CA2330100A1 - Ligand binding assay and kit with a separation zone for disturbing analytes - Google Patents

Ligand binding assay and kit with a separation zone for disturbing analytes Download PDF

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Publication number
CA2330100A1
CA2330100A1 CA002330100A CA2330100A CA2330100A1 CA 2330100 A1 CA2330100 A1 CA 2330100A1 CA 002330100 A CA002330100 A CA 002330100A CA 2330100 A CA2330100 A CA 2330100A CA 2330100 A1 CA2330100 A1 CA 2330100A1
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CA
Canada
Prior art keywords
analyte
reactant
component
matrix
ligand
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
CA002330100A
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French (fr)
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CA2330100C (en
Inventor
Jan Carlsson
Maria Lonnberg
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MAIIA AB
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2330100A1 publication Critical patent/CA2330100A1/en
Application granted granted Critical
Publication of CA2330100C publication Critical patent/CA2330100C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • G01N33/543—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
    • 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
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/97—Test strip or test slide
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/807—Apparatus included in process claim, e.g. physical support structures
    • Y10S436/81—Tube, bottle, or dipstick
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/825—Pretreatment for removal of interfering factors from sample

Abstract

The invention relates to a method for determining an analyte by means of binding reactions, which method comprises: i) applying the sample to an application zone for sample (ASZ) on a flow matrix in which transport of components present in the sample can take place (transport flow), the flow matrix further exhibiting: a) optionally an application zone (AR*Z) for a binding reactant (Reactant* = R*) which is analytically detectable; b) a detection zone (DZ), which is located downstream of ASZ and exhibits an additional binding reactant (Capturer) firmly anchored to the matrix, and in which a complex (signal complex) containing the Capturer and the analyte and/or Reactant* is formed during the reaction, and ii) detecting the signal complex in the detection zone, the measured signal being used for determining the analyte. According to the invention, the flow matrix comprises at least one separation zone (SZ) between ASZ and DZ, which zone exhibits a structure (ligand) having binding capability for a component that is transported in the matrix and which would affect the measurable signal if the component is transported into DZ. The invention also relates to a test kit comprising the flow matrix.

Claims (22)

  1. A method of determining an analyte in a sample by means of binding reactions, which method comprises:
    i. applying the sample to an application zone for sample (ASZ) on a flow matrix in which transport of components present in the sample may take place (transport flow), the flow matrix further comprising:
    a) optionally an application zone (AR*Z) for a binding reactant (Reactant* = R*) which is analytically detectable, b) a detection zone (DZ) which is located downstream of ASZ and comprises another binding reactant (Capturer) firmly anchored to the matrix and in which a complex (signal complex) containing the Capturer and the analyte and/or Reactant* is formed during the method, and ii, detecting the signal complex in the detection zone, the measured signal being used for determining the analyte, characterized in that the flow matrix comprises at least one separation zone {SZ) between ASZ and DZ and that this zone (SZ) exhibits a structure (ligand) having binding capability for either (i) at least one component other than the analyte which is transported in the matrix and which would affect the measurable signal if the component is transported into DZ, so that said component(s) substantially does (do) not disturb the detection of the analyte in DZ, or (ii) the analyte, and the binding capability of the ligand for the analyte is determined.
  2. 2. The method according to claim l, characterized in that said component is a heteroform to the analyte with regard to binding capability for the Capturer and/or R*.
  3. 3.The method according to claim 1 or 2, characterized in that the transport flow is driven by capillary forces.
  4. 4. The method according to any one of claims 1-3, characterized in that at least DZ and the most adjacent parts of the matrix are in the form of a membrane, and that the transport flow at least into, in and out of DZ is lateral.
  5. 5. The method according to any one of claims 1-4, characterized in that the separation zone exhibits a Ligand which is charged and attracts said component.
  6. 6. The method according to any one of claims 1-4, characterized in that the separation zone exhibits a Ligand which has biospecific affinity directed towards said component.
  7. 7. The method according to any one of claims 1-4 and 6, characterized in the separation zone exhibits a Ligand which has immunochemical affinity (i.e. the structure (ligand) is an antibody or an antigen/hapten) against said component.
  8. 8. The method according to any one of claims 1-7, characterized in that said component is not the analyte and that the binding capability of the ligand is to a binding site on said component, and that this binding site is not available to the same degree on the analyte.
  9. 9. The method according to any one of claims 1-8, characterized in that said component is not the analyte and that the Capturer in the detection zone exhibits binding capability to a binding site on the analyte which also is available on said component.
  10. 10. The method according to any one of claims 1-9, characterized in that said component is not the analyte and that Reactant* is used and has binding capability to a binding site which is available on a) both the analyte and said component, or b) only on the analyte.
  11. 11. The method according to any one of claims 1-l0, characterized in that the analyte and said component are heteroforms which differ with regard to carbohydrate structure.
  12. 12. A test kit for determining an analyte in a sample without other components disturbing the determination, which kit comprises A. a flow matrix which in one and the same transport flow comprises:
    a) an application zone for sample containing the analyte (ASZ), b) a detection zone (DZ) in which there is a biospecific affinity reactant (Capturer), which is directed towards the analyte or towards an analyte-related reactant and which is firmly anchored to the matrix in DZ, B. optionally an analytically detectable reactant (Reactant* = R*) having biospecific affinity to either the analyte or the Capturer, characterized in that the flow matrix comprises a separation zone (SZ) between ASZ and DZ, which zone exhibits a structure (ligand} having binding capability for at least one disturbing component, SZ being capable of affecting substantially all of said disturbing component.
  13. 13. The test kit according to claim 12, characterized in that at least DZ and the most adjacent parts of the matrix are in the form of a membrane and that the direction of the transport flow at least into, in and out of DZ is lateral.
  14. 14. The test kit according to any one of claims 12-13, characterized in that the transport channels of the flow matrix have capillary dimensions, i.e. are of such a form and surface character that aqueous media can be transported by capillary forces.
  15. 15. The test kit according to any one of claims 12-14, characterized in that the structure (ligand) has binding capability to disturbing components originating from the sample, usually heteroforms to the analyte with regard to binding capability to the Capturer and/or R*.
  16. 16. The test kit according to any one of claims 12-15, characterized in that the structure (ligand) exhibits one or more positive and/or negative charges at the conditions under which the matrix is to be used.
  17. 17. The test kit according to any one of claims 12-15, characterized in that the structure (ligand) is a biospecific affinity reactant, for example an antibody or an antigen or a hapten.
  18. 18. The test kit according to any one of claims 12-17, characterized in that the Capturer is a biospecific affinity reactant, for example an antibody or an antigen or a hapten.
  19. 19. The test kit according to any one of claims 12-18, characterized in that the kit comprises an analytically detectable reactant R*, that the flow matrix comprises an application zone for R* (AR*Z) and that AR*Z is located upstream and/or downstream of SZ but always upstream of DZ.
  20. 20. The test kit according to claim 19, characterized in that AR*Z is located upstream of, downstream of, or coincides with ASZ.
  21. 21. The test kit according to any one of claims 19-20, characterized in that R* is pre-deposited in AR*Z.
  22. 22. A test kit for determining the binding capability of a structure (ligand) to an analyte, which kit comprises A. a flow matrix which in one and the same transport flow comprises:
    a) an application zone for the analyte (ASZ), b) a detection zone (DZ) in which there is a biospecific affinity reactant (Capturer), which is directed towards an analyte or towards an analyte-related reactant and which is firmly anchored to the matrix in DZ, B) optionally an analytically detectable reactant (Reactant* = R*) having biospecific affinity to either the analyte or the Capturer, characterized in that the flow matrix comprises a separation zone (SZ) between ASZ
    and DZ, which zone exhibits said structure (ligand).
CA2330100A 1998-04-30 1999-04-30 Ligand binding assay and kit with a separation zone for disturbing analytes Expired - Fee Related CA2330100C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9801563-9 1998-04-30
SE9801563A SE9801563D0 (en) 1998-04-30 1998-04-30 Method of separation and kit to be used in the process
PCT/SE1999/000722 WO1999060402A1 (en) 1998-04-30 1999-04-30 Ligand binding assay and kit with a separation zone for disturbing analytes

Publications (2)

Publication Number Publication Date
CA2330100A1 true CA2330100A1 (en) 1999-11-25
CA2330100C CA2330100C (en) 2011-08-09

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2330100A Expired - Fee Related CA2330100C (en) 1998-04-30 1999-04-30 Ligand binding assay and kit with a separation zone for disturbing analytes

Country Status (10)

Country Link
US (2) US6737278B1 (en)
EP (2) EP1467210A1 (en)
JP (1) JP4579414B2 (en)
AT (1) ATE371189T1 (en)
AU (1) AU758583B2 (en)
CA (1) CA2330100C (en)
DE (1) DE69936916T2 (en)
ES (1) ES2293736T3 (en)
SE (1) SE9801563D0 (en)
WO (1) WO1999060402A1 (en)

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Also Published As

Publication number Publication date
CA2330100C (en) 2011-08-09
WO1999060402A1 (en) 1999-11-25
EP1467210A1 (en) 2004-10-13
EP1075661A1 (en) 2001-02-14
JP2002516393A (en) 2002-06-04
ES2293736T3 (en) 2008-03-16
EP1075661B1 (en) 2007-08-22
AU4303699A (en) 1999-12-06
US20040023412A1 (en) 2004-02-05
SE9801563D0 (en) 1998-04-30
ATE371189T1 (en) 2007-09-15
JP4579414B2 (en) 2010-11-10
US6737278B1 (en) 2004-05-18
AU758583B2 (en) 2003-03-27
DE69936916D1 (en) 2007-10-04
DE69936916T2 (en) 2008-05-15

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