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Monoclonal antibody mixtures and use thereof for enhanced sensitivity immunoassays

Assignee: Columbia University
•
Filing: 1982-05-21
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Granted: 1985-04-30
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Expires: 2002-05-21
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Abstract

Abstract Mixtures of monoclonal antibodies which contain effective assaying amounts of each of at least two monoclonal antibodies that bind to different antigenic sites on the antigen and are capable under appropriate conditions of binding simultaneously to an antigen are useful in enhanced sensitivity assays for the antigen. By utilizing such mixtures in diagnostic assays for important antigens such as the polypeptide human chorionic gonadotropin enhanced sensitivity can be achieved as compared with assays employing individual monoclonal antibodies.

Inventors

  • 👤 Robert E. Canfield
  • 👤 Paul H. Ehrlich
  • 👤 William R. Moyle

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-30 19:24
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/577; G01N33/5306; G01N33/543; G01N33/54393; G01N33/74; G01N33/76; Y; Y10; Y10S; Y10S435/00; Y10S435/962; Y10S435/965; Y10S436/00; Y10S436/804; Y10S436/815; Y10S436/817; Y10S436/818

Claims Analysis

Total Claims: 17
Claim 1
Independent Claim 118 words
An immunoassay for an antigen providing enhanced sensitivity which comprises contacting the antigen under suitable conditions with effective assaying amounts of each of at least two monoclonal antibodies which bind to different antigenic sites on the antigen and which are capable under appropriate conditions in a totally liquid phase of forming a stable complex which includes the antigen and all of the monoclonal antibodies, the monoclonal antibodies being further characterized in that they form a stable complex with the antigen when subjected to gel electrophoresis in the presence of the antigen and when subjected to gel filtration chromatography in the presence of the antigen, and detecting the complex which results from contacting the antigen with the monoclonal antibodies.
Claim 2
Dependent Claim 118 words
An immunoassay for an antigen providing enhanced sensitivity which comprises contacting the antigen under suitable conditions with effective assaying amounts of each of at least two monoclonal antibodies which bind to different antigenic sites on the antigen and which are capable under appropriate conditions in a totally liquid phase of forming a stable complex which includes the antigen and all of the monoclonal antibodies, the monoclonal antibodies being further characterized in that they form a stable complex with the antigen when subjected to gel electrophoresis in the presence of the antigen and when subjected to gel filtration chromatography in the presence of the antigen, and detecting the complex which results from contacting the antigen with the monoclonal antibodies.
Claim 3
Dependent Claim 11 words
An immunoassay according to claim 1 which comprises two monoclonal antibodies.
Claim 4
Dependent Claim 22 words
An immunoassay according to claim 1, wherein said antigen is a polypeptide and said antigenic sites are amino acid sequences contained therein.
Claim 5
Dependent Claim 14 words
An immunoassay according to claim 1, wherein said polypeptide antigen is human chorionic gonadotropin.
Claim 6
Dependent Claim 14 words
An immunoassay according to claim 1, wherein said polypeptide antigen is follicle stimulating hormone.
Claim 7
Dependent Claim 14 words
An immunoassay according to claim 1, wherein said polypeptide antigen is thyroid stimulating hormone.
Claim 8
Dependent Claim 13 words
An immunoassay according to claim 1, wherein said polypeptide antigen is luteinizing hormone.
Claim 9
Dependent Claim 37 words
An immunoassay according to claim 1, wherein said effective assaying amounts are amounts of each monoclonal antibody sufficient to permit at least about 10 percent of said antigen present in said sample to form said stable complex.
Claim 10
Dependent Claim 33 words
An immunoassay according to claim 1, wherein the amounts of each antibody relative to the amount of other antibodies is in the range from about 10 6 :1 to about 1:10 6 .
Claim 11
Dependent Claim 23 words
An immunoassay according to claim 9, wherein the amount is in the range from about 10 2 :1 to about 1:10 2 .
Claim 12
Dependent Claim 36 words
An immunoassay according to claim 9, wherein the amount of each antibody relative to the amount of other antibodies is substantially the same as the ratio of the binding constants of the antibodies to the antigen.
Claim 13
Dependent Claim 37 words
An immunoassay according to claim 4, which comprises two monoclonal antibodies, one of which binds to the α chain of human chorionic gonadotropin and the other of which binds to the β chain of human chorionic gonadotropin.
Claim 14
Dependent Claim 34 words
An immunoassay according to claim 12, wherein the antibody which binds to the α chain is designated A102 or A103 and the antibody which binds to the β chain is designated B102 to B103.
Claim 15
Dependent Claim 30 words
An immunoassay according to claim 4, which comprises two monoclonal antibodies, both of which bind to the β chain of human chorionic gonadotropin, said antibodies being designated B101 and B102.
Claim 16
Dependent Claim 20 words
An immunoassay according to claim 1, wherein at least one of the monoclonal antibodies is adsorbed onto a solid matrix.
Claim 17
Dependent Claim 17 words
An immunoassay according to claim 1, wherein the monoclonal antibodies are dissolved in a suitably buffered solution.

References Cited (Backward Citations)

US3935074A Cited
US4048298A Cited
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EP0044219A1 Cited
FR2487983A1 Cited
US4376110A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1988-04-29 1988-10-29 1989-04-30 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1992-04-29 1992-10-29 1993-04-30 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1996-04-29 1996-10-29 1997-04-30 $7700.00 Window Closed / Lapsed

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