CA2249303A1 - Chromatographic immunoassay device and method utilizing particle valency for quantitation - Google Patents

Chromatographic immunoassay device and method utilizing particle valency for quantitation

Info

Publication number
CA2249303A1
CA2249303A1 CA002249303A CA2249303A CA2249303A1 CA 2249303 A1 CA2249303 A1 CA 2249303A1 CA 002249303 A CA002249303 A CA 002249303A CA 2249303 A CA2249303 A CA 2249303A CA 2249303 A1 CA2249303 A1 CA 2249303A1
Authority
CA
Canada
Prior art keywords
receptor
analyte
trap
sample
complex
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
CA002249303A
Other languages
French (fr)
Other versions
CA2249303C (en
Inventor
Judith Fitzpatrick
Regina B. Lenda
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.)
Serex Inc
Original Assignee
Serex, Inc.
Judith Fitzpatrick
Regina B. Lenda
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 Serex, Inc., Judith Fitzpatrick, Regina B. Lenda filed Critical Serex, Inc.
Publication of CA2249303A1 publication Critical patent/CA2249303A1/en
Application granted granted Critical
Publication of CA2249303C publication Critical patent/CA2249303C/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
    • G01N33/558—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
    • Y10S435/805—Test papers
    • 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
    • Y10S435/81—Packaged device or kit
    • 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
    • Y10S435/968—High energy substrates, e.g. fluorescent, chemiluminescent, radioactive
    • 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
    • Y10S435/969—Multiple layering of reactants
    • 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
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/971—Capture of complex after antigen-antibody reaction
    • 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
    • Y10S435/973—Simultaneous determination of more than one analyte
    • 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
    • Y10S435/975—Kit
    • 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

Abstract

A method and device are provided for the semi-quantitative and quantitative determination of an analyte in a sample. A non-competitive trap which can bind unreacted labelled receptor to analyte but has virtually no binding capabilities to receptor in the presence of analyte is used. Labelled receptor: analyte complex is trapped in a second trap. The relative amounts of unbound receptor in the non-competitive trap versus the amount of receptor: analyte complex in the second trap is a measure of the amount of analyte in the sample.

Claims (16)

1. A device for detecting an analyte in a sample comprising a) a sample receiving site, b) a mobilization zone downstream of and in liquid communication with the sample receiving site, the mobilization zone comprising a liquid-mobilizeable labelled receptor capable of binding to the analyte in the sample to form a receptor:analyte complex, c) a non-competitive ligand trap zone downstream of and in liquid communication with the mobilization zone comprising an immobilized ligand which is essentially non-competitive with the analyte for the receptor under the assay conditions, whereby when analyte present in the sample forms a receptor:analyte complex, the immobilized non-competitive ligand in the trap will not bind complexed labelled receptor and will permit the complex to travel through the ligand trap, but wherein the non-competitive ligand will bind to labelled receptor not bound to analyte, and d) an means on the device for correlating the amount or the presence of the receptor:analyte complex, the trapped unbound receptor, or both to the presence of or the amount of analyte in the sample.
2. The device of Claim 1 wherein the non-competitive ligand in monomeric form has a lower dissociation rate than analyte for the receptor.
3. The device of Claim 2 wherein the association constant of the monomeric ligand and the receptor is from 10 3 M-1s-1 to 10 5 M-1s-1.
4. The device of Claim 2 wherein the receptor is labelled with colloidal gold.
5. The device of Claim 4 wherein downstream of the non-competitive ligand trap is a detection zone trap for receptor:analyte complex.
6. The device of Claim 5 which further comprises laminating strips which substantially enclose the entire device, except for the sample receiving site.
7. The device of Claim 6 wherein at least a portion of at least one of the laminating strips is transparent to enable the visualization of the detection zone.
8. The device of Claim 7 wherein the sample receiving site, the mobilization zone, and the non-competitive ligand trap are separate discrete elements in liquid communication.
9. The device of Claim 7 wherein the sample receiving site, the mobilization site, the non-competitive ligand trap, and the detection zone are present in a unitary continuous strip.
10. The device of Claim 7 wherein each of the non-competitive ligand trap and the detection zone trap is in the form of a ladder.
11. The device of Claim 7 wherein each of the non-competitive ligand trap and the detection zone trap is in the form of a block.
12. The device of claim 1 further comprising a trap binding a complex of receptor:analyte complex, wherein the complex has a higher number of receptor binding sites bound by analyte than the complex bound by the non-competitive ligand trap.
13. The device of claim 12 wherein the trap is selected from the group consisting of competitive ligand traps, immunogen traps, and affinity traps.
14. The device of claim 13 wherein the trap comprises antibody immunoreactive with heavy and light chains of antibody.
15. The device of claim 8 further comprising a wicking material attached at the proximal end for absorbing or filtering the sample.
16. A method for detecting or quantitating an analyte in a sample comprising a) contacting a mobilization zone on a device as defined by any of claims 1-15 with a sample suspected of containing the analyte, b) permitting the sample to move through the mobilization zone thereby to mobilize the labelled receptor and move the mobilized labelled receptor to a non-competitive ligand trap zone downstream of and in liquid communication with the mobilization zone, and c) correlating the amount or the presence of the receptor:analyte complex, the trapped unbound receptor, or both to the presence of or the amount of analyte in the sample.
CA2249303A 1996-03-20 1997-03-20 Chromatographic immunoassay device and method utilizing particle valency for quantitation Expired - Lifetime CA2249303C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US61857196A 1996-03-20 1996-03-20
US618,571 1996-03-20
PCT/US1997/005077 WO1997035205A1 (en) 1996-03-20 1997-03-20 Chromatographic immunoassay device and method utilizing particle valency for quantitation

Publications (2)

Publication Number Publication Date
CA2249303A1 true CA2249303A1 (en) 1997-09-25
CA2249303C CA2249303C (en) 2012-05-08

Family

ID=24478244

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2249303A Expired - Lifetime CA2249303C (en) 1996-03-20 1997-03-20 Chromatographic immunoassay device and method utilizing particle valency for quantitation

Country Status (5)

Country Link
US (1) US6121008A (en)
EP (1) EP0888552A1 (en)
AU (1) AU740812B2 (en)
CA (1) CA2249303C (en)
WO (1) WO1997035205A1 (en)

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Also Published As

Publication number Publication date
AU740812B2 (en) 2001-11-15
US6121008A (en) 2000-09-19
EP0888552A1 (en) 1999-01-07
CA2249303C (en) 2012-05-08
AU2553197A (en) 1997-10-10
WO1997035205A1 (en) 1997-09-25

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