WO2010116979A1 - 検体分析用具、検体分析用具の製造方法および展開部材の液体浸透性低下抑制方法 - Google Patents
検体分析用具、検体分析用具の製造方法および展開部材の液体浸透性低下抑制方法 Download PDFInfo
- Publication number
- WO2010116979A1 WO2010116979A1 PCT/JP2010/056187 JP2010056187W WO2010116979A1 WO 2010116979 A1 WO2010116979 A1 WO 2010116979A1 JP 2010056187 W JP2010056187 W JP 2010056187W WO 2010116979 A1 WO2010116979 A1 WO 2010116979A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sample
- analysis tool
- supply unit
- sample analysis
- hydrophilic component
- Prior art date
Links
Images
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
- G01N33/54386—Analytical elements
- G01N33/54387—Immunochromatographic test strips
- G01N33/54388—Immunochromatographic test strips based on lateral flow
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
- G01N33/525—Multi-layer analytical elements
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Definitions
- the present invention relates to a sample analysis tool, a method for manufacturing the sample analysis tool, and a method for suppressing a decrease in liquid permeability of a deployment member.
- an immunochromatography method (hereinafter sometimes referred to as an immunoassay method) is widely used because quantitative analysis, semi-quantitative analysis, qualitative analysis, and the like are possible simply and quickly.
- immunoassay methods using enzymes as labels (hereinafter also referred to as enzyme immunoassay methods) have been developed (see, for example, Patent Document 1).
- the conventional sample analysis tool 60 generally has a configuration in which a deployment member 61 is accommodated in a plastic case 66.
- FIG. 6A is a plan view of the sample analysis tool.
- FIG. 6B is a cross-sectional view seen in the III-III direction of FIG. In both the drawings, the same parts are denoted by the same reference numerals.
- a developing solution supply unit 62, a sample supply unit 63, and a detection unit 64 are arranged in the order described above from the upstream to the downstream of the flow of the developing solution (from the right side to the left side in the drawing).
- An antibody is immobilized on the detection unit 64 (hereinafter also referred to as an immobilized antibody).
- a developing solution supply port 67 In the plastic case 66, a developing solution supply port 67, a sample supply port 68, and a window 69 are formed.
- the developing solution supply port 67 is arranged such that the lower end thereof is in contact with the developing solution supply unit 62.
- the sample supply port 68 is disposed above the sample supply unit 63.
- the window 69 is disposed above the detection unit 64.
- an object of the present invention is to provide a sample analysis tool, a method for manufacturing the sample analysis tool, and a method for suppressing a decrease in liquid permeability of a developing member, which can prevent a decrease in analysis reactivity and reproducibility.
- the sample analysis tool of the present invention comprises: A deployment member and a plastic substrate; At least a portion of the deployment member is in contact with the plastic substrate; Furthermore, it has a hydrophilic component layer, The hydrophilic component layer is formed on a part or all of at least one of the surface of the plastic substrate and the surface of the developing member.
- the method for producing the sample analysis tool of the present invention includes: A method for producing a sample analysis tool in which at least a part of a deployment member is in contact with a plastic substrate, A hydrophilic component layer forming step of forming a hydrophilic component layer on a part or all of at least one of the surface of the plastic substrate and the surface of the developing member is characterized.
- the liquid permeability lowering suppression method of the deployment member of the present invention A deployment member and a plastic substrate;
- the plastic substrate comprises a hydrophobic component;
- a hydrophilic component layer is formed on a part or all of at least one of the surface of the plastic substrate and the surface of the deployment member in the sample analysis tool in which at least a part of the deployment member is in contact with the plastic substrate. Forming, The adhesion of the hydrophobic component to the spreading member is prevented by the hydrophilic component layer, thereby suppressing a decrease in the permeability of the liquid to the spreading member.
- FIG.1 (a) is a top view which shows the structure of an example of the expansion
- FIG. 1B is a cross-sectional view of the developing member shown in FIG.
- FIG.1 (c) is a top view which shows the structure of an example of the sample analysis tool of one Embodiment of this invention.
- FIG. 1D is a cross-sectional view of the sample analysis tool shown in FIG. 1C viewed in the II-II direction.
- FIG. 2 is a diagram illustrating an example of a hydrophilic component layer formed on the surface of the developing liquid supply unit.
- FIG. 3A is a cross-sectional view illustrating an immunoassay method according to an embodiment of the present invention.
- FIG. 3A is a cross-sectional view illustrating an immunoassay method according to an embodiment of the present invention.
- FIG. 3B is a schematic diagram showing detection of an antigen in the detection unit.
- FIG. 4 is a cross-sectional view showing the configuration of another example of the sample analysis tool of one embodiment of the present invention.
- FIG. 5 is a cross-sectional view showing the configuration of still another example of the sample analysis tool of one embodiment of the present invention.
- Fig.6 (a) is a top view which shows the structure of an example of the conventional sample analysis tool.
- FIG. 6B is a cross-sectional view of the sample analysis tool shown in FIG. 6A as viewed in the III-III direction.
- the present inventors first conducted a series of studies for the purpose of elucidating the cause of the decrease in the reactivity and reproducibility of the analysis in the conventional sample analysis tool.
- the present inventors have found that in the conventional sample analysis tool, for example, the permeability of the liquid supplied to the liquid supply unit such as the development liquid supply unit or the sample supply unit is reduced. I found out.
- the decrease in the permeability of the liquid means, for example, that the liquid does not penetrate into the deployment member, or that it takes time to penetrate into the deployment member. This decrease in permeability reduces the reactivity and reproducibility of the analysis.
- the present inventors have conducted further research, and as a result, the surface of the plastic substrate and the deployment member in the specimen analysis tool in which at least a part of the deployment member is in contact with the plastic substrate are obtained. It has been found that if a hydrophilic component layer is formed on part or all of at least one of the surfaces, a decrease in the permeability of the liquid can be suppressed, and the present invention has been achieved. According to the present invention, it is possible to prevent a decrease in analysis reactivity and reproducibility.
- the sample analysis tool of the present invention may be, for example, in a form in which the hydrophilic component layer is formed on part or all of the contact portion of the developing member with the plastic substrate.
- the developing member has a liquid supply part, and the hydrophilic component layer is formed on a part or all of the surface of the liquid supply part. Also good.
- the liquid supply unit is not particularly limited, and examples thereof include a developing liquid supply, a sample supply unit, a reagent supply unit, and a cleaning liquid supply unit.
- the contact portion of the developing member with the plastic substrate may include the liquid supply unit.
- the liquid supply unit includes a development liquid supply unit and a sample supply unit, and part or all of at least one of the surface of the development liquid supply unit and the surface of the sample supply unit
- the hydrophilic component layer may be formed.
- the hydrophilic component layer includes a non-volatile hydrophilic component.
- the hydrophilic component layer preferably contains components such as sugars, water-soluble polymers, surfactants, colloid particles, inorganic particles, and the like.
- the saccharide include sucrose, N-methylglucosamine, glucose, fructose, maltose, and lactose. Of these, sucrose or N-methylglucosamine is particularly preferred.
- the sample analysis tool of the present invention may have, for example, a form in which the plastic substrate includes a plastic case, and the development member is disposed in the plastic case.
- the sample analysis tool of the present invention may have a form in which, for example, a sample solution and a developing solution containing a sample are supplied from the sample supply unit and the developing solution supply unit, respectively.
- the development member further includes a detection unit, and the development liquid supply unit, the sample supply unit, and the detection unit are arranged upstream of the flow of the development liquid.
- the development liquid supply unit, the sample supply unit, and the detection unit are arranged upstream of the flow of the development liquid.
- the detection unit a substance that specifically binds to the analyte in the sample is immobilized on the detection unit, and the sample liquid containing the sample is supplied to the sample supply unit
- the developing solution is supplied to the developing solution supply unit, and is supplied by the development of the supplied developing solution in the developing member in the presence of a labeling substance that specifically binds to the analyte.
- the sample liquid is introduced into the detection unit, and in the detection unit, a complex of the immobilized specific binding substance, the analyte, and the labeled specific binding substance is formed, and the composite Of the sign in the body
- the output, analysis of the analyte may be in the form of place.
- the specific binding substance is appropriately selected according to the substance to be analyzed, for example, and may be a biological substance or an artificially generated (synthesized) substance.
- Examples of the specific binding substance include antibodies, antigens, probes, and the like.
- the sample analysis tool of the present invention may have a form in which, for example, the plastic substrate is formed so as to sandwich the development member.
- the sample analysis tool of the present invention may further include a reagent layer, and the plastic substrate may be formed so as to sandwich the developing member and the reagent layer.
- the plastic substrate contains a hydrophobic component.
- the hydrophobic component include a lubricant, a plasticizer, a release agent, a stabilizer, and an antioxidant.
- the hydrophilic component layer may be formed on part or all of the contact portion of the developing member with the plastic substrate. Good.
- the developing member has a liquid supply part, and in the hydrophilic component layer forming step, the hydrophilic property layer is partly or entirely on the surface of the liquid supply part.
- a component layer may be formed.
- the liquid supply unit includes a development liquid supply unit and a sample supply unit, and the surface of the development liquid supply unit and the sample are formed in the hydrophilic component layer forming step.
- the hydrophilic component layer may be formed on part or all of at least one of the surfaces of the supply unit.
- the developing member has a liquid supply part, and at least a part of the liquid supply part and the plastic substrate are in contact with each other.
- the hydrophilic component layer may be formed on a part or all of the surface of the liquid supply unit.
- the liquid supply unit includes a developing solution supply unit and a sample supply unit.
- the hydrophilic component layer may be formed on a part or all of at least one of the surfaces.
- the sample analysis tool of the present embodiment uses an immobilized antibody as the “immobilized specific binding substance” and a labeled antibody using an enzyme as a label as the “labeled specific binding substance” ( This is a sample analysis tool used in an immunoassay method (enzyme immunoassay method) using an enzyme-labeled antibody.
- FIG. 1 shows an example of the configuration of the sample analysis tool of this embodiment.
- Fig.1 (a) is a top view of the expansion
- FIG. 1B is a cross-sectional view taken in the II direction of FIG.
- the developing member 11 includes a developing solution supply unit 12, a sample supply unit 13, and a detection unit 14 in the order from upstream to downstream of the flow of the developing solution (from the right side to the left side in FIG. 1A). Is arranged in.
- the developing solution supply unit 12, the sample supply unit 13, and the detection unit 14 are each predetermined regions in the developing member 11.
- a hydrophilic component layer 15 is formed on the surface of the developing solution supply unit 12 so as to cover the entire surface of the developing solution supply unit 12.
- An antibody is immobilized on the detection unit 14 (immobilized antibody).
- FIG. 1C is a plan view of the sample analysis tool of the present embodiment.
- FIG. 1D is a cross-sectional view of the sample analysis tool shown in FIG. 1C viewed in the II-II direction.
- the sample analysis tool 10 of this example includes the deployment member 11 shown in FIG. 1A and a plastic case 16 that is the plastic substrate.
- the deployment member 11 is disposed in the plastic case 16.
- the plastic case 16 has a developing solution supply port 17, a sample supply port 18, and a window 19.
- the developing liquid supply port 17 is arranged so that the lower end thereof is in contact with the hydrophilic component layer 15.
- the sample supply port 18 is disposed above the sample supply unit 13.
- the window 19 is disposed above the detection unit 14.
- the hydrophilic component layer 15 is formed in a circular shape so as to cover the entire surface of the sample supply unit 12.
- the present invention is not limited to this example.
- the hydrophilic layer 15 is formed in a rectangular shape so as to cover the entire surface of the specimen supply unit 12.
- the hydrophilic layer 15 may be formed in a rectangular shape so as to cover a part of the surface of the specimen supply unit 12
- the hydrophilic layer 15 may be formed in a cross shape so as to cover a part of the surface of the specimen supply unit 12.
- the hydrophilic component layer 15 is formed at a contact portion between the developing member 11 (developing liquid supply part 12) and the plastic case 16 (lower end part of the developing liquid supply port 17). It is in the state. Further, the lower end portion of the developing solution supply port 17 is in contact with the hydrophilic component layer 15, but the present invention is not limited to this example, and the lower end portion of the developing solution supply port 17 has the hydrophilic property. It does not have to be in contact with the component layer 15. Further, in the sample analysis tool 10, the hydrophilic component layer 15 is formed on the surface of the developing solution supply unit 12.
- the hydrophilic component layer 15 is for example, it may be formed on a part or all of the surface of the sample supply unit 13, or may be formed on both the developing solution supply unit 12 and the sample supply unit 13, for example.
- the expansion member may be a porous structure that exhibits a capillary action.
- the material for forming the developing member include a porous film, a granular material, and a fine particle powder.
- the porous membrane include cellulose membranes, cellulose derivative membranes such as cellulose acetate and nitrocellulose, glass filters, filter paper and the like.
- the granular material or fine particle powder include polymer beads, glass beads, titanium dioxide, cellulose, salts, and hydrophobic polysaccharides.
- the size of the developing member is not particularly limited, and can be set as appropriate according to, for example, the standard of the analyzer.
- the hydrophilic component layer may contain a hydrophilic component.
- the hydrophilic component layer is formed on part or all of the surface of the developing solution supply unit.
- a hydrophobic component for example, a lubricant, a plasticizer, a mold release agent, a stabilizer, an antioxidant, etc.
- a hydrophobic component contained in the plastic case adheres to a part or all of the surface of the developing liquid supply unit. The permeability of the developing solution is reduced.
- the adhesion of the hydrophobic component is remarkable, for example, when stored in a high temperature (for example, 30 ° C. or higher) environment or when stored for a long period (for example, 6 months or longer).
- the hydrophilic component layer is formed on a part or all of the surface of the developing solution supply unit, thereby preventing the attachment of the hydrophobic component. Reduces permeability loss.
- the present invention is not limited or limited by these inferences.
- the location where the said hydrophilic component layer is formed is not limited only to the above-mentioned developing liquid supply part. The effect of the present invention can be obtained if the hydrophilic component layer is formed on a part or all of at least one of the plastic substrate surface and the developing member surface.
- the hydrophilic component layer may contain a hydrophilic component.
- the hydrophilic component include saccharides, water-soluble polymers, surfactants, colloidal particles, and inorganic particles.
- one type of the hydrophilic component may be included alone, or two or more types may be included.
- the saccharide include sucrose, N-methylglucosamine, glucose, fructose, maltose, and lactose. Of these, sucrose or N-methylglucosamine is particularly preferred.
- the water-soluble polymer include polyvinyl alcohol, polyvinyl pyrrolidone, and polyethylene glycol.
- Examples of the surfactant include polyoxyethylene sorbitan alkyl ester (Tween surfactant, etc.), polyoxyethylene-pt-octylphenyl ether (Triton surfactant, etc.), sodium dodecyl sulfate (SDS). Etc.
- Examples of the colloid particles include gold colloid particles, ferric hydroxide colloid particles, and silver colloid particles.
- Examples of the inorganic particles include silica powder, alumina, titania, calcium carbonate, magnesium carbonate and the like.
- the immobilized antibody may be an antibody that binds to an antigen that is an analyte in a sample.
- the antibody can be appropriately set according to the antigen described later.
- the antibody may be, for example, an antibody derived from a living body or an artificially synthesized antibody.
- Examples of the biologically derived antibody include immunoglobulin (Ig), antibody fragment, chimeric antibody and the like.
- immunoglobulin include IgG, IgA, IgM, IgE, and IgD.
- Examples of the antibody fragment include Fab, Fab ', F (ab') 2, and the like.
- Examples of the chimeric antibody include a humanized antibody.
- the antibody may be derived from mammals such as mice, rabbits, cows, pigs, horses, sheep and goats, birds such as chickens, and animal species such as humans, and is not particularly limited.
- the antibody is not particularly limited, and may be prepared from, for example, serum derived from the animal species by a conventionally known method, or various commercially available antibodies may be used.
- the artificially synthesized antibody include affibodies and the like.
- Examples of the method for immobilizing the antibody to the detection unit include a method in which an antibody solution containing the antibody is applied to a developing member such as a porous membrane using a coating apparatus and air-dried with a dryer or the like. .
- the material of the plastic case examples include polyethylene, polystyrene, polypropylene, acrylonitrile-butadiene-styrene copolymer synthetic resin, and the like.
- the plastic case preferably includes a hydrophobic component.
- the hydrophobic component include lubricants, plasticizers, mold release agents, stabilizers, antioxidants and the like.
- the shape and size of the plastic case are not particularly limited, and can be appropriately set according to the shape and size of the developing member and the like.
- the sample analysis tool of the present invention is not particularly limited, but is preferably manufactured by the manufacturing method of the present invention. In the production method of the present invention, each step may be performed sequentially or simultaneously. Below, an example of the manufacturing method of the sample analysis tool of this embodiment is demonstrated with reference to FIG.
- the hydrophilic component layer 15 is formed on a part or all of the surface of the developing solution supply unit 12 in the developing member 11.
- the hydrophilic component layer is formed as follows, for example. That is, first, a solution or suspension containing the hydrophilic component is prepared.
- the concentration of the hydrophilic component in the solution or the like is, for example, in the range of 0.1 to 10% by weight, preferably in the range of 0.5 to 7.5% by weight, more preferably 1 to 5% by weight. Range.
- the solution or the like can be prepared, for example, by dissolving or suspending the hydrophilic component in a solvent. Examples of the solvent include water and a buffer solution.
- the buffer solution is not particularly limited, and examples thereof include a buffer solution described later.
- the hydrophilic component layer is formed by applying the solution containing the hydrophilic component to the developing member using, for example, a coating apparatus or the like and air-drying it with a dryer or the like.
- the deployment member 11 is placed in the plastic case 16.
- deployment member 11 (developing liquid supply part 12) are contacted via the said hydrophilic component layer 15.
- the sample analysis tool of this embodiment shown in FIG. 1 can be manufactured.
- the method for manufacturing the sample analysis tool of the present embodiment is not limited to this example.
- the enzyme immunoassay method using the sample analysis tool of the present embodiment is performed using, for example, a sample solution, an enzyme-labeled antibody, a developing solution, a substrate, and the like.
- the sample solution only needs to contain a sample.
- the specimen is not particularly limited, and examples thereof include biological samples and foods.
- the specimen may be in a liquid form or a solid form dissolved, suspended or dispersed in a buffer solution or the like.
- the liquid biological sample include nasal aspirate, nasal wash, nasal swab, nasal discharge, throat swab, gargle, saliva, whole blood, serum, plasma, sweat, urine and the like.
- Examples of the solid biological sample include cells and feces.
- Examples of the food include foods such as animals and plants, and processed foods.
- the buffer is not particularly limited, and examples thereof include Tris buffer, phosphate buffer, acetate buffer, and borate buffer.
- the pH of the buffer solution is not particularly limited, and is, for example, in the range of pH 4 to 10, and preferably in the range of pH 6 to 9.
- the analyte in the sample is an antigen that binds to the above-described immobilized antibody and a labeled antibody described later.
- the antigen is not particularly limited.
- the sample solution may contain, for example, a buffer solution, a surfactant, an antibacterial agent, and the like.
- the buffer solution is not particularly limited, and examples thereof include the aforementioned buffer solution.
- the surfactant is not particularly limited, and examples thereof include an anionic surfactant, a nonionic surfactant, and an amphoteric surfactant.
- the antibacterial agent is not particularly limited, and examples thereof include sodium azide, 5-chloro-2-methyl-4-isothiazolin-3-one, and 2-methyl-4-isothiazolin-3-one.
- the enzyme-labeled antibody may be an enzyme-labeled antibody that binds to an antigen that is an analyte in the sample.
- Examples of the antibody of the enzyme-labeled antibody include antibodies against the above-mentioned various antigens and the like, and can be appropriately set according to the antigen or the like.
- Examples of the antibody include the antibodies exemplified as the antibody of the above-mentioned immobilized antibody.
- the enzyme of the enzyme-labeled antibody is not particularly limited, and examples thereof include peroxidase, alkaline phosphatase, ⁇ -D-galactosidase and the like.
- the method for preparing the enzyme-labeled antibody is not particularly limited, and for example, a conventionally known method may be used.
- the enzyme-labeled antibody may be preliminarily contained in the sample solution, for example, or may be impregnated in advance in the developing member or a pad provided separately. However, for example, it is preferable that the enzyme-labeled antibody is preliminarily contained in the sample liquid because analysis with higher sensitivity is possible without separately providing the pad or the like.
- the developing solution for example, Tris buffer solution, phosphate buffer solution, acetate buffer solution, borate buffer solution or the like may be used.
- a stabilizer, an antibacterial agent and the like may be appropriately added to the developing solution.
- the supply amount of the developing liquid can be appropriately set according to the supply amount of the specimen liquid, for example.
- the substrate is not particularly limited, and for example, a substrate that develops color or emits light in response to the enzyme is preferable.
- the type of the substrate is not particularly limited, and can be selected according to, for example, the type of enzyme in the enzyme-labeled antibody.
- ABTS 2,2′-azino-bis (3-ethylbenzothiazoline-6-sulfonic acid)
- TMB 3,3 ′, 5,5′-tetramethylbenzidine
- DAB diamino Bendidine
- BCIP 5-bromo-4-chloro-3-indolyl phosphate
- MIP 3,3 ′, 5,5′-tetramethylbenzidine
- DAB diamino Bendidine
- 5B diamino Bendidine
- BCIP 5-bromo-4-chloro-3-indolyl phosphate
- MIP 3,5-methylumbellylphenyl- ⁇ -D-galactoside
- AMGPD 3- (2'-spiroadamantane)- 4-methoxy-4- (3 ′′ - ⁇ -D-galactopyranosyl) phenyl-1,2-dioxetane
- the substrate can be introduced into the detection unit from the development solution supply unit through the sample supply unit, for example, by developing the development solution.
- the substrate may be preliminarily included in the developing solution, the substrate may be preliminarily included in the sample solution, or the developing member is impregnated with the substrate. You may leave it.
- the development member or the like is impregnated with the substrate, for example, the substrate is placed between the sample supply unit and the detection unit of the development member or between the development liquid supply unit and the sample supply unit. Or the like.
- FIG. 3A is a cross-sectional view of the sample analysis tool.
- FIG. 3B is a schematic diagram showing detection of an antigen in the detection unit.
- the sample liquid is supplied to the sample supply unit 13 through the sample supply port 18 (arrow a).
- the enzyme-labeled antibody may be pre-mixed in the sample solution before supply, or may be impregnated in the vicinity of the sample supply unit 13 of the development member 11 in advance.
- the developing solution is supplied through the developing solution supply port 17 to the developing solution supply unit 12 whose entire surface is covered with the hydrophilic component layer 15 (arrow b). At this time, since the entire surface of the developing solution supply unit 12 is covered with the hydrophilic component layer 15, the supplied developing solution is adversely affected by the hydrophobic component derived from the plastic case 16.
- the developing liquid that has permeated into the developing member 11 moves from the upstream side to the downstream side of the developing member 11 in the developing member 11 toward the detection unit 14 (leftward in the figure). expand.
- the substrate is impregnated in advance in the developing member 11 in the vicinity of the developing solution supply unit 12, the substrate moves toward the detecting unit 14 by the development of the developing solution.
- the said substrate may be previously mix
- the substrate 33, the sample liquid, and the enzyme-labeled antibody are immobilized on the antibody 33 by the development of the development solution (arrow d) in the development member 11 in the presence of the labeled antibody.
- the detection unit 14 is introduced. As shown in FIG. 3B, a complex 34 of the immobilized antibody 33, the antigen 32 that is the analyte of the sample, and the enzyme-labeled antibody 31 is formed in the detection unit 14. Then, the enzyme 35 in the complex 34 reacts with the substrate introduced into the detection unit 14 to generate color or light emission. In this manner, the detection unit 14 detects color development or luminescence generated by the reaction between the enzyme 35 and the substrate by observation from the window 19.
- the antigen 32 can be indirectly detected (quantitative analysis, semi-quantitative analysis, qualitative analysis, etc.).
- the detection may be performed by visual determination, for example, or may be performed using a colorimeter, a fluorometer, a photon counter, a photosensitive film, or the like.
- the sample analysis tool may further include, for example, a developing solution receiving pad and a waste solution absorbing pad in order to promote the development of the developing solution.
- the sample analysis tool may include a support, for example, in order to keep the shape stable. Specifically, for example, by arranging the developing member, the developing solution receiving pad, the waste solution absorbing pad, and the like on the support, each component member inside the sample analysis tool can be supported.
- the material of the developing solution receiving pad and the waste solution absorbing pad is not particularly limited, and examples thereof include polyethylene, glass fiber, rayon, nylon, paper, and cellulose.
- the shape and size of the developing solution receiving pad are not particularly limited, and can be appropriately set according to the shape of the developing member, for example.
- the material of the support is not particularly limited, and examples thereof include polyethylene terephthalate, polyethylene, polystyrene, polyester, and cellulose acetate.
- the shape of the support is not particularly limited, and examples thereof include a film shape, a sheet shape, and a plate shape.
- the shape and size of the support are not particularly limited, and can be set as appropriate according to the deployment member and the like.
- the developing member, the developing solution receiving pad, and the waste solution absorbing pad can be disposed on the support by a conventional method, for example. Specifically, for example, it may be fixed on the support using a double-sided tape or an adhesive.
- FIG. 4 is a cross-sectional view showing the configuration of another example of the sample analysis tool of this embodiment.
- the sample analysis tool 40 includes a developing member 41, a developing solution receiving pad 42, a waste solution absorbing pad 43, a support body 44, and a plastic case 46 as main components.
- the developing solution receiving pad 42 is disposed adjacent to the upstream side (right side in the figure) of the developing member 41.
- the waste liquid absorption pad 43 is disposed adjacent to the downstream side (left side in the figure) of the detection member 14 of the deployment member 41.
- the development member 41, the development liquid receiving pad 42, and the waste liquid absorption pad 43 are disposed on the support 44 and are accommodated in the plastic case 46 in this state.
- the plastic case 46 has a developing solution supply port 47, a sample supply port 48 and a window 49.
- the developing solution supply unit 12 is arranged on the developing solution receiving pad 42 arranged adjacent to the upstream side of the developing member 41 (integrated with the developing member 41).
- the hydrophilic component layer 15 is formed so as to cover the entire surface of the developing solution supply unit 12.
- the developing solution supply unit 12 is a predetermined region in the developing solution receiving pad 42.
- Other configurations are the same as those of the sample analysis tool 10 described above.
- the developing solution is supplied to the developing solution receiving pad 42 through the developing solution supply port 47. Except these, it is the same as the above-mentioned immunoassay method.
- the substrate may be included in the developing solution in advance, or may be impregnated in the developing solution receiving pad 42 in advance.
- the detection unit may include an immobilized antigen instead of the immobilized antibody.
- an immobilized antigen instead of the immobilized antibody.
- the antibody that is the analyte in the sample is not particularly limited and includes various antibodies.
- the antigen of the immobilized antigen may be any antigen that can bind to the antibody that is the analyte in the sample.
- the antibody of the enzyme-labeled antibody is not particularly limited as long as it is an antibody that binds to an antibody that is an analyte in the sample.
- the antigen of the enzyme-labeled antigen is not particularly limited as long as it is an antigen that binds to an antibody that is an analyte in the sample.
- conventionally known methods can be applied to the antibody preparation and labeling method in the enzyme-labeled antibody, and examples of the enzyme are the same as those described above.
- conventionally known methods can be applied to the method for preparing and labeling the antigen in the enzyme-labeled antigen, and examples of the enzyme are the same as those described above.
- Examples of the method for producing the immobilized antigen include conventionally known methods and are not particularly limited.
- a method for immobilizing the immobilized antigen to the detection unit for example, a conventionally known method can be used, and there is no particular limitation.
- the sample analysis tool of this embodiment is a sample analysis tool used in an immunoassay method using colored insoluble carrier particles as a label for a labeled antibody.
- the colored insoluble carrier particles are not particularly limited, and examples thereof include colored latex particles, metal colloid particles, colored polymethyl methacrylate particles, colored polylactic acid particles, colored porous glass particles, colored silica particles, colored agarose particles, colored dextran. Particles and the like.
- the colored latex particles are not particularly limited, and examples thereof include blue latex particles and red latex particles.
- the metal colloid particles are not particularly limited, and examples thereof include gold colloid particles and platinum colloid particles.
- the method for labeling the colored insoluble carrier particles with the antibody is not particularly limited.
- the colored insoluble carrier particles are suspended in a buffer solution, the antibody is added to the suspension, and the two are reacted.
- the buffer solution is not particularly limited, and examples thereof include the aforementioned buffer solution.
- a labeled antibody to which the colored insoluble carrier particles are bound may be preliminarily included in the sample liquid, or the colored insoluble carrier particles may be added to the developing member or a pad provided separately. You may impregnate the labeled antibody which couple
- the antigen is indirectly detected (quantitative analysis, semi-quantitative analysis, qualitative analysis, etc.) by detecting coloring due to aggregation of the colored insoluble carrier particles in the detection unit.
- no substrate is used.
- the detection may be performed by visual determination, for example, or by using a colorimeter or the like. The rest is the same as in the first embodiment.
- the sample analysis tool of this embodiment is a sample analysis tool used in an immunoassay method using a fluorescent dye as a label for a labeled antibody.
- the fluorescent dye is not particularly limited, and examples thereof include FITC.
- a fluorescent dye for example, the immobilized antibody, a complex of the antigen as the analyte and the labeled antibody, or the immobilized antigen, the antibody to be analyzed and the labeling
- the antibody or the labeled antigen By forming a complex of the antibody or the labeled antigen and irradiating the complex with excitation light, light emission of the labeled antibody or the fluorescent dye of the labeled antigen can be detected.
- the sample analysis tool of this embodiment is a sample analysis tool used for an analysis method in which a sample solution is reacted with a reagent contained in a reagent layer.
- the sample analysis tool 50 includes a developing member 51 having a sample supply unit 53, a reagent layer 54, and a pair of plastic base materials 56.
- a reagent layer 54 is disposed on the surface of the developing member 51 opposite to the sample supply unit 53.
- the pair of plastic base materials 56 sandwich the developing member 51 and the reagent layer 54.
- a hydrophilic component layer 55 is formed so as to cover the entire surface of the specimen supply unit 53.
- the hydrophilic component layer 55 is made of the pair of plastics of the developing member 51.
- the form of being formed in the contact part with the base material 56 may be sufficient. Even in such a form, it is possible to prevent the hydrophobic component derived from the plastic substrate from adhering to the specimen supply unit.
- the hydrophilic component layer 55 is formed on both the sample supply unit 53 and the contact unit. It may be in the form of being.
- the plastic base material 56 is a pair, but the present invention is not limited to this example.
- the plastic base material having a different shape is used as the developing member and the reagent. You may form so that a layer may be pinched
- the spreading member and the hydrophilic component layer are the same as described above.
- the reagent layer is, for example, a porous member impregnated with a reagent and dried.
- a conventionally well-known thing can be used as said porous member.
- the kind of the reagent to be impregnated is appropriately determined according to the analysis object in the specimen described later.
- the material of the pair of plastic base materials is not particularly limited, and examples thereof include the same plastic case or support as described above.
- the pair of plastic base materials 56 has a shape that sandwiches the developing member 51 and the reagent layer 54.
- the shape of the plastic base material is not particularly limited, and for example, a film
- the sheet may be in the form of a sheet, a sheet, or a plate, or may be stacked on the developing member 51 and the reagent layer 54 to support the developing member 51 and the reagent layer 54.
- Specimen analysis using the specimen analysis tool of this embodiment can be performed as follows. First, a sample solution is supplied to the sample supply unit 53. At this time, since the entire surface of the specimen supply unit 53 is covered with the hydrophilic component layer 55, the supplied specimen liquid is not adversely affected by the hydrophobic component derived from the plastic substrate 56. And it penetrates rapidly into the developing member 51 while dissolving the hydrophilic component of the hydrophilic component layer 55. Next, when the sample liquid comes into contact with the reagent layer 54, the test object in the sample liquid reacts with the reagent to cause color development or color change. The detection of color development, color tone change, and the like may be performed by visual determination, or may be performed using a colorimeter or the like.
- the sample solution only needs to contain a sample.
- the analyte in the specimen include glucose, cholesterol, triglyceride, ammonia, uric acid, creatinine, urea nitrogen, calcium, inorganic phosphorus, magnesium, GGT, GOT, GPT, LDH, amylase, total protein, albumin, Examples include fructosamine, creatine phosphokinase, pyrilvin, alkaline phosphatase, HDL and the like.
- the sample analysis tool 40 having the configuration shown in FIG. 4 was produced by the following procedure. That is, first, a porous material made of nitrocellulose having a length of 50 mm, a width of 4 mm, and a thickness of 5 ⁇ m is a developing member 41, and is made of glass fiber having a length of 20 mm, a width of 4 mm, and a thickness of 0.5 mm.
- the material is a developing solution receiving pad 42, a length: 25 mm, a width: 4 mm, a thickness: 1.5 mm, a porous material made of cellulose, a waste liquid absorbing pad 43, and a length: 80 mm, width: 4 mm backing sheet (PET).
- Example 2 A sample analysis tool 40 of this example was produced in the same manner as in Example 1 except that 16 ⁇ L of a 5% by weight sucrose aqueous solution was applied.
- Example 3 A sample analysis tool 40 of this example was produced in the same manner as in Example 1 except that 16 ⁇ L of 5 wt% N-methylglucosamine aqueous solution was applied.
- Example 4 A sample analysis tool 40 of this example was produced in the same manner as in Example 1 except that 16 ⁇ L of a 1% by weight sodium dodecyl sulfate (SDS) aqueous solution was applied.
- SDS sodium dodecyl sulfate
- Example 5 A sample analysis tool 40 of this example was produced in the same manner as in Example 1 except that 16 ⁇ L of a 1% by weight polyvinylpyrrolidone aqueous solution was applied.
- Example 1 A sample analysis tool of this comparative example was produced in the same manner as in Example 1 except that the hydrophilic component layer 15 was not formed.
- Comparative Example 2 A sample analysis tool of this comparative example was produced in the same manner as in Example 1 except that 16 ⁇ L of water was applied.
- sample solution 10 ⁇ L of egg white specific IgE positive serum and 60 ⁇ L of alkaline phosphatase labeled antibody (enzyme labeled antibody, 10 ⁇ g, derived from goat) in 50 mmol / L Tris-HCl buffer (pH: 7.4) ) To prepare a sample solution.
- the immunoassay method was performed as follows using the sample analysis tool of each example and each comparative example. That is, first, 10 ⁇ L of the sample liquid was supplied to the sample supply unit 13 through the sample supply port 48. Next, 100 ⁇ L of the developing solution was supplied to the developing solution supply unit 12 through the developing solution supply port 47.
- the color development line of the detection unit 14 was analyzed using an immunoanalyzer (trade name “Spotchem IL SL-4720” manufactured by ARKRAY, Inc.).
- the analysis result is displayed as a numerical value of 0 to 6, or “E”, depending on the density of the color development line.
- the numerical value is displayed as “2 to 6”, it indicates that a colored line was confirmed and analyzed as positive (+).
- the numerical value is displayed as “0 or 1”, or when “E” is displayed, it indicates that the color development line was not confirmed and the analysis was negative ( ⁇ ).
- the developing solution penetrates into the developing member 11 1 minute after the supply of the developing solution.
- the permeability was good.
- Comparative Example 1 in which the hydrophilic component layer 15 is not formed and Comparative Example 2 to which water is applied, the sample is developed even after 20 minutes from the supply of the developing solution.
- the liquid did not penetrate into the developing member 11 and remained in the developing liquid supply unit 12 in the form of water droplets. That is, the permeability of the developing solution was poor.
- the present invention can be suitably used for detection of specific substances (quantitative analysis, semi-quantitative analysis, qualitative analysis, etc.) contained in, for example, whole blood, serum, plasma, saliva, urine, spinal fluid and the like.
- specific substances quantitative analysis, semi-quantitative analysis, qualitative analysis, etc.
- the present invention can be applied to fields such as clinical tests, biochemical tests, medical research, and the like, and its application is not limited and can be applied to a wide range of fields.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Chemical & Material Sciences (AREA)
- Urology & Nephrology (AREA)
- Biotechnology (AREA)
- Biochemistry (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Microbiology (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Automatic Analysis And Handling Materials Therefor (AREA)
- Sampling And Sample Adjustment (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
Description
展開部材と、プラスチック基材とを備え、
前記展開部材の少なくとも一部が、前記プラスチック基材と接触しており、
さらに、親水性成分層を有し、
前記プラスチック基材の表面および前記展開部材の表面の少なくとも一方の一部または全部に、前記親水性成分層が形成されていることを特徴とする。
展開部材の少なくとも一部が、プラスチック基材と接触した検体分析用具を製造する方法であって、
前記プラスチック基材の表面および展開部材の表面の少なくとも一方の一部または全部に、親水性成分層を形成する親水性成分層形成ステップを含むことを特徴とする。
展開部材と、プラスチック基材とを備え、
前記プラスチック基材が、疎水性成分を含み、
前記展開部材の少なくとも一部が、前記プラスチック基材と接触している検体分析用具における、前記プラスチック基材の表面および前記展開部材の表面の少なくとも一方の一部または全部に、親水性成分層を形成し、
前記展開部材への前記疎水性成分の付着を、前記親水性成分層により防止することで、前記展開部材への液体の浸透性の低下を抑制することを特徴とする。
本実施形態の検体分析用具は、前記「固定化された特異的結合物質」として固定化抗体を用い、前記「標識化された特異的結合物質」として、酵素を標識として用いた標識化抗体(酵素標識化抗体)を用いた免疫分析方法(酵素免疫分析方法)に用いる検体分析用具である。
本実施形態の検体分析用具は、標識化抗体の標識として、着色不溶性担体粒子を用いた免疫分析方法に用いる検体分析用具である。
本実施形態の検体分析用具は、標識化抗体の標識として、蛍光色素を用いた免疫分析方法に用いる検体分析用具である。
本実施形態の検体分析用具は、検体液を、試薬層に含まれる試薬と反応させる分析方法に用いる検体分析用具である。
〔検体分析用具の作製〕
下記の手順により、図4に示す構成の検体分析用具40を作製した。すなわち、まず、長さ:50mm、幅:4mm、厚み:5μmのニトロセルロース製の多孔質材を展開部材41、長さ:20mm、幅:4mm、厚み:0.5mmのガラス繊維製の多孔質材を展開液受取パッド42、長さ:25mm、幅:4mm、厚み:1.5mmのセルロース製の多孔質材を廃液吸収パッド43、および長さ:80mm、幅:4mmのバッキングシート(PET)を支持体44として、それぞれ準備した。前記展開部材41の一端(図4における右側端部)から30mmの位置に卵白アレルゲン抽出蛋白質水溶液(1mg/mL(5mmol/L)ホウ酸緩衝液(pH8.5)で希釈後、透析した水溶液)を、幅1mmとなるように塗布した。このようにして、前記展開部材41表面に、検出部14を形成した。また、前記展開液受取パッド42の一端(図4における右側端部)から10mmの位置に、基質として、5-ブロモ-4-クロロ-3-インドリルリン酸(20mg/mL、ベーリンガーマンハイム社製、商品名「BCIP」)5μLを塗布し、37℃で1時間放置して乾燥させた。ついで、前記展開液受取パッド42の前記展開液供給部12の全部を覆うように、塗布装置を用いて、1重量%のスクロース水溶液16μLを塗布し(塗布面積:4~8mm2)、乾燥させ、前記展開液受取パッド42に、親水性成分層15を形成した。これらの部材を、図4に示すように、プラスチックケース46内に収容し、本実施例の検体分析用具40を作製した。ついで、本実施例の検体分析用具40を、60℃で1週間保管した。
5重量%のスクロース水溶液16μLを塗布したこと以外は、実施例1と同様にして、本実施例の検体分析用具40を作製した。
5重量%のN-メチルグルコースアミン水溶液16μLを塗布したこと以外は、実施例1と同様にして、本実施例の検体分析用具40を作製した。
1重量%のドデシル硫酸ナトリウム(SDS)水溶液16μLを塗布したこと以外は、実施例1と同様にして、本実施例の検体分析用具40を作製した。
1重量%のポリビニルピロリドン水溶液16μLを塗布したこと以外は、実施例1と同様にして、本実施例の検体分析用具40を作製した。
親水性成分層15を形成しなかったこと以外は、実施例1と同様にして、本比較例の検体分析用具を作製した。
水16μLを塗布したこと以外は、実施例1と同様にして、本比較例の検体分析用具を作製した。
(1)検体液の調製
50mmol/L Tris-HCl緩衝液(pH:7.4)に、10μLの卵白特異IgE陽性血清、および60μLのアルカリホスファターゼ標識化抗体(酵素標識化抗体、10μg、ヤギ由来)を含ませて、検体液を調製した。
100mmol/L 炭酸ナトリウム/炭酸水素ナトリウム緩衝液(pH10.0)を調製した。この緩衝液を展開液とした。
各実施例および各比較例の検体分析用具を用いて、以下のようにして免疫分析方法を行った。すなわち、まず、前記検体供給口48を通して、前記検体供給部13に、前記検体液10μLを供給した。ついで、前記展開液供給口47を通して、前記展開液供給部12に、前記展開液100μLを供給した。
展開液の供給から、1分後および20分後に、前記展開液供給部12を目視で観察することにより、展開液の浸透性を、下記の評価基準に従って評価した。
G :前記展開液が、完全に浸透した。
NG:前記展開液が、完全には浸透せず、残存していた。
展開液の供給から、20分後に、前記検出部14の発色ラインを、免疫分析装置(アークレイ(株)製、商品名「スポットケムIL SL-4720」)を用いて分析を行った。前記免疫分析装置では、前記発色ラインの濃さに応じて、前記分析結果が0~6の数値、または「E」で表示される。なお、前記数値が「2~6」と表示された場合、発色ラインが確認され、陽性(+)と分析されたことを示す。一方、前記数値が「0または1」と表示された場合、または「E」が表示された場合は、発色ラインが確認されず、陰性(-)と分析されたことを示す。
実施例1 実施例2 実施例3 実施例4 実施例5
浸透性評価
1分後 G G G G G
20分後 G G G G G
免疫分析評価 + + + + +
(装置の表示) (3) (3) (3) (3) (3)
比較例1 比較例2
浸透性評価
1分後 NG NG
20分後 NG NG
免疫分析評価 - -
(装置の表示) (E) (E)
11、41、51、61 展開部材
12、62 展開液供給部
13、53、63 検体供給部
14、64 検出部
15、55 親水性成分層
16、46、66 プラスチックケース
17、47、67 展開液供給口
18、48、68 検体供給口
19、49、69 窓
31 酵素標識化抗体
32 抗原
33 固定化抗体
34 複合体
35 酵素
42 展開液受取パッド
43 廃液吸収パッド
44 支持体
54 試薬層
56 一対のプラスチック基材
a、b、c、d 矢印
Claims (23)
- 展開部材と、プラスチック基材とを備え、
前記展開部材の少なくとも一部が、前記プラスチック基材と接触しており、
さらに、親水性成分層を有し、
前記プラスチック基材の表面および前記展開部材の表面の少なくとも一方の一部または全部に、前記親水性成分層が形成されていることを特徴とする検体分析用具。 - 前記展開部材の前記プラスチック基材との接触部の一部または全部に、前記親水性成分層が形成されている、請求の範囲1記載の検体分析用具。
- 前記展開部材が、液体供給部を有し、
前記液体供給部の表面の一部または全部に、前記親水性成分層が形成されている、請求の範囲1または2記載の検体分析用具。 - 前記展開部材の前記プラスチック基材との接触部が、前記液体供給部を含む、請求の範囲3記載の検体分析用具。
- 前記液体供給部が、展開液供給部および検体供給部を有し、
前記展開液供給部の表面および前記検体供給部の表面の少なくとも一方の一部または全部に、前記親水性成分層が形成されている、請求の範囲3または4記載の検体分析用具。 - 前記親水性成分層が、不揮発性の親水性成分を含む、請求の範囲1から5のいずれか一項に記載の検体分析用具。
- 前記親水性成分層が、糖類、水溶性ポリマー、界面活性剤、コロイド粒子、無機粒子からなる群から選択される少なくとも一つの成分を含む、請求の範囲1から5のいずれか一項に記載の検体分析用具。
- 前記糖類が、スクロースおよびN-メチルグルコースアミンの少なくとも一方を含む、請求の範囲7記載の検体分析用具。
- 前記プラスチック基材が、プラスチックケースを含み、
前記展開部材が、前記プラスチックケース内に配置されている、請求の範囲1から8のいずれか一項に記載の検体分析用具。 - 検体を含む検体液および展開液が、それぞれ、前記検体供給部および前記展開液供給部から供給される、請求の範囲5から9のいずれか一項に記載の検体分析用具。
- 前記展開部材が、さらに、検出部を有し、
前記展開部材に、前記展開液供給部、前記検体供給部および前記検出部が、展開液の流れの上流から下流にかけて、前記順序で配置されており、
前記検出部には、検体中の分析対象物に特異的に結合する物質が固定化されており、
前記検体供給部に、検体含む検体液が供給され、
前記展開液供給部に、前記展開液が供給され、
前記分析対象物に特異的に結合する標識化物質の存在下、前記供給された展開液の前記展開部材における展開により、前記供給された検体液が前記検出部に導入され、
前記検出部において、前記固定化された特異的結合物質、前記分析対象物、および前記標識化された特異的結合物質の複合体が形成され、
前記複合体における前記標識の検出により、前記分析対象物の分析が行われる、請求の範囲5から10のいずれか一項に記載の検体分析用具。 - 前記特異的結合物質が、抗原または抗体である、請求の範囲11記載の検体分析用具。
- 前記プラスチック基材が、前記展開部材を挟持するように形成されている、請求の範囲1から8のいずれか一項に記載の検体分析用具。
- さらに、試薬層を備え、
前記プラスチック基材が、前記展開部材および前記試薬層を挟持するように形成されている、請求の範囲13記載の検体分析用具。 - 前記プラスチック基材が、疎水性成分を含む、請求の範囲1から14のいずれか一項に記載の検体分析用具。
- 展開部材の少なくとも一部が、プラスチック基材と接触した検体分析用具を製造する方法であって、
前記プラスチック基材の表面および前記展開部材の表面の少なくとも一方の一部または全部に、親水性成分層を形成する親水性成分層形成ステップを含むことを特徴とする検体分析用具の製造方法。 - 前記親水性成分層形成ステップにおいて、
前記展開部材の前記プラスチック基材との接触部の一部または全部に、前記親水性成分層を形成する、請求の範囲16記載の検体分析用具の製造方法。 - 前記展開部材が、液体供給部を有し、
前記親水性成分層形成ステップにおいて、
前記液体供給部の表面の一部または全部に、前記親水性成分層を形成する、請求の範囲16または17記載の検体分析用具の製造方法。 - 前記展開部材の前記プラスチック基材との接触部が、前記液体供給部を含む、請求の範囲18記載の検体分析用具の製造方法。
- 前記液体供給部が、展開液供給部および検体供給部を有し、
前記親水性成分層形成ステップにおいて、
前記展開液供給部の表面および前記検体供給部の表面の少なくとも一方の一部または全部に、前記親水性成分層を形成する、請求の範囲18または19記載の検体分析用具の製造方法。 - 展開部材と、プラスチック基材とを備え、
前記プラスチック基材が、疎水性成分を含み、
前記展開部材の少なくとも一部が、前記プラスチック基材と接触している検体分析用具における、前記プラスチック基材の表面および前記展開部材の表面の少なくとも一方の一部または全部に、親水性成分層を形成し、
前記展開部材への前記疎水性成分の付着を、前記親水性成分層により防止することで、前記展開部材への液体の浸透性の低下を抑制することを特徴とする展開部材の液体浸透性低下抑制方法。 - 前記展開部材が、液体供給部を有し、
前記液体供給部の少なくとも一部と前記プラスチック基材とが接触している検体分析用具における、前記液体供給部の表面の一部または全部に、前記親水性成分層を形成する、請求の範囲21記載の展開部材の液体浸透性低下抑制方法。 - 前記液体供給部が、展開液供給部および検体供給部を有する検体分析用具における、前記展開液供給部の表面および前記検体供給部の表面の少なくとも一方の一部または全部に、前記親水性成分層を形成する、請求の範囲22記載の展開部材の液体浸透性低下抑制方法。
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201080016057.0A CN102388310B (zh) | 2009-04-09 | 2010-04-05 | 抑制展开部件的液体浸透性降低的方法 |
JP2011508358A JP5793075B2 (ja) | 2009-04-09 | 2010-04-05 | 検体分析用具、検体分析用具の製造方法および展開部材の液体浸透性低下抑制方法 |
US13/263,729 US9903864B2 (en) | 2009-04-09 | 2010-04-05 | Sample analysis tool, method for producing sample analysis tool, and method for inhibiting decrease in liquid permeability of development member |
EP10761678.1A EP2418488B1 (en) | 2009-04-09 | 2010-04-05 | Sample analyzing tool, method of manufacturing sample analyzing tool, and method of minimizing drop in solution permeability of deployment member |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2009-094836 | 2009-04-09 | ||
JP2009094836 | 2009-04-09 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2010116979A1 true WO2010116979A1 (ja) | 2010-10-14 |
Family
ID=42936262
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2010/056187 WO2010116979A1 (ja) | 2009-04-09 | 2010-04-05 | 検体分析用具、検体分析用具の製造方法および展開部材の液体浸透性低下抑制方法 |
Country Status (5)
Country | Link |
---|---|
US (1) | US9903864B2 (ja) |
EP (1) | EP2418488B1 (ja) |
JP (2) | JP5793075B2 (ja) |
CN (1) | CN102388310B (ja) |
WO (1) | WO2010116979A1 (ja) |
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103033610A (zh) * | 2011-09-29 | 2013-04-10 | 富士胶片株式会社 | 色谱试剂盒及色谱方法 |
WO2015152312A1 (ja) * | 2014-04-04 | 2015-10-08 | 田中貴金属工業株式会社 | 免疫クロマト分析方法 |
JP2017523433A (ja) * | 2014-08-08 | 2017-08-17 | オーソ−クリニカル・ダイアグノスティックス・インコーポレイテッドOrtho−Clinical Diagnostics, Inc. | 流動狭窄部を有するラテラルフローアッセイデバイス |
JP2017525951A (ja) * | 2014-07-25 | 2017-09-07 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | 検体試験ストリップアッセイおよび試験ストリップならびにその実施における使用のためのキット |
JP6426872B1 (ja) * | 2018-08-02 | 2018-11-21 | 積水メディカル株式会社 | イムノクロマト用試験片及びイムノクロマト検出キット |
WO2019093353A1 (ja) * | 2017-11-08 | 2019-05-16 | 株式会社カネカ | 検査用デバイス |
JP2019083772A (ja) * | 2017-11-08 | 2019-06-06 | 株式会社カネカ | 検査用デバイス |
JP2019083773A (ja) * | 2017-11-08 | 2019-06-06 | 株式会社カネカ | 検査用デバイス |
WO2020105079A1 (ja) | 2018-11-19 | 2020-05-28 | 積水メディカル株式会社 | イムノクロマト用試験片及びイムノクロマト検出キット |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP6595439B2 (ja) * | 2015-12-09 | 2019-10-23 | アークレイ株式会社 | 分析用具および分析システム |
KR102631862B1 (ko) * | 2021-12-21 | 2024-01-30 | 주식회사 미리메딕스 | 면역 크로마토그래피 검사의 감도 향상을 위한 방법 |
Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH10505909A (ja) * | 1994-09-23 | 1998-06-09 | ユニパス・リミテツド | 不織試料採集領域をもつ検定装置 |
JPH10177028A (ja) * | 1996-12-18 | 1998-06-30 | Nippon Kayaku Co Ltd | 乳頭分泌液中の特定物質の測定方法 |
WO2002040999A1 (fr) * | 2000-11-20 | 2002-05-23 | Matsushita Electric Industrial Co., Ltd. | Diagnostics extrasomatiques |
WO2005007698A1 (ja) * | 2003-07-23 | 2005-01-27 | Fujirebio Inc. | 抗インフルエンザb型ウイルスモノクローナル抗体及び該抗体を用いる免疫測定器具 |
JP2007524813A (ja) * | 2003-06-06 | 2007-08-30 | アドバンテイジ ダイアグノスティックス コーポレイション | サンプル中の分析物についての診断試験 |
JP2007218593A (ja) * | 2006-02-14 | 2007-08-30 | Bl:Kk | バイオピリン検出用イムノクロマトグラフィー測定方法及び装置 |
JP2007248073A (ja) * | 2006-03-13 | 2007-09-27 | Fujirebio Inc | 免疫測定用吸収パッド、免疫測定用ストリップ及び免疫測定装置 |
JP2008116235A (ja) * | 2006-11-01 | 2008-05-22 | Arkray Inc | イムノクロマトグラフ検体分析用具 |
JP2008544282A (ja) * | 2005-06-22 | 2008-12-04 | アドヒーシブズ・リサーチ・インコーポレーテッド | 分子インプリントポリマー及び診断デバイスにおけるその使用 |
Family Cites Families (34)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3640318A1 (de) | 1986-11-26 | 1988-06-09 | Boehringer Mannheim Gmbh | Verfahren und testtraeger zur bestimmung eines analyten |
DE3733084A1 (de) | 1987-09-30 | 1989-04-13 | Boehringer Mannheim Gmbh | Testtraeger zur analytischen bestimmung eines bestandteils einer koerperfluessigkeit |
EP0310940B1 (en) | 1987-09-30 | 1994-11-23 | Fujirebio Kabushiki Kaisha | Analytical element for enzyme immunoassays |
JPH087216B2 (ja) * | 1987-09-30 | 1996-01-29 | 富士写真フイルム株式会社 | 乾式免疫分析要素 |
US4876076A (en) | 1988-02-10 | 1989-10-24 | Tampa Electric Company | Process of desulfurization |
GB8903627D0 (en) | 1989-02-17 | 1989-04-05 | Unilever Plc | Assays |
CA2025476A1 (en) | 1989-09-27 | 1991-03-28 | Shan F. Ching | Hydrophilic laminated porous membranes and methods of preparing same |
DE4015589A1 (de) | 1990-05-15 | 1991-11-21 | Boehringer Mannheim Gmbh | Vorrichtung und deren verwendung zur abtrennung von plasma aus vollblut |
DE59208894D1 (de) | 1991-12-02 | 1997-10-16 | Riemschneider Randolph Prof Dr | Wässrige synthetische Organextrakte |
DK88293A (da) | 1992-08-03 | 1994-02-04 | Becton Dickinson Co | Fastfaseanalyse |
US5756362A (en) | 1993-10-12 | 1998-05-26 | Cornell Research Foundation, Inc. | Liposome-enhanced immunoaggregation assay and test device |
JP3498188B2 (ja) | 1994-03-30 | 2004-02-16 | アークレイ株式会社 | 液体中成分の分析用試験片の製造方法 |
US5846359A (en) | 1995-02-10 | 1998-12-08 | Kyoto Daiichi Kagaku Co., Ltd. | Ultrasonic direct fixing of reagent layer and method for preparing peel type test piece |
JP3438050B2 (ja) | 1995-02-10 | 2003-08-18 | アークレイ株式会社 | 超音波による試薬層の直接固定方法 |
US6303081B1 (en) * | 1998-03-30 | 2001-10-16 | Orasure Technologies, Inc. | Device for collection and assay of oral fluids |
JP4171135B2 (ja) | 1999-04-28 | 2008-10-22 | 積水化学工業株式会社 | 免疫クロマトグラフィー装置 |
JP2001083152A (ja) * | 1999-09-16 | 2001-03-30 | Fuji Photo Film Co Ltd | 乾式免疫分析方法及び乾式分析要素 |
JP2001249133A (ja) | 2000-03-03 | 2001-09-14 | Nitto Denko Corp | 免疫学的検査片 |
CN1327159A (zh) * | 2000-06-05 | 2001-12-19 | 刘永详 | 测定被糖化蛋白的免疫分析方法、试剂及其装置 |
JP4268358B2 (ja) * | 2001-12-18 | 2009-05-27 | 株式会社トクヤマデンタル | 抗体および免疫学的測定方法 |
WO2003062824A1 (en) | 2002-01-23 | 2003-07-31 | Boditech Inc. | Lateral flow quantitative assay method and strip and laser-induced fluoerescence detection device therefor |
JP2003304868A (ja) | 2002-04-17 | 2003-10-28 | Sanyo Chem Ind Ltd | ポリペプチド含有基材 |
JP3920741B2 (ja) | 2002-08-28 | 2007-05-30 | 森永乳業株式会社 | 物質の検出試薬及び検出方法 |
US6927062B2 (en) * | 2002-11-25 | 2005-08-09 | Agdia, Inc. | Controls and standards for assays and method for manufacture thereof |
JP4030438B2 (ja) | 2003-01-29 | 2008-01-09 | 株式会社トクヤマ | 免疫学的測定方法および免疫クロマトグラフィー法測定キット。 |
JP2005061910A (ja) | 2003-08-08 | 2005-03-10 | Fujirebio Inc | Hiv抗原抗体測定用免疫測定器具及び測定方法 |
JPWO2005106463A1 (ja) | 2004-04-30 | 2008-03-21 | アークレイ株式会社 | 検体分析用具 |
JP4339200B2 (ja) * | 2004-07-26 | 2009-10-07 | 三菱化学メディエンス株式会社 | イムノクロマトグラフ装置用試料供給要素 |
JP2008519757A (ja) | 2004-11-12 | 2008-06-12 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフトング | 抗egfr抗体の固形物 |
CN101078726A (zh) * | 2005-09-05 | 2007-11-28 | 因韦尔尼斯医药瑞士股份有限公司 | 一种检测免疫球蛋白的装置 |
WO2007061793A2 (en) | 2005-11-18 | 2007-05-31 | THE GOVERNMENT OF THE UNITED STATES OF AMERICA as represented by THE SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMAN SCIENCES, CENTERS FOR DISEASE CONTROL AND PREVENTION | Modified cardiolipin and uses therefor |
JP2009086378A (ja) | 2007-09-28 | 2009-04-23 | Fujifilm Corp | 光学補償フィルム、偏光板及び液晶表示装置 |
US9110058B2 (en) | 2008-06-30 | 2015-08-18 | Sekisui Medical Co., Ltd. | Porous solid phase for binding assay, and binding assay method using the same |
CN101403758B (zh) * | 2008-10-20 | 2013-07-24 | 马义才 | 三聚氰胺快速检测试剂盒 |
-
2010
- 2010-04-05 US US13/263,729 patent/US9903864B2/en active Active
- 2010-04-05 CN CN201080016057.0A patent/CN102388310B/zh active Active
- 2010-04-05 EP EP10761678.1A patent/EP2418488B1/en not_active Revoked
- 2010-04-05 JP JP2011508358A patent/JP5793075B2/ja active Active
- 2010-04-05 WO PCT/JP2010/056187 patent/WO2010116979A1/ja active Application Filing
-
2015
- 2015-05-01 JP JP2015094064A patent/JP2015135351A/ja not_active Withdrawn
Patent Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH10505909A (ja) * | 1994-09-23 | 1998-06-09 | ユニパス・リミテツド | 不織試料採集領域をもつ検定装置 |
JPH10177028A (ja) * | 1996-12-18 | 1998-06-30 | Nippon Kayaku Co Ltd | 乳頭分泌液中の特定物質の測定方法 |
WO2002040999A1 (fr) * | 2000-11-20 | 2002-05-23 | Matsushita Electric Industrial Co., Ltd. | Diagnostics extrasomatiques |
JP2007524813A (ja) * | 2003-06-06 | 2007-08-30 | アドバンテイジ ダイアグノスティックス コーポレイション | サンプル中の分析物についての診断試験 |
WO2005007698A1 (ja) * | 2003-07-23 | 2005-01-27 | Fujirebio Inc. | 抗インフルエンザb型ウイルスモノクローナル抗体及び該抗体を用いる免疫測定器具 |
JP2008544282A (ja) * | 2005-06-22 | 2008-12-04 | アドヒーシブズ・リサーチ・インコーポレーテッド | 分子インプリントポリマー及び診断デバイスにおけるその使用 |
JP2007218593A (ja) * | 2006-02-14 | 2007-08-30 | Bl:Kk | バイオピリン検出用イムノクロマトグラフィー測定方法及び装置 |
JP2007248073A (ja) * | 2006-03-13 | 2007-09-27 | Fujirebio Inc | 免疫測定用吸収パッド、免疫測定用ストリップ及び免疫測定装置 |
JP2008116235A (ja) * | 2006-11-01 | 2008-05-22 | Arkray Inc | イムノクロマトグラフ検体分析用具 |
Non-Patent Citations (1)
Title |
---|
See also references of EP2418488A4 * |
Cited By (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103033610A (zh) * | 2011-09-29 | 2013-04-10 | 富士胶片株式会社 | 色谱试剂盒及色谱方法 |
WO2015152312A1 (ja) * | 2014-04-04 | 2015-10-08 | 田中貴金属工業株式会社 | 免疫クロマト分析方法 |
JP2015200517A (ja) * | 2014-04-04 | 2015-11-12 | 田中貴金属工業株式会社 | 免疫クロマト分析方法 |
US10591470B2 (en) | 2014-04-04 | 2020-03-17 | Tanaka Kikinzoku Kogyo K.K. | Immunochromatographic analysis method |
JP2017525951A (ja) * | 2014-07-25 | 2017-09-07 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | 検体試験ストリップアッセイおよび試験ストリップならびにその実施における使用のためのキット |
JP2017523433A (ja) * | 2014-08-08 | 2017-08-17 | オーソ−クリニカル・ダイアグノスティックス・インコーポレイテッドOrtho−Clinical Diagnostics, Inc. | 流動狭窄部を有するラテラルフローアッセイデバイス |
WO2019093353A1 (ja) * | 2017-11-08 | 2019-05-16 | 株式会社カネカ | 検査用デバイス |
JP2019083772A (ja) * | 2017-11-08 | 2019-06-06 | 株式会社カネカ | 検査用デバイス |
JP2019083773A (ja) * | 2017-11-08 | 2019-06-06 | 株式会社カネカ | 検査用デバイス |
US11702650B2 (en) | 2017-11-08 | 2023-07-18 | Kaneka Corporation | Chromatographic test device |
JP2020020724A (ja) * | 2018-08-02 | 2020-02-06 | 積水メディカル株式会社 | イムノクロマト用試験片及びイムノクロマト検出キット |
JP6426872B1 (ja) * | 2018-08-02 | 2018-11-21 | 積水メディカル株式会社 | イムノクロマト用試験片及びイムノクロマト検出キット |
WO2020105079A1 (ja) | 2018-11-19 | 2020-05-28 | 積水メディカル株式会社 | イムノクロマト用試験片及びイムノクロマト検出キット |
Also Published As
Publication number | Publication date |
---|---|
EP2418488B1 (en) | 2015-08-12 |
US20120034140A1 (en) | 2012-02-09 |
JPWO2010116979A1 (ja) | 2012-10-18 |
JP2015135351A (ja) | 2015-07-27 |
EP2418488A4 (en) | 2012-09-26 |
US9903864B2 (en) | 2018-02-27 |
CN102388310A (zh) | 2012-03-21 |
EP2418488A1 (en) | 2012-02-15 |
JP5793075B2 (ja) | 2015-10-14 |
CN102388310B (zh) | 2014-07-16 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP5793075B2 (ja) | 検体分析用具、検体分析用具の製造方法および展開部材の液体浸透性低下抑制方法 | |
EP2376906B1 (en) | Method for amplification of signal in immunochromatographic assay and immunochromatographic kit using the method | |
US8802426B2 (en) | Method and device for assay | |
US8999730B2 (en) | Immunochromatography method | |
JP5340575B2 (ja) | イムノクロマトグラフィー用試験具 | |
JP2006189317A (ja) | イムノクロマトグラフ法用試験具 | |
KR19990029688A (ko) | 면역 크로마토그라피장치 | |
US20070092978A1 (en) | Target ligand detection | |
CN112513613A (zh) | 用于放大侧向流动测定信号的系统、装置和方法 | |
JP5066498B2 (ja) | アッセイ方法 | |
EP2784509B1 (en) | Chromatography method, and chromatography kit | |
JP5509198B2 (ja) | 分析方法、検体液の逆流防止方法およびバックグラウンド上昇の防止方法 | |
JP2012137326A (ja) | 検体分析用具 | |
JP2001021564A (ja) | 乾式分析方法及び乾式分析要素 | |
JP2010060297A (ja) | 免疫分析方法およびそれに用いる検体分析用具 | |
JP2018091678A (ja) | 分析方法及び分析用具 | |
JP2008116235A (ja) | イムノクロマトグラフ検体分析用具 | |
WO2024122616A1 (ja) | イムノクロマト法検査デバイスの試料展開部の形成方法およびイムノクロマト法検査デバイス | |
JP5265423B2 (ja) | クロマトグラフ方法 | |
JP2018091679A (ja) | 分析用具及び分析方法 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
WWE | Wipo information: entry into national phase |
Ref document number: 201080016057.0 Country of ref document: CN |
|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 10761678 Country of ref document: EP Kind code of ref document: A1 |
|
ENP | Entry into the national phase |
Ref document number: 2011508358 Country of ref document: JP Kind code of ref document: A |
|
WWE | Wipo information: entry into national phase |
Ref document number: 13263729 Country of ref document: US |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2010761678 Country of ref document: EP |