WO2010108310A1 - 流体检测试片及其制造方法 - Google Patents
流体检测试片及其制造方法 Download PDFInfo
- Publication number
- WO2010108310A1 WO2010108310A1 PCT/CN2009/070941 CN2009070941W WO2010108310A1 WO 2010108310 A1 WO2010108310 A1 WO 2010108310A1 CN 2009070941 W CN2009070941 W CN 2009070941W WO 2010108310 A1 WO2010108310 A1 WO 2010108310A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- detecting test
- flow path
- fluid detecting
- test strip
- fluid
- Prior art date
Links
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
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/25—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving enzymes not classifiable in groups C12Q1/26 - C12Q1/66
-
- 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
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
Definitions
- the present invention relates to a test strip, and more particularly to a fluid test strip for use in biochemical detection and immunoassay.
- BACKGROUND OF THE INVENTION In a known technique for performing biochemical detection and immunodetection using a fluid detecting test piece, the fluid detecting test piece is designed with a concave flow path or a start channel structure on its substrate or substrate, and is matched with surface affinity/hydrophobicity.
- the fluid to be tested can flow in the flow channel without overflowing the flow channel, but because the fluid around the flow channel is not absorbent material, and the fluid to be tested is mostly composed of a highly viscous composition such as protein or sugar, when it is to be tested After the fluid flows, it will remain around the flow path, so that the fluid to be tested cannot be completely reacted. This will not only cause waste of the fluid to be tested, but also cause errors in the final test results.
- the fluid detecting test piece of the prior art can be designed with a flow path structure for fluid transfer, and utilizes the capillary phenomenon generated by the open channel structure to passively transfer fluid through the flow path to the reaction detection area; Then, when the fluid to be tested is injected, the driving force of the fluid is given by means of pressurization or vacuum negative pressure, or more than one valve (micro-actuator or valve) is arranged in the flow channel, so that the fluid can be active and sequential. Through the flow path, the reaction detection area is reached.
- the fluid to be tested is often injected or entangled in the flow path to cause the flow path to be blocked, causing an error in the actual measurement, and even causing the test to fail, and the micro--
- the addition of the actuator or valve) increases the difficulty of the overall design and the cost of the test piece.
- the test strips of the known technology are used for molding, injection molding, and stamping.
- the present invention provides a fluid detecting test piece, which mainly comprises a substrate and a flow path structure.
- the substrate has a planar first surface, and the flow channel structure is formed on the first surface of the substrate in a predetermined pattern such that the surface height of the flow path structure is not lower than the first surface height of the substrate.
- the flow channel structure has a hollow network structure, and the hydrophilicity of the flow channel structure is higher than the hydrophilicity of the first surface of the substrate.
- the fluid detecting test strip may further include a reactive material formed in the hollow mesh structure. Accordingly, it is a primary object of the present invention to provide a fluid detecting test piece which has a hollow structure and thus prevents liquid from remaining around the flow path. Another object of the present invention is to provide a fluid detecting test piece having a hydrophilic hollow mesh structure.
- Another object of the present invention is to provide a fluid detecting test piece, in which a bubble in a fluid is destroyed due to a fluid flowing through a hollow mesh structure of a flow path, thereby eliminating large bubbles and avoiding micro flow.
- the condition of the bubble blocking channel occurs, which in turn affects the quantitative analysis results.
- the flow path or micro-channel structure is made up, which saves a lot of cost for manufacturing fluid test strips.
- Still another object of the present invention is to provide a method of manufacturing a fluid detecting test piece, which is capable of producing a fluid detecting test piece which is low in cost and more accurate in measurement.
- the height of the surface of the flow path structure is higher than the height of the first surface.
- the cross section of the flow path structure further has a configuration convex to the first surface.
- the material of the flow path structure is selected from the group consisting of nitrocellulose and glass fiber.
- the flow path structure further includes a plurality of branch flow paths.
- at least one of the branch flow paths further includes an enlarged region whose shape is selected from the group consisting of a circular arc shape, a rectangular shape, and an island shape.
- the flow path structure is dried and solidified in a solution to form a hollow network structure selected from the group consisting of a nitrocellulose solution and a glass fiber solution.
- the substrate is a biocompatible material.
- the substrate is flexible.
- the reaction material is injected into the flow path structure with a reaction solution, and is formed after the drying process.
- the drying process is freeze drying or air drying.
- a fluid detecting test strip according to the present invention wherein the reactive material is an antibody and a chemical reagent.
- the fluid detecting test strip according to the present invention further includes a pair of planar electrodes formed between the first surface and the flow path structure.
- the fluid detecting test strip according to the present invention further includes a stack flow path formed on the flow path structure.
- a method of manufacturing a fluid detecting test strip comprising: providing a substrate having a planar first surface; providing a solution, the solution is applied in a coating manner Forming a pattern on the first surface; drying the coated solution, thereby forming a flow path structure having the predetermined pattern such that a height of a surface of the flow path structure is not lower than a height of the first surface,
- the flow channel structure has a hollow mesh structure, and the flow channel structure is more hydrophilic than the first surface; and a reactive material formed in the hollow mesh structure is provided.
- a method of manufacturing a fluid detecting test strip comprising: providing a substrate having a planar first surface; providing a mask, the mask comprising a hollowed out pre- Having a pattern; temporarily bonding the mask to the substrate; providing a solution to saturate the solution with the hollow predetermined pattern; drying the solution on the predetermined pattern; removing the mask, thereby Forming a flow path structure having the predetermined pattern such that a height of a surface of the flow path structure is not lower than a height of the first surface, the flow path structure has a hollow mesh structure, and the flow path structure is hydrophilic Higher than the hydrophilicity of the first surface; and providing a reactive material formed in the hollow network structure.
- a method of manufacturing a fluid detecting test strip according to the present invention wherein a height of a surface of the flow path structure is higher than a height of the first surface.
- a method of manufacturing a fluid detecting test strip according to the present invention wherein the cross section of the flow path structure further has a configuration convex to the first surface.
- a method of manufacturing a fluid detecting test strip according to the present invention wherein the coating method is selected from the group consisting of: lithography, gravure printing, letterpress printing, screen printing, scribing, ink jetting, casting, dip dyeing.
- the flow path structure further comprises a plurality of branch flow paths.
- a method of manufacturing a fluid detecting test strip according to the present invention wherein the at least one branch flow path further comprises an enlarged region whose shape is selected from the group consisting of a circular arc shape, a rectangular shape, and an island shape.
- the flow path structure is dried and solidified in a solution to form a hollow network structure selected from the group consisting of a nitrocellulose solution and a glass fiber solution.
- the substrate is a biocompatible material.
- the reaction material is injected into the flow path structure with a reaction solution, and is formed after the drying process.
- the method for producing a fluid test strip according to the present invention wherein the drying process is freeze drying or air drying.
- FIG. 1A is a schematic view of a fluid detecting test piece according to a first embodiment of the present invention.
- Fig. 1B is a cross-sectional view of the fluid detecting test piece 1 shown in Fig. 1A taken along line AA.
- Fig. 1C is another schematic view of a fluid detecting test piece according to a first preferred embodiment of the present invention.
- Fig. 1D is still another schematic view of the fluid detecting test piece of the first preferred embodiment of the present invention.
- Fig. 1A is a schematic view of a fluid detecting test piece according to a first embodiment of the present invention.
- Fig. 1B is a cross-sectional view of the fluid detecting test piece 1 shown in Fig. 1A taken along line AA.
- Fig. 1C is another schematic view of a fluid detecting test piece according to a first preferred embodiment of the present invention.
- Fig. 1D is still another schematic view of the fluid detecting test piece of the first preferred embodiment of the present invention.
- FIG. 2 is a flow chart showing a method of manufacturing a fluid detecting test strip according to a second preferred embodiment of the present invention.
- Fig. 3A is a flow chart showing a method of manufacturing a fluid detecting test strip according to a third preferred embodiment of the present invention.
- Fig. 3B is a schematic view of a fluid detecting test piece according to a third preferred embodiment of the present invention.
- DETAILED DESCRIPTION OF THE INVENTION The present invention discloses a fluid testing test strip. Since the physical, chemical principles and solution coating techniques utilized therein are well known to those of ordinary skill in the relevant art, the description below will no longer be complete. description.
- FIG. 1A there is shown a schematic view of a fluid detecting test piece according to a first embodiment of the present invention.
- the fluid detecting test piece 1 includes a substrate 10 and a flow path structure 11.
- the substrate 10 has a planar first surface 100, and the flow channel structure 11 is formed on the first surface 100 of the substrate 10 in a predetermined pattern 12, and the surface height of the flow channel structure 11 is not lower than the first surface 100 of the substrate 10.
- the flow path structure 11 has a hollow mesh structure which is more hydrophilic than the first surface 100 of the substrate 10.
- the flow path structure 11 can be a highly hydrophilic solution by lithography, gravure printing, letterpress printing, screen printing, line marking, inkjet, casting or dipping. Paint Covering the first surface 100 of the substrate 10, the composition thereof may be nitrocellulose or glass fiber. After drying and solidifying, it has a porous hollow network structure, which can absorb the fluid to be tested, so that the fluid to be tested remains in the flow. Problems around the road. When the fluid flows through the flow path structure 11, the bubbles in the fluid are destroyed, and the blockage of the bubbles can be avoided.
- the present invention further includes a pair of planar electrodes 13 formed between the first surface 100 of the substrate 10 and the flow channel structure 11 for detecting an electrochemical reaction of the fluid to be tested.
- the substrate 10 is a biocompatible material and may also be a flexible material.
- Fig. 1B there is shown a cross-sectional view of the fluid detecting test strip 1 shown in Fig. 1A along line AA.
- the nitrocellulose solution may have a cross-section of the flow channel structure having a structure protruding from the first surface 100 during the drying and solidification process, and the flow channel structure 11 is formed on the first surface 100 of the substrate 10, so the flow path structure
- the surface 110 has a height difference h from the first surface 100 of the substrate 10, that is, the height of the flow path structure surface 110 is not lower than the height of the first surface 100 of the substrate 10.
- reaction material is included in the hollow network structure of the flow path structure 11, and the composition of the reaction material is related to the type of the component to be tested contained in the fluid.
- the manner in which the solution for forming the flow path structure 11 is formed is as follows. Nitrocellulose powder
- nitrocellulose powder is formed by mixing a mixture of an organic solvent containing an ester and a ketone organic solvent, or dissolving the glass fiber in a specific solvent to form a mixed solution, and then coating the mixed solution according to a predetermined pattern. Covering the first surface 100 of the substrate 10, after drying, the formed flow channel structure 11 has a hollow mesh structure and has a liquid absorbing capability. Therefore, when the fluid to be tested is injected into the fluid detecting test piece 1, the flow path structure 11 transmits the fluid to be tested to the reaction area (not shown) for reaction by the liquid absorbing ability possessed by the hollow network structure. Further, since the flow path structures 11 used in the present embodiment are all of a hollow mesh structure, the amount of absorbed liquid per unit volume is constant.
- the corresponding solution volume can be deduced from the volume of the fluid to be measured to be absorbed; thus, the volume of the liquid required for detection can be fixed, and is suitable for the detection of the amount of the fluid.
- a preferred mode in which the reaction material is formed in the hollow mesh structure of the flow path structure 11 is as follows. After the mixed solution is applied onto the substrate 10 and dried to form the flow channel structure 11, the reaction solution containing the reaction material is injected into the flow channel structure 11, and after air drying or freeze drying, the reaction material remains in a powder form. In the runner structure 11. Due to the different components to be tested, the reactions required for the detection are also different; and depending on the type of reaction, various signals are generated.
- enzymes are used to catalyze fluids.
- the substance to be tested and the luminescence chemical reagent thereby generating a specific wavelength of light signal for detection; or using a specific enzyme to react with the substance to be tested (for example, using catalase to detect blood sugar), causing a change in current or potential , thereby performing electrochemical detection. Therefore, for biochemical testing, the reaction material will contain enzymes and corresponding chemical reagents.
- specific antibodies are used to specifically target the protein to be tested.
- the fluid detecting test piece provided by the present invention can be used for detecting various components to be tested in various biological samples (such as urine, blood, and the like).
- Fig. 1C there is shown another schematic view of a fluid detecting test strip according to a first preferred embodiment of the present invention.
- the runner structure 11 may further include at least one branch runner 111 and an enlarged region 112.
- a stack flow path 113 may be formed on the first surface 100 of the substrate 10, and includes a first flow path structure 1131, a second flow path structure 1132, and a third flow path node structure 1133.
- Each of the flow path structures in the flow path 113 may be formed by the same flow path pattern, or by different flow path patterns, depending on the type of test to be performed and the type of fluid to be tested.
- the present invention provides a method of manufacturing a plurality of fluid detecting test pieces in addition to the fluid detecting test piece of the first embodiment described above, as described in the following second and third preferred embodiments.
- FIG. 2 which is a flow chart of a method for manufacturing a fluid detecting test strip according to a second preferred embodiment of the present invention, and the structural features of the fluid detecting test strip mentioned in the embodiment are as described above.
- the reference numerals of the respective components are referred to FIG. 1A to FIG. 1C, and the following is not repeated.
- the manufacturing method of the fluid detecting test piece mainly comprises the following steps: Step 21: First, a substrate 1 having a planar first surface 100 is provided. Step 22: A solution is provided, which is formed on the first surface 100 along the predetermined pattern 12 in a coating manner. Step 23: The coated solution is dried, thereby forming a flow path structure 11 having a predetermined pattern 12. The surface height of the dried flow path structure 11 has a height difference h from the substrate 10.
- the solution coating method may be lithography, gravure printing, letterpress printing, screen printing, scribing, ink jetting.
- a third preferred embodiment of the present invention is another manufacturing method of the fluid detecting test piece. Please refer to FIG. 3A and FIG. 3B.
- FIG. 3A is a flow chart showing a method of manufacturing a fluid detecting test piece according to a third preferred embodiment of the present invention
- FIG. 3B is a schematic view showing the structure of a fluid detecting test piece in the manufacturing process according to the manufacturing method of the present embodiment.
- the manufacturing method of the fluid detecting test piece provided in this embodiment mainly includes the following steps: Step 31: First, a substrate 30 is provided, and the substrate 30 has a planar first surface 300.
- Step 32 A mask 33 is provided, and the mask 33 includes a hollow preset pattern 32.
- Step 33 The mask 33 is temporarily bonded to the substrate 30.
- Step 34 A solution is provided to saturate the solution with a hollow preset pattern 32.
- Step 35 Drying the solution on the predetermined pattern 32.
- Step 36 The mask 33 is removed, thereby forming a runner structure 31 having a predetermined pattern 32.
- the height of the surface of the flow-through structure 31 after dry forming is not lower than the height of the first surface 300 of the substrate 30, and the flow path structure 31 has a hollow mesh structure.
- the hydrophilicity of the runner structure 31 is higher than the hydrophilicity of the first surface 300 of the substrate 30.
- Step 37 The reaction material is provided to be formed in the hollow network structure of the flow path structure 31.
- the method of forming the flow path structure 31 of the above embodiment, the material of the solution, and the method of forming the reaction material in the hollow mesh structure are the same as those described in the first preferred embodiment, and will not be described here.
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Priority Applications (11)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020117022002A KR101329846B1 (ko) | 2009-03-23 | 2009-03-23 | 분석 스트립 및 그의 제조 방법 |
NZ595103A NZ595103A (en) | 2009-03-23 | 2009-03-23 | Analytical strip and the manufacturing method thereof |
EP09842047A EP2413141A4 (en) | 2009-03-23 | 2009-03-23 | FLUID TEST CHIP AND METHOD FOR PREPARING THE SAME |
JP2012501106A JP2012521543A (ja) | 2009-03-23 | 2009-03-23 | 分析用ストリップ及びその製造方法 |
CN2009801582327A CN102395884A (zh) | 2009-03-23 | 2009-03-23 | 流体检测试片及其制造方法 |
AU2009342863A AU2009342863B2 (en) | 2009-03-23 | 2009-03-23 | Analytical Strip and the Manufacturing Method Thereof |
PCT/CN2009/070941 WO2010108310A1 (zh) | 2009-03-23 | 2009-03-23 | 流体检测试片及其制造方法 |
CA2755347A CA2755347A1 (en) | 2009-03-23 | 2009-03-23 | Analytical strip and the manufacturing method thereof |
RU2011141298/15A RU2011141298A (ru) | 2009-03-23 | 2009-03-23 | Аналитическая полоска и способ ее изготовления |
BRPI0925015A BRPI0925015A2 (pt) | 2009-03-23 | 2009-03-23 | chip de teste de fluido e método para produzir o mesmo |
US12/762,165 US8367015B2 (en) | 2009-03-23 | 2010-04-16 | Analytical strip and the manufacturing method thereof |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/CN2009/070941 WO2010108310A1 (zh) | 2009-03-23 | 2009-03-23 | 流体检测试片及其制造方法 |
Publications (1)
Publication Number | Publication Date |
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WO2010108310A1 true WO2010108310A1 (zh) | 2010-09-30 |
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Family Applications (1)
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PCT/CN2009/070941 WO2010108310A1 (zh) | 2009-03-23 | 2009-03-23 | 流体检测试片及其制造方法 |
Country Status (10)
Country | Link |
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US (1) | US8367015B2 (zh) |
EP (1) | EP2413141A4 (zh) |
JP (1) | JP2012521543A (zh) |
KR (1) | KR101329846B1 (zh) |
CN (1) | CN102395884A (zh) |
AU (1) | AU2009342863B2 (zh) |
BR (1) | BRPI0925015A2 (zh) |
CA (1) | CA2755347A1 (zh) |
RU (1) | RU2011141298A (zh) |
WO (1) | WO2010108310A1 (zh) |
Families Citing this family (3)
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JP5610389B2 (ja) * | 2010-11-05 | 2014-10-22 | 国立大学法人北陸先端科学技術大学院大学 | イムノクロマト分析用ストリップ、及びイムノクロマト分析方法 |
KR102074974B1 (ko) * | 2018-01-23 | 2020-02-07 | 윤형열 | 패턴 형성 장치 및 방법 |
CN109738428B (zh) * | 2019-02-28 | 2021-08-10 | 杭州艾克瑞尔检测科技有限公司 | 一种空气中甲醛含量的显色滴定检测装置及其检测方法 |
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- 2009-03-23 EP EP09842047A patent/EP2413141A4/en not_active Withdrawn
- 2009-03-23 BR BRPI0925015A patent/BRPI0925015A2/pt not_active IP Right Cessation
- 2009-03-23 JP JP2012501106A patent/JP2012521543A/ja active Pending
- 2009-03-23 WO PCT/CN2009/070941 patent/WO2010108310A1/zh active Application Filing
- 2009-03-23 CA CA2755347A patent/CA2755347A1/en not_active Abandoned
- 2009-03-23 CN CN2009801582327A patent/CN102395884A/zh active Pending
- 2009-03-23 RU RU2011141298/15A patent/RU2011141298A/ru not_active Application Discontinuation
- 2009-03-23 AU AU2009342863A patent/AU2009342863B2/en not_active Ceased
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Also Published As
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EP2413141A1 (en) | 2012-02-01 |
KR101329846B1 (ko) | 2013-11-14 |
AU2009342863A1 (en) | 2011-09-29 |
US20100240120A1 (en) | 2010-09-23 |
CA2755347A1 (en) | 2010-09-30 |
KR20110129411A (ko) | 2011-12-01 |
RU2011141298A (ru) | 2013-04-27 |
BRPI0925015A2 (pt) | 2018-02-27 |
EP2413141A4 (en) | 2013-03-06 |
CN102395884A (zh) | 2012-03-28 |
US8367015B2 (en) | 2013-02-05 |
JP2012521543A (ja) | 2012-09-13 |
AU2009342863B2 (en) | 2013-09-05 |
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