US5120643A
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Process for immunochromatography with colloidal particles
Assignee: Alere Switzerland GmbH
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Filing: 1987-07-13
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Granted: 1992-06-09
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Expires: 2007-07-13
Abstract
Abstract The present invention relates to improved specific binding assay methods, kits and devices utilizing chromatographically mobile specific binding reagents labelled with colloidal particles. Specific binding reagents labelled with colloidal particles such as gold and selenium may be subjected to rapid chromatographic solvent transport on chromatographic media by means of selected solvents and chromatographic transport facilitating agents. Further, impregnation of solid substrate materials with labile protein materials including colloidal particle and enzyme labelled reagents in the presence of meta-soluble proteins provides for the rapid resolubilization of such materials which have been dried onto such substrate materials.
Inventors
- 👤 Shanfun Ching
- 👤 Patricia Billing
- 👤 Julian Gordon
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-01 08:45
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/58; G01N33/585; G01N33/587; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54388; G01N33/54393; G01N33/74; G01N33/76; G01N30/00; G01N30/90; Y; Y10; Y10S; Y10S435/00; Y10S435/967; Y10S435/97; Y10S435/975; Y10S436/00; Y10S436/801; Y10S436/807; Y10S436/808; Y10S436/826
Claims Analysis
Total Claims: 34
Claim 1
Independent Claim
155 words
A method for determining the presence or amount of an analyte in a test sample, comprising the steps of: a) contacting a chromatographic medium with the test sample, said medium comprising at least two reaction sites, a first reaction site comprising a dried solution of a labelled specific binding reagent in the presence of a meta-soluble protein, and a second reaction site comprising an immobilized specific binding reagent capable of immobilizing said labelled reagent in relation to the presence or amount of the analyte in the test sample; b) solubilizing said labelled reagent and transporting at least a portion of said labelled reagent to said second reaction site, and binding said labelled reagent to said second reaction site in relation to the presence or amount of the analyte in the test sample; and c) detecting said labelled reagent at said second site to determine the presence or amount of the analyte in the test sample.
Claim 2
Independent Claim
155 words
A method for determining the presence or amount of an analyte in a test sample, comprising the steps of: a) contacting a chromatographic medium with the test sample, said medium comprising at least two reaction sites, a first reaction site comprising a dried solution of a labelled specific binding reagent in the presence of a meta-soluble protein, and a second reaction site comprising an immobilized specific binding reagent capable of immobilizing said labelled reagent in relation to the presence or amount of the analyte in the test sample; b) solubilizing said labelled reagent and transporting at least a portion of said labelled reagent to said second reaction site, and binding said labelled reagent to said second reaction site in relation to the presence or amount of the analyte in the test sample; and c) detecting said labelled reagent at said second site to determine the presence or amount of the analyte in the test sample.
Claim 3
Dependent Claim
20 words
The method according to claim 1 wherein said immobilized specific binding reagent and said labelled reagent specifically bind the analyte.
Claim 4
Dependent Claim
22 words
The method according to claim 1 wherein said labelled reagent and the analyte compete in binding to said immobilized specific binding reagent.
Claim 5
Dependent Claim
25 words
The method according to claim 1, wherein said meta-soluble protein is selected from the group consisting of casein, zein and meta-soluble non-albumin egg white protein.
Claim 6
Dependent Claim
12 words
The method according to claim 4, wherein said meta-soluble protein is casein.
Claim 7
Dependent Claim
20 words
The method according to claim 1, wherein said labelled specific binding reagent is a colloidal particle labelled specific binding reagent.
Claim 8
Dependent Claim
21 words
The method according to claim 6, wherein said colloidal particles have diameters varying from about 1 nm to about 200 nm.
Claim 9
Dependent Claim
21 words
The method according to claim 7, wherein said colloidal particles have diameters ranging from about 40 nm to about 80 nm.
Claim 10
Dependent Claim
14 words
The method according to claim 6, wherein said colloidal particles are colloidal metal particles.
Claim 11
Dependent Claim
14 words
The method according to claim 9, wherein said colloidal particles are colloidal gold particles.
Claim 12
Dependent Claim
14 words
The method according to claim 6, wherein said colloidal particles are colloidal non-metal particles.
Claim 13
Dependent Claim
14 words
The method according to claim 11, wherein said colloidal particles are colloidal selenium particles.
Claim 14
Dependent Claim
19 words
The method according to claim 1, wherein said labelled specific binding reagent is an enzyme labelled specific binding reagent.
Claim 15
Dependent Claim
21 words
The method according to claim 1, wherein said chromatographic medium has a pore size from about 0.05 to about 20 microns.
Claim 16
Dependent Claim
20 words
The method according to claim 14, wherein said chromatographic medium comprises nitrocellulose having a pore size of about 5.0 microns.
Claim 17
Dependent Claim
118 words
A test device for determining the presence or amount of an analyte in a test sample, comprising: a chromatographic medium having capillarity and the capacity for transport of non-immobilized reagents and reactive sample components, and comprising at least two reaction sites, wherein a first reaction site comprises a dried solution of a labelled specific binding reagent in the presence of a meta-soluble protein, said labelled specific binding reagent being solubilized and transported through said chromatographic medium upon contact with a chromatographic solvent or a test sample, and wherein a second reaction site comprises an immobilized specific binding reagent capable of immobilizing said labelled reagent in relation to the presence or amount of the analyte in the test sample.
Claim 18
Dependent Claim
118 words
A test device for determining the presence or amount of an analyte in a test sample, comprising: a chromatographic medium having capillarity and the capacity for transport of non-immobilized reagents and reactive sample components, and comprising at least two reaction sites, wherein a first reaction site comprises a dried solution of a labelled specific binding reagent in the presence of a meta-soluble protein, said labelled specific binding reagent being solubilized and transported through said chromatographic medium upon contact with a chromatographic solvent or a test sample, and wherein a second reaction site comprises an immobilized specific binding reagent capable of immobilizing said labelled reagent in relation to the presence or amount of the analyte in the test sample.
Claim 19
Dependent Claim
21 words
The test device according to claim 16, wherein said immobilized specific binding reagent and said labelled reagent specifically bind the analyte.
Claim 20
Dependent Claim
23 words
The test device according to claim 16, wherein said labelled reagent and the analyte compete in binding to said immobilized specific binding reagent.
Claim 21
Dependent Claim
26 words
The test device according to claim 16, wherein said meta-soluble protein is selected from the group consisting of casein, zein and meta-soluble non-albumin egg white protein.
Claim 22
Dependent Claim
13 words
The test device according to claim 19, wherein said meta-soluble protein is casein.
Claim 23
Dependent Claim
21 words
The test device according to claim 16, wherein said labeled specific binding reagent is a colloidal particle labeled specific binding reagent.
Claim 24
Dependent Claim
22 words
The test device according to claim 21, wherein said colloidal particles have diameters ranging from about 1 nm to about 200 nm.
Claim 25
Dependent Claim
22 words
The test device according to claim 21, wherein said colloidal particles have diameters ranging from about 40 nm to about 80 nm.
Claim 26
Dependent Claim
15 words
The test device according to claim 21, wherein said colloidal particles are colloidal metal particles.
Claim 27
Dependent Claim
15 words
The test device according to claim 24, wherein said colloidal particles are colloidal gold particles.
Claim 28
Dependent Claim
15 words
The test device according to claim 21, wherein said colloidal particles are colloidal non-metal particles.
Claim 29
Dependent Claim
15 words
The test device according to claim 26, wherein said colloidal particles are colloidal selenium particles.
Claim 30
Dependent Claim
20 words
The test device according to claim 16, wherein said labeled specific binding reagent is an enzyme labeled specific binding reagent.
Claim 31
Dependent Claim
21 words
The device according to claim 16, wherein said chromatographic medium has a pore size from about 0.05 to about 20 microns.
Claim 32
Dependent Claim
20 words
The device according to claim 29, wherein said chromatographic medium comprises nitrocellulose having a pore size of about 5.0 microns.
Claim 33
Dependent Claim
126 words
A kit for use in specific binding assays for determining the presence or amount of an analyte in a test sample, comprising: a) a chromatographic medium having a capillarity and the capacity for transport of non-immobilized reagents and reactive sample components, and comprising at least two reaction sites, wherein a first reaction site comprises a labelled specific binding reagent, in the presence of a meta-soluble protein, wherein said labelled specific binding reagent is capable of being solubilized and transported through said chromatographic medium upon contact with a chromatographic solvent, and wherein a second reaction site comprises an immobilized specific binding reagent capable of immobilizing said labelled reagent in relation to the presence or amount of the analyte in the test sample; and b) a chromatographic solvent.
Claim 34
Dependent Claim
126 words
A kit for use in specific binding assays for determining the presence or amount of an analyte in a test sample, comprising: a) a chromatographic medium having a capillarity and the capacity for transport of non-immobilized reagents and reactive sample components, and comprising at least two reaction sites, wherein a first reaction site comprises a labelled specific binding reagent, in the presence of a meta-soluble protein, wherein said labelled specific binding reagent is capable of being solubilized and transported through said chromatographic medium upon contact with a chromatographic solvent, and wherein a second reaction site comprises an immobilized specific binding reagent capable of immobilizing said labelled reagent in relation to the presence or amount of the analyte in the test sample; and b) a chromatographic solvent.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1995-06-09 | 1995-12-09 | 1996-06-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-06-09 | 1999-12-09 | 2000-06-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-06-09 | 2003-12-09 | 2004-06-09 | $7700.00 | Window Closed / Lapsed |