CA2396116A1 - Immunochromatographic assay devices with separators - Google Patents

Immunochromatographic assay devices with separators Download PDF

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Publication number
CA2396116A1
CA2396116A1 CA002396116A CA2396116A CA2396116A1 CA 2396116 A1 CA2396116 A1 CA 2396116A1 CA 002396116 A CA002396116 A CA 002396116A CA 2396116 A CA2396116 A CA 2396116A CA 2396116 A1 CA2396116 A1 CA 2396116A1
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CA
Canada
Prior art keywords
separator
assay device
binding partner
kit
absorbent pad
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
CA002396116A
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French (fr)
Other versions
CA2396116C (en
Inventor
Ming Guan
Hsiao Ying Chen
Theresa Puifun Chow
Adrian Rennie Pereira
Ping Kuen Mun
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.)
MP Biomedicals Asia Pacific Pte Ltd
Original Assignee
Genelabs Diagnostics Pte Ltd.
Ming Guan
Hsiao Ying Chen
Theresa Puifun Chow
Adrian Rennie Pereira
Ping Kuen Mun
Mp Biomedicals Asia Pacific Pte. Ltd.
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Publication date
Application filed by Genelabs Diagnostics Pte Ltd., Ming Guan, Hsiao Ying Chen, Theresa Puifun Chow, Adrian Rennie Pereira, Ping Kuen Mun, Mp Biomedicals Asia Pacific Pte. Ltd. filed Critical Genelabs Diagnostics Pte Ltd.
Publication of CA2396116A1 publication Critical patent/CA2396116A1/en
Application granted granted Critical
Publication of CA2396116C publication Critical patent/CA2396116C/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
    • G01N33/558—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
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/08—RNA viruses
    • G01N2333/15—Retroviridae, e.g. bovine leukaemia virus, feline leukaemia virus, feline leukaemia virus, human T-cell leukaemia-lymphoma virus
    • G01N2333/155—Lentiviridae, e.g. visna-maedi virus, equine infectious virus, FIV, SIV
    • G01N2333/16—HIV-1, HIV-2
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/205—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Campylobacter (G)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/35—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Mycobacteriaceae (F)
    • 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
    • Y10S435/97—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

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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)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Assay devices, kits, and methods for detection of one or more analytes in a sample are provided. The assay device features the controlled release of reagents and hence is particularly suitable for binding assays such as immunoassays. The assay device achieves greater sensitivity than conventiona l rapid test assays, leading to stronger and/or more stable visual signals tha n those produced by conventional devices, easier interpretation of results, an d reduced occurrence of indeterminate results. The device can be used for detecting analyte in a variety of biological samples without the need for conventional sample filtration techniques, and thus is suitable for use by untrained personnel without specialized equipment. In addition, the device c an be used to simultaneously analyze a number of analytes using a single sample .

Claims (56)

1. An assay device or kit comprising:
a) a chromatographic element comprising a sample receiving end, a reagent releasing end, and a reaction zone;
b) an absorbent pad; and c) a separator positioned between the chromatographic element and the absorbent pad.
2. The assay or kit device of claim 1, wherein the reagent releasing end comprises a releasable binding partner.
3. The assay device or kit of claim 2, wherein the releasable binding partner comprises one or more antibodies directed against one or more conserved regions of a human antibody.
4. The assay device or kit of claim 2, wherein the releasable binding partner comprises a detectable label.
5. The assay device or kit of claim 1, wherein the sample receiving end comprises a first releasable binding partner, and the reagent releasing end comprises a second releasable binding partner.
6. The assay device or kit of claim 1, wherein the reaction zone comprises an immobilized binding partner for a specific analyte.
7. The assay device or kit of claim 6, wherein the immobilized binding partner comprises one or more antigens selected from the group consisting of a recombinant HIV 1 antigen, a recombinant HIV 2 antigen, a Helicobacter pylori-derived antigen, and a Mycobacterium tuberculosis-derived antigen.
8. The assay device or kit of claim 1, wherein the separator comprises a fluid-impermeable barrier.
9. The assay device or kit of claim 8, wherein the separator protrudes beyond the chromatographic element and the absorbent pad.

37~
10. The assay device or kit of claim 1, wherein the separator comprises a semi-permeable membrane.
11. The assay device or kit of claim 1, wherein the separator comprises a material which dissolves over time upon exposure to an aqueous solution.
12. The assay device or kit of claim 1, further comprising:
d) a casing surrounding at least a portion of the chromatographic element, absorbent pad and separator.
13. The assay device or kit of claim 12, wherein a portion of the separator protrudes from the casing.
14. The assay device or kit of claim 1, further comprising an aqueous solution.
15. The assay device or kit of claim 1, further comprising one or more of:
a container for holding the chromatographic element, the separator, the absorbent pad, or a combination thereof; packaging materials for packaging the chromatographic element, the separator, the absorbent pad, or a combination thereof; and an instruction set.
16. An assay device or kit comprising:
a) a chromatographic element comprising a sample receiving end, a reagent releasing end, and a reaction zone, wherein the reaction zone comprises an immobilized first binding partner, and the reagent releasing end comprises a labeled releasable second binding partner;
b) an absorbent pad; and c) a separator positioned between the chromatographic element and the absorbent pad.
17. The assay device or kit of claim 16, further comprising:
d) a casing surrounding at least a portion of the chromatographic element, absorbent pad and separator.
18. The assay device or kit of claim 16, further comprising an aqueous solution.
19. The assay device or kit of claim 16, further comprising one or more of: a container for holding the chromatographic element, the separator, the absorbent pad, or a combination thereof; packaging materials for packaging the chromatographic element, the separator, the absorbent pad, or a combination thereof; and an instruction set.
20. An assay device or kit comprising:
a) a chromatographic element comprising a sample receiving end, a reagent releasing end, and a reaction zone, wherein the sample receiving end comprises a releasable first binding partner, the reaction zone comprises an immobilized second binding partner, and the reagent releasing zone comprises a labeled releasable third binding partner;
b) an absorbent pad; and c) a separator positioned between the chromatographic element and the absorbent pad.
21. The assay device or kit of claim 20, further comprising:
d) a casing surrounding at least a portion of the chromatographic element, absorbent pad and separator.
22. The assay device or kit of claim 20, further comprising an aqueous solution.
23. The assay device or kit of claim 20, further comprising one or more of: a container for holding the chromatographic element, the separator, the absorbent pad, or a combination thereof; packaging materials for packaging the chromatographic element, the separator, the absorbent pad, or a combination thereof; and an instruction set.
24. An assay device or kit comprising:
a) a chromatographic element comprising a sample receiving end, a reagent releasing end, and a reaction zone, wherein the reaction zone comprises an immobilized first binding partner, and the reagent releasing end comprises a releasable second binding partner and a labeled third binding partner;
b) an absorbent pad; and c) a separator positioned between the chromatographic element and the absorbent pad.
25. The assay device or kit of claim 24, further comprising:
d) a casing surrounding at least a portion of the chromatographic element, absorbent pad and separator.
26. The assay device or kit of claim 24, further comprising an aqueous solution.
27. The assay device or kit of claim 24, further comprising one or more of: a container for holding the chromatographic element, the separator, the absorbent pad, or a combination thereof; packaging materials for packaging the chromatographic element, the separator, the absorbent pad, or a combination thereof; and an instruction set.
28. An assay device or kit comprising:
a) a chromatographic element comprising a sample receiving end, a reagent releasing end, and a reaction zone, wherein the reaction zone comprises an immobilized first binding partner, the reagent releasing zone comprises a labeled releasable second binding partner, and the separator comprises a material which becomes permeable over time;
b) an absorbent pad; and c) a separator positioned between the chromatographic element and the absorbent pad.
29. The assay device or kit of claim 28, further comprising:
d) a casing surrounding at least a portion of the chromatographic element, absorbent pad and separator.
30. A method for detecting an analyte in a sample, the method comprising:
a) adding the sample to the sample receiving end of the chromatographic element of the assay device or kit of claim 1;
b) allowing the sample to flow from the sample receiving end and through at least a portion of the reaction zone of the chromatographic element;
c) reacting the analyte within the sample with a first binding partner immobilized within the reaction zone to form a first complex;

d) adding an aqueous solution to the reagent releasing end of the chromatographic element and solubilizing a releasable second binding partner incorporated therein, wherein the releasable second binding partner comprises a label;
e) removing the separator from the assay device to bring the absorbent pad into contact with the chromatographic element;
f) allowing the releasable second binding partner to flow from the reagent releasing end and through at least the portion of the reaction zone of the chromatographic element;
g) forming a second complex between the releasable second binding partner and a substrate selected from the group consisting of the analyte, the first binding partner, and the first complex; and h) detecting the second complex.
31. The method of claim 30, wherein the adding the aqueous solution and solubilizing a releasable second binding partner is performed prior to the removing the separator from the assay device.
32. The method of claim 30, wherein the removing the separator from the assay device is performed prior to the adding the aqueous solution and solubilizing a releasable second binding partner.
33. The method of claim 30, wherein the removing the separator from the assay device is performed concomitant with the adding the aqueous solution and solubilizing a releasable second binding partner.
34. The method of claim 30, wherein the separator is removed by pulling the separator from between the chromatographic element and the absorbent pad.
35. The method of claim 30, wherein the separator is removed by permeabilizing the separator.
36. The method of claim 30, wherein the separator is removed by dissolving the separator.
37. The method of claim 30, wherein the analyte comprises an IgM, and IgG, an antigen, an antibody, or both an antigen and an antibody.
38. A method for detecting an analyte in a sample, the method comprising:
a) adding a sample to the sample receiving end of the chromatographic element of the assay device or kit of claim 1;
b) allowing the analyte to react with a releasable first binding partner incorporated in the sample receiving end, to form a first complex;
c) allowing the first complex to flow from the sample receiving end and through at least a portion of the reaction zone of the chromatographic element;
d) reacting the first complex with a second binding partner immobilized within the reaction zone to form a second complex;
e) adding to the reagent releasing end of the chromatographic element an aqueous solution and solubilizing a releasable third binding partner incorporated therein;
f) removing the separator from the assay device to bring the absorbent pad into contact with the chromatographic element;
g) allowing the releasable third binding partner to flow through at least the portion of the reaction zone;
h) forming a third complex between the releasable third binding partner and a substrate selected from the group consisting of the analyte, the releasable first binding partner, the first complex, and the second complex; and i) detecting the third complex.
39. The method of claim 38, wherein the adding the aqueous solution and solubilizing a releasable third binding partner is performed prior to the removing the separator from the assay device.
40. The method of claim 38, wherein the removing the separator from the assay device is performed prior to the adding the aqueous solution and solubilizing a releasable third binding partner.
41. The method of claim 38, wherein the removing the separator from the assay device is performed concomitant with the adding the aqueous solution and solubilizing a releasable third binding partner.
42. The method of claim 38, wherein the separator is removed by pulling the separator from between the chromatographic element and the absorbent pad.
43. The method of claim 38, wherein the separator is removed by permeabilizing the separator.
44. The method of claim 38, wherein the separator is removed by dissolving the separator.
45. The method of claim 38, wherein the analyte comprises an IgM, and IgG, an antigen, an antibody, or both an antigen and an antibody.
46. A method for detecting an analyte in a sample, the method comprising:
a) adding the sample to the sample receiving end of the chromatographic element of the assay device or kit of claim 1;
b) allowing the sample to flow from the sample receiving end and through at least a portion of the reaction zone of the chromatographic element;
c) reacting the analyte within the sample with a first binding partner immobilized within the reaction zone to form a first complex;
d) adding an aqueous solution to the reagent releasing end of the chromatographic element and solubilizing a releasable second binding partner and a labeled releasable third binding partner incorporated therein;
e) removing the separator from the assay device to bring the absorbent pad into contact with the chromatographic element;
f) binding the releasable second binding partner to the releasable third binding partner to form a second complex;
g) allowing the second complex to flow from the reagent releasing end and through at least the portion of the reaction zone of the chromatographic element;
h) forming a third complex between the first complex and the second complex;
and i) detecting the third complex.
47. The method of claim 46, wherein the adding the aqueous solution is performed prior to the removing the separator from the assay device.
48. The method of claim 46, wherein the removing the separator from the assay device is performed prior to the adding the aqueous solution.
49. The method of claim 46, wherein the removing the separator from the assay device is performed concomitant with the adding the aqueous solution.
50. Use of an assay device or kit for detecting the presence of one or more analytes in a sample, the assay device or kit comprising:
a) a chromatographic element comprising a sample receiving end, a reagent releasing end, and a reaction zone;
b) an absorbent pad; and c) a separator positioned between the chromatographic element and the absorbent pad.
51. Use of an assay device or kit for detecting the presence of one or more analytes in a sample, the assay device or kit comprising:
a) a chromatographic element comprising a sample receiving end, a reagent releasing end, and a reaction zone, wherein the reaction zone comprises an immobilized first binding partner, and the reagent releasing end comprises a labeled releasable second binding partner;
b) an absorbent pad; and c) a separator positioned between the chromatographic element and the absorbent pad.
52. Use of an assay device or kit for detecting the presence of one or more analytes in a sample, the assay device or kit comprising:
a chromatographic element comprising a sample receiving end, a reagent releasing end, and a reaction zone, wherein the sample receiving end comprises a releasable first binding partner, the reaction zone comprises an immobilized second binding partner, and the reagent releasing zone comprises a labeled releasable third binding partner;
b) an absorbent pad; and c) a separator positioned between the chromatographic element and the absorbent pad.
53. Use of an assay device or kit for detecting the presence of one or more analytes in a sample, the assay device or kit comprising:

a chromatographic element comprising a sample receiving end, a reagent releasing end, and a reaction zone, wherein the reaction zone comprises an immobilized first binding partner, and the reagent releasing end comprises a releasable second binding partner and a labeled third binding partner;
b) an absorbent pad; and c) a separator positioned between the chromatographic element and the absorbent pad.
54. Use of an assay device or kit for detecting the presence of one or more analytes in a sample, the assay device or kit comprising:
a chromatographic element comprising a sample receiving end, a reagent releasing end, and a reaction zone, wherein the reaction zone comprises an immobilized first binding partner, the reagent releasing zone comprises a labeled releasable second binding partner, and the separator comprises a material which becomes permeable over time;
b) an absorbent pad; and c) a separator positioned between the chromatographic element and the absorbent pad.
55. Use of an assay device or kit selected from any one of the assay devices or kits of claims 1 to 29 for practicing a method selected from any one of claims 30 to 49.
56. An assay utilizing a use set forth in any one of claims 50 to 55.
CA2396116A 2000-01-28 2001-01-25 Immunochromatographic assay devices with separators Expired - Fee Related CA2396116C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/493,408 2000-01-28
US09/493,408 US6316205B1 (en) 2000-01-28 2000-01-28 Assay devices and methods of analyte detection
PCT/US2001/002554 WO2001055723A1 (en) 2000-01-28 2001-01-25 Immunochromatographic assay devices with separators

Publications (2)

Publication Number Publication Date
CA2396116A1 true CA2396116A1 (en) 2001-08-02
CA2396116C CA2396116C (en) 2011-03-15

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Country Status (8)

Country Link
US (3) US6316205B1 (en)
EP (1) EP1250598B1 (en)
CN (1) CN1168985C (en)
AT (1) ATE307338T1 (en)
AU (1) AU782582B2 (en)
CA (1) CA2396116C (en)
DE (1) DE60114146D1 (en)
WO (1) WO2001055723A1 (en)

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