Inspection devices

Abstract

To provide an inspection device that shortens a flow path length of a sample, shortens a processing time by bio-marker detection, and uses an immuno-chromatography method enabling detection even with a small amount of sample.SOLUTION: A bio-marker inspection device comprises a base member, a micro needle, a conjugation part, a test part, a control part, and a water soaking part. The conjugation part and test part are laminated from a first surface toward a second surface in this order, the conjugation part and control part are laminated from the first surface toward the second surface in this order, and the micro needle, conjugation part, test part, control part and water soaking part are connected to each other. In the inspection device, a liquid sample including a bio-marker is flowable from the micro needle to the control part and test part.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a test device using immunochromatography. [Background Art]

[0002] A substance in a living organism that has the property of reflecting the presence and progression of a disease through its concentration is called a biomarker. Examples of biomarkers include proteins in blood. Immunochromatography is one of the methods for measuring biomarkers using capillary action, and is widely used as a simple testing method for pregnancy tests and influenza tests.

[0003] Microneedle technology is known as a technique for administering a drug between the stratum corneum of the skin, which does not allow polymer compounds to pass through, and the dermis, which has many pain points. Microneedles have a needle diameter of less than 1 mm and a very small needle length, so they are less likely to cause pain to the subject. Microneedles have been developed for allowing insulin, vaccines, cosmetics, and other drugs to permeate. In recent years, there have also been reported cases of their use for the purpose of collecting in-vivo specimens such as blood and interstitial fluid.

[0004] For example, the diagnostic patch described in Patent Document 1 utilizes immunochromatography. It comprises a microneedle array configured to collect a specimen from a subject, and an immunochromatographic unit that is supplied with the specimen from the microneedle array and performs immunochromatography, and is configured to detect an analyte present in the specimen. [Prior Art Literature] [Patent Literature]

[0005] [Patent Document 1] International Publication No. 2019 / 118420 [Summary of the Invention] [Problem to be Solved by the Invention]

[0006] However, the diagnostic patch described in Patent Document 1 has the following problems. Specifically, in the diagnostic patch described in Patent Document 1, the immunochromatography unit that provides the immunochromatographic method is positioned in the direction of the pad surface, and the collected sample flows in the direction of the pad surface. Therefore, in the diagnostic patch of Patent Document 1, the flow path length of the sample is likely to become redundant, and with the redundancy of the flow path length of the sample, the processing time until biomarker detection becomes longer, and a large amount of sample is required for detection.

[0007] The present invention has been made in view of these circumstances, and aims to provide an immunochromatographic testing device that shortens the flow path length of the sample, shortens the processing time until biomarker detection, and enables detection even with small amounts of sample. [Means for solving the problem]

[0008] To solve the above problems, this invention proposes the following means.

[0009] (1) A biomarker testing device comprising: a substrate; a microneedle placed on a first surface of the substrate; a conjugation section contained in the substrate and containing a labeling substance that specifically labels the biomarker; a test section contained in the substrate and containing a first antibody that captures a complex of the biomarker and the labeling substance; a control section contained in the substrate and containing a second antibody that captures the labeling substance; and a water absorption section detachably placed on a second surface of the substrate, wherein the conjugation section and the test section are stacked in this order from the first surface to the second surface, and the conjugation section and the control section are stacked in this order from the first surface to the second surface, and the microneedle, the conjugation section, the test section, the control section and the water absorption section are interconnected, and a liquid sample containing the biomarker can be flowed from the microneedle to the control section and the test section.

[0010] (2) The inspection device according to (1), wherein two or more microneedles are connected to one of the conjugation sections.

[0011] (3) The inspection device according to (1) or (2), comprising two or more of the test sections.

[0012] (4) The inspection device according to (3), comprising two or more conjugation units and control units, wherein the conjugation unit comprises a first conjugation unit comprising a first labeling substance as the labeling substance and a second conjugation unit comprising a second labeling substance as the labeling substance, the test unit comprises a first test unit that captures a first composite containing the first labeling substance as the composite and a second test unit that captures a second composite containing a second labeling substance as the composite, and the control unit comprises a first control unit that captures the first labeling substance as the labeling substance and a second control unit that captures the second labeling substance as the labeling substance.

[0013] (5) The conjugation unit, the test unit, and the control unit are stacked in that order, An inspection device according to any one of (1) to (4), which is arranged to be openable and closable between the test unit and the control unit.

[0014] (6) The inspection device according to (5), wherein, in a plan view from the second surface, the conjugation portion overlaps with the test portion and is located inside the test portion, and the test portion overlaps with the control portion and is located inside the control portion.

[0015] (7) An inspection device according to any one of (1) to (4), comprising two or more conjugation sections, a first structure on which the conjugation sections and the test section are stacked, and a second structure on which the conjugation sections and the control section are stacked.

[0016] (8) The test device according to (7), wherein in a plan view from the second surface, the conjugation portion overlaps with the test portion and is disposed inside the test portion.

[0017] (9) The test device according to (7) or (8), wherein in a plan view from the second surface, the conjugation portion overlaps with the control portion and is disposed inside the control portion.

[0018] (10) The test device according to any one of (7) to (9), comprising two or more of the control portion and two or more of the test portion, wherein in a plan view from the second surface, the two or more control portions and the two or more test portions are arranged in a grid pattern.

[0019] (11) The test device according to any one of (1) to (4), wherein a plurality of the test portions and a plurality of the control portions are connected to one of the conjugation portions. Effects of the Invention

[0020] According to the present invention, there can be provided a test device using immunochromatography that shortens the flow path length of a sample, shortens the processing time until biomarker detection, and enables detection even with a small amount of sample. Brief Description of the Drawings

[0021] [Figure 1] It is a schematic cross-sectional view of the test device according to the first embodiment. [Figure 2] It is a transmission view from the second surface direction of the first embodiment. [Figure 3] It is a schematic cross-sectional view when using the test device according to the first embodiment. [Figure 4] It is a perspective view of the first embodiment. [Figure 5] It is a schematic cross-sectional view of the test device according to the second embodiment. [Figure 6] It is a schematic cross-sectional view of the test device according to the third embodiment. [Figure 7] It is a schematic cross-sectional diagram of the inspection device according to the fourth embodiment. Mode for Carrying Out the Invention

[0022] [First Embodiment] Hereinafter, the inspection device according to the first embodiment of the present invention will be described with reference to FIG. 1. In all the drawings below, the dimensions and proportions of each constituent element are appropriately varied to improve the visibility of the drawing.

[0023] FIG. 1 is a schematic cross-sectional diagram showing the inspection device 1A of the present embodiment. The inspection device 1A according to the present embodiment includes a base material 2a, microneedles 3 disposed on a first surface 21 of the base material 2a, a conjugation pad 4 accommodated in the base material 2a, a test section 5 accommodated in the base material 2a, a control section 6 accommodated in the base material 2a, and an absorbent portion 9 detachably attached to a second surface 22 of the base material 2a.

[0024] The inspection device is used with the first surface 21 facing the subject's skin S and directly fixed to the skin S. A detailed structure will be described later.

[0025] In the following description, the first surface 21 side of the base material 2a is defined as "lower", the second surface 22 side of the base material 2a is defined as "upper", and the direction from the first surface 21 side of the base material 2a toward the second surface 22 side of the base material 2a is defined as "upward direction".

[0026] (Base Material) The base material 2a holds the microneedles 3, the conjugation pad 4, the test section 5, the control section 6, and the absorbent portion 9. The material, dimensions and shape of the base material 2a are not particularly limited, and general materials applicable to contact-type inspection devices can be used. The shape of the base material 2a is not particularly limited, as long as it can hold the microneedles 3, the conjugation pad 4, the test section 5, the control section 6, and the absorbent portion 9.

[0027] As the material for the base material 2a, a biocompatible material is preferred. Examples of biocompatible base material 2a include, but are not limited to, medical-grade silicone, polyglycolic acid, polycarbonate, or thermoplastic resins such as cyclic olefin copolymers.

[0028] The first surface 21 of the substrate 2a may have an adhesive layer (not shown) for attachment to the subject's skin. If the substrate 2a has an adhesive layer on the first surface 21, the thickness of the adhesive layer should be set to a value smaller than the length of the microneedle 3 in the communication direction.

[0029] (Microneedles) The microneedle 3 is inserted into the subject's skin and used to collect liquid samples such as bodily fluids from the subject's body. The sample collected from the subject is drawn up by the microneedle 3 (capillary action) and introduced into the substrate 2. The testing device 1A has multiple microneedles 3 on its first surface 21.

[0030] The material for microneedle 3 can be any general material applicable to microneedles. A biocompatible material is preferred for microneedle 3. Examples of biocompatible materials for microneedle 3 include, but are not limited to, medical-grade silicone, polyglycolic acid, polycarbonate, or thermoplastic resins such as cyclic olefin copolymers.

[0031] The structure of the microneedle 3 is not particularly limited as long as it can be inserted into the skin and collect liquid samples such as bodily fluids from the subject's body. In such a microneedle 3, a through-hole 31 extending in the longitudinal direction of the microneedle 3 may be formed in order to introduce the sample into the substrate 2. In addition, in the microneedle 3, a plurality of pores formed on the surface and inside of the microneedle 3 may be interconnected and continuous in the longitudinal direction of the microneedle 3.

[0032] The length of the microneedle 3 in the direction of communication is adjusted as appropriate according to the location of the sample to be collected. For example, when the testing device 1A collects interstitial fluid as a sample, the length of the microneedle 3 should be set to a length that extends beyond the stratum corneum and reaches the location of the interstitial fluid.

[0033] (Conjugation Department) The conjugation unit 4 contains a labeling substance that specifically labels the biomarker to be detected. Hereinafter, the biomarker to be detected will be referred to as the "detected substance".

[0034] The lower surface 41a of the conjugation section 4 is connected to the microneedle 3. The conjugation section 4 is capable of drawing up the sample introduced via the microneedle 3 (capillary action) and flowing it into the inside of the testing device 1A.

[0035] The material and shape of the conjugation portion 4 are not limited as long as they have the property of causing the substance to be detected to flow upward from the through-hole 31 of the microneedle 3. The material of the conjugation portion 4 is preferably a porous material that can cause liquids and components dispersed therein to flow by capillary action. The material of the conjugation portion 4 is not limited to the following, but examples include cellulose, nitrocellulose, cellulose acetate, polyvinylidene difluoride (PVDF), glass fiber, nylon, and polyketone, with a thin film made of nitrocellulose being preferred.

[0036] Furthermore, the microneedle 3 and the lower surface 41a of the conjugation portion 4 do not need to be directly connected, as long as the through-hole 31 of the microneedle 3 and the lower surface 41a of the conjugation portion 4 are arranged to allow the sample containing the substance to be detected to flow upward. For example, a layer having properties that allow the sample containing the substance to be detected to flow upward may be provided between the microneedle 3 and the lower surface 41a of the conjugation portion 4. The material of such a layer is preferably the same as the material of the conjugation portion 4.

[0037] A labeled substance has a binding portion that specifically binds to the substance to be detected and a labeling portion that labels the substance. Examples of binding substances include antibodies, fragmented antibodies, and aptamers. Preferred labeling elements include metal colloid particles, fluorescent dye particles, colored latex particles, upconversion phosphorescent particles, and quantum dot particles. Furthermore, the particle size of the labeling elements is preferably between 20 nm and 1000 nm.

[0038] The distance between the centers of the conjugation sections 4 and the distance between the centers of the microneedles 3 may be the same. When a liquid sample is introduced into the conjugation section 4 via the microneedle 3, the substance to be detected in the sample binds to the labeling substance in the conjugation section 4 and is labeled. Hereinafter, the substance in which the substance to be detected has been labeled with the labeling substance will be referred to as a "complex."

[0039] (Testing Department) Test section 5 contains a primary antibody that specifically captures the complex. The primary antibody is immobilized on test section 5. The primary antibody can be any antibody that captures the formed complex through an immunoassay consisting of the primary antibody, the substance to be detected, and a labeling substance. The primary antibody is not limited to the following, but examples include antibodies, fragmented antibodies, aptamers, etc. The concentration of the primary antibody should be sufficient to determine the presence or absence of the detected substance, i.e., to determine positive or negative, based on the intensity (signal) of coloration, fluorescence, etc., derived from the captured labeling substance. Examples of coloration and fluorescence derived from the labeling substance include luminescence, coloration, and staining. Furthermore, known methods may be used to measure the intensity of coloration and fluorescence derived from the labeling substance.

[0040] The lower surface 51a of the test section 5 is connected to the upper surface 42a of the conjugation section 4. The test section 5 is capable of drawing up the sample (substance to be detected) from inside the conjugation section 4 (by capillary action) and causing it to flow into the test section 5.

[0041] However, this shall not apply if the lower surface 51a of the test section 5 and the upper surface 42a of the conjugation section 4 are arranged so that the sample containing the substance to be detected can flow upward. For example, a layer having properties that allow the sample containing the substance to be detected to flow upward may be provided between the lower surface 51a of the test section 5 and the upper surface 42a of the conjugation section 4. The material of such a layer is preferably the same as the material of the conjugation section 4.

[0042] The structure in which the conjugation section 4 and the test section 5 are stacked corresponds to the "first structure 7" in the present invention. The inspection device 1A has multiple first structures 7.

[0043] The material and shape of the test section 5 are not limited, as long as they have the property of causing the substance to be detected to flow upward from the conjugation section 4. The material of the test section 5 is preferably the same as the material of the conjugation section 4.

[0044] The distance between the centers of the test sections 5 and the distance between the centers of the microneedles 3 may be the same.

[0045] The complex is introduced into the test section 5 via the conjugation section 4. The introduced complex is captured by the first antibody. The complex captured by the first antibody becomes dense on the test section 5, causing the test section 5 to change color.

[0046] (Control Unit) The control unit 6 contains a secondary antibody that specifically captures the labeled substance. The secondary antibody is immobilized on the control unit 6. The secondary antibody can be any antibody that can confirm the flow of the labeled substance through an immunoassay involving the secondary antibody and the labeled substance. Examples of secondary antibodies include antibodies, fragmented antibodies, aptamers, etc. The concentration of the second antibody should be such that the labeling substance is concentrated by the second antibody immobilized on the control unit 6, and the intensity (signal) of luminescence or fluorescence originating from the labeling substance can be detected and determined visually or using a detection instrument.

[0047] The lower surface 61a of the control unit 6 is connected to the upper surface 42a of the conjugation unit 4. The control unit 6 is capable of drawing up the sample (substance to be detected) from inside the conjugation unit 4 (by capillary action) and causing it to flow into the control unit 6.

[0048] However, this does not apply if the lower surface 61a of the control section 6 and the upper surface 42a of the conjugation section 4 are arranged so that the sample containing the substance to be detected can flow upward. For example, a layer having properties that allow the sample containing the substance to be detected to flow upward may be provided between the lower surface 61a of the control section 6 and the upper surface 42a of the conjugation section 4. The material of such a layer is preferably the same as the material of the conjugation section 4.

[0049] The structure in which the conjugation unit 4 and the control unit 6 are stacked corresponds to the "second structure 8" in the present invention. The inspection device 1 has multiple second structures 8.

[0050] The material and shape of the control unit 6 are not limited, as long as it has the property of causing the detected substance to flow upward from the conjugation unit 4. The material of the control unit 6 is preferably the same as the material of the conjugation unit 4.

[0051] The distance between the centers of the control units 6 and the distance between the centers of the microneedles 3 may be the same.

[0052] The labeled substance is introduced into the control unit 6 via the conjugation unit 4. The introduced labeled substance is captured by the second antibody. The labeled substance captured by the second antibody becomes dense on the control unit 6, causing the control unit 6 to change color.

[0053] Figure 2 is a transparent view of the substrate 2a as seen from the second surface 22 side. In the first structure 7, the conjugation section 4 overlaps with the test section 5 and is located inside the test section 5. In the second structure 8, the conjugation section 4 overlaps with the control section 6 and is located inside the control section 6.

[0054] In the first structure 7, the sample drawn up by the microneedle 3 moves upward as it is drawn up in the order of the conjugation section 4 and then the test section 5. At this time, the sample spreads isotropically in the conjugation section 4 and the test section 5, and as a whole, it is drawn up upward. If, for example, in the field of view of Figure 2, the test section 5 of the first structure 7 is smaller (narrower) than the conjugation section 4, then the sample (compound) that has spread throughout the conjugation section 4 can only flow into the test section 5 from the portion that overlaps with the lower surface of the test section 5, resulting in an increase in the amount of compound that is not used for color development in the test section 5 (cannot move to the test section 5).

[0055] In contrast, in the first structure 7, the conjugation section 4 is positioned to overlap with the test section 5 and to be located inside the test section 5, thereby promoting the flow of the sample containing the substance to be detected and effectively causing the test section 5 to develop color. The same effect can be obtained in the second structure 8 as well.

[0056] (Water absorption part) The water absorption section 9 draws up (by capillary action) and absorbs the sample containing the substance to be detected, the labeled substance, and the composite introduced from the test section 5 and the control section 6.

[0057] The water-absorbing part 9 is detachably attached to the second surface 22 of the base material 2a. This detachably connects the water-absorbing part 9 to the upper surface 52a of the test section 5, which constitutes the first structure 7. Furthermore, the water-absorbing part 9 is detachably connected to the upper surface 62a of the control section 6, which constitutes the second structure 8.

[0058] The water-absorbing part 9 has a connecting part 23a that connects to the base material 2a. This allows the water-absorbing part 9 to be handled integrally with the base material 2a even after being removed from it. However, the water-absorbing part 9 does not necessarily have to have a connecting part 23a.

[0059] The material of the absorbent section 9 can be any material that absorbs the sample containing the substance to be detected or the labeling substance that has moved from the test section 5 or the control section 6, and that creates a constant upward flow in the testing device 1. A fibrous material made of cellulose is preferred as the material of the absorbent section 9. Examples of fibrous materials made of cellulose include CelluloseFiberSamplePad (manufactured by Millipore).

[0060] The water absorption section 9 continuously absorbs water from the sample, thereby creating a constant flow of the sample upwards towards the testing device 1A.

[0061] Figure 3 is a schematic cross-sectional view of the inspection device 1A of this embodiment in use.

[0062] As described above, the testing device 1A consists of a microneedle 3 (through-hole 31), a conjugation section 4, a test section 5, a control section 6, and a water absorption section 9, all of which are interconnected. The microneedle 3 has a fine through-hole 31, and the conjugation section 4, test section 5, control section 6, and water absorption section 9 are each made of porous material. Therefore, when a liquid sample comes into contact with the through-hole 31, the sample is drawn up by capillary action and flows through the inside of the testing device 1 from the through-hole 31 to the test section 5 and control section 6.

[0063] The testing device 1A is in contact with the subject's skin S on its first surface 21. Microneedles 3 placed on the first surface 21 absorb the sample present in the subject's body through through-holes 31. The sample includes the substance to be detected 101.

[0064] The absorbed substance to be detected 101 flows together with the sample and reaches the conjugation section 4. The substance to be detected 101 that reaches the conjugation section 4 is captured by the labeling substance 102 which specifically captures the substance to be detected 101, and forms a complex 103.

[0065] The complex 103 formed in the conjugation portion 4 of the first structure 7 moves upward by capillary action and reaches the test portion 5. The complex 103 that reaches the test portion 5 is captured by the first antibody 104, which specifically captures the complex. The complex 103 captured by the first antibody 104 becomes highly concentrated in the test portion 5, causing the test portion 5 to change color. In addition, the complex 103 captured by the first antibody 104 immobilized in the test portion 5 remains in the test portion 5.

[0066] Any substances not captured by the labeling substance, such as the detected object 101, the labeling substance 102, and the components of the sample, further move upward by capillary action and reach the water absorption section 9.

[0067] Meanwhile, the complex 103 formed in the conjugation portion 4 of the second structure 8, and the labeled substance 102 that did not capture the target substance, move upward by capillary action and reach the control portion 6. The labeled substance 102 that reaches the control portion 6 is captured by the second antibody 105, which specifically captures the labeled substance 102. The labeled substance 102 captured by the second antibody 105 becomes highly concentrated in the control portion 6, causing the control portion 6 to change color. In addition, the labeled substance 102 captured by the second antibody 105 immobilized in the control portion 6 remains in the control portion 6.

[0068] Any substances not captured by the labeling substance, such as the detected object 101, the complex 103, and the components of the sample, further move upward by capillary action and reach the water absorption section 9.

[0069] After sufficient time has elapsed for the sample to reach the test section 5 and the control section 6, the absorbent section 9, which is detachably attached to the second surface 22 of the substrate 2a, is removed. It is advisable to conduct preliminary experiments beforehand to determine a suitable time for the "sufficient time for the sample to reach the test section." The presence or absence of the substance to be detected 101 is determined by checking the color changes in the test section 5 and the control section 6.

[0070] Figure 4 is a perspective view of the inspection device 1A, and is an explanatory diagram showing the state after the water absorption part 9 has been removed from the substrate 2a. The test part 5 of the first structure 7 and the control part 6 of the second structure 8 are installed so as to be exposed on the second surface 22 of the substrate 2a.

[0071] In the inspection device 1A shown in Figure 4, there are an equal number of test units 5 and control units 6. Furthermore, in inspection device 1A, the test units 5 and control units 6 are arranged in a staggered pattern, with the test units 5 and control units 6 adjacent to each other in the row and column directions. However, the arrangement of the test units 5 and control units 6 is not limited to this configuration; various arrangements can be adopted.

[0072] By arranging the test unit 5 and the control unit 6 in a staggered pattern, the visibility of the results may be improved.

[0073] If the test unit 5 and the control unit 6 are adjacent to each other in the row or column direction, the visibility of the results may be improved.

[0074] If the concentration of the sample decreases from the center to the periphery of the testing device 1A, the number of test units 5 and control units may be different in order to improve the detection sensitivity of the substance to be detected at the periphery of the testing device 1A.

[0075] In such a testing device 1A, for example, if the control unit 6 changes color after sufficient time has elapsed for the sample to reach the test unit 5 and the control unit 6, it can be determined that a sufficient amount of sample has been supplied to the testing device 1A.

[0076] Furthermore, if the test section 5 changes color, it can be determined that the sample collected via the microneedle 3 contained the substance to be detected 101 (positive).

[0077] On the other hand, if, after sufficient time has elapsed for the sample to reach both the test unit 5 and the control unit 6, the test unit 5 does not change color and only the control unit 6 changes color, it can be determined that the sample did not contain the substance to be detected 101 (negative).

[0078] Furthermore, if, after sufficient time has elapsed for the sample to reach both the test section 5 and the control section 6, only the test section 5 changes color, or if neither the test section 5 nor the control section 6 changes color, then the test result can be determined to be abnormal (invalid). In this case, the test should be repeated as necessary.

[0079] By providing multiple test sections 5 and control sections 6 on the second surface 22 of the substrate 2a, the following effects can be expected.

[0080] First, a testing device 1 equipped with multiple test units 5 can reduce the likelihood of misjudging the results as "false negatives" (incorrectly determining a negative result) and "false positives" (incorrectly determining a positive result). Immunochromatography is a simple testing method and, in principle, is prone to false negatives and false positives. In contrast, a testing device 1 equipped with multiple test units 5 can simultaneously determine positive or negative results in multiple test units 5, thus reducing the likelihood of incorrect judgments.

[0081] The step of checking the color development of the test section 5 and the control section 6 from the second surface 22 direction of the substrate 2a may be performed by imaging the test section 5 and the control section 6 from the second surface 22 direction and using image recognition with the obtained images. As an image recognition method, a known method used for determining positive and negative results in immunochromatography can be employed. Furthermore, to facilitate image recognition, the colors of the test section 5 and the control section 6 may be made different when color development occurs by labeling them with multiple labeling substances.

[0082] With the inspection device 1A configured as described above, the sample (substance to be detected) collected from the subject moves upward through the microneedle 3 via capillary action. Because the sample moves upward through the inspection device 1A, the flow path length is shortened compared to conventional techniques in which the sample moves left and right, making it possible to shorten the detection time.

[0083] In this embodiment, there is no limit to the number of first structures 7 and second structures 8; each of the first structures 7 and second structures 8 may be present as just one.

[0084] Furthermore, although the testing device 1A of this embodiment has been described as having a labeling substance 102, a first antibody 104, and a second antibody 105 for the substance to be detected 101, it is not limited to this. While the testing device 1A can suitably detect the substance to be detected 101 labeled by the labeling substance 102, the testing device 1A can be made capable of simultaneously detecting multiple types of substances to be detected by the following configuration changes.

[0085] In other words, the testing device 1A may include a second conjugation section equipped with a second labeling substance that specifically binds to a second substance different from the substance to be detected 101, a second test section on which a first antibody that specifically detects a complex of the second substance to be detected and the second labeling substance (the second complex) is immobilized, and a second control section on which a second antibody that specifically detects the second labeling substance is immobilized. These second conjugation section, second test section, and second control section can adopt the same configuration as the conjugation section 4, test section 5, and control section 6, except that the labeling substances and antibodies they contain differ.

[0086] In this case, the object to be detected shown in this embodiment is the first object to be detected, and the conjugation portion comprising a first labeling substance that specifically binds to the first object to be detected is the "first conjugation portion" in the present invention. Similarly, a test section on which a first antibody that specifically detects a complex of the first substance to be detected and the first labeled substance (the first complex) is immobilized is the "first test section" in this invention. Similarly, a control unit on which a second antibody that specifically captures the first labeling substance is immobilized is the "first control unit" in this invention.

[0087] Furthermore, in order to enable the detection of a third or more objects, a third conjugation unit, a third test unit, a third control unit, etc., may be provided as appropriate, based on a similar approach.

[0088] [Second Embodiment] Figure 5 is a schematic cross-sectional view of inspection device 1B according to the second embodiment of the present invention. The inspection device of this embodiment is partially common with the device of the first embodiment. Therefore, the same reference numerals are used for components common with the first embodiment in this embodiment, and detailed descriptions are omitted.

[0089] In Figure 5, two microneedles 3 are installed in one conjugation section 4. The number of microneedles 3 installed in one conjugation section 4 may be three or more.

[0090] With the inspection device 1B having the above configuration, a sample containing the substance to be detected can be supplied to a single conjugation section 4 from two or more microneedles. Therefore, the supply of the sample to a single conjugation section amount of supply This increases the number of detections, allowing for stable detection results.

[0091] [Third Embodiment] Figure 6 is a schematic cross-sectional view of an inspection device 1C according to a third embodiment of the present invention. The inspection device of this embodiment is partially the same as the device of the first embodiment. Therefore, the same reference numerals are used for components common to the first embodiment in this embodiment, and detailed descriptions are omitted.

[0092] (base material) Base material 2c is composed of base material 2x and base material 2y. y The conjugation section 4c and the test section 5c are housed in the base material 2. x The control unit 6c is housed within it. The water absorption unit 9 is connected to the upper surface 22b of the base material 2y.

[0093] The inspection device 1C shown in Figure 6 has the conjugation section 4c, test section 5c, and control section 6c stacked in that order from the first surface 21, which is the bottom surface of the substrate 2c, to the second surface 22, which is the top surface. More specifically, the conjugation section 4c and test section 5c are stacked on the substrate 2x, and the control section 6c, which is housed on the substrate 2y, is further stacked with the conjugation section 4c and test section 5c.

[0094] In such an inspection device 1C, the base material 2c opens and closes between its constituent base material 2x and base material 2y. The base material 2x and base material 2y may be connected by a connecting portion 23c.

[0095] (Control Unit) The lower surface 61c of the control section 6c is connected to the upper surface 52c of the test section 5c. The control section 6c is capable of allowing the sample (substance to be detected) inside the test section 5c to flow into the control section 6c. However, this is not the case if the lower surface 61c of the control section 6c and the upper surface 52c of the test section 5c are arranged in such a way that the sample containing the substance to be detected can flow upward. For example, a layer having properties that allow the sample containing the substance to be detected to flow upward may be provided between the lower surface 61c of the control section 6c and the upper surface 52c of the test section 5c. The material of such a layer is preferably the same as that of the conjugation section 4c.

[0096] In the inspection device 1C, the conjugation section 4c, the test section 5c, and the control section 6c are stacked in this order.

[0097] In the transparency view of the substrate 2c from the second surface 22 side, the conjugation section 4c is positioned to overlap with the test section 5c and to be located inside the test section 5c. The test section 5c is also positioned to overlap with the control section 6c and to be located inside the control section 6c.

[0098] The conjugation section 4c may extend over almost the entire lower surface 21c of the substrate 2c. The conjugation section 4c, test section 5c, and control section 6c may have the same functions as those of the first embodiment described above.

[0099] Even with the inspection device 1C configured as described above, the flow path length is shorter compared to conventional techniques in which the sample moves in the left-right direction, making it possible to shorten the detection time.

[0100] In Figure 6, only one layered structure (hereinafter simply referred to as the layered structure) of the conjugation section 4c, test section 5c, and control section 6c is shown, but the device is not limited to this. The inspection device 1C may have multiple layers of the above-described layered structure in the substrate 2c.

[0101] [Fourth Embodiment] Figure 7 is a schematic cross-sectional view of an inspection device 1D according to a fourth embodiment of the present invention. The inspection device of this embodiment is partially the same as the device of the first embodiment. Therefore, the same reference numerals are used for components common to the first embodiment in this embodiment, and detailed descriptions are omitted.

[0102] (Conjugation Department) The lower surface 41d of the conjugation section 4d is connected to two or more microneedles 3. The conjugation section 4d is capable of drawing up the sample introduced via the microneedles 3 (capillary action) and flowing it into the inside of the testing device 1D. The upper surface 42d of the conjugation section 4d is connected to the lower surface 51d of the test section 5d. The test section 5d is capable of flowing the sample (substance to be detected) inside the conjugation section 4d into the test section 5d.

[0103] The conjugation section 4d may extend over almost the entire lower surface 21d of the substrate 2d. The conjugation section 4d, test section 5d, and control section 6d may have the same functions as those of the first embodiment described above.

[0104] Furthermore, the upper surface 42d of the conjugation unit 4d is connected to the lower surface 61d of the control unit 6d. The control unit 6d is capable of causing the sample (substance to be detected) inside the conjugation unit 4d to flow into the control unit 6d.

[0105] However, this does not apply if the lower surface 51d of the test section 5d and the upper surface 42d of the conjugation section 4d are arranged so that the sample containing the substance to be detected can flow upward. For example, a layer having properties that allow the sample containing the substance to be detected to flow upward may be provided between the lower surface 51d of the test section 5d and the upper surface 42d of the conjugation section 4d. The material of such a layer is preferably the same as that of the conjugation section 4d. The control section 6d can also be configured in the same way as the test section 5d.

[0106] In the inspection device 1D, the conjugation unit 4d is connected to the test unit 5d and also to the control unit 6d.

[0107] The conjugation section 4d may include a second labeling substance that specifically binds to the second substance to be detected. In that case, the substrate 2d may include a second test section on which a first antibody that specifically captures the second complex is immobilized, and a second control section on which a second antibody that specifically captures the second labeling substance is immobilized.

[0108] Furthermore, in order to enable the detection of a third or more substances to be detected, a third labeling substance, a third test section, a third control section, etc., may be provided as appropriate, based on a similar approach.

[0109] With the inspection device 1D configured as described above, the flow path length is shorter compared to conventional technologies in which the sample moves in the left-right direction, and the detection time can be reduced. Furthermore, in the configuration of inspection device 1D, the conjugation section 4d is connected to the test section 5d and the control section 6d respectively (the conjugation section 4d is shared by the test section 5d and the control section 6d), which simplifies the manufacturing process and reduces manufacturing costs compared to inspection devices 1A and 1B which have a fine layered structure.

[0110] In Figure 6, only one structure is shown in which two test units 5d and two control units 6d are connected to one conjugation unit 4d, but the structure is not limited to this. The number of test units 5d connected to the conjugation unit 4d may be one or three or more. Similarly, the number of control units 6d connected to the conjugation unit 4d may be one or three or more. Furthermore, the inspection device 1D may have multiple laminated structures in the substrate 2d, each consisting of a conjugation unit 4d, a test unit 5d, and a control unit 6d.

[0111] Preferred embodiments of the present invention have been described above with reference to the attached drawings, but the present invention is not limited to these examples. The shapes and combinations of the constituent members shown in the above examples are merely examples, and can be modified in various ways based on design, specifications, etc., without departing from the spirit of the present invention. [Explanation of Symbols]

[0112] 1. Inspection device 2 Base material 21 First surface of substrate 2 22 Second surface of base material 2 23 Connection part connecting the base material 2 and the water absorption part 9 3 Microneedles 4. Conjugation Department 5. Test Section 6. Control Unit 7 First structure 8 Second structure 9 Water absorption part

Claims

1. A biomarker testing device, Substrate and A microneedle is placed on the first surface of the substrate, A conjugation portion contained within the substrate and containing a labeling substance that specifically labels the biomarker, A test section containing a first antibody that captures a complex of the biomarker and the labeled substance, which is housed in the substrate, A control unit containing a second antibody that captures the labeled substance, which is housed in the substrate, The substrate comprises a water-absorbing part detachably installed on the second surface thereof, The conjugation section and the test section are stacked in this order from the first surface toward the second surface. The conjugation unit and the control unit are stacked in this order from the first surface toward the second surface. A testing device in which the microneedle, the conjugation section, the test section, the control section, and the water absorption section are interconnected, and a liquid sample containing the biomarker can be flowed from the microneedle to the control section and the test section.

2. The inspection device according to claim 1, wherein two or more microneedles are connected to one of the conjugation portions.

3. The inspection device according to claim 1 or 2, comprising two or more of the aforementioned test units.

4. The system comprises two or more of the aforementioned conjugation units and control units. The conjugation portion comprises a first conjugation portion which includes a first labeling substance as the labeling substance, It has a second conjugation portion which is provided with a second labeling substance as the labeling substance, The test unit includes a first test unit that captures the first composite, which contains the first labeled substance as the composite, The test section includes a second test section that captures a second composite containing a second labeled substance as the composite, The control unit includes a first control unit that captures the first labeling substance as the labeling substance, The inspection device according to claim 3, further comprising a second control unit that captures a second labeling substance as the labeling substance.

5. The conjugation unit, the test unit, and the control unit are stacked in that order. The inspection device according to claim 1 or 2, wherein the substrate is arranged to be openable and closable between the test section and the control section.

6. In the plan view from the second surface, The conjugation section overlaps with the test section and is located inside the test section. The inspection device according to claim 5, wherein the test unit overlaps with the control unit and is located inside the control unit.

7. The conjugation unit comprises two or more of the above-mentioned units. The conjugation section and the first structure on which the test section is stacked, The inspection device according to claim 1 or 2, further comprising the conjugation portion and a second structure on which the control portion is stacked.

8. The inspection device according to claim 7, wherein, in a plan view from the second surface, the conjugation portion overlaps with the test portion and is located inside the test portion.

9. The inspection device according to claim 7, wherein, in a plan view from the second surface, the conjugation portion overlaps with the control portion and is located inside the control portion.

10. The system comprises two or more of the control unit and the test unit, The inspection device according to claim 7, wherein, in a plan view from the second surface, two or more control units and two or more test units are arranged in a grid pattern.

11. The inspection device according to claim 1 or 2, wherein a plurality of test units and a plurality of control units are connected to one of the conjugation units.

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