EP0101912A2
Expired / Lapsed
EP
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Antigen assay method and kit
Assignee: GENETIC DIAGNOSTIC Corp
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Filing: 1983-07-23
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Granted: —
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Expires: 2003-07-23
Abstract
Abstract A method of determining the concentration of an antigen in a sample solution comprising a) coating an antigen-protein conjugate onto a solid matrix, b) conjugating an enzyme to an antibody specific for said antigen, c) to a known quantity of a solution containing the antibody-enzyme conjugate of (b) adding a specified quantity of a sample containing an unknown amount of the antigen whose content is to be determined, d) contacting the coated solid matrix of (a) with the solution (c) and incubate so as to effect binding between the antibody and antigen, some of the antigen being that from the sample and some being that on the solid matrix, e) removing the solid matrix from the solution and washing, f) immersing the solid matrix in a solution containing a known amount of an enzyme-substrate which is acted upon by the enzyme so as to effect reaction between the enzyme and enzyme-substrate to produce a product. and then separating the solid matrix from the solution of enzyme-substrate, and g) then measuring the solid matrix and/or the solution of enzyme-substrate with a pre-established standard to indicate the amount of antigen which was in the sample added in (c).
Inventors
- 👤 Alice Deutsch
- 👤 Harvey Brandwein
- 👤 Herbert Platt
- 👤 Dianne M. Hunter
- 👤 Andrew Dubitsky
- 👤 Susan M. Durham
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-06 17:01
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/74; G01N33/743; G01N33/94; G01N33/9453; Y; Y10; Y10S; Y10S435/00; Y10S435/8215; Y10S435/948
Claims Analysis
Total Claims: 34
Claim 1
Independent Claim
57 words
An assay element comprising a) a solid matrix, b) a multiplicity of protein molecules carried on said matrix, c) a multiplicity of antigen molecules respectively conjugated to said protein molecules, d) a plurality of antibody molecules bound to only some of said antigen molecules, and e) a plurality of enzyme molecules respectively conjugated to said antibody molecules.
Claim 2
Dependent Claim
57 words
An assay element comprising a) a solid matrix, b) a multiplicity of protein molecules carried on said matrix, c) a multiplicity of antigen molecules respectively conjugated to said protein molecules, d) a plurality of antibody molecules bound to only some of said antigen molecules, and e) a plurality of enzyme molecules respectively conjugated to said antibody molecules.
Claim 3
Dependent Claim
13 words
An element according to claim 1, wherein the antibody is a monoclonal antibody.
Claim 4
Dependent Claim
17 words
An element according to claim 1, wherein said antigen is at least one of digoxin and digitoxin.
Claim 5
Dependent Claim
11 words
An element according to claim 1, wherein said antigen is progesterone.
Claim 6
Dependent Claim
11 words
An element according to claim 1, wherein said antigen is thyroxine.
Claim 7
Dependent Claim
14 words
An element according to claim 1, wherein said antigen comprises at least one estrogen.
Claim 8
Dependent Claim
11 words
An element according to claim 1, wherein said antigen is dilantin.
Claim 9
Dependent Claim
11 words
An element according to claim 1, wherein said antigen is theophylline.
Claim 10
Dependent Claim
12 words
An element according to claim 1, wherein said antigen is a peptide.
Claim 11
Dependent Claim
11 words
An.element according to claim 1, wherein said antigen is a saccharide.
Claim 12
Dependent Claim
12 words
An element according to claim 1, wherein said antigen is a glycoprotein.
Claim 13
Dependent Claim
12 words
An element according to claim 1, wherein said antigen is a protein.
Claim 14
Dependent Claim
12 words
An element according to claim 1, wherein said antigen is a steroid.
Claim 15
Dependent Claim
12 words
An element according to claim 1, wherein said antigen is a glycolipid.
Claim 16
Dependent Claim
13 words
An element according to claim 1, wherein said antigen is a nucleic acid.
Claim 17
Dependent Claim
19 words
An element according to claim 1, wherein said solid matrix is a plastic or other material for immobilizing antigen.
Claim 18
Dependent Claim
13 words
An element according to claim 1, wherein said solid matrix is a polystyrene.
Claim 19
Dependent Claim
11 words
An element according to claim 1, wherein said protein is albumin.
Claim 20
Dependent Claim
13 words
An element according to claim 1, wherein said protein is bovine serum albumin.
Claim 21
Dependent Claim
12 words
An element according to claim 1, wherein said enzyme is a ß-galactosidase.
Claim 22
Dependent Claim
13 words
An element according to claim 1, wherein said enzyme is an alkaline phosphatase.
Claim 23
Dependent Claim
12 words
An element according to claim 1, wherein said enzyme is a peroxidase.
Claim 24
Dependent Claim
12 words
An element according to claim 1, wherein said enzyme is an esterase.
Claim 25
Dependent Claim
80 words
A kit for assaying the antigen content of a biological sample comprising a) a solid matrix carrying a known quantity of said antigen, b) a solution containing a known quantity of an antibody specific for said antigen, said antibody being conjugated to an enzyme, c) at least one wash solution, and d) a solution containing a known quantity of a substrate capable of being acted upon by the enzyme to produce a measurable change in a property of said substrate.
Claim 26
Dependent Claim
80 words
A kit for assaying the antigen content of a biological sample comprising a) a solid matrix carrying a known quantity of said antigen, b) a solution containing a known quantity of an antibody specific for said antigen, said antibody being conjugated to an enzyme, c) at least one wash solution, and d) a solution containing a known quantity of a substrate capable of being acted upon by the enzyme to produce a measurable change in a property of said substrate.
Claim 27
Dependent Claim
29 words
A kit according to claim 24, wherein said enzyme-substrate in (d) is one which when acted upon by the enzyme produces a difference in wave length of transmitted light.
Claim 28
Dependent Claim
25 words
A kit according to claim 24, wherein said enzyme-substrate in (d) is one which when acted upon by the enzyme produces a difference in fluorescence.
Claim 29
Dependent Claim
18 words
A kit according to claim 25, wherein said antigen is digoxin and said antibody is a monoclonal antibody.
Claim 30
Dependent Claim
103 words
A process for making an element according to . claim 1, comprising a) coating an antigen-protein conjugate onto the solid matrix, and b) independently conjugating the enzyme molecules to the molecules of antibody specific for said antigen, c) contacting the conjugate of (b) with a solution of the antigen and with the coated solid matrix to cause the antibody-enzyme conjugate to bind with antigen, reaching an equilibrium distribution between the antigen carried on the matrix and the antigen in solution, the amount of bound antigen-antibody-enzyme on the solid matrix being an index of the amount of antigen in the solution of the antigen.
Claim 31
Independent Claim
194 words
A method of determining the concentration of an antigen in a sample solution comprising a) coating the antigen-protein conjugate onto a solid matrix, b) independently conjugating an enzyme to an antibody specific for said antigen, c) to a known quantity of a solution containing the antibody-enzyme conjugate of (b) adding a specified quantity of a sample containing an unknown amount of the antigen whose content is to be determined, d) contacting the coated solid matrix of (a) with the solution (c) and incubate so as to effect binding between the antibody and antigen, some of the antigen being that from the sample and some being that on the solid matix, e) removing the solid matrix from the solution and washing, f) immersing the solid matrix in a solution con taining a known amount of an enzyme-substrate which is acted upon by the enzyme so as to effect reaction between the enzyme and enzyme-substrate, and then separating the solid matrix from the solution of enzyme-substrate, and g) then measuring the solid matrix or the solution of enzyme-substrate with a pre-established standard to indicate the amount of antigen which was in the sample added in (c).
Claim 32
Independent Claim
194 words
A method of determining the concentration of an antigen in a sample solution comprising a) coating the antigen-protein conjugate onto a solid matrix, b) independently conjugating an enzyme to an antibody specific for said antigen, c) to a known quantity of a solution containing the antibody-enzyme conjugate of (b) adding a specified quantity of a sample containing an unknown amount of the antigen whose content is to be determined, d) contacting the coated solid matrix of (a) with the solution (c) and incubate so as to effect binding between the antibody and antigen, some of the antigen being that from the sample and some being that on the solid matix, e) removing the solid matrix from the solution and washing, f) immersing the solid matrix in a solution con taining a known amount of an enzyme-substrate which is acted upon by the enzyme so as to effect reaction between the enzyme and enzyme-substrate, and then separating the solid matrix from the solution of enzyme-substrate, and g) then measuring the solid matrix or the solution of enzyme-substrate with a pre-established standard to indicate the amount of antigen which was in the sample added in (c).
Claim 33
Dependent Claim
13 words
The digoxin monoclonal antibody produced by the process of Example (a) and (b).
Claim 34
Dependent Claim
13 words
The digoxin monoclonal antibody produced by the process of Example (a) and (b).
References Cited (Backward Citations)
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