Detection equipment

Abstract

To provide a detection instrument capable of accurate detection.SOLUTION: A detection instrument 1 comprises: a test piece 100 including a solid-phase carrier 130, a labeling substance holding portion 120, and an absorber 140 on a base material sheet 110 extending in a first direction X; and a housing 200 including a first member 210 and a second member 220 that hold the test piece 100 therebetween. The first member 210 includes an opening 219, and a first pressing portion 211 and a second pressing portion 212 as a part of a peripheral portion 217 of the opening. The first pressing portion 211 presses a region 120A1, which extends in a whole second direction Y intersecting with the first direction X, of an overlapping portion 160 of the base material sheet 110, the solid-phase carrier 130, and the labeling substance holding portion 120. The second pressing portion 212 presses a region 140B1, which extends in the whole second direction Y, of an overlapping portion 170 of the base material sheet 110, the solid-phase carrier 130, and the absorber 140.SELECTED DRAWING: Figure 7

Description

[Technical Field]

[0001] The present invention relates to a detection device for detecting an analyte in a liquid sample. [Background technology]

[0002] Immunoassays are widely used as methods for detecting a test substance in a liquid sample derived from a living organism, etc., particularly when the test substance is a protein, in which the test substance is detected by causing an antigen-antibody reaction using a substance (antibody / antigen) that specifically binds to the test substance. A particularly well-known method for detecting a test substance quickly and simply is immunochromatography, in which a capture substance (antibody / antigen) that specifically binds to the test substance is immobilized at a predetermined position on a solid-phase carrier, a liquid sample containing the test substance is spread on the solid-phase carrier, the test substance is captured at the predetermined position, and the capture is then detected visually or otherwise.

[0003] In order to easily detect a test substance in a liquid sample using chromatography such as immunochromatography, detection instruments have been developed that include a test piece containing a solid-phase carrier on which a capture substance that binds to the test substance is immobilized, and a housing that houses the test piece.

[0004] For example, Patent Document 1 describes a testing device including a test strip and a housing for accommodating the test strip, and describes that the inner surface of the housing is provided with a series of protrusions, each of which contacts the test strip. Patent Document 1 also describes that the height of at least one of the series of protrusions is different from the height of another of the series of protrusions, and that in an attached configuration, the series of protrusions is configured to generate a pressure gradient that allows fluid to flow at a predetermined flow rate along the length of the test strip between the first and last protrusions in the series.

[0005] Patent Document 2 describes an immunochromatography device having a structure in which a test strip is sandwiched between a first case member covering a first surface of the test strip and a second case member covering a second surface of the test strip, the test strip including a sample addition member, a label retention member, and a chromatographic membrane carrier, the sample addition member being disposed so as to overlap at least a portion of the label retention member, the first case member being provided with at least two convex portions in the direction of sample development of the test strip, at least one of the convex portions of the first case member being provided above the sample addition member overlapping with the label retention member, and the second case member being provided with convex portions facing the at least two convex portions of the first case member. According to Patent Document 2, the provision of these convex portions has the effect of partially adhering the sample addition member, label retention member, and chromatographic membrane carrier to each other.

[0006] Patent Document 3 describes a test kit that includes a first member including a region in which a labeled substance, in which a label is fixed to a substance that specifically binds to a substance to be detected, is retained, and a second member that has a detection zone that captures the labeled substance via the substance to be detected and is connected downstream in the direction of development of the first member. Patent Document 3 further describes that a case that houses the test kit is provided with multiple pressing parts that press the test kit in the thickness direction.

[0007] Patent Document 4 describes a test kit including a test strip in which a sample dropping pad, a labeling substance holding pad, an immobilization membrane, and an absorbent pad are connected in this order, and a first case for housing the test strip. Patent Document 4 describes that a pressing unit is provided in the first case, and that this pressing unit presses a portion of the overlapping portion of the labeling substance holding pad and the immobilization membrane in a direction perpendicular to the direction of development of the liquid sample, thereby bringing the labeling substance holding pad and the immobilization membrane into close contact and enabling smooth development of the liquid sample. Patent Document 4 also describes that the first case is provided with pressing units that press the overlapping portion of the sample dropping pad and the labeling substance holding pad and the overlapping portion of the immobilization membrane and the absorbent pad over the entire direction perpendicular to the direction of development, respectively.

[0008] Patent Document 5 describes a container for a liquid sample testing device that includes a housing that houses a developing substrate having a sample pad, a membrane, and an absorbent pad arranged on a base card. Patent Document 5 also describes that an upper housing that constitutes part of the housing has a detection hole formed in an area corresponding to the membrane of the developing substrate, and that the end of the peripheral wall surface surrounding the detection hole on the developing substrate side is flat, and that this flat surface presses against the membrane. The upper housing in Patent Document 5 further includes a pressing wall for pressing against the conjugate pad.

[0009] Patent document 6 describes a liquid sample testing device that has an upper case, a lower case, and a test strip housed between them, in which a pressure pin or pressure member is placed on the inner surface of the upper case facing the test strip. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] Japanese Patent Publication No. 2020-126077 [Patent Document 2] Japanese Patent Application Laid-Open No. 2005-37384 [Patent Document 3] Japanese Patent Application Laid-Open No. 2014-178153 [Patent Document 4] Japanese Patent Application Publication No. 2018-36199 [Patent Document 5] Utility Model Registration No. 3212222 [Patent Document 6] Patent Publication No. 2021-18240 Summary of the Invention [Problem to be solved by the invention]

[0011] The present inventors have found that the following problems exist when detecting an analyte in a liquid sample using a detection device including a test strip having a labeled substance holding portion, a solid phase carrier, and an absorbent arranged in this order from upstream to downstream in the spreading direction on a base sheet, and a housing for accommodating the test strip. First, there is a problem that if the flow of the liquid sample spreading on the test strip is uneven across the width of the test strip, the detection results become unclear. Second, there is a problem that if the contact between the labeled substance holding portion and the solid phase carrier and the contact between the solid phase carrier and the absorbent are insufficient, the spreading liquid sample will stagnate at the contact points of the respective components. As described above, the problems described above cannot be fully solved by Patent Documents 1 to 6. Therefore, an object of the present invention is to provide a detection instrument that can solve the problems described above. [Means for solving the problem]

[0012] The present invention provides the following: [1] A detection device for detecting a test substance in a liquid sample, comprising: A test piece and a housing for accommodating the test piece are provided. The test strip comprises a base sheet, a labeled substance holding portion, a solid phase carrier, and an absorbent; the base sheet extends in a first direction from a first end to a second end, and has a first surface along the first direction and a second surface on the back side of the first surface along the first direction; a labeled substance holding portion, a solid phase carrier, and an absorber are arranged in this order on a first surface of a base sheet along a first direction so as to at least partially overlap one another; the housing includes a first member disposed opposite a first surface of the base sheet and a second member disposed opposite a second surface of the base sheet, the first member sandwiching and holding the test piece therebetween; an opening is formed in the first member at a position facing the solid phase carrier of the test piece; the first member includes a first pressing portion and a second pressing portion, which are part of the peripheral portion of the opening, on a surface of the test piece facing the first surface of the base sheet and press the test piece toward the second member; the first pressing portion has a first pressing surface that abuts against a region of the surface of the test piece at a portion where the base sheet, the solid phase carrier, and the labeled substance holding portion overlap, the region extending over the entire surface in a second direction that intersects with the first direction; The second pressing portion has a second pressing surface that contacts an area extending over the entire surface of the test piece in the second direction at the portion where the base sheet, the solid phase carrier, and the absorbent overlap. A detection instrument characterized by:

[0013] [2] In the test piece, the labeling substance holding portion is a porous body containing a labeling substance capable of being released and capable of binding to the test substance; The solid phase carrier includes a capture portion on which a capture substance that binds to the test substance is immobilized, The absorbent is a porous body that absorbs a liquid sample. the solid phase carrier extends in a first direction from a third end located between the first end and the second end of the base sheet to a fourth end located between the third end and the second end of the base sheet, and is arranged so as to cover a part of the base sheet in the first direction from the first surface side of the base sheet; the capture portion of the solid phase carrier is disposed between the third end and the fourth end of the solid phase carrier; the labeled substance holding section extends in the first direction from a fifth end located closer to the first end of the base sheet than the third end of the solid phase carrier to a sixth end located between the third end of the solid phase carrier and the capture section, and is arranged so as to cover a part of the base sheet and the solid phase carrier in the first direction from the side of the first surface of the base sheet; the absorber extends in the first direction from a seventh end located between the capture portion and the fourth end of the solid phase carrier to an eighth end located closer to the second end of the base sheet than the fourth end of the solid phase carrier, and is arranged so as to cover a part of the base sheet and the solid phase carrier in the first direction from the side of the first surface of the base sheet; In the first member of the housing, the opening is formed in the first member at a position facing a portion of the test piece including the capture portion of the solid phase carrier; the first pressing surface of the first pressing unit abuts against a region of the surface of the labeled substance holding unit in a portion of the test piece where the base sheet, the solid phase carrier, and the labeled substance holding unit overlap, the region extending over the entire surface in a second direction intersecting with the first direction; the second pressing surface of the second pressing unit abuts against a region extending entirely in the second direction on the surface of the absorbent body in a portion of the test piece where the base sheet, the solid phase carrier, and the absorbent body overlap, the portion including the seventh end of the absorbent body; the first pressing portion is a part of a peripheral edge portion of the opening adjacent to the opening on a side where the first end portion of the base sheet of the test piece is located in the first direction; The second pressing portion is a part of the peripheral edge of the opening adjacent to the opening on the side where the second end of the base sheet of the test piece is located in the first direction. [1] The detection device described in [1].

[0014] [3] In the test strip, the portion of the labeled substance holding portion that covers the solid phase carrier is not adhered to the solid phase carrier, and the portion of the absorber that covers the solid phase carrier is not adhered to the solid phase carrier. [2] The detection device described in [2].

[0015] [4] The first member of the housing further includes a third pressing portion on a surface of the test piece facing the first surface of the base sheet thereof, the third pressing portion pressing the test piece toward the second member; the third pressing portion has a third pressing surface that abuts against a partial region in the second direction of the surface of the absorbent in a portion of the test piece where the base sheet, the solid phase carrier, and the absorbent overlap, the portion including the fourth end of the solid phase carrier; [2] or [3].

[0016] [5] A detection instrument according to [4], wherein the third pressing surface of the third pressing portion is positioned at a position protruding toward the test piece more than the second pressing surface of the second pressing portion.

[0017] [6] The test strip further comprises a sample receiving portion that is a porous body that receives a liquid sample; the sample receiving section extends in the first direction from a ninth end located closer to the first end of the base sheet than the fifth end of the labeled substance holding section to a tenth end located between the fifth end of the labeled substance holding section and the third end of the solid phase carrier, and is arranged so as to cover a part of the base sheet and the labeled substance holding section in the first direction from the side of the first surface of the base sheet; The detection instrument according to any one of [2] to [5].

[0018] [7] The test strip further comprises a sample receiving portion that is a porous body that receives a liquid sample; the sample receiving section is disposed on the first surface of the base sheet so as to overlap at least a portion of the sample receiving section with the labeled substance holding section; The detection instrument according to any one of [1] to [5].

[0019] [8] The first member of the housing further includes a fourth pressing portion on a surface of the test piece facing the first surface of the base sheet, the fourth pressing portion pressing the test piece toward the second member; the fourth pressing portion has a fourth pressing surface that abuts against a partial area in the second direction of the surface of the test piece at a portion where the base sheet, the labeled substance holding portion, and the sample receiving portion overlap; [7] The detection device described in [7].

[0020] [9] The first member of the housing includes first fitting portions at a pair of positions between the first pressing portion and the fourth pressing portion in the first direction and facing each other in the second direction with the test piece interposed therebetween, the second member of the housing has second fitting portions at a pair of positions facing the first fitting portions of the first member, the second fitting portions being engageable with the first fitting portions, [8] The detection device described in [8].

[0021]

[10] The second member of the housing includes a fifth pressing portion on a surface of the test piece facing the second surface of the base sheet, the fifth pressing portion pressing the test piece toward the first member; the fifth pressing portion has a fifth pressing surface that abuts against a region of the second surface of the base sheet that extends entirely in the second direction in a portion of the test piece where the base sheet, the solid phase carrier, and the labeled substance holding portion overlap; The detection instrument according to any one of [1] to [9].

[0022]

[11] The labeling substance held in the labeling substance holding portion of the test strip contains a first antibody molecule that immunologically binds to the test substance; the capture substance immobilized on the capture portion of the solid phase carrier of the test piece contains a second antibody molecule that immunologically binds to the test substance; The detection instrument according to any one of [1] to

[10] .

[0023]

[12] A kit for detecting a test substance in a sample, comprising the detection instrument according to any one of [1] to

[11] and a sample pretreatment reagent. [Effects of the Invention]

[0024] The detection instrument of the present invention enables more accurate detection. [Brief explanation of the drawings]

[0025] [Figure 1] FIG. 1 is a perspective view of the entire detection instrument according to one embodiment of the present invention. [Figure 2] 2 is an exploded perspective view showing a schematic relationship between a first member of a housing, a test piece, and a second member of a housing in a detection device according to one embodiment of the present invention. Arrows in FIG. 2 and subsequent figures indicate first and second directions. [Figure 3A] FIG. 3A is a plan view of a first member of a housing in a detection instrument according to one embodiment of the present invention, as viewed from inside the housing. [Figure 3B] 3B is a cross-sectional view of a first member of a housing in a detection instrument according to one embodiment of the present invention, taken along line II shown in FIG. 3A. [Figure 3C]FIG. 3C is a perspective view of a first member of a housing in a detection instrument according to one embodiment of the present invention, as viewed from inside the housing. [Figure 4A] FIG. 4A is a plan view of a second member of a housing in a detection instrument according to one embodiment of the present invention, as viewed from inside the housing. [Figure 4B] 4B is a cross-sectional view of the second member of the housing of the detection instrument according to one embodiment of the present invention, taken along line II-II shown in FIG. 4A. [Figure 5A] FIG. 5A is a plan view of a test piece in a detection instrument according to one embodiment of the present invention, viewed from the side of the first surface of the base sheet. [Figure 5B] 5B is a cross-sectional view of the test piece in the detection instrument according to one embodiment of the present invention taken along line III-III shown in FIG. 5A. [Figure 5C] FIG. 5C is a plan view of the test piece in the detection instrument according to one embodiment of the present invention, viewed from the side of the second surface of the base sheet. [Figure 6] Fig. 6 is a cross-sectional view of a detection device according to one embodiment of the present invention, in which the cross-section of the first member of the housing is taken along line II shown in Fig. 3A, the cross-section of the second member of the housing is taken along line II-II shown in Fig. 4A, and the cross-section of the test piece is taken along line III-III shown in Fig. 5A. [Figure 7] Fig. 7 is a partially enlarged view of the cross-sectional view of the detection device according to one embodiment of the present invention shown in Fig. 6. The enlarged view at the bottom left of Fig. 7 shows the first and fourth pressing portions of the first member of the housing, the fifth pressing portion of the second member of the housing, and the test piece pressed by them. The enlarged view at the bottom right of Fig. 7 shows the second and third pressing portions of the first member of the housing, and the test piece pressed by them. DETAILED DESCRIPTION OF THE INVENTION

[0026] An embodiment of a detection instrument according to the present invention will be described with reference to the drawings.

[0027] The detection instrument 1 is a detection instrument 1 for detecting a test substance in a liquid sample, and is characterized by comprising a test strip 100 and a housing 200 for accommodating the test strip 100.

[0028] The housing 200 includes a first member 210 disposed opposite the first surface 110A of the base sheet 110, and a second member 220 disposed opposite the second surface 110B of the base sheet 110, which sandwich and hold the test piece 100 therebetween. The housing 200 is formed by assembling the first member 210 and the second member 220 (see FIGS. 1, 2, 6, and 7). The housing 200 can be a molded body made of a water-impermeable moldable material, such as polyethylene, polypropylene, polystyrene, polyethylene terephthalate, or polyvinyl chloride.

[0029] The test piece 100 is not particularly limited in shape or size, but may be, for example, a substantially rectangular parallelepiped with a length of 40 mm to 120 mm, a width of 3 mm to 20 mm, and a thickness of 10 μm to 5.0 mm. The shape and size can be modified as appropriate. The characteristics of the test piece 100 will be described mainly with reference to FIGS. 5A, 5B, and 5C.

[0030] The test strip 100 comprises at least a base sheet 110 , a labeling substance holding portion 120 , a solid phase carrier 130 and an absorbent 140 . In the illustrated embodiment, the labeled substance holding portion 120 is a porous body containing a labeled substance that binds to the test substance in a releasable state, the solid phase carrier 130 includes a capture portion 135 in part to which a capture substance that binds to the test substance is fixed, and the absorber 140 is a porous body that absorbs the liquid sample.

[0031] The illustrated embodiment of test strip 100 further includes sample receiving portion 150, which is a porous body that receives a liquid sample.

[0032] The base sheet 110 is also called a backing sheet. The base sheet 110 is preferably a resin sheet that is impermeable to water. The base sheet 110 may be a resin sheet made of, for example, polypropylene, polystyrene, polyester, or vinyl chloride.

[0033] The labeling substance holding section 120 is a porous body containing a labeling substance in a state that allows it to be released when the liquid sample to be analyzed is developed. It is preferably an aggregate of fibers, such as glass fiber, cellulose fiber, polyester fiber, polyethylene fiber, or polypropylene fiber. The labeling substance is not particularly limited as long as it binds to the analyte and can be detected on the solid-phase support 130 after the liquid sample is developed. Examples of the labeling substance include conjugates of known labeling substances, such as colored particles, enzymes, biotin, and digoxigenin, linked to a substance for binding to the analyte. Examples of colored particles include metal particles, colored latex particles, colored polystyrene particles, colored cellulose particles, fluorescent cellulose particles, and silica nanoparticles containing dyes. Examples of metal particles include colloidal metal particles, such as colloidal gold particles, colloidal silver particles, and colloidal platinum particles. The substance for binding to the test substance can be selected appropriately depending on the test substance. For example, if the test substance is a polypeptide, an antibody capable of specifically binding to the polypeptide can be used; if the test substance is an antigen molecule, an antibody capable of specifically binding to the antigen molecule can be used; if the test substance is a polynucleotide such as DNA, a polynucleotide capable of specifically binding to the polynucleotide can be used.

[0034] The solid phase carrier 130 serves as a solid phase when the liquid sample (mobile phase) develops. The solid phase carrier 130 can be, for example, a thin film (membrane), and can be a membrane made of a material such as nitrocellulose, cellulose, cellulose acetate, polyethersulfone, nylon, polyester, or glass fiber.

[0035] The solid phase carrier 130 includes a capture section 135 at a portion thereof to which a capture substance that binds to the analyte is immobilized. The capture section 135 is a site at which a capture substance that can bind to the analyte is immobilized, and can be, for example, a linear section, usually called a test line, arranged along the second direction Y, which is the width direction of the solid phase carrier 130. When the liquid sample developed on the solid phase carrier 130 contains the analyte, a complex between the analyte and the labeling substance binds to the capture substance in the capture section 135.

[0036] The capture substance may be any substance capable of binding to the analyte bound to the labeling substance, and may be appropriately selected depending on the analyte. For example, if the analyte is a polypeptide, an antibody capable of specifically binding to the polypeptide may be used; if the analyte is an antigen molecule, an antibody capable of specifically binding to the antigen molecule may be used; if the analyte is a polynucleotide such as DNA, a polynucleotide capable of specifically binding to the polynucleotide may be used.

[0037] When the test substance is a polypeptide, it is preferable that the labeling substance held in labeling substance holding section 120 is a conjugate formed by linking the labeling substance to a first antibody molecule that immunologically binds to the test substance, and that the capture substance immobilized on capture section 135 of solid phase support 130 is a second antibody molecule that immunologically binds to the test substance. The detection instrument 1 according to this preferred embodiment is a device for immunochromatography.

[0038] The absorbent 140 is a porous body provided to absorb and retain the liquid sample after it has been developed from the upstream side of the test strip 100 and passed through the solid phase carrier 130, preventing the liquid sample from flowing back. The absorbent 140 is also called an absorbent pad. The absorbent 140 is preferably an assembly of fibers, and may be, for example, an assembly of fibers such as glass fiber, cellulose fiber, polyester fiber, polyethylene fiber, or polypropylene fiber.

[0039] The sample receiving portion 150, which is a porous body that receives a liquid sample, is the portion onto which the liquid sample is loaded (e.g., dropped), and is also called a sample pad. The sample receiving portion 150 is preferably an assembly of fibers, such as glass fiber, cellulose fiber, polyester fiber, polyethylene fiber, or polypropylene fiber.

[0040] Next, the structure of the test piece 100 will be described.

[0041] The base sheet 110 extends in a first direction X, which is the longitudinal direction, from a first end 111 to a second end 112, and has a first surface 110A along the first direction X, and a second surface 110B along the first direction X on the back side of the first surface 110A.

[0042] The labeled substance holding portion 120, the solid phase carrier 130, and the absorber 140 are arranged in this order along the first direction so as to at least partially overlap with each other on the first surface 110A of the base sheet 110. That is, adjacent labeled substance holding portions 120 and solid phase carriers 130 are arranged on the first surface 110A of the base sheet 110 so as to partially overlap with each other, and adjacent solid phase carriers 130 and absorber 140 are arranged on the first surface 110A of the base sheet 110 so as to partially overlap with each other.

[0043] Further, on the first surface 110A of the base sheet 110, a sample receiving section 150 is arranged so that at least a portion of the sample receiving section 150 overlaps with the labeled substance holding section 120.

[0044] In the illustrated embodiment, test strip 100 further comprises the following features.

[0045] The solid phase carrier 130 extends in the first direction X from a third end 131 located between the first end 111 and the second end 112 of the base sheet 110 to a fourth end 132 located between the third end 131 and the second end 112 of the base sheet 110, and is arranged so as to cover a part of the base sheet 110 in the first direction X from the side of the first surface 110A of the base sheet 110. The solid phase carrier 130 is typically a thin layer fixed to the first surface 110A of the base sheet 110.

[0046] Here, the capture portion 135 of the solid phase carrier 130 is disposed between the third end 131 and the fourth end 132 of the solid phase carrier 130. As in the illustrated example, it is preferable for the capture portion 135 to be a linear region that is part of the first direction X of the solid phase carrier 130 and that is disposed over the entire second direction Y that intersects (preferably perpendicular to) the first direction X, for good visibility.

[0047] The labeled substance holding section 120 extends in the first direction X from a fifth end 121, which is located closer to the first end 111 of the base sheet 110 than the third end 131 of the solid phase carrier 130, to a sixth end 122, which is located between the third end 131 of the solid phase carrier 130 and the capture section 135, and is arranged so as to cover part of the base sheet 110 and the solid phase carrier 130 in the first direction X from the side of the first surface 110A of the base sheet 110. That is, the labeled substance holding section 120 has a portion 120B including the fifth end 121 covering the base sheet 110, and a portion 120C including the sixth end 122 covering a part of the solid phase carrier 130 including the third end 131.

[0048] Here, it is preferable that the portion 120C of the labeled substance holding unit 120 that covers the solid phase carrier 130 is not adhered to the solid phase carrier 130 and is placed directly on the solid phase carrier 130 without using an adhesive, because this allows for smooth movement of the liquid sample from the labeled substance holding unit 120 to the solid phase carrier 130. On the other hand, it is preferable that the portion 120B of the labeled substance holding unit 120 that covers the base sheet 110 is adhered to the base sheet 110 to prevent the labeled substance holding unit 120 from falling off from the base sheet 110.

[0049] The absorbent 140 extends in the first direction X from a seventh end 141 located between the capture portion 135 and the fourth end 132 of the solid phase carrier 130 to an eighth end 142 located closer to the second end 112 of the base sheet 110 than the fourth end 132 of the solid phase carrier 130, and is arranged so as to cover a portion of the base sheet 110 and the solid phase carrier 130 in the first direction X from the side of the first surface 110A of the base sheet 110. That is, a portion 140C of the absorbent 140 including the seventh end 141 covers a portion including the fourth end 132 of the solid phase carrier 130, and a portion 140B including the eighth end 142 covers the base sheet 110.

[0050] Here, it is preferable that the portion 140C of the absorbent 140 that covers the solid phase carrier 130 is not adhered to the solid phase carrier 130 and is placed directly on the absorbent 140 without using an adhesive, since this allows for smooth movement of the liquid sample from the solid phase carrier 130 to the absorbent 140. On the other hand, it is preferable that the portion 140B of the absorbent 140 that covers the base sheet 110 is adhered to the base sheet 110 to prevent the absorbent 140 from falling off from the base sheet 110.

[0051] The sample receiving portion 150 extends in the first direction X from a ninth end 151 located closer to the first end 111 of the base sheet 110 than the fifth end 121 of the labeled substance holding portion 120 to a tenth end 152 located between the fifth end 121 of the labeled substance holding portion 120 and the third end 131 of the solid phase carrier 130, and is disposed so as to cover part of the base sheet 110 and the labeled substance holding portion 120 in the first direction X from the side of the first surface 110A of the base sheet 110. That is, a portion 150C of the sample receiving portion 150 including the tenth end 152 covers a portion including the fifth end 121 of the labeled substance holding portion 120, and a portion 150B including the ninth end 151 covers the base sheet 110.

[0052] Here, it is preferable that portion 150C of sample receiving portion 150 that covers labeled substance holding portion 120 is not adhered to labeled substance holding portion 120 and is placed directly without an adhesive, because this allows smooth movement of the liquid sample from sample receiving portion 150 to labeled substance holding portion 120. On the other hand, it is preferable that portion 150B of sample receiving portion 150 that covers base sheet 110 is adhered to base sheet 110 to prevent the sample receiving portion 150 from falling off from base sheet 110.

[0053] Next, the features of the first member 210 that constitutes the housing 200 will be described mainly with reference to FIGS. 3A, 3B, 3C, 6, and 7. FIG.

[0054] An opening 219 is formed in the first member 210 at a position facing the solid phase carrier 130 of the test strip 100. In particular, the opening 219 in the first member 210 is preferably formed at a position facing a portion including the capture portion 135 of the solid phase carrier 130 of the test strip 100. According to this embodiment, the capture portion 135 of the solid phase carrier 130 of the test strip 100 can be observed from outside the housing 200 through the opening 219.

[0055] The first member 210 has a first pressing portion 211 and a second pressing portion 212 on a surface 210A opposite to the first surface 110A of the base sheet 110 of the test piece 100, which press the test piece 100 toward the second member 220 in the thickness direction of the test piece 100.

[0056] The first pressing portion 211 has a first pressing surface 211A that abuts against a region 120A1 (see FIG. 5A ) that extends entirely in a second direction Y that intersects with (orthogonal to) the first direction X, on the surface of the test strip 100 at a portion 160 where the base sheet 110, solid phase carrier 130, and labeled substance holding portion 120 overlap. The first pressing surface 211A of the first pressing portion 211 particularly abuts against a region 120A1 (see FIG. 5A ) that extends entirely in the second direction Y that intersects with (orthogonal to) the first direction X, on the surface 120A of the labeled substance holding portion 120 at a portion 160 where the base sheet 110, solid phase carrier 130, and labeled substance holding portion 120 overlap.

[0057] 7 schematically shows a state in which the first pressing portion 211 of the first member 210 presses a portion 160 of the test strip 100 where the base sheet 110, the solid phase carrier 130, and the labeled substance holding portion 120 overlap. The pressing by the first pressing portion 211 of the first member 210 presses the portion 160 of the test strip 100 toward the second member 220. As a result, the solid phase carrier 130 and the labeled substance holding portion 120 come into close contact with each other, and the labeled substance holding portion 120, which is a porous body, is crushed. This promotes the movement of the liquid sample from the labeled substance holding portion 120 to the solid phase carrier 130, and prevents the liquid sample from accumulating at the interface between the labeled substance holding portion 120 and the solid phase carrier 130. Moreover, the first pressing surface 211A of the first pressing unit 211 presses the entire surface 120A of the labeled substance holding unit 120 in the second direction Y, and therefore the flow of the liquid sample developed on the test strip 100 is made uniform throughout the entire second direction Y, which is the width direction of the test strip 100. Furthermore, in an embodiment in which the first pressing surface 211A and the region 120A1 of the first pressing unit 211 are rectangular in shape having a sufficient width in the first direction X as well as in the second direction Y (for example, a rectangle in which the width in the first direction X is 0.5 times or more the width in the second direction Y), as shown in the figure, this is highly effective in making the flow of the liquid sample developed on the test strip 100 uniform in both the first direction X and the second direction Y, and is therefore preferable.

[0058] The second pressing portion 212 has a second pressing surface 212A that abuts against a region 140A1 (see FIG. 5A) that extends entirely in the second direction Y on the surface of the test piece 100 at a portion 170 where the base sheet 110, solid phase carrier 130, and absorber 140 overlap. The second pressing surface 212A of the second pressing portion 212 particularly abuts against a region 140A1 (see FIG. 5A) that extends entirely in the second direction Y on the surface 140A of the absorber 140 at a portion 171 that includes the seventh end 141 of the absorber 140, in the portion 170 where the base sheet 110, solid phase carrier 130, and absorber 140 overlap.

[0059] The enlarged view at the bottom right of Figure 7 schematically shows a state in which the second pressing portion 212 of the first member 210 is pressing a portion 171 of the test strip 100, which includes the seventh end 141 of the absorber 140, within a portion 170 of the test strip 100 where the base sheet 110, the solid phase carrier 130, and the absorber 140 overlap. The pressing by the second pressing portion 212 of the first member 210 presses the portion 171 of the test strip 100 toward the second member 220. As a result, the solid phase carrier 130 and the absorber 140 come into close contact with each other and the porous absorber 140 is crushed, thereby facilitating the movement of the liquid sample from the solid phase carrier 130 to the absorber 140 and preventing the liquid sample from accumulating at the interface between the solid phase carrier 130 and the absorber 140. Moreover, the second pressing surface 212A of the second pressing portion 212 presses the entire surface 140A of the absorber 140 in the second direction Y, and therefore the flow of the liquid sample developed on the test strip 100 is made uniform throughout the entire second direction Y, which is the width direction of the test strip 100. Furthermore, in an embodiment in which the second pressing surface 212A and region 140A1 of the second pressing portion 212 are rectangular in shape with a sufficient width in the first direction X as well as in the second direction Y (for example, a rectangle in which the width in the first direction X is 0.5 times or more the width in the second direction Y), as shown in the figure, this is highly effective in making the flow of the liquid sample developed on the test strip 100 uniform in both the first direction X and the second direction Y, and is therefore preferable.

[0060] The first member 210 has a peripheral portion 217 that surrounds the opening 219 and protrudes from the surface 210A opposite the first surface 110A of the base sheet 110 of the test piece 100 toward the test piece 100, and the first pressing portion 211 and the second pressing portion 212 are part of the circumferential direction of the peripheral portion 217.

[0061] The first pressing portion 211 is a part of the peripheral portion 217 adjacent to the opening 219 on the side where the first end 111 of the base sheet 110 of the test piece 100 is located in the first direction X (i.e., the upstream side of development). The second pressing portion 212 is a part of the peripheral portion 217 adjacent to the opening 219 on the side where the second end 112 of the base sheet 110 of the test piece 100 is located in the first direction X (i.e., the downstream side of development).

[0062] First pressing surface 211A of first pressing portion 211 and second pressing surface 212A of second pressing portion 212 are preferably arranged on the same imaginary plane. With this configuration, the portion of test strip 100 including solid phase carrier 130 is pressed evenly against second member 220 over the entire first direction, which makes it easier to make the flow of liquid sample developed on test strip 100 more uniform.

[0063] Preferably, the first member 210 of the housing 200 further includes a third pressing portion 213, which presses the test strip 100 toward the second member 220, on a surface 210A of the test strip 100 that faces the first surface 110A of the base sheet 110. Here, the third pressing portion 213 has a third pressing surface 213A that abuts against a partial region 140A2 (see FIG. 5A ) in the second direction Y of the surface 140A of the absorber 140 in a portion 172 that includes the fourth end 132 of the solid phase carrier 130, of the portion 170 of the test strip 100 where the base sheet 110, the solid phase carrier 130, and the absorber 140 overlap.

[0064] The region 140A2 of the surface 140A of the absorber 140 is a part of the second direction Y, and is preferably two dot-like regions aligned along the second direction Y as shown in Fig. 5A. The third pressing surface 213A of the third pressing portion 213 is a surface having a shape corresponding to the region 140A2. In the illustrated example, the third pressing portion 213 is two cylindrical protrusions, but is not limited to this form.

[0065] The enlarged view at the bottom right of Figure 7 schematically shows a state in which the portion 172 of the test strip 100 is pressed by the third pressing portion 213 in addition to the second pressing portion 212 of the first member 210. The pressing by the third pressing portion 213 prevents the absorber 140 from lifting from the fourth end 132 of the solid phase carrier 130 and ensures close contact, thereby more efficiently preventing the liquid sample from accumulating at the interface between the fourth end 132 of the solid phase carrier 130 and the absorber 140. Furthermore, the third pressing surface 213A of the third pressing portion 213 presses only a partial region 140A2 of the surface 140A of the absorber 140 in the second direction Y, thereby preventing the absorber 140 from being excessively pressed against the fourth end 132 of the solid phase carrier 130, causing bending and hindering the movement of the liquid sample to the absorber 140.

[0066] 7, it is more preferable that the third pressing surface 213A of the third pressing portion 213 be disposed at a position that protrudes more toward the test piece 100 than the second pressing surface 212A of the second pressing portion 212. According to this embodiment, the above-described effect of the third pressing portion 213 is further enhanced.

[0067] As shown in the figure, in an embodiment in which the test strip 100 further has a sample receiving section 150 upstream of the labeled substance holding section 120, the first member 210 of the housing 200 preferably further comprises a fourth pressing section 214, which is provided on a surface 210A of the test strip 100 that faces the first surface 110A of the base sheet 110, and presses the test strip 100 toward the second member 220. Here, the fourth pressing section 214 has a fourth pressing surface 214A that abuts against a partial region 150A1 (see FIG. 5A ) in the second direction Y of the surface of the test strip 100 at a portion 180 where the base sheet 110, labeled substance holding section 120, and sample receiving section 150 overlap. The fourth pressing surface 214A of the fourth pressing portion 214 particularly abuts against a partial region 150A1 (see Figure 5A) in the second direction Y of the surface 150A of the sample receiving portion 150 in the portion 180 where the base sheet 110, the labeled substance holding portion 120, and the sample receiving portion 150 of the test strip 100 overlap.

[0068] Region 150A1 of surface 150A of sample receiving portion 150 is a part of second direction Y, and is preferably two dot-like regions aligned along second direction Y as shown in FIG. 5A. Fourth pressing surface 214A of fourth pressing portion 214 is a surface having a shape corresponding to region 150A1. In the illustrated example, fourth pressing portion 214 is two cylindrical protrusions, but is not limited to this form.

[0069] 7 schematically shows the state in which the portion 180 of the test strip 100 is pressed by the fourth pressing portion 214 of the first member 210. The pressing by the fourth pressing portion 214 brings the sample receiving portion 150 and the labeled substance holding portion 120 into close contact, thereby preventing the liquid sample from accumulating at the interface between the sample receiving portion 150 and the labeled substance holding portion 120. Moreover, the fourth pressing surface 214A of the fourth pressing portion 214 presses only a partial region 150A1 of the surface 150A of the sample receiving portion 150 in the second direction Y, thereby preventing the movement of the liquid sample from being hindered.

[0070] In the preferred embodiment shown, the first member 210 of the housing 200 further has the following features:

[0071] A sample supply hole 240 is formed in the first member 210 at a position facing the sample receiving portion 150 of the test strip 100. A liquid sample can be supplied from outside the housing 200 through the sample supply hole 240 to the sample receiving portion 150 of the test strip 100 using an appropriate device such as a pipette or syringe, and development of the liquid sample in the test strip 100 can be initiated.

[0072] In the preferred embodiment shown in the drawings, a plurality of ventilation holes 250 are further formed in the first member 210 at a position facing the absorbent body 140 of the test piece 100 .

[0073] Next, preferred features of the second member 220 constituting the housing 200 will be described mainly with reference to FIGS. 5A, 5B, 6 and 7. FIG.

[0074] The second member 220 of the housing 200 preferably includes a fifth pressing portion 225, which presses the test strip 100 toward the first member 210, on a surface 220A facing the second surface 110B of the base sheet 110 of the test strip 100. Here, the fifth pressing portion 225 has a fifth pressing surface 225A that abuts against a region 110B1 (see FIG. 5A ) that extends entirely in the second direction Y on the second surface 110B of the base sheet 110 in the portion 160 of the test strip 100 where the base sheet 110, the solid phase carrier 130, and the labeled substance holding portion 120 overlap. The fifth pressing surface 225A of the fifth pressing portion 225 particularly abuts against a region 110B1 (see Figure 5A) extending entirely in the second direction Y on the second surface 110B of the base sheet 110 in a portion 161 including the third end 131 of the solid phase carrier 130 in the portion 160 of the test piece 100 where the base sheet 110, the solid phase carrier 130, and the labeled substance holding portion 120 overlap.

[0075] The enlarged view at the bottom left of Figure 7 schematically shows a state in which the fifth pressing portion 225 of the second member 220 is pressing a portion 161 including the third end 131 of the solid phase carrier 130 in an overlapping portion 160 of the test strip 100 where the base sheet 110, solid phase carrier 130, and labeled substance holding portion 120 are present. The fifth pressing portion 225 of the second member 220 is disposed opposite a part of the first pressing portion 211 of the first member 210. The fifth pressing portion 225 of the second member 220, together with the first pressing portion 211, presses the portion 161 including the third end 131 of the solid phase carrier 130 in an overlapping portion 160 where the base sheet 110, solid phase carrier 130, and labeled substance holding portion 120 are present, thereby further strengthening the adhesion between the vicinity of the third end 131 of the solid phase carrier 130 and the labeled substance holding portion 120. Furthermore, the fifth pressing surface 225A of the fifth pressing portion 225 presses the entire second surface 110B of the base sheet 110 in the second direction Y, which is preferable because the flow of the liquid sample developed on the test piece 100 is made uniform throughout the entire second direction Y, which is the width direction of the test piece 100.

[0076] Next, the assembly of the test piece 100, the first member 210 of the housing 200, and the second member 220 of the housing 200 in the detection instrument 1 of this embodiment will be described mainly with reference to Figures 2, 3A, 3C, 4A, and 6.

[0077] On the surface 220A of the second member 220 of the housing 200, which faces the second surface 110B of the base sheet 110 of the test piece 100, a plurality of positioning members 260 for installing and positioning the test piece 100 are arranged in positions surrounding the periphery of the test piece 100.

[0078] The test piece 100 is placed on the surface 220A of the second member 220 of the housing 200, and the surface 210A of the first member 210 of the housing 200 is further positioned so as to face the first surface 110A of the base sheet 110 of the test piece 100. The first member 210 and the second member 220 are fixed together to assemble the housing 200, thereby completing the detection instrument 1.

[0079] At this time, the means for fixing the first member 210 and the second member 220 together is not particularly limited, but preferably they can be fixed together via a fitting portion as shown in the figure.

[0080] In a preferred embodiment, as shown The first member 210 of the housing 200 includes first fitting portions 231 (e.g., fitting recesses) at a pair of positions between the first pressing portion 211 and the fourth pressing portion 214 in the first direction X, the first fitting portions 231 facing each other in the second direction Y across the test piece 100, The second member 220 of the housing 200 is provided with second fitting portions 232 (for example, fitting protrusions) that can be fitted into the first fitting portions 231 at a pair of positions facing the first fitting portions 231 of the first member 210, respectively.

[0081] By arranging the first fitting portion 231 and the second fitting portion 232 in this position, the above-mentioned advantageous effects of the first pressing portion 211 and the fourth pressing portion 214 of the first member 210 and the fifth pressing portion 225 of the second member 220 are further enhanced.

[0082] In a further preferred embodiment, as shown The first member 210 of the housing 200 includes third fitting portions 233 (e.g., fitting recesses) at a pair of positions facing each other in the second direction Y with the second pressing portion 212 interposed therebetween, The second member 220 of the housing 200 is provided with fourth fitting portions 234 (for example, fitting protrusions) that can be fitted into the third fitting portions 233 at a pair of positions facing the third fitting portions 233 of the first member 210, respectively.

[0083] By arranging the third fitting portion 233 and the fourth fitting portion 234 at these positions, the advantageous effect of the second pressing portion 212 of the first member 210 described above is further enhanced.

[0084] More preferably, the first member 210 of the housing 200 is provided with a pair of fifth fitting portions 235 and a pair of seventh fitting portions 237 at the corner portions. In this case, the second member 220 of the housing 200 is provided with a pair of sixth fitting portions 236 at positions facing the pair of fifth fitting portions 235 of the first member 210 at the corner portions, and is provided with a pair of eighth fitting portions 238 at positions facing the pair of seventh fitting portions 237 of the first member 210.

[0085] Another embodiment of the present invention relates to a kit for detecting an analyte in a sample, comprising the detection device 1 and a sample pretreatment reagent.

[0086] The sample pretreatment reagent is not particularly limited as long as it is a reagent used to make the sample developable on the device, and may be, for example, a sample dilution solution, a cell lysis solution, an organic solvent, etc. Preferably, the sample pretreatment reagent is a sample dilution solution.

[0087] Depending on the type of sample to be measured, the kit according to this embodiment may include a filtration filter, a centrifuge tube, a cotton swab for collecting samples, a cup / dropper, a squeeze tube, etc. Furthermore, the kit may include a color gauge to assist in determining the line after development, and an instruction manual. [Explanation of symbols]

[0088] 1:Detection equipment 100: Test piece 110: Base sheet 110A: First surface of base sheet 110B: Second surface of base sheet 120: Labeled substance holding part 130: Solid phase carrier 135: Capture unit 140: Absorbent 150: Sample receiving section 200: Cabinet 210: First member 220: Second member 211: First pressing part 212: Second pressing unit 213: Third pressing part 214: Fourth pressing part 225: 5th pressing part 219:Aperture 217: Periphery 231: First fitting part 232: Second fitting part 233: Third fitting part 234: Fourth fitting part 235: 5th fitting part 236: 6th fitting part 237: 7th fitting part 238: 8th fitting part X: 1st direction Y: Second direction

Claims

1. 1. A detection device for detecting an analyte in a liquid sample, comprising: A test piece and a housing for accommodating the test piece are provided. The test strip comprises a base sheet, a labeled substance holding portion, a solid phase carrier, and an absorbent; the base sheet extends in a first direction from a first end to a second end, and has a first surface along the first direction and a second surface on the back side of the first surface along the first direction; a labeled substance holding portion, a solid phase carrier, and an absorber are arranged in this order on a first surface of a base sheet along a first direction so as to at least partially overlap one another; the housing includes a first member disposed opposite a first surface of the base sheet and a second member disposed opposite a second surface of the base sheet, the first member sandwiching and holding the test piece therebetween; an opening is formed in the first member at a position facing the solid phase carrier of the test piece; the first member includes a first pressing portion and a second pressing portion, which are part of the peripheral portion of the opening, on a surface of the test piece facing the first surface of the base sheet and press the test piece toward the second member; the first pressing portion has a first pressing surface that abuts against a region of the surface of the test piece at a portion where the base sheet, the solid-phase carrier, and the labeled substance holding portion overlap, the region extending over the entire surface in a second direction intersecting with the first direction, and the first pressing surface is rectangular in shape with a width in the first direction that is 0.5 or more times its width in the second direction; the second pressing portion has a second pressing surface that contacts a region extending entirely in the second direction on the surface of the test piece at a portion where the base sheet, the solid phase carrier, and the absorbent overlap, and the second pressing surface is rectangular in shape, with the width in the first direction being 0.5 times or more the width in the second direction; A detection instrument characterized by:

2. In the test piece, the labeling substance holding portion is a porous body containing a labeling substance capable of being released and capable of binding to the test substance; The solid phase carrier includes a capture portion on which a capture substance that binds to the test substance is immobilized, The absorbent is a porous body that absorbs a liquid sample. the solid phase carrier extends in a first direction from a third end located between the first end and the second end of the base sheet to a fourth end located between the third end and the second end of the base sheet, and is arranged so as to cover a part of the base sheet in the first direction from the first surface side of the base sheet; the capture portion of the solid phase carrier is disposed between the third end and the fourth end of the solid phase carrier; the labeled substance holding section extends in the first direction from a fifth end located closer to the first end of the base sheet than the third end of the solid phase carrier to a sixth end located between the third end of the solid phase carrier and the capture section, and is disposed so as to cover a part of the base sheet and the solid phase carrier in the first direction from the side of the first surface of the base sheet; the absorber extends in the first direction from a seventh end located between the capture portion and the fourth end of the solid phase carrier to an eighth end located closer to the second end of the base sheet than the fourth end of the solid phase carrier, and is disposed so as to cover a part of the base sheet and the solid phase carrier in the first direction from the side of the first surface of the base sheet; In the first member of the housing, the opening is formed in the first member at a position facing a portion of the test piece including the capture portion of the solid phase carrier; the first pressing surface of the first pressing unit abuts against a region of the surface of the labeled substance holding unit in a portion of the test piece where the base sheet, the solid phase carrier, and the labeled substance holding unit overlap, the region extending over the entire surface in a second direction intersecting with the first direction; the second pressing surface of the second pressing unit abuts against a region of the surface of the absorbent body that extends entirely in the second direction in a portion of the test piece where the base sheet, the solid phase carrier, and the absorbent body overlap, the portion including the seventh end of the absorbent body; the first pressing portion is a part of a peripheral edge portion of the opening adjacent to the opening on a side where the first end of the base sheet of the test piece is located in the first direction; The second pressing portion is a part of the peripheral edge of the opening adjacent to the opening on the side where the second end of the base sheet of the test piece is located in the first direction. The detection instrument of claim 1 .

3. In the test strip, the portion of the labeled substance holding part that covers the solid phase carrier is not adhered to the solid phase carrier, and the portion of the absorber that covers the solid phase carrier is not adhered to the solid phase carrier.

3. The detection instrument of claim 2.

4. the first member of the housing further includes a third pressing portion on a surface of the test piece facing the first surface of the base sheet, the third pressing portion pressing the test piece toward the second member; the third pressing portion has a third pressing surface that abuts against a partial region in the second direction of the surface of the absorbent in a portion of the test piece where the base sheet, the solid phase carrier, and the absorbent overlap, the portion including the fourth end of the solid phase carrier; 4. The detection instrument according to claim 2 or 3.

5. The detection instrument according to claim 4 , wherein the third pressing surface of the third pressing portion is disposed at a position that protrudes further toward the test piece than the second pressing surface of the second pressing portion.

6. The test strip further includes a sample receiving portion that is a porous body that receives a liquid sample; the sample receiving portion extends in the first direction from a ninth end located closer to the first end of the base sheet than the fifth end of the labeled substance holding portion to a tenth end located between the fifth end of the labeled substance holding portion and the third end of the solid phase carrier, and is arranged so as to cover a part of the base sheet and the labeled substance holding portion in the first direction from the side of the first surface of the base sheet; The detection instrument according to any one of claims 2 to 5.

7. The test strip further includes a sample receiving portion that is a porous body that receives a liquid sample; the sample receiving section is disposed on the first surface of the base sheet so as to overlap at least a portion of the sample receiving section with the labeled substance holding section; The detection instrument according to any one of claims 1 to 5.

8. the first member of the housing further includes a fourth pressing portion on a surface of the test piece facing the first surface of the base sheet, the fourth pressing portion pressing the test piece toward the second member; the fourth pressing portion has a fourth pressing surface that abuts against a partial area in the second direction of the surface of the test strip at a portion where the base sheet, the labeled substance holding portion, and the sample receiving portion overlap; 8. The detection instrument of claim 7.

9. the first member of the housing includes first fitting portions at a pair of positions facing each other in the second direction across the test piece between the first pressing portion and the fourth pressing portion in the first direction, the second member of the housing includes second fitting portions at a pair of positions facing the first fitting portions of the first member, the second fitting portions being engageable with the first fitting portions, 9. The detection instrument of claim 8.

10. the second member of the housing includes a fifth pressing portion on a surface of the test piece facing the second surface of the base sheet, the fifth pressing portion pressing the test piece toward the first member; the fifth pressing portion has a fifth pressing surface that abuts against a region of the second surface of the base sheet that extends entirely in the second direction in a portion of the test piece where the base sheet, the solid phase carrier, and the labeled substance holding portion overlap; The detection instrument according to any one of claims 1 to 9.

11. the labeling substance held in the labeling substance holding portion of the test strip contains a first antibody molecule that immunologically binds to the test substance; the capture substance immobilized on the capture portion of the solid phase carrier of the test piece contains a second antibody molecule that immunologically binds to the test substance; The detection instrument according to any one of claims 1 to 10.

12. A kit for detecting a target substance in a sample, comprising the detection instrument according to any one of claims 1 to 11 and a sample pretreatment reagent.

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