibody is applied to the bottom surface 7A of the recess 7, so that the bottom surface 7A of one recess 7 is applied. The formation of the detection unit 3 including the above and the application of the capture antibody can be performed in one operation. Therefore, the tact time does not increase due to the formation of the detection unit 3, and the manufacturing cost does not increase.

<Modification 1>
The following modifications can be taken in the later flow test kit 100 according to the first embodiment.

The detection region t may include at least one detection unit 3.
In the immunochromatographic test kit 100, each detection unit 3 has the same configuration as each other, but the present invention is not limited to this. In the immunochromatographic test kit 100, the concentration of the capture antibody immobilized on each detection unit 3 is constant, but the concentration of the capture antibody immobilized on each detection unit 3 may be different from each other. For example, it may be provided so that the concentration of the capture antibody gradually decreases from one side to the other in the direction orthogonal to the deployment direction D. Further, a set of patterns composed of a plurality of detection units 3 having different concentrations of captured antibodies may be arranged side by side. Such a plurality of detection units 3 can be easily formed by using a plurality of coating mechanisms 14 in which the concentrations of the captured antibodies in the coating material stored in the coating material container 22 are different from each other.

Further, the out-of-plane shape of each detection unit 3, the dot width of each detection unit 3, the distance between two adjacent detection units 3, the out-of-plane shape of the bottom surface 7A of each recess 7, the maximum width of each bottom surface 7A, and each. At least one of the depths of the bottom surface 7A may be different. Such a plurality of detection units 3 can be easily formed by using a plurality of types of coating needles 21 or by using a plurality of types of coating conditions.

In the lateral flow test kit 100, a plurality of recesses 7 are formed in the detection region t of the carrier 6, and one detection unit 3 includes the bottom surface 7A of the recess 7, but the present invention is not limited to this. ..

Each detection unit 3 may include the entire bottom surface 7A of each recess 7 and at least a part of the wall surface 7B. Further, each detection unit 3 may include the entire bottom surface 7A and wall surface 7B of each recess 7. Further, each detection unit 3 may include the entire bottom surface 7A and wall surface 7B of each recess 7, and an annular region of the upper surface of the carrier 6 connected to the wall surface 7B.

The plurality of detection units 3 may include at least one detection unit 3 shown in FIG. 4 and at least one detection unit 3 shown in FIG. The plurality of detection units 3 shown in FIG. 11 include only the upper surface of the carrier 6. Such a detection unit 3 can be easily moved upward without being pushed downward after the coating material 70 adhering to the tip or the tip of the coating needle 21 in the above manufacturing method comes into contact with the upper surface of the carrier 6. Can be formed. Further, all of the detection units 3 may be configured as the detection unit 3 shown in FIG. That is, a plurality of recesses 7 may not be formed in the detection region t of the carrier 6.

As shown in FIG. 12, in the lateral flow test kit 100, a plurality of detection units 3 may be arranged at intervals in the deployment direction D. The distance between the two adjacent detection units 3 in the deployment direction D is, for example, equal to the distance between the two adjacent detection units 3 in the direction orthogonal to the deployment direction D.

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

Further, in order to further improve the accuracy in the coating process of the coating material 70 by the coating needle 21, the moving 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 moving speed of the coating needle 21 is reduced before the second state is realized. The decrease in the moving speed of the coating needle 21 is realized by reducing the rotational speed of the servomotor 41.

By performing such control, when the coating needle 21 comes into contact with the carrier 6, the moving speed of the coating needle 21 is sufficiently low, so that the coating material 70 and the carrier 6 attached to the tip or the tip of the coating needle 21 Contact time can be lengthened. Therefore, since the amount of the captured antibody applied to the carrier 6 can be increased and the concentration can be increased, the antigen-antibody reaction with the detection target can be further stabilized.

In the immunochromatographic test kit 100, the sample dropping portion 1 and the conjugate portion 2 may be formed on a single porous member separated from the carrier 6. In the immunochromatographic test kit 100, the conjugate portion 2 may be formed on the carrier 6, and the sample dropping portion 1 may be formed on a porous member separated from the carrier 6. In the immunochromatographic test kit 100, the absorption unit 5 may be formed on the carrier 6.

(Embodiment 2)
The immunochromatographic test kit 101 according to the second embodiment has basically the same configuration as the immunochromatographic test kit 100 according to the first embodiment and has the same effect, but has a plurality of detection units as shown in FIG. 3 is different from the immunochromatographic test kit 100 in that the first detection unit 3A and the second detection unit 3B are included.

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

As shown in FIG. 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 arranged at intervals from each other in a direction orthogonal to the deployment direction D. The plurality of first detection units 3A are arranged one-dimensionally, for example. The plurality of second detection units 3B are arranged at intervals from each other in a direction orthogonal to the deployment direction D. The plurality of second detection units 3B are arranged one-dimensionally, for example.

The plurality of first detection units 3A and the plurality of second detection units 3B are arranged at intervals in a direction orthogonal to the deployment direction D. The shortest distance between the first detection unit 3A and the second detection unit 3B is longer than the shortest distance between the two adjacent first detection units 3A and the shortest distance between the two adjacent second detection units 3B. .. The plurality of first detection units 3A and the plurality of second detection units 3B are arranged one-dimensionally as a whole, for example.

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

The detection area t is divided into a first detection area t1 in which a plurality of first detection units 3A are arranged and a second detection area t2 in which a plurality of second detection units 3B are arranged. .. The first detection region t1 and the second detection region t2 are arranged side by side in a direction orthogonal to the development direction D.

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.

According to the immunochromatographic test kit 101 according to the second embodiment, two types of detection objects can be detected by laterochromatography from a single sample.

The immunochromatographic test kit 101 can be manufactured in the same manner as the immunochromatographic test kit according to the first embodiment. Preferably, the coating device has a first coating mechanism 14 for forming the first detection unit 3A by applying the first capture antibody to the carrier 6, and a second capture antibody by applying the second capture antibody to the carrier 6. 2 A second coating mechanism 14 for forming the detection unit 3B is provided. The first coating mechanism 14 includes a first coating needle 21 and a first coating material container 22 in which a coating material containing a 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 the coating material containing the second capture antibody is stored.

In the method for producing the immunochromatographic test kit 101, the first coating needle 21 holds the first capture antibody at its tip. The second coating needle 21 holds the second capture antibody at its tip. In the step of forming the plurality of detection units 3, the first detection unit 3A is formed by applying the first capture antibody to the first region of the carrier 6 using the first coating needle 21. Further, by applying the second capture antibody to the second region of the carrier 6 using the second coating needle 21, the second detection unit 3B is formed.

By manufacturing the immunochromatographic test kit 101 using such a coating device, it is possible to reduce the manufacturing man-hours as compared with the case of manufacturing the immunochromatographic test kit 101 using one coating device provided with only one coating mechanism 14. Further, the manufacturing cost can be reduced as compared with the case where the immunochromatographic test kit 101 is manufactured by using a plurality of coating devices provided with only one coating mechanism 14.

<Modification 2>
The immunochromatographic test kit 101 according to the second embodiment can also take the same modified example as the immunochromatographic test kit 100 according to the first embodiment.

Further, the immunochromatographic test kit 101 may take the following modifications.
Each of the plurality of first detection units 3A and the plurality of second detection units 3B may be arranged side by side alternately.

As shown in FIGS. 14 to 16, the plurality of detection units 3 may further include a plurality of third detection units 3C in addition to the first detection unit 3A and the second detection unit 3B. A third capture antibody having a property of binding to a first-type detection target and a third-type detection target different from the second-type detection target is immobilized on each third detection unit 3C.

As shown in FIG. 14, each of the plurality of first detection units 3A, the plurality of second detection units 3B, and the plurality of third detection units 3C alternately alternates, for example, one by one in a direction orthogonal to the deployment direction D. They are arranged side by side.

As shown in FIG. 15, each of the plurality of first detection units 3A, the plurality of second detection units 3B, and the plurality of third detection units 3C alternates, for example, in a direction orthogonal to the deployment direction D. They are arranged side by side. In this case, the distance between the two adjacent first detection units 3A and the distance between the two adjacent second detection units 3B are shorter than, for example, the distance between the adjacent first detection units 3A and the second detection unit 3B. .. The distance between the two adjacent second detection units 3B and the distance between the two adjacent third detection units 3C are shorter than, for example, the distance between the adjacent second detection units 3B and the third detection unit 3C.

As shown in FIG. 16, each of the plurality of first detection units 3A, the plurality of second detection units 3B, and the plurality of third detection units 3C are arranged one-dimensionally, for example, in the deployment direction D. Further, each of the plurality of first detection units 3A, the plurality of second detection units 3B, and the plurality of third detection units 3C are arranged one by one in a direction orthogonal to the deployment direction D. The distance between the first detection unit 3A and the second detection unit 3B adjacent to each other in the direction orthogonal to the deployment direction D is, for example, the distance between the two adjacent first detection units 3A and the two adjacent second detection units 3A in the development direction D. It is longer than the distance between the detection units 3B. The distance between the second detection unit 3B and the third detection unit 3C adjacent to each other in the direction orthogonal to the deployment direction D is, for example, the distance between the two adjacent second detection units 3B and the two adjacent third detection units 3B in the development direction D. It is longer than the distance between the detection units 3C.

In the modification shown in FIGS. 14 to 16, in a set of the first detection unit 3A, the second detection unit 3B, and the third detection unit 3C, the out-of-plane shape of each detection unit 3 and the dots of each detection unit 3 At least one of the width, the distance between the two adjacent detection units 3, the out-of-plane 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 may be different from each other. ..

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. ..

The out-of-plane shape of the second detection unit 3B may be rectangular, and the out-of-plane shape of each of the detection units 3 of the first detection unit 3A and the third detection unit 3C may be circular.

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. ..

The distance between the first detection unit 3A and the second detection unit 3B is 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. It may be longer than the distance of.

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

By doing so, the first detection unit 3A, the second detection unit 3B, and the third detection unit 3C can be easily identified in one visual field.

(Embodiment 3)
The immunochromatographic test kit 102 according to the third embodiment has basically the same configuration as the immunochromatographic test kit 100 according to the first embodiment and has the same effect, but the sample dropping section 1 and the conjugate section 2 are carriers. It differs from the immunochromatographic test kit 100 in that it is formed in 6. That is, in the immunochromatographic test kit 102, the sample dropping unit 1, the conjugate unit 2, the plurality of detection units 3, and the control unit 4 are formed on the upper surface of a single porous member (one carrier 6).

In the laterl flow test kit 102 shown in FIG. 17, the absorption unit 5 is also formed on the carrier 6.

The sample dropping section 1 is a region on the carrier 6 on which the sample is dropped, and is arranged on one side of the developing direction D. The conjugate portion 2 is a region on which the labeled antibody is applied on the upper surface of the carrier 6, and is arranged between the sample dropping portion 1 and the detection region t in the development direction D. The absorption unit 5 is a region in which the excess sample is absorbed in the carrier 6, and is arranged on the other side of the development direction D with respect to the control region C.

According to the immunochromatographic test kit 102, the number of parts is reduced as compared with the immunochromatographic test kit 100, so that the manufacturing cost of the immunochromatographic test kit 102 can be reduced as compared with the manufacturing cost of the immunochromatographic test kit 100.

<Modification 3>
The immunochromatographic test kit 102 according to the third embodiment can also take the same modified examples as the immunochromatographic test kit 100 according to the first embodiment and the immunochromatographic test kit 101 according to the second embodiment.

(Embodiment 4)
The immunochromatographic test kit 103 according to the fourth embodiment has basically the same configuration and the same effect as the immunochromatographic test kit 100 according to the first embodiment, but has a plurality of immunochromatographic tests as shown in FIG. The kits 100A to 100C are different from the immunochromatographic test kit 100 in that they are configured as a connected body connected in a direction orthogonal to the deployment direction D. The detection objects of the Lateral Flow Test Kits 100A to 100C are different from each other.

Each of the immunochromatographic test kits 100A to 100C may be fixed to each other by any method, but is adhered to each other, for example.

According to the immunochromatographic test kit 103 according to the fourth embodiment, three types of detection objects can be detected by the lateral flow test using one immunochromatographic test kit 103 configured as a conjugate.

(Example 1)
In this example, the result of observation using the electron microscope of the detection unit 3 of the immunochromatographic test kit 100 will be described.

<Sample>
The carrier 6 was a porous member made of nitrocellulose. Each detection unit 3 was formed so as to include the bottom surface 7A of the recess 7 by using a coating needle 21 having a truncated cone shape at the tip and a tip diameter of 50 μm.

<Observation method>
FIG. 19 is a microscope image obtained by observing the detection unit 3 of the sample using a microscope.

As shown in FIG. 19, in the microscope image, a difference occurs between the background and the detection unit 3 due to the defocus caused by the recess 7, so that the bottom surface 7A of the recess 7 can be easily searched and includes the bottom surface 7A. The minute detection unit 3 could be easily searched.

(Example 2)
In this example, the result of performing the immunochromatography using the immunochromatographic test kit 100 will be described.

<Sample>
The sample dropping portion 1 and the conjugate portion 2 were made of glass fiber pads. The carrier 6 was a porous member made of nitrocellulose. Each detection unit 3 was formed so as to include the bottom surface 7A of the recess 7 by using a coating needle 21 having a truncated cone shape at the tip and a tip diameter of 50 μm.

<Inspection method>
The inspection method was the same as the inspection method of the above-mentioned immunochromatographic test kit.

FIG. 20 is an electron microscope image obtained by observing the detection unit 3 of the sample using an electron microscope.

As shown in FIG. 20, since the contrast of light and darkness caused by the concave portion 7 occurs in the electron microscope image, the bottom surface 7A of the concave portion 7 can be easily searched, and the minute detection unit 3 including the bottom surface 7A can be easily searched. rice field.

Further, FIG. 21 is an electron microscope image of observing the detection unit 3 before the auxiliary liquid is dropped, and FIG. 22 is an electron microscope image of observing the detection unit 3 after the auxiliary liquid is dropped.

In the image shown in FIG. 22, it was confirmed that the edges of the image were clearer than those in the image shown in FIG.

The embodiments and examples disclosed this time should be considered to be exemplary in all respects and not restrictive. The scope of the present invention is shown by the scope of claims rather than the above description, and is intended to include the meaning equivalent to the scope of claims and all modifications within the scope.

1 Specimen dropping part, 2 conjugate part, 3 detection part, 3A first detection part, 3B second detection part, 3C third detection part, 4 control part, 5 absorption part, 6 carrier, 7 recesses, 7A bottom surface, 7B Wall surface, 11 X-axis table, 12 Y-axis table, 13 Z-axis table, 14 coating mechanism, 15 observation optical system, 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 Moving part, 47 Coating needle holder fixing part, 48 Coating needle holder storage part, 49 Linear guide, 50 Spring, 51, 52 Fixing pin, 70 Coating material, 100, 100A, 100C, 101, 102, 103 Immunochromatography test kit.

Claims (9)

The sample dropping part where the sample is dropped and the sample dropping part
A conjugate portion to which a labeled antibody having a property of binding to a detection target in the sample is immobilized, and
It is provided with at least one detection unit to which a capture antibody having a property of binding to the detection target is attached.
The sample dropping portion, the conjugate portion, and the at least one detection portion are formed on the porous member.
The out-of-plane shape of the at least one detection unit is dot-shaped.
An immunochromatographic test kit in which the width of the at least one detection unit is less than 1 mm. At least one recess is formed in the porous member, and the porous member has at least one recess.
The immunochromatographic test kit according to claim 1, wherein the at least one detection unit includes a bottom surface of the at least one recess. The immunochromatographic test kit according to claim 1 or 2, wherein the width of the at least one detection unit is 100 μm or less. The immunochromatographic test kit according to any one of claims 1 to 3, wherein the at least one detection unit is a plurality of detection units. The immunochromatographic test kit according to claim 4, wherein the plurality of detection units are arranged one-dimensionally or two-dimensionally. The immunochromatographic test kit according to claim 4 or 5, wherein the shortest distance between two adjacent detection units among the plurality of detection units is less than 1 mm. The plurality of detection units have a first detection unit in which a first capture antibody having a property of binding to the first type of detection object is immobilized, and a property of binding to the second type of detection object. The immunochromatographic test kit according to any one of claims 4 to 6, further comprising a second detection unit to which a second capture antibody is immobilized. The immunochromatographic test kit according to any one of claims 1 to 7, wherein the sample dropping portion, the conjugate portion, and the at least one detection portion are formed on a single porous member. The immunochromatographic test kit according to any one of claims 1 to 7, wherein the sample dropping portion, the conjugate portion, and the at least one detection portion are formed on a plurality of the porous members.

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