CA2026843A1 - Self-Performing Immunochromatographic Device - Google Patents

Self-Performing Immunochromatographic Device

Info

Publication number
CA2026843A1
CA2026843A1 CA2026843A CA2026843A CA2026843A1 CA 2026843 A1 CA2026843 A1 CA 2026843A1 CA 2026843 A CA2026843 A CA 2026843A CA 2026843 A CA2026843 A CA 2026843A CA 2026843 A1 CA2026843 A1 CA 2026843A1
Authority
CA
Canada
Prior art keywords
test result
analyte
strip
patient sample
present
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA2026843A
Other languages
French (fr)
Other versions
CA2026843C (en
Inventor
Eugene W. Osikowicz
Michael J. Beggs
Paul P. Brookhart
Russell B. Richerson
Frank J. Walsworth
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alere Switzerland GmbH
Original Assignee
Eugene W. Osikowicz
Michael J. Beggs
Paul P. Brookhart
Russell B. Richerson
Frank J. Walsworth
Abbott Laboratories
Inverness Medical Switzerland Gmbh
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 Eugene W. Osikowicz, Michael J. Beggs, Paul P. Brookhart, Russell B. Richerson, Frank J. Walsworth, Abbott Laboratories, Inverness Medical Switzerland Gmbh filed Critical Eugene W. Osikowicz
Publication of CA2026843A1 publication Critical patent/CA2026843A1/en
Application granted granted Critical
Publication of CA2026843C publication Critical patent/CA2026843C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • 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
    • G01N33/53—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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

Improved chromatographic strip binding assay devices are provided for determining the presence or amount of an analyte present in a patient sample. Assay label reagents interact with capture reagents immobilized in a testing region on the strip substrate to generate a visually detectable image indicative of the test result. The test result images include a minus sign (-) to indicate a negative test result for analyte which image is generated if the suspect analyte is absent in the patient sample and a plus sign (+) to indicate a positive test result for analyte which image is generated if the suspect analyte is present or is present at a pre-determined concentration in the patient sample. The immobilized capture reagents responsible for the location and configuration of the test result images are applied to the strip at an angled orientation with respect to the fluid flow direction of the strip to ensure that sharp substantially complete test result images are formed during performance of the assay. The devices provide substantially self-performing assays having inherently clear test results which are not subject to misinterpretation by the skilled or untrained user.
CA002026843A 1989-10-05 1990-10-03 Self-performing immunochromatographic device Expired - Lifetime CA2026843C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/417,346 US5075078A (en) 1989-10-05 1989-10-05 Self-performing immunochromatographic device
US417,346 1989-10-05

Publications (2)

Publication Number Publication Date
CA2026843A1 true CA2026843A1 (en) 1991-04-06
CA2026843C CA2026843C (en) 1999-05-04

Family

ID=23653607

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002026843A Expired - Lifetime CA2026843C (en) 1989-10-05 1990-10-03 Self-performing immunochromatographic device

Country Status (10)

Country Link
US (1) US5075078A (en)
EP (1) EP0421294B1 (en)
JP (1) JP2999238B2 (en)
KR (1) KR910008407A (en)
AT (1) ATE128235T1 (en)
AU (1) AU637830B2 (en)
CA (1) CA2026843C (en)
DE (2) DE69022521T2 (en)
ES (1) ES2027215T3 (en)
GR (1) GR910300086T1 (en)

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JPH03176659A (en) 1991-07-31
EP0421294A2 (en) 1991-04-10
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ES2027215T1 (en) 1992-06-01
DE69022521T2 (en) 1996-04-25
EP0421294A3 (en) 1993-03-17
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AU6385590A (en) 1991-04-11
US5075078A (en) 1991-12-24
GR910300086T1 (en) 1991-12-10
JP2999238B2 (en) 2000-01-17
CA2026843C (en) 1999-05-04
DE69022521D1 (en) 1995-10-26
KR910008407A (en) 1991-05-31
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AU637830B2 (en) 1993-06-10
DE421294T1 (en) 1991-08-14

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