JP2023131822A - detection instrument - Google Patents

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

The present invention relates to a detection instrument for detecting an analyte in a liquid sample.

As a method for detecting test substances in liquid samples derived from living organisms, etc., especially when the test substance is a protein, antigen-antibody reaction is performed using a substance (antibody/antigen) that specifically binds to the test substance. Immunoassays are widely used to detect test substances by producing In particular, as a method for quickly and easily detecting a test substance, a capture substance (antibody/antigen) that specifically binds to the test substance is immobilized on a predetermined position of a solid phase carrier, and the capture substance containing the test substance is immobilized on a predetermined position of a solid phase carrier. An immunochromatographic method is known in which a liquid sample is developed, a test substance is captured at the predetermined position, and detected visually or the like.

In order to easily detect a test substance in a liquid sample using chromatography such as immunochromatography, a test piece containing a solid phase carrier on which a capture substance that binds to the test substance is immobilized, and the test piece are Detection instruments that include a housing for accommodating the detection device have been developed in the past.

For example, Patent Document 1 describes a test device that includes a test strip and a housing that accommodates the test strip, and describes providing a series of protrusions on the inner surface of the housing, each protrusion contacting the test strip. ing. In Patent Document 1, the height of at least one protrusion of the series of protrusions is different from the height of another protrusion of the series of protrusions, and in the attached configuration, the series of protrusions is configured to create a pressure gradient that allows fluid to flow at a predetermined flow rate between a first protrusion and a last protrusion in said series of protrusions along the length of the strip; It is stated that.

Patent Document 2 discloses an immunochromatography device having a structure in which a test strip is sandwiched between a first case member that covers the first surface of the test strip and a second case member that covers the second surface of the test strip. The test strip includes a sample addition member, a label holding member, and a chromatography membrane carrier, the sample addition member is arranged to overlap at least a portion of the label holding member, and the test strip is attached to the first case member. At least two convex portions are provided in the sample development direction, at least one of the convex portions of the first case member is provided on the upper part of the sample addition member that overlaps with the label holding member, and the second case member is provided with the An immunochromatography device is described in which a first case member is provided with protrusions opposing at least two protrusions. According to Patent Document 2, by providing these convex portions, an effect is produced in that the sample addition member, the label holding member, and the chromatographic membrane carrier are partially brought into close contact with each other.

Patent Document 3 discloses a first member including a region in which a labeled substance is retained, in which a label is immobilized on a substance that specifically binds to the detected substance, and a detection device that captures the labeled substance via the detected substance. A test kit is described that includes a second member having a zone and connected downstream of the first member in the deployment direction. Patent Document 3 further describes that a case that accommodates the test kit is provided with a plurality of pressing parts that press the test kit in the thickness direction.

Patent Document 4 describes a test kit that includes a test strip in which a sample dropping pad, a labeling substance holding pad, an immobilization membrane, and an absorption pad are connected in this order, and a first case that accommodates the test strip. . In Patent Document 4, a pressing part is provided in the first case, and the pressing part presses a part of the region where the labeled substance holding pad and the immobilization membrane overlap in a direction perpendicular to the direction in which the liquid sample is developed. It is stated that by doing so, the labeled substance holding pad and the immobilization membrane come into close contact with each other, allowing smooth development of the liquid sample. In Patent Document 4, the area where the sample dropping pad and the labeling substance holding pad overlap and the area where the immobilization membrane and the absorption pad overlap are each pressed over the entire area in a direction perpendicular to the development direction. It is also described that the pressing part is provided in the first case.

Patent Document 5 describes a container for a liquid sample testing device that includes a casing that accommodates a developing base material in which a sample pad, a membrane, and an absorbent pad are arranged on a base card. In Patent Document 5, a detection hole is formed in the upper casing that constitutes a part of the casing in a region corresponding to the membrane of the deployable base material, and the end of the peripheral wall surface surrounding the detection hole on the deployable base material side It is described that the section is a flat surface, and that the flat surface presses the membrane. The upper housing of Patent Document 5 further includes a pressing wall for pressing the conjugate pad.

Patent Document 6 describes that in a liquid sample testing device equipped with an upper case, a lower case, and a test strip housed between them, a presser pin or a presser member is arranged on the inner surface of the upper case facing the test strip. has been done.

Japanese Patent Application Publication No. 2020-126077 Japanese Patent Application Publication No. 2005-37384 Japanese Patent Application Publication No. 2014-178153 Japanese Patent Application Publication No. 2018-36199 Utility model registration No. 3212222 JP2021-18240A

Using a detection instrument comprising a test piece in which a labeled substance holding part, a solid phase carrier, and an absorber are arranged in this order from upstream to downstream in the development direction on a base sheet, and a casing that houses the test piece. The present inventors have discovered that the following problem exists when detecting a test substance in a liquid sample. First, if the flow of the liquid sample spread onto the test piece becomes non-uniform in the width direction of the test piece, there is a problem that the detection results become unclear. In addition, if the contact between the labeling substance holding part and the solid phase carrier and the contact between the solid phase carrier and the absorber are not sufficient, the developed liquid sample will stagnate at the contact points of each member. There are challenges.
As mentioned above, Patent Documents 1 to 6 cannot sufficiently solve the above problems. Therefore, an object of the present invention is to provide a detection instrument that can solve the above problems.

The present invention provides the following.
[1] A detection instrument for detecting a test substance in a liquid sample,
Comprising a test piece and a casing that accommodates the test piece,
The test piece includes a base sheet, a labeling substance holding part, a solid phase carrier, and an absorber,
The base sheet extends in the first direction from the first end to the 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. It has two sides,
On the first surface of the base sheet, a labeling substance holding part, a solid phase carrier, and an absorber are arranged in this order along the first direction so as to at least partially overlap,
The casing includes a first member disposed facing the first surface of the base sheet, and a second member disposed facing the second surface of the base sheet, which holds the test piece therebetween. and
An opening is formed in the first member at a position facing the solid phase carrier of the test piece,
The first member has a first pressing portion and a first pressing portion, which is a part of the periphery of the opening, which presses the test specimen toward the second member, on a surface opposite to the first surface of the base sheet of the test specimen. Equipped with 2 pressing parts,
The first pressing part is in contact with a region of the surface of the test piece at a portion where the base sheet, the solid phase carrier, and the labeling substance holding part overlap, extending in the entire second direction intersecting the first direction. having a first pressing surface;
The second pressing part has a second pressing surface that comes into contact with an area extending in the entire second direction of the surface of the test piece at a portion where the base sheet, the solid phase carrier, and the absorber overlap. Characteristic detection equipment.

[2] In the test piece,
The labeling substance holding part is a porous body containing a labeling substance that binds to the test substance in a releasable state,
The solid phase carrier partially includes a capture part on which a capture substance that binds the test substance is immobilized,
The absorber is a porous body that absorbs a liquid sample,
The solid phase carrier is arranged in a first direction from a third end located between the first end and the second end of the base sheet to a third end located between the third end and the second end of the base sheet. Extending to the fourth end located between, the base sheet 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 part of the solid phase carrier is arranged between the third end and the fourth end of the solid phase carrier,
The labeling substance holding part is arranged in a first direction from a fifth end located closer to the first end of the base sheet than the third end of the solid support, to a third end of the solid support and a capture part. extending to the sixth end located between and disposed so as to cover a portion of the base sheet and the solid support in the first direction from the first surface side of the base sheet,
The absorber is arranged in the first direction from a seventh end located between the capturing part and the fourth end of the solid phase carrier to a second end of the base sheet rather than a fourth end of the solid phase carrier. Extending to the eighth end located closer to the base sheet and disposed so as to cover a part of the base sheet and the solid phase carrier in the first direction from the first surface side of the base sheet,
In the first member of the housing,
The opening is formed at a position of the first member facing a portion including the capturing portion of the solid phase carrier of the test piece,
The first pressing surface of the first pressing part is the surface of the labeling substance holding part in the portion where the base sheet, the solid phase carrier, and the labeling substance holding part of the test piece overlap, in a second direction intersecting the first direction. abutting an area extending throughout;
The second pressing surface of the second pressing part is the surface of the absorber in the portion of the test piece where the base sheet, the solid phase carrier, and the absorber overlap, including the seventh end of the absorber. in contact with a region extending entirely in the second direction;
The first pressing portion is a part of the peripheral edge of the opening adjacent to the opening on the side where the first end of the base sheet of the test piece is located in the first direction,
The detection instrument according to [1], wherein the second pressing part is a part of the peripheral edge of the opening, which is 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.

[3] In the test piece, the part of the labeling substance holding part that covers the solid phase carrier is not bonded to the solid phase carrier, and the part of the absorber that covers the solid phase carrier is not bonded to the solid phase carrier. It has not been,
The detection instrument according to [2].

[4] The first member of the casing further includes a third pressing part that presses the test piece toward the second member on a surface opposite to the first surface of the base sheet of the test piece,
The third pressing part is a portion of the test piece where the base sheet, the solid phase carrier, and the absorbent overlap, and the portion including the fourth end of the solid phase carrier, on the surface of the absorber in the second direction. having a third pressing surface that comes into contact with a part of the area;
The detection instrument according to [2] or [3].

[5] The detection instrument according to [4], wherein the third pressing surface of the third pressing section is arranged at a position that projects toward the test piece more than the second pressing surface of the second pressing section.

[6] The test piece further includes a sample receiving portion that is a porous body that receives a liquid sample,
The sample receiving part is connected in the first direction from a ninth end located closer to the first end of the base sheet than the fifth end of the labeling substance holding part to a fifth end of the labeling substance holding part. Extends to the tenth end located between the third end of the phase carrier and covers a part of the base sheet and the labeling substance holding part in the first direction from the first surface side of the base sheet. arranged so that
The detection instrument according to any one of [2] to [5].

[7] The test piece further includes a sample receiving portion that is a porous body that receives a liquid sample,
The sample receiving section is arranged on the first surface of the base sheet so that at least a portion thereof overlaps with the labeling substance holding section.
The detection instrument according to any one of [1] to [5].

[8] The first member of the casing further includes a fourth pressing part that presses the test piece toward the second member on a surface opposite to the first surface of the base sheet of the test piece,
The fourth pressing part has a fourth pressing surface that comes into contact with a partial area in the second direction of the surface of the portion of the test piece where the base sheet, the labeling substance holding part, and the sample receiving part overlap.
The detection instrument according to [7].

[9] The first member of the casing is provided with a first fitting at a pair of positions facing each other in the second direction with the test piece interposed between the first pressing part and the fourth pressing part in the first direction. Equipped with a joint,
The second member of the casing is provided with second fitting portions that are respectively capable of fitting with the first fitting portion at a pair of positions facing the first fitting portion of the first member.
The detection instrument according to [8].

[10] The second member of the casing includes a fifth pressing portion that presses the test piece toward the first member on a surface opposite to the second surface of the base sheet of the test piece,
The fifth pressing part is in contact with a region of the test piece that extends entirely in the second direction on the second surface of the base sheet at a portion where the base sheet, the solid phase carrier, and the labeled substance holding part overlap. , having a fifth pressing surface;
The detection instrument according to any one of [1] to [9].

[11] The labeling substance retained in the labeling substance holding portion of the test strip includes 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 strip contains a second antibody molecule that immunologically binds to the test substance.
The detection instrument according to any one of [1] to [10].

[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.

According to the detection instrument of the present invention, more accurate detection is possible.

FIG. 1 is an overall perspective view of a detection instrument according to an embodiment of the present invention. FIG. 2 is an exploded perspective view schematically showing the relationship between the first member of the housing, the test piece, and the second member of the housing in a detection instrument according to an embodiment of the present invention. Arrows in the figures after FIG. 2 indicate the first direction and the second direction. FIG. 3A is a plan view of the first member of the casing in the detection instrument according to one embodiment of the present invention, viewed from inside the casing. FIG. 3B is a cross-sectional view of the first member of the casing of the detection instrument according to the embodiment of the present invention, taken along line II shown in FIG. 3A. FIG. 3C is a perspective view of the first member of the casing in the detection instrument according to the embodiment of the present invention, viewed from inside the casing. FIG. 4A is a plan view of the second member of the casing in the detection instrument according to the embodiment of the present invention, viewed from inside the casing. FIG. 4B is a cross-sectional view of the second member of the casing in the detection instrument according to the embodiment of the present invention, taken along the line II-II shown in FIG. 4A. FIG. 5A is a plan view of a test piece in a detection instrument according to an embodiment of the present invention, viewed from the first surface side of the base sheet. FIG. 5B is a cross-sectional view of a test piece in a detection instrument according to an embodiment of the present invention, taken along line III-III shown in FIG. 5A. FIG. 5C is a plan view of a test piece in a detection instrument according to an embodiment of the present invention, viewed from the second surface side of the base sheet. FIG. 6 is a cross-sectional view of a detection instrument according to an embodiment of the invention. The cross section of the first member of the housing is a cross section along line II shown in FIG. 3A, and the cross section of the second member of the housing is a cross section along line II-II shown in FIG. 4A, The cross section of the test piece was along the line III-III shown in FIG. 5A. FIG. 7 is a partially enlarged view of the cross-sectional view of the detection instrument according to the embodiment of the present invention shown in FIG. The lower left enlarged view of FIG. 7 shows the first pressing part and the fourth pressing part of the first member of the casing, the fifth pressing part of the second member of the casing, and the test piece pressed by them. The lower right enlarged view of FIG. 7 shows the second pressing part and the third pressing part of the first member of the casing, and the test piece pressed by them.

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

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 piece 100 and a housing 200 that accommodates the test piece 100.

The casing 200 includes a first member 210 disposed facing the first surface 110A of the base sheet 110, which holds the test piece 100 therebetween, and a first member 210 facing the second surface 110B of the base sheet 110. and a second member 220 arranged as shown in FIG. The housing 200 is constructed by assembling the first member 210 and the second member 220 (see FIGS. 1, 2, 6, and 7). The housing 200 may be a molded body of a water-impermeable moldable material such as polyethylene, polypropylene, polystyrene, polyethylene terephthalate, polyvinyl chloride, or the like.

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

The test piece 100 includes at least a base sheet 110, a labeling substance holding portion 120, a solid phase carrier 130, and an absorber 140.
In the illustrated embodiment, the labeling substance holding part 120 is a porous body containing a labeling substance that binds to a test substance in a releasable state, and the solid phase carrier 130 has a capture substance that binds to a test substance immobilized thereon. The absorber 140 is a porous body that absorbs a liquid sample.

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

Base sheet 110 is also called a backing sheet. The base sheet 110 is preferably a resin sheet that does not allow water to penetrate. As the base sheet 110, for example, a sheet made of resin such as polypropylene, polystyrene, polyester, vinyl chloride, etc. can be used.

The labeling substance holding part 120 is a porous body containing a labeling substance in a state that can be released when a liquid sample to be analyzed is developed, and is preferably an aggregate of fibers, such as glass fiber or cellulose. It can be an aggregate of fibers such as fibers, polyester fibers, polyethylene fibers, polypropylene fibers, etc. The labeling substance is not particularly limited as long as it binds to the test substance and can be detected on the solid phase carrier 130 after development of the liquid sample, but examples include known labels such as colored particles, enzymes, biotin, and digoxigenin. An example is a conjugate in which a substance and a substance for binding to a test substance are linked. Examples of colored particles include metal particles, colored latex particles, colored polystyrene particles, colored cellulose particles, fluorescent cellulose particles, and silica nanoparticles containing pigments. Examples of the 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 as appropriate depending on the test substance. For example, if the test substance is a polypeptide, use an antibody that can specifically bind to the polypeptide. If the test substance is an antigen molecule, an antibody that can specifically bind to the antigen molecule can be used; if the test substance is a polynucleotide such as DNA, an antibody that can specifically bind to the antigen molecule can be used. It can be a polynucleotide that can specifically bind to a polynucleotide.

The solid phase carrier 130 becomes a solid phase when a liquid sample (mobile phase) is developed. The solid support 130 can be, for example, a thin film (membrane), and can be a membrane made of materials such as nitrocellulose, cellulose, cellulose acetate, polyethersulfone, nylon, polyester, and glass fiber.

The solid phase carrier 130 includes in part a capture portion 135 on which a capture substance that binds the analyte is immobilized. The capture section 135 is a region on which a capture substance capable of binding to a test substance is fixed, and is arranged, for example, along a second direction Y, which is the width direction of the solid phase carrier 130 and is usually called a test line. It can be linear. When the liquid sample developed on the solid phase carrier 130 contains a test substance, the complex of the test substance and the labeling substance binds to the capture substance in the capture section 135.

The capture substance may be any substance as long as it can bind to the analyte to which the labeling substance is bound, and can be selected as appropriate depending on the analyte. For example, if the test substance is a polypeptide, an antibody that can specifically bind to the polypeptide can be used, and if the test substance is an antigen molecule, an antibody that can specifically bind to the antigen molecule can be used. If the test substance is a polynucleotide such as DNA, the antibody can be a polynucleotide that can specifically bind to the polynucleotide.

When the test substance is a polypeptide, the labeling substance held in the labeling substance holding section 120 is a conjugate in which the labeling substance is linked to a first antibody molecule that immunologically binds to the test substance. It is preferable that the capture substance immobilized on the capture portion 135 of the solid phase carrier 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.

The absorber 140 is a porous body provided to absorb and retain the liquid sample developed from upstream of the test piece 100 after passing through the solid support 130 so that the liquid sample does not flow back. . The absorbent body 140 is also called an absorbent pad. The absorbent body 140 is preferably a fiber aggregate, and can be, for example, a fiber aggregate such as glass fiber, cellulose fiber, polyester fiber, polyethylene fiber, or polypropylene fiber.

The sample receiving part 150, which is a porous body that receives a liquid sample, is a part into which a liquid sample is loaded (for example, dropped), and is also called a sample pad. The sample receiving part 150 is preferably a fiber aggregate, and can be, for example, a fiber aggregate such as glass fiber, cellulose fiber, polyester fiber, polyethylene fiber, or polypropylene fiber.

Next, the structure of the test piece 100 will be explained.

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

On the first surface 110A of the base sheet 110, the labeling substance holding section 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. . That is, adjacent labeling substance holding parts 120 and solid phase carriers 130 are arranged on the first surface 110A of base sheet 110 so as to partially overlap, and adjacent solid phase carriers 130 and absorbers 140 are arranged so that they partially overlap. , are arranged on the first surface 110A of the base sheet 110 so as to partially overlap.

A sample receiving section 150 is further arranged on the first surface 110A of the base sheet 110 so that at least a portion thereof overlaps with the labeling substance holding section 120.

In the illustrated embodiment, test strip 100 further includes the following features.

The solid phase carrier 130 moves from a third end 131 located between the first end 111 and the second end 112 of the base sheet 110 in the first direction 110 to the fourth end 132 located between the second end 112 of the base sheet 110 and covers a part of the base sheet 110 in the first direction X from the first surface 110A side of the base sheet 110. It is arranged so that Solid phase carrier 130 is typically a thin layer fixed to first surface 110A of base sheet 110.

Here, the capture portion 135 of the solid phase carrier 130 is arranged between the third end 131 and the fourth end 132 of the solid phase carrier 130. As in the illustrated example, the trapping section 135 is a part of the solid phase carrier 130 in the first direction It is preferable that the area is a linear area with good visibility.

The labeling substance holding unit 120 moves the solid phase carrier 130 in the first direction from the first surface 110A of the base sheet 110 to the sixth end 122 located between the third end 131 and the capture part 135 of the base sheet 110 and the solid phase carrier 130. It is arranged so as to cover a part of one direction X. That is, in the labeling substance holding portion 120, a portion 120B including the fifth end 121 covers the base sheet 110, and a portion 120C including the sixth end 122 includes the third end 131 of the solid phase carrier 130. Cover.

Here, when the portion 120C of the labeled substance holding portion 120 that covers the solid phase carrier 130 is not bonded to the solid phase carrier 130 and is placed directly without using an adhesive, the labeled substance holding portion 120C is This is preferable because the liquid sample can be smoothly transferred from the portion 120 to the solid support 130. On the other hand, in order to prevent falling off from the base sheet 110, the portion 120B of the labeling substance holding section 120 that covers the base sheet 110 is preferably adhered to the base sheet 110.

The absorber 140 extends in the first direction It extends to the eighth end 142 located near the second end 112 of the base sheet 110, and extends from the first surface 110A of the base sheet 110 in the first direction of the base sheet 110 and the solid phase carrier 130. It is arranged so as to cover a part of X. That is, in the absorber 140, a portion 140C 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. do.

Here, when the portion 140C of the absorber 140 that covers the solid phase carrier 130 is not adhered to the solid phase carrier 130 and is placed directly without using an adhesive, the portion 140C that covers the solid phase carrier 130 is This is preferable because the liquid sample moves smoothly to the absorber 140. On the other hand, in order to prevent falling off from the base sheet 110, the portion 140B of the absorber 140 that covers the base sheet 110 is preferably adhered to the base sheet 110.

In the first direction 120 and the third end 131 of the solid phase carrier 130, from the first surface 110A side of the base sheet 110 and a part of the labeling substance holding section 120 in the first direction X. That is, in the sample receiving part 150, a part 150C including the tenth end 152 covers a part including the fifth end 121 of the labeling substance holding part 120, and a part 150B including the ninth end 151 covers the base sheet. 110 is coated.

Here, when the portion 150C of the sample receiving section 150 that covers the labeling substance holding section 120 is not bonded to the labeling substance holding section 120 and is placed directly without using an adhesive, the sample receiving section 150 is This is preferable because the liquid sample can be smoothly moved from the section 150 to the labeling substance holding section 120. On the other hand, in order to prevent falling off from the base sheet 110, the portion 150B of the sample receiving section 150 that covers the base sheet 110 is preferably adhered to the base sheet 110.

Next, the characteristics of the first member 210 constituting the housing 200 will be described mainly with reference to FIGS. 3A, 3B, 3C, 6, and 7.

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

The first member 210 presses the test piece 100 in the thickness direction of the test piece 100 onto a surface 210A of the test piece 100 opposite to the first surface 110A of the base sheet 110, with the test piece 100 facing the second member 220. The first pressing section 211 and the second pressing section 212 are provided.

The first pressing part 211 intersects (perpendicularly in the illustrated example) the first direction It has a first pressing surface 211A that comes into contact with a region 120A1 (see FIG. 5A) that extends entirely in the second direction Y. The first pressing surface 211A of the first pressing part 211 is particularly the surface 120A of the labeling substance holding part 120 in the portion 160 of the test piece 100 where the base sheet 110, the solid phase carrier 130, and the labeling substance holding part 120 overlap. The contact area 120A1 (see FIG. 5A) extends throughout the second direction Y that intersects (orthogonally in the illustrated example) the first direction X.

In the lower left enlarged view of FIG. 7, the first pressing part 211 of the first member 210 presses a portion 160 of the test piece 100 where the base sheet 110, the solid phase carrier 130, and the labeling substance holding part 120 overlap. The state is schematically shown. The portion 160 of the test piece 100 is pressed toward the second member 220 by the pressure by the first pressing portion 211 of the first member 210 . As a result, the solid phase carrier 130 and the labeling substance holding part 120 come into close contact with each other, and the porous labeling substance holding part 120 is crushed, so that the movement of the liquid sample from the labeling substance holding part 120 to the solid phase carrier 130 is prevented. This is promoted, and the retention of the liquid sample at the interface between the labeling substance holding section 120 and the solid phase carrier 130 is suppressed. Moreover, since the first pressing surface 211A of the first pressing section 211 presses the entire surface 120A of the labeling substance holding section 120 in the second direction Y, the flow of the liquid sample developed onto the test piece 100 is It is made uniform throughout the second direction Y, which is the width direction of 100. Furthermore, the first pressing surface 211A and the area 120A1 of the first pressing part 211 have a rectangular shape (for example, a rectangular shape having a sufficient width in the first direction In a rectangular form in which the width in the first direction X is 0.5 times or more the width in the first direction It is preferable because it has a high uniformity effect.

The second pressing part 212 is a region 140A1 (see FIG. 5A ) has a second pressing surface 212A that comes into contact with the second pressing surface 212A. In particular, the second pressing surface 212A of the second pressing part 212 is located at the seventh end 141 of the absorber 140 in the portion 170 of the test piece 100 where the base sheet 110, the solid phase carrier 130, and the absorber 140 overlap. The area 140A1 (see FIG. 5A) that extends entirely in the second direction Y of the surface 140A of the absorbent body 140 in the portion 171 including the area 171 contacts the area 140A1 (see FIG. 5A).

In the lower right enlarged view of FIG. 7, the second pressing part 212 of the first member 210 removes the absorber 140 from the portion 170 of the test piece 100 where the base sheet 110, the solid phase carrier 130, and the absorber 140 overlap. A state in which a portion 171 including the seventh end 141 of is pressed is schematically shown. The portion 171 of the test piece 100 is pressed toward the second member 220 by the pressure by the second pressing portion 212 of the first member 210 . 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, so that the movement of the liquid sample from the solid phase carrier 130 to the absorber 140 is promoted, and the solid phase carrier Retention of the liquid sample at the interface between 130 and absorber 140 is suppressed. Moreover, since the second pressing surface 212A of the second pressing part 212 presses the entire surface 140A of the absorber 140 in the second direction Y, the flow of the liquid sample developed on the test piece 100 is It is made uniform throughout the second direction Y, which is the width direction. Furthermore, the second pressing surface 212A and the area 140A1 of the second pressing part 212 have a rectangular shape (for example, a rectangular shape having a sufficient width in the first direction X in addition to the second direction Y) as shown in the figure. In a rectangular form in which the width in the first direction X is 0.5 times or more the width in the first direction It is preferable because it has a high uniformity effect.

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

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

The first pressing surface 211A of the first pressing section 211 and the second pressing surface 212A of the second pressing section 212 are preferably arranged on the same virtual plane. With this configuration, the portion of the test piece 100 that includes the solid support 130 is evenly pressed against the second member 220 throughout the first direction, so that the flow of the liquid sample spread onto the test piece 100 is more uniform. easy to become

The first member 210 of the casing 200 has a third pressing portion 213 that presses the test piece 100 toward the second member 220 on a surface 210A opposite to the first surface 110A of the base sheet 110 of the test piece 100. It is preferable to further include. Here, the third pressing portion 213 is a portion 170 of the test piece 100 that includes the fourth end portion 132 of the solid phase carrier 130, of the portion 170 where the base sheet 110, the solid phase carrier 130, and the absorber 140 overlap. It has a third pressing surface 213A that comes into contact with a partial region 140A2 (see FIG. 5A) of the surface 140A of the absorber 140 in the second direction Y.

The region 140A2 of the surface 140A of the absorbent body 140 is a part of the second direction Y, and is preferably two dotted 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 area 140A2. In the illustrated example, the third pressing portion 213 is two cylindrical projections, but is not limited to this embodiment.

The lower right enlarged view of FIG. 7 schematically shows a state in which the portion 172 of the test piece 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 part 213 suppresses the lifting of the absorber 140 from the fourth end 132 of the solid phase carrier 130 and brings the absorber 140 into close contact with the fourth end 132 of the solid phase carrier 130 . Retention of the liquid sample at the interface with the liquid sample is more efficiently suppressed. Moreover, since the third pressing surface 213A of the third pressing part 213 presses only a part of the region 140A2 in the second direction Y of the surface 140A of the absorber 140, the absorber 140 This can prevent the liquid sample from being excessively pressed by the end portion 132 and bending, thereby inhibiting the movement of the liquid sample to the absorber 140 .

As shown in the lower right enlarged view of FIG. 7, the third pressing surface 213A of the third pressing section 213 is arranged at a position that protrudes toward the test piece 100 more than the second pressing surface 212A of the second pressing section 212. It is even more preferable to do so. According to this aspect, the above effects of the third pressing portion 213 are further enhanced.

As shown in the figure, in an embodiment in which the test strip 100 further includes a sample receiving section 150 upstream of the labeling substance holding section 120, the first member 210 of the housing 200 It is preferable to further include a fourth pressing part 214 that presses the test piece 100 toward the second member 220 on the surface 210A facing the second member 220 . Here, the fourth pressing part 214 presses a part of the area 150A1 ( (see FIG. 5A). In particular, the fourth pressing surface 214A of the fourth pressing section 214 is a surface 150A of the sample receiving section 150 in the portion 180 of the test piece 100 where the base sheet 110, the labeling substance holding section 120, and the sample receiving section 150 overlap. It comes into contact with a part of the region 150A1 in the second direction Y (see FIG. 5A).

The area 150A1 of the surface 150A of the sample receiving portion 150 is a part of the second direction Y, and is preferably two dotted areas aligned along the second direction Y as shown in FIG. 5A. The fourth pressing surface 214A of the fourth pressing portion 214 is a surface having a shape corresponding to the area 150A1. In the illustrated example, the fourth pressing portion 214 is two cylindrical projections, but is not limited to this embodiment.

The lower left enlarged view of FIG. 7 schematically shows a state in which the portion 180 of the test piece 100 is pressed by the fourth pressing portion 214 of the first member 210. The pressure by the fourth pressing section 214 causes the sample receiving section 150 and the labeling substance holding section 120 to come into close contact with each other, and the retention of the liquid sample at the interface between the sample receiving section 150 and the labeling substance holding section 120 is suppressed. Moreover, the fourth pressing surface 214A of the fourth pressing section 214 presses only a part of the region 150A1 in the second direction Y of the surface 150A of the sample receiving section 150, so that inhibition of movement of the liquid sample can be suppressed.

In the illustrated preferred embodiment, the first member 210 of the housing 200 further has the following features.

A sample supply hole 240 is formed in the first member 210 at a position facing the sample receiving portion 150 of the test piece 100. A liquid sample is supplied from the outside of the housing 200 to the sample receiving part 150 of the test piece 100 through the sample supply hole 240 using a suitable instrument such as a pipette or syringe, and the liquid sample is spread on the test piece 100. You can start.

In the illustrated preferred embodiment, a plurality of ventilation holes 250 are further formed in the first member 210 at a position facing the absorber 140 of the test piece 100.

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

The second member 220 of the housing 200 has a fifth pressing part 225 for pressing the test piece 100 toward the first member 210 on a surface 220A opposite to the second surface 110B of the base sheet 110 of the test piece 100. It is preferable to have one. Here, the fifth pressing section 225 presses the second surface of the second surface 110B of the base sheet 110 at the portion 160 where the base sheet 110, the solid phase carrier 130, and the labeling substance holding section 120 of the test piece 100 overlap. It has a fifth pressing surface 225A that comes into contact with the region 110B1 (see FIG. 5A) extending throughout the direction Y. In particular, the fifth pressing surface 225A of the fifth pressing section 225 is the third pressing surface 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 labeling substance holding section 120 overlap. The portion 161 including the end portion 131 comes into contact with a region 110B1 (see FIG. 5A) extending throughout the second direction Y of the second surface 110B of the base sheet 110.

In the lower left enlarged view of FIG. 7, the fifth pressing part 225 of the second member 220 presses the solid phase of the portion 160 of the test piece 100 where the base sheet 110, the solid phase carrier 130, and the labeling substance holding part 120 overlap. A state in which a portion 161 including the third end 131 of the carrier 130 is pressed is schematically shown. The fifth pressing part 225 of the second member 220 is arranged to face a part of the first pressing part 211 of the first member 210. The fifth pressing section 225 of the second member 220, together with the first pressing section 211, is located at the third end of the solid phase carrier 130 in the portion 160 where the base sheet 110, the solid phase carrier 130, and the labeling substance holding section 120 overlap. By pressing the portion 161 including the portion 131, the vicinity of the third end portion 131 of the solid phase carrier 130 and the labeling substance holding portion 120 are brought into even stronger contact. Moreover, since the fifth pressing surface 225A of the fifth pressing section 225 presses the entire second surface 110B of the base sheet 110 in the second direction Y, the flow of the liquid sample developed on the test piece 100 is This is preferable because it is uniform throughout the second direction Y, which is the width direction of the piece 100.

Next, regarding 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 according to the present embodiment, mainly FIGS. This will be explained with reference to FIG. 4A and FIG.

A plurality of positioning members 260 for installing and positioning the test piece 100 are provided on a surface 220A of the second member 220 of the casing 200 that faces the second surface 110B of the base sheet 110 of the test piece 100. 100.

The test piece 100 is placed on the surface 220A of the second member 220 of the casing 200, and the side of the surface 210A of the first member 210 of the casing 200 is placed on the first surface 110A of the base sheet 110 of the test piece 100. The detection instrument 1 is completed by assembling the housing 200 by fixing the first member 210 and the second member 220 so as to face each other.

At this time, the means for fixing the first member 210 and the second member 220 is not particularly limited, but preferably, they can be fixed via a fitting portion as illustrated.

In a preferred embodiment, as shown in the figure, the first member 210 of the housing 200 is moved in the second direction Y through the test piece 100 between the first pressing part 211 and the fourth pressing part 214 in the first direction X. A first fitting part 231 (for example, a fitting recess) is provided at a pair of positions facing each other,
The second member 220 of the housing 200 has second fitting portions 232 (for example, (fitting protrusion).

By arranging the first fitting part 231 and the second fitting part 232 at this position, the first pressing part 211 and the fourth pressing part 214 of the first member 210 and the fifth pressing part of the second member 220 The above-mentioned advantageous effects of H.225 are further enhanced.

In a further preferred embodiment, as shown in the figure, the first member 210 of the housing 200 has third fitting portions 233 at a pair of positions facing each other in the second direction Y with the second pressing portion 212 interposed therebetween. (for example, a fitting recess),
The second member 220 of the housing 200 has fourth fitting portions 234 (for example, (fitting protrusion).

By arranging the third fitting part 233 and the fourth fitting part 234 in this position, the above-mentioned advantageous effect of the second pressing part 212 of the first member 210 is further enhanced.

More preferably, the first member 210 of the housing 200 includes 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 casing 200 is provided with a pair of sixth fitting parts 236 in a corner portion at a position facing the pair of fifth fitting parts 235 of the first member 210, and A pair of eighth fitting parts 238 are provided at positions facing the pair of seventh fitting parts 237 of 210 .

Another embodiment of the present invention relates to a kit for detecting a test substance in a sample, which includes a detection instrument 1 and a sample pretreatment reagent.

The sample pretreatment reagent is not particularly limited as long as it is used to make the sample developable on the device, and can be, for example, a sample diluent, a cell lysate, an organic solvent, etc. . Preferably, the sample pretreatment reagent is a sample diluent.

The kit according to this embodiment may include a filter for filtration, a tube for centrifugation, a cotton swab for collecting a sample, a cup/dropper, a squeeze tube, etc., depending on the type of sample to be measured. Furthermore, a color gauge and instructions for use may be provided to assist in determining the line after development.

1: Detection instrument 100: Test piece 110: Base sheet 110A: First surface of base sheet 110B: Second surface of base sheet 120: Marking substance holding section 130: Solid phase carrier 135: Capture section 140: Absorber 150: sample receiving section 200: housing 210: first member 220: second member 211: first pressing section 212: second pressing section 213: third pressing section 214: fourth pressing section 225: fifth pressing section 219 : Opening 217 : Peripheral part 231 : First fitting part 232 : Second fitting part 233 : Third fitting part 234 : Fourth fitting part 235 : Fifth fitting part 236 : Sixth fitting part 237 : Seventh fitting part 238: Eighth fitting part X: First direction Y: Second direction

Claims (12)

A detection instrument for detecting a test substance in a liquid sample,
Comprising a test piece and a casing that accommodates the test piece,
The test piece includes a base sheet, a labeling substance holding part, a solid phase carrier, and an absorber,
The base sheet extends in the first direction from the first end to the 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. It has two sides,
On the first surface of the base sheet, a labeling substance holding part, a solid phase carrier, and an absorber are arranged in this order along the first direction so as to at least partially overlap,
The casing includes a first member disposed facing the first surface of the base sheet, and a second member disposed facing the second surface of the base sheet, which holds the test piece therebetween. and
An opening is formed in the first member at a position facing the solid phase carrier of the test piece,
The first member has a first pressing portion and a first pressing portion, which is a part of the periphery of the opening, which presses the test specimen toward the second member, on a surface opposite to the first surface of the base sheet of the test specimen. Equipped with 2 pressing parts,
The first pressing part is in contact with a region of the surface of the test piece at a portion where the base sheet, the solid phase carrier, and the labeling substance holding part overlap, extending in the entire second direction intersecting the first direction. having a first pressing surface;
The second pressing part has a second pressing surface that comes into contact with an area extending in the entire second direction of the surface of the test piece at a portion where the base sheet, the solid phase carrier, and the absorber overlap. Characteristic detection equipment. In the test piece,
The labeling substance holding part is a porous body containing a labeling substance that binds to the test substance in a releasable state,
The solid phase carrier partially includes a capture part on which a capture substance that binds the test substance is immobilized,
The absorber is a porous body that absorbs a liquid sample,
The solid phase carrier is arranged in a first direction from a third end located between the first end and the second end of the base sheet to a third end located between the third end and the second end of the base sheet. Extending to the fourth end located between, the base sheet 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 part of the solid phase carrier is arranged between the third end and the fourth end of the solid phase carrier,
The labeling substance holding part is arranged in a first direction from a fifth end located closer to the first end of the base sheet than the third end of the solid support, to a third end of the solid support and a capture part. extending to the sixth end located between and disposed so as to cover a portion of the base sheet and the solid support in the first direction from the first surface side of the base sheet,
The absorber is arranged in the first direction from a seventh end located between the capturing part and the fourth end of the solid phase carrier to a second end of the base sheet rather than a fourth end of the solid phase carrier. Extending to the eighth end located closer to the base sheet and disposed so as to cover a part of the base sheet and the solid phase carrier in the first direction from the first surface side of the base sheet,
In the first member of the housing,
The opening is formed at a position of the first member facing a portion including the capturing portion of the solid phase carrier of the test piece,
The first pressing surface of the first pressing part is the surface of the labeling substance holding part in the portion where the base sheet, the solid phase carrier, and the labeling substance holding part of the test piece overlap, in a second direction intersecting the first direction. abutting an area extending throughout;
The second pressing surface of the second pressing part is the surface of the absorber in the portion of the test piece where the base sheet, the solid phase carrier, and the absorber overlap, including the seventh end of the absorber. in contact with a region extending entirely in the second direction;
The first pressing portion is a part of the peripheral edge of the opening adjacent to the opening on the side where the first end of the base sheet of the test piece is located in the first direction,
The detection instrument according to claim 1, wherein the second pressing part is a part of the peripheral edge of the opening, which is 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. In the test piece, the part of the labeling substance holding part that covers the solid phase carrier is not bonded to the solid phase carrier, and the part of the absorber that covers the solid phase carrier is not bonded to the solid phase carrier. ,
The detection instrument according to claim 2. The first member of the housing further includes a third pressing part that presses the test piece toward the second member on a surface opposite to the first surface of the base sheet of the test piece,
The third pressing portion is a portion of the test piece where the base sheet, the solid phase carrier, and the absorbent overlap, and the portion including the fourth end of the solid phase carrier, on the surface of the absorber in the second direction. having a third pressing surface that comes into contact with a part of the area;
The detection instrument according to claim 2 or 3. The detection instrument according to claim 4, wherein the third pressing surface of the third pressing section is disposed at a position that projects toward the test piece more than the second pressing surface of the second pressing section. The test piece further includes a sample receiving part that is a porous body that receives a liquid sample,
The sample receiving part is connected in the first direction from a ninth end located closer to the first end of the base sheet than the fifth end of the labeling substance holding part to a fifth end of the labeling substance holding part. Extends to the tenth end located between the third end of the phase carrier and covers a part of the base sheet and the labeling substance holding part in the first direction from the first surface side of the base sheet. arranged so that
The detection instrument according to any one of claims 2 to 5. The test piece further includes a sample receiving part that is a porous body that receives a liquid sample,
The sample receiving section is arranged on the first surface of the base sheet so that at least a portion thereof overlaps with the labeling substance holding section.
The detection instrument according to any one of claims 1 to 5. The first member of the casing further includes a fourth pressing part that presses the test piece toward the second member on a surface opposite to the first surface of the base sheet of the test piece,
The fourth pressing part has a fourth pressing surface that comes into contact with a partial area in the second direction of the surface of the portion of the test piece where the base sheet, the labeling substance holding part, and the sample receiving part overlap.
The detection instrument according to claim 7. The first member of the casing has first fitting portions at a pair of positions facing each other in the second direction with the test piece interposed between the first pressing portion and the fourth pressing portion in the first direction. Prepare,
The second member of the casing is provided with second fitting portions that are respectively capable of fitting with the first fitting portion at a pair of positions facing the first fitting portion of the first member.
The detection instrument according to claim 8. The second member of the housing includes a fifth pressing portion that presses the test piece toward the first member on a surface opposite to the second surface of the base sheet of the test piece,
The fifth pressing part is in contact with a region of the test piece that extends entirely in the second direction on the second surface of the base sheet at a portion where the base sheet, the solid phase carrier, and the labeled substance holding part overlap. , having a fifth pressing surface;
The detection instrument according to any one of claims 1 to 9. The labeling substance held in the labeling substance holding part of the test strip includes 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 strip contains a second antibody molecule that immunologically binds to the test substance.
Detection instrument according to any one of claims 1 to 10. A kit for detecting a test 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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