WO2003044534A1 - Bande d'essai immunochromatographique permettant de mesurer en quantite de trace un objet d'analyse dans un specimen - Google Patents

Bande d'essai immunochromatographique permettant de mesurer en quantite de trace un objet d'analyse dans un specimen Download PDF

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Publication number
WO2003044534A1
WO2003044534A1 PCT/JP2002/011973 JP0211973W WO03044534A1 WO 2003044534 A1 WO2003044534 A1 WO 2003044534A1 JP 0211973 W JP0211973 W JP 0211973W WO 03044534 A1 WO03044534 A1 WO 03044534A1
Authority
WO
WIPO (PCT)
Prior art keywords
test strip
reagent
sample
analyte
specimen
Prior art date
Application number
PCT/JP2002/011973
Other languages
English (en)
Japanese (ja)
Inventor
Hidekazu Matsuoka
Fujiko Kanezawa
Toshio Watanabe
Original Assignee
Wakunaga Pharmaceutical Co.,Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Wakunaga Pharmaceutical Co.,Ltd. filed Critical Wakunaga Pharmaceutical Co.,Ltd.
Priority to JP2003546112A priority Critical patent/JPWO2003044534A1/ja
Priority to AU2002343815A priority patent/AU2002343815A1/en
Publication of WO2003044534A1 publication Critical patent/WO2003044534A1/fr

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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

Definitions

  • the present invention relates to the field of immunodiagnosis, particularly to a simple and accurate test strip for a small amount of a sample using immunochromatography.
  • test strip in the form of a strip using immunochromatography analysis results can be obtained simply by applying a sample.
  • a device in which a strip using immunochromatography is cascaded with a moisture-impermeable solid material, such as a pregnancy test drug is the mainstream in the market.
  • test strips intended for use in ordinary households there is no need to consider the limitation of the sample volume because urine is used for the sample.
  • whole blood samples have a deep red color that substantially interferes with dye or other visible tests, thus inhibiting red blood cells, hemoglobin, and other measurements. Harmful substances must be separated from plasma or serum by incorporating a blood cell separation membrane or the like into the test strip before the blood sample is analyzed for a particular analyte. In addition, even when other samples are used, they often contain measurement inhibitory substances, so it is necessary to separate these substances in order to perform accurate measurement.
  • Patent No. 2,940,990 describes a test strip such as a test strip for a blood cell separation membrane using a hydrophilic sintered porous matrix incorporating hemagglutinin. Discloses that it can be used as a component of
  • Japanese Patent Publication No. 7-85083 discloses a device characterized by containing glass fibers coated with polyvinyl alcohol or polyvinyl alcohol / polyvinyl acetate.
  • JP-T-7-504747 describes a method of applying a matrix containing an antibody against erythrocytes to Depis.
  • Japanese Patent Application Laid-Open No. 2000-321278 discloses a method in which a whole blood sample is applied to a non-porous liquid receiving member, and a detection unit detects an analyte while sequentially absorbing the reagent. The method is presented. This method has excellent blood cell separation ability because the whole blood sample is absorbed from the end of the test strip, and it is considered that the reaction is completed with a smaller amount of the whole blood sample.
  • this method also requires a certain amount of plasma sample, depending on the other components of the test strip, the size of the binding pad and the cross-linking pad, etc. There was a limit to reducing the amount of whole blood.
  • An object of the present invention is to provide a simple and accurate test strip using immunochromatography, which can be measured with a small amount of a sample.
  • the present invention provides an immunocytomatography test strip having a porous carrier for qualitatively or quantitatively determining an analyte in a sample.
  • the detection area (1) where the capture reagent for detecting the analyte is fixed downstream of the carrier (1), A reagent area (2) containing a developing solution receiving area (2) for receiving a drug and containing a labeled reagent having an affinity for the analyte between the two areas, and a substance that inhibits measurement from the sample are separated.
  • Another object of the present invention is to provide an immunochromatography test strip comprising a separation region (4).
  • FIG. 1 shows one embodiment of the immunochromatography test strip of the present invention.
  • Embodiment of the Invention is one embodiment of the immunochromatography test strip of the present invention.
  • FIG. 1 shows an example of a typical embodiment of the present invention.
  • (1) is a detection area in which a capture reagent for detecting an analyte is fixed
  • (2) is a developing liquid receiving area for receiving the developed reagent
  • (3) is an affinity with the analyte.
  • the reagent region containing the labeling reagent, and (4) shows the separation region for separating the substance that inhibits the measurement from the sample, respectively, and the positional relationship between (3) and (4) may be reversed.
  • description will be made in accordance with this, but the present invention is not limited to this mode.
  • the developing solution moves by capillary action from the developing solution receiving region (2) made of a fibrous material, and the reagent region (4) located in the downstream region thereof.
  • the labeling reagent having an affinity for the analyte is dissolved and further developed together with the developing solution.
  • On the downstream side there is a contact point (5) with a separation region (4) for separating a substance that inhibits measurement from the sample, and contains a sample purified in the separation region and a labeled reagent developed from the upstream.
  • the developing solution merges here and reaches the detection area (1) where the capture reagent is immobilized while the analyte and the labeling reagent form a complex. If the analyte is present in the sample, the complex of the analyte and the labeling reagent is captured by the supplementary reagent and observed as an arbitrary signal.
  • Each of these regions may be on the same porous matrix, or may be on a different matrix, even if the reagents and samples are in contact so that they can move. good.
  • the porous carrier used for the test strip is not particularly limited as long as a developing solution, a reagent, an object to be analyzed, and the like can flow from upstream to downstream by capillary action.
  • Examples include glass fiber, celluloses (filter paper, nitrocellulose, etc.), porous plastics such as polyethylene, polypropylene, and the like, and nylon. More preferred are nitrocellulose, nylon, cellulose and glass fiber.
  • an arbitrary filter, a resin, a hemagglutinating agent, or the like can be used, although it differs depending on the sample.
  • a blood cell separation membrane such as a glass fiber membrane or a hemagglutinating agent such as antibody lectin or sugar alcohol can be used.
  • the separation region (4) has a structure branched from the test slip, and portions other than the branch point (5) are prevented from directly contacting the slip.
  • a portion other than the branch point of the separation region or a portion corresponding to the separation region of the strip ( 6) can be coated.
  • the labeling reagent used in the present invention refers to a reagent that has an affinity for the analyte to be labeled with an arbitrary labeling reagent, and for example, labeled antibodies, antigens, haptens, and the like can be used.
  • the labeling method includes direct labeling and indirect labeling (enzymes such as alkaline phosphatase and the like, and biotin labeling). Direct labeling that does not require a substrate is preferred.
  • Direct labels include, for example, metals such as platinum, gold, silver and copper, silver iodide, silver bromide, silver hydroxide, iron oxide, iron hydroxide or iron oxide hydrate, aluminum hydroxide or water.
  • Examples of the capture reagent immobilized on the detection region used in the present invention include an antibody, an antigen, a hapten, an avidin, a receptor, etc., which specifically bind to an analyte.
  • sample that can be used in the present invention examples include blood, urine, saliva, mucus, and the like.
  • Blood is particularly preferable, and components to be measured include, for example, proteins, viral antigens, and tumor markers. And inflammation markers, hormones or drugs.
  • immunologically specific binding assay examples include a competitive binding assay and a sandwich assay (including a sandwich assay using the binding of a biotinylated antibody and avidin). Although it is applicable, the sandwich method is particularly preferable.
  • Example 1 Example 1
  • the anti-HCG antibody was applied to the imminodyne membrane ABC in a line using a dispenser, dried, blocked with a casein solution, washed with a PBS solution, and then dried at 25 ° C. Preparation of gold colloid labeling reagent finally cut into 5 mm x 25 mm strip
  • the gold colloid solution was labeled with anti-HCG antibody using Bldg. Gold-sol G40 according to the protocol. Gold colloid labeling reagent was applied to the conjugate pad with a dispenser and lyophilized. A 5 mm x 5 mm knot was used for the final 0 shank.
  • the cellulose membrane was cut to a width of 5 mm ⁇ 10 mm to provide a mixed region of the plasma component and the labeling reagent.
  • the conduit gate pad was cut into 5mmxl0nnn, which was used as a developer receiving part.
  • An immunodyne membrane with a detection area is pasted on an adhesive-coated polyethylene film, and a cellulose membrane, a pad containing a gold colloid labeling reagent, and a developer receiving section are sequentially attached to one end of the membrane. And one strip.
  • one end of a blood cell separation membrane Hemasep (5mmxl0mm) is brought into contact with the contact part of the cellulose membrane and the pad containing the gold colloid labeling reagent, and this contact part is applied to an adhesive-coated film. More bonded. A part of the surface of the developing solution receiving part was covered with an impermeable film coated with an adhesive so that a part other than the contact part of the blood cell separation membrane did not contact the developing reagent receiving area.
  • HCG HCG was added to the whole blood sample so that it became 100 IU / L, and 10 L was added to the blood cell separation area of the test strip prepared as described above. After 5 minutes, add the developing solution ⁇ to the developing solution receptor, and lower it so that it reaches the detection area. After developing for 15 minutes in the flow direction, the colored line in the detection area was measured with 520 nm reflected light.
  • a general test strip using a blood cell separation membrane in the developing solution receiving part was prepared and used as a control. The control samples were measured by adding 10 ⁇ L of whole blood sample, adding 10 / XL of whole blood sample, and then adding 100 developing solution.
  • Table 1 shows a comparison between the measurement results of the test strip of the present invention and the measurement results of the control product.
  • the immunochromatographic test strip of the present invention is simple and convenient. Since accurate measurement is possible, it can be widely applied from clinical sites to home use.

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  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne une bande d'essai immunochromatographique comprenant un support poreux doté d'une zone de détection (1) possédant un réactif de capture immobilisé permettant de détecter l'objet à analyser dans la direction aval, d'une zone réceptrice d'une solution de développement (2) permettant de recevoir un réactif de développement dans la direction amont et d'une zone de réactif (3), située entre ces deux zones, renfermant un réactif d'étiquetage présentant une affinité pour l'objet à analyser, ainsi que d'une zone de séparation (4) permettant de séparer des substances empêchant d'effectuer la mesure à partir du spécimen.
PCT/JP2002/011973 2001-11-22 2002-11-15 Bande d'essai immunochromatographique permettant de mesurer en quantite de trace un objet d'analyse dans un specimen WO2003044534A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2003546112A JPWO2003044534A1 (ja) 2001-11-22 2002-11-15 微量検体中の分析対象物を測定するための免疫クロマトグラフィーテストストリップ
AU2002343815A AU2002343815A1 (en) 2001-11-22 2002-11-15 Immunochromatographic test strip for measuring analysis subject in specimen in trace amount

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2001357895 2001-11-22
JP2001-357895 2001-11-22

Publications (1)

Publication Number Publication Date
WO2003044534A1 true WO2003044534A1 (fr) 2003-05-30

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PCT/JP2002/011973 WO2003044534A1 (fr) 2001-11-22 2002-11-15 Bande d'essai immunochromatographique permettant de mesurer en quantite de trace un objet d'analyse dans un specimen

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JP (1) JPWO2003044534A1 (fr)
AU (1) AU2002343815A1 (fr)
WO (1) WO2003044534A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007534935A (ja) * 2004-02-09 2007-11-29 ラピッド パトゲン スクリーニング インコーポレイテッド ヒトの体液中のターゲットを高速に診断する方法
JP2009133740A (ja) * 2007-11-30 2009-06-18 Tanaka Kikinzoku Kogyo Kk イムノクロマトグラフィー用試験片
KR101406923B1 (ko) 2013-03-04 2014-06-12 아주대학교산학협력단 능삼무늬 형태의 포획자 구획을 구비한 정량적 면역크로마토그래피 분석용 검정스트립 및 이를 이용한 정량적 면역크로마토그래피 분석방법
CN106680476A (zh) * 2017-01-22 2017-05-17 英科新创(厦门)科技有限公司 一种用于分泌物样本的免疫层析检测装置

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11248708A (ja) * 1997-12-24 1999-09-07 Roche Diagnostics Gmbh 分析要素の多目的構造体およびアナライト測定のためのその用途

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11248708A (ja) * 1997-12-24 1999-09-07 Roche Diagnostics Gmbh 分析要素の多目的構造体およびアナライト測定のためのその用途

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007534935A (ja) * 2004-02-09 2007-11-29 ラピッド パトゲン スクリーニング インコーポレイテッド ヒトの体液中のターゲットを高速に診断する方法
US10001482B2 (en) 2004-02-09 2018-06-19 Quidel Corporation Device for the detection of an analyte in a fluid sample
JP2009133740A (ja) * 2007-11-30 2009-06-18 Tanaka Kikinzoku Kogyo Kk イムノクロマトグラフィー用試験片
KR101406923B1 (ko) 2013-03-04 2014-06-12 아주대학교산학협력단 능삼무늬 형태의 포획자 구획을 구비한 정량적 면역크로마토그래피 분석용 검정스트립 및 이를 이용한 정량적 면역크로마토그래피 분석방법
CN106680476A (zh) * 2017-01-22 2017-05-17 英科新创(厦门)科技有限公司 一种用于分泌物样本的免疫层析检测装置

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JPWO2003044534A1 (ja) 2005-03-24
AU2002343815A1 (en) 2003-06-10

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