EP0095089A1
Expired / Lapsed
EP
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Improved homogeneous binding assay method and reagent system, test kit and test device therefor
Assignee: Bayer Corp
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Filing: 1983-05-11
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Granted: —
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Expires: 2003-05-11
Abstract
Abstract An improved homogenous binding assay for determining polyvalent analytes employing labeled binding partners for the analyte, such as labeled antibodies. Binding of the labeled binding partner to analyte results in a change in the response from the label due to steric hindrance of access to the label by a member of a reagent detection system which generates the response by interaction with the label. The improvement comprises adding to the system a macromolecular binder selective for binding to analyte, e.g., anti-analyte, whereby the resulting steric hindrance is enhanced.
Inventors
- 👤 Kenneth James Dean
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-30 20:19
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/536; G01N33/542
Claims Analysis
Total Claims: 13
Claim 1
Independent Claim
130 words
A homogeneous binding assay method for determining an analyte in a test sample, wherein said sample is combined with a labeled binding partner for said analyte and a reagent detection system for the label comprised in said labeled binding partner, said label interacting with a member of said detection system to provide a response which is measurably different when said labeled binding partner is bound to said analyte compared to when not so bound due to steric hindrance of access of said detection system member tn said label; and wherein said response is measured as a function of the analyte in the test sample, characterized in that said test sample is combined additionally with a macromolecular binder which binds with said analyte but not significantly with said labeled binding partner.
Claim 2
Dependent Claim
130 words
A homogeneous binding assay method for determining an analyte in a test sample, wherein said sample is combined with a labeled binding partner for said analyte and a reagent detection system for the label comprised in said labeled binding partner, said label interacting with a member of said detection system to provide a response which is measurably different when said labeled binding partner is bound to said analyte compared to when not so bound due to steric hindrance of access of said detection system member tn said label; and wherein said response is measured as a function of the analyte in the test sample, characterized in that said test sample is combined additionally with a macromolecular binder which binds with said analyte but not significantly with said labeled binding partner.
Claim 3
Dependent Claim
15 words
The method of Claim 1 characterized in that said macromolecular binder is a binding protein.
Claim 4
Dependent Claim
20 words
The method of Claim 2 characterized in that said binding protein is an antibody or an aggregate or fragment thereof.
Claim 5
Independent Claim
30 words
The method of any of Claims 1 to 3 characterized in that said labeled binding partner is a labeled form of an antibody or of an aggregate or fragment thereof.
Claim 6
Independent Claim
46 words
The method of any one of Claims 1 to 4, characterized in that said label is a participant in an enzyme catalyzed reaction comprised in said detection system and preferably is an enzyme substrate, a coenzyme, an enzyme prosthetic group, an enzyme inhibitor, or an enzyme.
Claim 7
Independent Claim
25 words
The method of any of Claims 1 to 5, characterized in that said analyte has a molecular weight greater than 10.000, preferably greater than 100.000.
Claim 8
Dependent Claim
137 words
A homogeneous immunoassay method according to Claim 1 for determining a polyvalent analyte having a molecular weight greater than 10.000 in a test sample, wherein said sample is combined with (i) a labeled monoclonal anti-analyte preparation in which said monoclonal anti-analyte is substantially the only labeled component, and (ii) a reagent detection system for the label comprised in said labeled monoclonal anti-analyte, said label interacting with a member of said detection system to provide a response which is measurably different when said labeled anti-analyte is bound to said analyte compared to when not so bound due to steric hindrance of access of said detection system member to said label; and wherein said response is measured as a function of the analyte in the test sample, characterized in that said test sample is combined additionally with unlabeled anti-analyte.
Claim 9
Dependent Claim
110 words
A reagent system for performing a homogeneous binding assay to determine analyte in a test sample, comprising: (1) a labeled binding partner for said analyte; (2) a reagent detection system for the label comprised in said labeled binding partner, said label interacting with a member of said detection system to provide a response which is measurably different when said labeled binding partner is bound to said analyte compared to when not so bound due to steric hindrance of access of said detection system member to said label; characterized in that it additionally comprises (3) a macromolecular binder which binds with said analyte but not significantly with said labeled binding partner.
Claim 10
Dependent Claim
110 words
A reagent system for performing a homogeneous binding assay to determine analyte in a test sample, comprising: (1) a labeled binding partner for said analyte; (2) a reagent detection system for the label comprised in said labeled binding partner, said label interacting with a member of said detection system to provide a response which is measurably different when said labeled binding partner is bound to said analyte compared to when not so bound due to steric hindrance of access of said detection system member to said label; characterized in that it additionally comprises (3) a macromolecular binder which binds with said analyte but not significantly with said labeled binding partner.
Claim 11
Dependent Claim
107 words
A test kit for performing a homogeneous immunoassay to determine a polyvalent analyte having a molecular weight greater than 10.000 in a test sample, comprising: (1) a labeled monoclonal anti-analyte preparation in which said monoclonal anti-analyte is substantially the only labeled component, (2) a reagent detection system for the label comprised in said labeled monoclonal anti-analyte, said label interacting with a member of said detection system to provide a response which is measurably different when said labeled anti-analyte is bound to said analyte compared to when not so bound due to steric hindrance of access of said detection system member to said label; and (3) unlabeled anti-analyte.
Claim 12
Dependent Claim
107 words
A test kit for performing a homogeneous immunoassay to determine a polyvalent analyte having a molecular weight greater than 10.000 in a test sample, comprising: (1) a labeled monoclonal anti-analyte preparation in which said monoclonal anti-analyte is substantially the only labeled component, (2) a reagent detection system for the label comprised in said labeled monoclonal anti-analyte, said label interacting with a member of said detection system to provide a response which is measurably different when said labeled anti-analyte is bound to said analyte compared to when not so bound due to steric hindrance of access of said detection system member to said label; and (3) unlabeled anti-analyte.
Claim 13
Dependent Claim
34 words
A test device for the homogeneous binding assay determination of an analyte in a test sample, characterized in that it comprises the reagent system of Claim 8 and a solid carrier member incorporated therewith.
References Cited (Backward Citations)
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