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US4837167A Expired / Lapsed US ⏱️ 0.0 years remaining

Immunoassay for multi-determinant antigens using high-affinity

Assignee: General Hospital Corp
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Filing: 1984-04-24
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Granted: 1989-06-06
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Expires: 2004-04-24
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Abstract

Abstract A simultaneous sandwich immunoassay employing high-affinity monoclonal antibodies is disclosed. This simultaneous sandwich assembly has surprising sensitivity compared to forward and reverse sandwich assays for the detection of multi-determinant antigens such as hepatitis B surface antigen.

Inventors

  • 👤 Hubert J. P. Schoemaker
  • 👤 Jack R. Wands
  • 👤 Barbara L. Westrick
  • 👤 Vincent R. Zurawski, Jr.

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-04 09:40
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/577; G01N33/576; Y; Y10; Y10S; Y10S436/00; Y10S436/804; Y10S436/819; Y10S436/82; Y10S530/00; Y10S530/806; Y10S530/863; Y10S530/864

Claims Analysis

Total Claims: 17
Claim 1
Independent Claim 86 words
In an immunoassay for detecting the presence of a multi-determinant antigen in a liquid sample wherein said sample is simultaneously incubated in the presence of an immunoadsorbent containing immobilized antibody for said antigen and labeled antibody for said antigen, and thereafter detecting the amount of labeled antibody bound to said immunoadsorbent as an indication of the amount of antigen present in said sample: the improvement wherein said immobilized antibody and said labeled antibody comprise high-affinity IgM monoclonal antibodies directed against a multiply-appearing determinant of said antigen.
Claim 2
Dependent Claim 86 words
In an immunoassay for detecting the presence of a multi-determinant antigen in a liquid sample wherein said sample is simultaneously incubated in the presence of an immunoadsorbent containing immobilized antibody for said antigen and labeled antibody for said antigen, and thereafter detecting the amount of labeled antibody bound to said immunoadsorbent as an indication of the amount of antigen present in said sample: the improvement wherein said immobilized antibody and said labeled antibody comprise high-affinity IgM monoclonal antibodies directed against a multiply-appearing determinant of said antigen.
Claim 3
Dependent Claim 20 words
The improvement of claim 1 wherein said labeled monoclonal antibody and said immobilized monoclonal antibody comprise the same monoclonal antibody.
Claim 4
Dependent Claim 21 words
The improvement of claims 1 or 2 wherein said antigen is a viral antigen comprising a virus or antigenically-active portion thereof.
Claim 5
Dependent Claim 14 words
The improvement of claim 3 wherein said viral antigen comprises an hepatitis viral antigen.
Claim 6
Dependent Claim 12 words
The improvement of claim 4 wherein said hepatitis viral antigen comprises HBsAg.
Claim 7
Dependent Claim 127 words
An immunoassay for detecting the presence of a multi-determinant antigen in a liquid sample comprising: a. forming an incubation mixture containing: i. liquid sample: ii. a solid-phase immunoadsorbent containing immobilized high-affinity IgM monoclonal antibody directed against a multiply-appearing determinant of said antigen; and, iii. labeled, soluble, high-affinity, IgM monoclonal antibody directed against a multiply-appearing determinant of said antigen; b. incubating said incubation mixture under conditions and for a period of time sufficient for antigen in the liquid sample to bind to both immobilized monoclonal antibody and labeled, soluble, monoclonal antibody; c. separating said solid-phase immunoadsorbent from the incubation mixture after said incubation; and, d. detecting for labeled monoclonal antibody bound to said solid-phase immunoadsorbent as an indication of the amount of said antigen in the liquid sample.
Claim 8
Dependent Claim 127 words
An immunoassay for detecting the presence of a multi-determinant antigen in a liquid sample comprising: a. forming an incubation mixture containing: i. liquid sample: ii. a solid-phase immunoadsorbent containing immobilized high-affinity IgM monoclonal antibody directed against a multiply-appearing determinant of said antigen; and, iii. labeled, soluble, high-affinity, IgM monoclonal antibody directed against a multiply-appearing determinant of said antigen; b. incubating said incubation mixture under conditions and for a period of time sufficient for antigen in the liquid sample to bind to both immobilized monoclonal antibody and labeled, soluble, monoclonal antibody; c. separating said solid-phase immunoadsorbent from the incubation mixture after said incubation; and, d. detecting for labeled monoclonal antibody bound to said solid-phase immunoadsorbent as an indication of the amount of said antigen in the liquid sample.
Claim 9
Dependent Claim 21 words
An immunoassay of claim 6 wherein said labeled, soluble monoclonal antibody and said immobilized monoclonal antibody comprise the same monoclonal antibody.
Claim 10
Dependent Claim 22 words
An immunoassay of claims 6 or 7 wherein said multi-determinant antigen is a viral antigen comprising a virus or antigenically-active portion thereof.
Claim 11
Dependent Claim 14 words
An immunoassay of claim 8 wherein said viral antigen comprises an hepatitis viral antigen.
Claim 12
Dependent Claim 12 words
An immunoassay of claim 9 wherein said hepatitis viral antigen comprises HBsAg.
Claim 13
Dependent Claim 15 words
An immunoassay of claim 10 wherein said labeled, soluble, monoclonal antibody contains a radioactive label.
Claim 14
Dependent Claim 12 words
An immunoassay of claim 11 wherein said radioactive label comprises 125 I.
Claim 15
Dependent Claim 17 words
An immunoassay of claim 10 wherein said labeled, soluble, monoclonal antibody is labeled with an enzyme label.
Claim 16
Dependent Claim 17 words
An immunoassay of claim 10 wherein said labeled, soluble, monoclonal antibody is labeled with an optical label.
Claim 17
Dependent Claim 13 words
An immunoassay of claim 14 wherein said optical label comprises a fluorescent material.

References Cited (Backward Citations)

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EP0038642A1 Cited
GB2074727A Cited
US4361647A Cited
EP0045103A2 Cited
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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) 1992-06-05 1992-12-05 1993-06-06 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1996-06-05 1996-12-05 1997-06-06 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2000-06-05 2000-12-05 2001-06-06 $7700.00 Window Closed / Lapsed

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