JP2012198159A - Specimen detection device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a specimen detection device capable of simply and quickly analyzing a small amount of specimen liquid.SOLUTION: The specimen detection device includes: an expansion part 30 including a detection target substance detection part 33 for carrying a detection target substance detection reagent for detecting a detection target substance in a casing 10; a belt-like member 40 configured so that one end part forming a specimen introduction part 40a for introducing a specimen is exposed from a first aperture 12 of the casing 10 and the other end part 40b is stored in the casing 10; a support 41 for supporting the belt-like member 40; and a buffer solution storage part 20 for storing a buffer solution in a cap 15 to be attached to the casing 10 and configured so that at least a part of the storage part 20 is composed of a breakable protection film 17. The belt-like member 40 includes an opening part 43 which when the cap 15 is attached to the casing 10, opens the protection film 17 and allows the buffer solution 21 to leak, and a taper part 42 for moving the leaked buffer solution 21 to the expansion part 30.

Description

  The present invention is a method for quantifying a substance to be detected contained in a specimen, a buffer solution storage part for containing a buffer solution, a substance detection part for carrying a substance detection reagent for detecting the substance to be detected, It is related with the kit for immunochromatography measurement provided with.

  Examination of biological components contained in body fluids (for example, blood, urine, and saliva) is important for diagnosis of infectious diseases and various other diseases. It is desirable that such a test can be easily performed at home without going to a medical institution.

Numerous devices exist in the art for collecting and testing the body fluid for the presence of an analyte. As relatively fast and inexpensive sample collection and analysis devices, there are several approaches to collecting sample fluid, infiltrating the sample fluid within the test device, and performing sample analysis.

  Patent Document 1 includes a solution reservoir that can hold a solution in advance or can be injected with a solution, a capillary that has a first end and a second end, and stores a liquid sample; A test piece for measuring a component to be measured in the sample, the solution reservoir and the second end of the capillary can communicate with each other, and the first end of the capillary can be in contact with the test piece Has been. When the solution in the solution reservoir and the second end of the capillary communicate with each other, and the first end of the capillary is brought into contact with the test piece, the sample is pushed into the solution and applied to the test piece Is described.

  Patent Document 2 discloses an immunoassay test instrument used for an assay using an immunochromatography method, which includes a stationary phase composed of a water-absorbing base material stretched in the longitudinal direction, and one end in the longitudinal direction of the stationary phase. A casing that is disposed near a portion, contains a liquid therein, and is composed of a film material made of a film material that can be broken at least partially, and a stationary phase and a liquid storage container. A casing main body having a sample dropping window and a determination window on its upper surface and having an opening at a position engageable with the liquid storage container, and a breakage with respect to the liquid storage container slidably attached to the opening A test instrument for immunoassay is described, characterized in that it has a casing comprising a slider with means.

Japanese Patent No. 4283112 JP 2008-164333 A

  In Patent Document 1, since sample collection is performed with a capillary, there is a problem that the sample is clogged in the capillary and a problem that breaks during sample collection.

  In Patent Document 2, an operation that a sample must be dropped with a dropper or the like is necessary, and there is a problem that a technique is required for measurement. For example, a test sample for immunochromatographic measurement should be placed in a container such as a test tube in advance with a biological sample such as tears, eyelids, sputum, saliva, stool, etc. of the suspected patient, The sample is immersed in an extraction container, and the substance to be analyzed is dispersed or dissolved to prepare a sample solution. Then, after the sample liquid is sucked up by a pipette or the like, the analysis is performed by injecting and infiltrating the sample liquid into the sample injection portion of the sample detection device. Therefore, an object of the present invention is to provide a sample detection device that can analyze a small amount of sample liquid easily and quickly.

In order to achieve the above object, the first characteristic configuration of the analyte detection device according to the present invention is:
A casing, a sample introduction part that is partially exposed from the casing and that introduces a sample; and a detection target that is disposed in the casing and carries a detection substance detection reagent and is an analysis target included in the sample Detected substance detection unit for detecting a substance, a developing unit in which a buffer solution is applied to the specimen, and penetrates and guides the detected substance detection unit, and is removable from the casing and protected A cap having a buffer solution storage part that contains the buffer solution through a membrane, and when the cap is mounted on the casing, the protective film is broken as the specimen introduction part and the buffer solution storage part approach each other. And the sample to which the buffer solution is applied is guided from the buffer solution storage unit to the detection target substance detection unit.

  According to this configuration, when the cap is attached to the casing, the protective film is torn and opened with the approach of the sample introduction unit and the buffer solution storage unit, and the buffer solution is leaked. The sample and the buffer solution can be mixed. The specimen mixed with the buffer solution penetrates into the development part and can be quantified by the detection target substance detection part.

  In this configuration, even if the volume of the specimen is very small, the volume can be increased with a buffer solution before permeating at the developing portion. The specimen having an increased capacity can be surely penetrated to the detection target substance detecting section in the downstream direction without stopping the penetration due to the lack of capacity. As described above, in the sample detection device of this configuration, the sample amount can be easily increased and the penetration portion can be surely penetrated by simply attaching the cap to the casing after collecting the sample. The quantitative operation can be performed easily and quickly.

  A second characteristic configuration of the sample detection device according to the present invention is that the sample introduction part is formed of a band-shaped member. In this configuration, since the part where the protective film is opened is the specimen introduction part, the specimen held in the specimen introduction part can be reliably mixed.

  A third characteristic configuration of the sample detection device according to the present invention is that the protective film is broken and opened by an end portion of the sample introduction portion by mounting the cap on the casing.

  According to this configuration, when the cap is attached to the casing, the opening part that is the end part of the sample introduction part opens the buffer solution storage part to leak the buffer solution, and the sample held in the sample introduction part Buffers can be mixed. Therefore, it is not opened until the cap is attached to the casing, so that the buffer solution storage portion is not accidentally opened to leak the buffer solution, and the malfunction of the specimen detection device can be prevented beforehand.

  A fourth characteristic configuration of the sample detection device according to the present invention is that the band-shaped member is made of a porous material, and the upper diameter of the sample introduction portion is larger than the lower size.

  According to this structure, the quantity which can be hold | maintained in a film with the hole diameter and area prescribed | regulated with the porous film can be quantified and hold | maintained. When the film has a pore size capable of separating blood cells, if an anticoagulant is added to the film, whole blood can be measured while suppressing an increase in background due to red blood cells. In addition, if an anti-hemoglobin antibody is added to and retained on the film, hemoglobin can be separated even in hemolyzed whole blood to suppress increase in background.

  According to a fifth characteristic configuration of the sample detection device according to the present invention, the band-shaped member has one end tapered, and when the cap is attached to the casing, the end of the development portion is located with respect to the taper surface. The protective film is broken at the other end.

  According to this configuration, when the cap is mounted on the casing, the end portion of the development portion rides on the tapered surface that is one end of the belt-like member, and the belt-like member and the development portion come into contact with each other. As a result, the protective film of the buffer solution storage portion is broken at the other end of the belt-shaped member, and the sample mixed with the buffer solution easily penetrates into the development portion.

  A sixth characteristic configuration of the sample detection device according to the present invention is that the band-shaped member can be fitted to the casing and the sample introduction part can be replaced.

  According to this configuration, the strip-shaped member having the sample introduction portion and the casing can be fitted, so that it is easy to collect the sample in advance. In addition, the measurement time can be shortened because the measurement can be performed collectively.

It is the schematic which shows the sample detection device of this invention. It is a plane sectional view showing the sample detection device of the present invention. It is sectional drawing which shows the sample detection device of this invention. It is sectional drawing at the time of the sample measurement of the sample detection device of this invention. It is a block diagram of the sample introduction part of a strip-shaped member. It is sectional drawing which shows a sample collection device.

[Embodiment 1]
Embodiments of the present invention will be described below with reference to the drawings.

  Various test methods have been used in clinical tests, and among these test methods, the dry chemistry method is known. In the dry chemistry method, a liquid specimen is spotted on a reagent carried in a dry state on a permeation matrix such as a film or a test paper, and a test substance in the specimen is measured. Thus, the dry chemistry method is easy to operate and maintain because it does not require the preparation of an enzyme reaction solution and a piping system as in the liquid method.

  The sample detection device of the present invention can be used, for example, as an immunochromatography in which a reagent is supported on a single-layer permeation matrix (developing part). In order to quantify the substance to be detected contained in the specimen, the sample detection device detects the substance by allowing a mobile phase (such as a liquid) containing the substance to pass through the surface or the inside of the development part, which is a stationary phase. Separate material. In this embodiment, the case where a blood sample containing an antigen or an antibody is used as the sample is exemplified, but the present invention is not limited to this.

  As shown in FIGS. 1 to 3, the specimen detection device X is a substance to be detected that carries a substance detection reagent for detecting the substance to be detected in the casing 10 in order to quantify the substance to be detected contained in the specimen. One end of the developing unit 30 including the detection unit 33 and the sample introduction unit 40a for introducing the sample is exposed from the first opening 12 of the casing 10, and the other end 40b is the second opening of the casing 10. A strip-shaped member 40 exposed from the portion 13 and housed in the casing 10.

  The band-shaped member 40 opens the buffer solution storage part 20 sealed with the protective film 17 when the band-shaped member 40 is transferred into the cap mounting part 16 by mounting the cap 15 on the casing 10. And an unsealing portion 43 for leaking the buffer solution 21.

  Furthermore, the belt-like member 40 includes a tapered portion 42 that comes into contact with the specimen permeation portion 31 by wearing the cap 15 with the casing 10.

(casing)
The casing 10 may be in any form as long as it can accommodate the development part 30, but it is necessary to select a material that has a certain degree of strength and does not absorb the buffer solution 21. As the material, for example, hard vinyl chloride (PVC) is suitable.

  The buffer solution storage unit 20 is formed in a mode that can store the buffer solution 21 in a watertight manner. Any buffer solution 21 may be used as long as it does not chemically and biologically react with the substance to be detected. The buffer solution storage unit 20 is configured such that its side surface is sealed by the protective film 17 and can be easily opened by the opening unit 43 of the band-shaped member 40 (details will be described later). As a material for the protective film 17, an aluminum laminate film is preferable. The deployment unit 30 is placed on the deployment unit placement unit 14, and the specimen permeation unit 31, which is the upstream end of the deployment unit 30, is disposed adjacent to the taper portion 42 of the band-shaped member 40. For example, glass wool is suitable as the specimen permeation unit 31. The water absorption pad 32 which is the downstream end part of the expansion | deployment part 30 is arrange | positioned adjacent to the expansion | deployment part 30, and absorbs a liquid. For example, glass wool is suitable as the material.

  The casing 10 is formed with a first opening 12 that exposes one end 40 a of the belt-like member 40 and a second opening 13 that exposes the other end 40 b of the belt-like member 40. The first opening 12 is an opening having such a width that the one end 40 a of the belt-like member 40 can be transferred into the cap wearing part 16.

  The casing 10 may be, for example, a long cube, and may be formed to fit in a size of, for example, about 100 mm (length) × 30 mm (width) × 10 mm (height) in order to improve portability. Moreover, although the casing 10 can be comprised, for example with a transparent member so that the result of fixed_quantity | quantitative_assay can be visually recognized, you may form the opening part which can visually recognize the said result not only in this.

(cap)
The cap 15 is disposed so that the protruding portion 11 protruding from the casing 10, the cap mounting portion 16 to be mounted, and the buffer solution storage portion 20 sealed by the protective film 17 are adjacent to each other. The projecting portion 11 may have either a structure that can be integrated with or separated from the casing 10. As the material of the protruding portion 11 and the cap 15, hard vinyl chloride (PVC) which is the same as that of the casing 10 is suitable.

(Development part)
The developing unit 30 includes a detected substance detection unit 33 that carries a detected substance detection reagent that detects the detected substance on a solid phase carrier.

The immunochromatography method is a test method using an antigen-antibody reaction and capillary action. Therefore, the development part 30 should just be an aspect in which the mobile phase flows down by capillary action. For example, a nitrocellulose membrane / acetate mixed nitrocellulose membrane / nylon membrane / polyether sulfone having a pore diameter of 10 to 200 μm and a thickness of 100 to 3000 μm. A membrane / polyvinylidene difluoride membrane is preferably used, and a nitrocellulose membrane (manufactured by Nippon Millipore) is particularly preferred.

  In the detected substance detection unit 33, a reagent containing an antigen or an antibody that immunologically reacts with the detected substance (detected substance detection reagent) is carried on the above-described membrane.

  When quantifying the substance to be detected, a specimen containing a substance to be detected (for example, an antigen) is added to the specimen introduction section 40a, and the specimen is permeated into the developing section 30 by capillary action, for example, a sandwich type antigen-antibody reaction. By coloring the reaction site using the (sandwich method), antigen identification, presence / absence, or antigen amount is measured.

  The form of the antigen-antibody reaction is not limited to the sandwich method, and a competitive antigen-antibody reaction (competition method) may be used. For example, the sandwich method is used when the molecular weight of the substance to be detected is large, and the competition method is used when the molecular weight of the substance to be detected is small.

  In the method of color development with dye, color development with fluorescence or enzyme reaction, color development with chemical reaction, fluorescence, luminescence, etc., if an inflowing reagent is required, it can be dried and temporarily held in the specimen permeation section, or buffered You may mix with the buffer solution 21 in the part 20. FIG.

(Strip member)
The band-shaped member 40 has a sample introduction part 40 a formed on the first opening 12 side and the other end 40 b formed on the second opening 13 side inside the casing 10. The belt-like member 40 is laminated with a porous film that is the specimen introduction portion 40a and a support body 41 that supports the porous film. The support 41 is made of an elastic member having a certain degree of hardness. As the elastic member, for example, a thermoplastic resin (polypropylene, polycarbonate, polyvinyl chloride, etc.) or a thermosetting resin (epoxy resin, phenol resin, alkyd resin, etc.) can be used. However, the elastic member is not limited to this. Absent.

The sample introduction part 40a is a part for collecting a sample. For example, when the sample is blood, the sample can be collected by dripping the blood into the sample introduction unit 40a or immersing the sample introduction unit 40a in the blood. The sample introduction unit 40a holds the sample amount collected by the sample introduction unit 40a as it is when the sample introduction unit 40a is transferred into the cap wearing unit 16 by wearing the cap 15 with the casing 10. It may be configured so that it can be maintained.

  The sample introduction unit 40a may be configured to hold a very small amount of sample of, for example, about 2 μL, but may be configured to hold a larger amount of sample.

For example, as shown in FIG. 5, the specimen introduction part 40a can quantify and hold the amount that can be held in the film with the pore diameter and area defined by the porous film. The porous film is made of a polymer such as polyethersulfone having a pore diameter of 0.1 to 6.0 μm and an area of 0.1 to 5.0 cm ² . Specifically, Vivid Plasma Separation Membrane GR (manufactured by Pall) was used. (Thickness: 330 ± 20 μm)
Furthermore, the sample introduction part 40a includes an opening part 43 that opens the buffer solution storage part 20 and leaks the buffer solution 21. Further, the band-shaped member 40 opens the buffer solution storage unit 20 sealed with the protective film 17 when the sample introduction unit 40a is transferred into the cap mounting unit 16 by mounting the cap 15 on the casing 10. And an opening 43 for leaking the buffer solution 21.

  Furthermore, the belt-like member 40 includes a tapered portion 42 that comes into contact with the specimen permeation portion 31 by wearing the cap 15 with the casing 10.

  According to this configuration, as shown in FIG. 4, when the sample introduction part 40 a is transferred into the cap attachment part 16 by attaching the cap 15 to the casing 10, the unsealing part 43 becomes the buffer solution storage part. The protective film 17 sealing 20 is opened to leak the buffer solution 21 and move to the sample introduction part 40a. Further, by attaching the cap 15 to the casing 10, the sample introduction unit 40 a comes into contact with the sample infiltration unit 31 by the taper unit 42, and the solution in which the buffer solution 21 and the sample are mixed moves to the development unit 30, It can be quantified by the detected substance detection unit 33. The taper portion 42 is easy to come into contact with the specimen permeation portion 31 because the cross section in the longitudinal direction is tapered.

  As described above, in this configuration, even if the volume of the specimen is very small, the volume can be increased by the buffer solution 21 before the sample is permeated by the developing unit 30. The sample whose volume has increased can reliably infiltrate the solution to the detection target substance detection portion in the downstream direction without stopping the penetration due to insufficient capacity.

  Furthermore, in this configuration, since the specimen introduction part 40a is a porous film, the sample can be more reliably permeated in the downstream direction without clogging or breaking like a capillary.

  Specifically, the opening portion 43 is formed at the tip of the sample introduction portion 40a that is one end portion of the belt-like member 40. The material of the unsealing part 43 is the same material as that of the belt-like member 40, and the tip is preferably made sharper by making it narrower than the width of the specimen introduction part 40a so that the protective film 17 can be easily broken. The tip shape is not limited to this, and may be the same width as the specimen introduction part 40a as long as it can be broken.

(Specimen and target substance)
The “analyte” described in the present specification refers to a liquid sample containing or possibly containing a target substance to be quantified. The specimen may be derived from any source, but blood, urine, serum, plasma, saliva, sputum and the like obtained from a biopsy sample or the like can be used.

  The “substance to be detected” contained in the specimen is captured by the binding between the target substance and a binding substance that can form a specific conjugate. A specific complex is a result of a binding pair assay, and as described above, an immunochemical complex resulting from an antigen-antibody reaction, a complex resulting from hybridization of complementary nucleic acids, etc. Is preferably exemplified. The substance to be detected can be any substance such as chemical substances, polymers such as proteins, DNA fragments, interleukins, microorganisms or viruses and fragments thereof, hormones, lipid-derived excretion trace substances.

[Embodiment 2]
In the above-described embodiment, the case where the protruding portion 11 is integrated with the casing 10 and the sample is collected by the sample introducing portion 40a has been described. However, the present invention is not limited to such an embodiment, and a configuration may be adopted in which a sample is collected by the protruding portion 11 separated from the casing 10 and the sample introduction portion 40a.

That is, as shown in FIG. 6, after the sample is collected by the sample collection device configured to collect the sample by the protruding portion 11 separated from the casing 10 and the sample introduction portion 40a, the sample collection device is attached to the casing 10. Assemble. Thereafter, the detection target substance is quantified by the same operation as in the first embodiment. If comprised in this way, since a sample collection device is small, sample collection can be performed easily.

X Specimen Detection Device 10 Casing 11 Projecting Part 12 First Opening Part 13 Second Opening Part 14 Deployment Part Placement Part 15 Cap 16 Cap Mounting Part 17 Protective Film 20 Buffer Solution Storage Unit 21 Buffer Solution 30 Development Unit 31 Sample Permeation Part 32 Water absorption pad 33 Detected substance detection part 40 Band-like member 40a Sample introduction part 40b Other end part 41 Support body 42 Taper part 43 Unsealing part

Claims (6)

A casing,
A specimen introduction part that is partially exposed from the casing and introduces the specimen;
A detected substance detection unit disposed in the casing and carrying a detected substance detection reagent to detect a detected substance to be analyzed contained in the specimen;
A buffer solution is applied to the specimen, and a deployment unit that penetrates and guides the detected substance detection unit;
A cap that has a buffer solution storage portion that stores the buffer solution through a protective film, and is detachable from the casing;
When the cap is attached to the casing, the protective film is torn and opened with the approach of the sample introduction portion and the buffer solution storage portion, and the sample to which the buffer solution is applied from the buffer solution storage portion is opened. A specimen detection device that is guided to a target substance detection unit.   The sample detection device according to claim 1, wherein the sample introduction part is formed of a band-shaped member.   The specimen detection device according to claim 1 or 2, wherein the protective film is torn and opened by an end of the specimen introduction section by attaching the cap to the casing.   The specimen detection according to any one of claims 1 to 3, wherein the belt-like member is made of a porous material, and has a larger pore diameter in the upper part of the specimen introduction part than in the lower part. device.   The band-shaped member has a tapered surface at one end, and when the cap is mounted on the casing, the end of the development portion rides on the tapered surface, and the protective film is broken at the other end. The specimen detection device according to any one of claims 1 to 4.   The specimen detection device according to any one of claims 1 to 5, wherein the belt-like member can be fitted to the casing and the specimen introduction part can be replaced.

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