Immunoassay utilizing monoclonal high affinity IgM antibodies

• US 4,879,219 A
• Filed: 09/19/1980
• Issued: 11/07/1989
• Est. Priority Date: 09/19/1980
• Status: Expired due to Term

• Current Assignee: General Hospital Corporation Fruit St Boston 02114
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Wands, Jack R., Zurawski, Vincent R. Jr., Schoemaker, Hubert J. P.
• Primary Examiner(s): Moskowitz, Margaret
• Assistant Examiner(s): Kushan, Jeff P.
• Application Number:
  US06/188,735
• Time in Patent Office: 3,336 Days
• Field of Search: 424/1, 424/12, 424/1.5, 424/85, 424/86, 424/1.1, 23/230 B, 435/7, 435/68, 435/5, 435/70, 435/948, 260/112 R, 436/503, 436/504, 436/536-542, 436/804, 436/811, 436/824, 436/825
• US Class Current: 435/5
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: C07K 14/005 from viruses
• CPC Class Codes: C07K 16/082 Hepadnaviridae, e.g. hepatitis B virus
• CPC Class Codes: C07K 16/10 from RNA viruses
• CPC Class Codes: C12N 2730/10122 New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
• CPC Class Codes: Y10S 435/948 using viruses or cell lines
• CPC Class Codes: Y10S 436/804 Radioisotope, e.g. radioimmunoassay
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function
• CPC Class Codes: Y10S 436/82 Hepatitis associated antigens and antibodies
• CPC Class Codes: Y10S 530/826 Viruses
• CPC Class Codes: Y10S 530/864 Monoclonal

Abstract

Hybridomally produced monoclonal IgM antibodies having high affinity are useful for the immunoassay and purification of viral antigens.

Claims

1. An immunoassay method utilizing an antibody to assay for a substance comprising hepatitis B-surface antigen (HBsAg) determinants which comprises the steps of:

contacting a test sample containing said substance comprising HBsAg determinants with said antibody; and

determining the presence of said substance in said sample;

wherein said antibody is a monoclonal high affinity IgM antibody having a binding affinity constant for said HBsAg determinants of at least 10⁹ M^-1.

2. The assay method of claim 1 wherein said constant is at least 10¹⁰ M^-1.

3. The assay method of claim 1 which is selected from the group consisting of radioimmunoassay, enzyme immunoassay, agglutination immunoassay, and fluorescence immunoassay.

4. The assay method of claim 3 which is radioimmunoassay.

5. The method of claim 1 wherein said HBsAg determinants are present in Hepatitis B virus.

6. The assay method of claim 1 wherein said monoclonal high affinity IgM antibodies are coupled to an insoluble solid phase.

7. Monoclonal high affinity IgM antibodies immunoreactive with HBsAg determinants wherein said antibodies are coupled to an insoluble solid phase, and wherein the binding affinity constant of said antibodies for said HBsAg determinants is at least 10⁹ M^-1.

8. The antibodies of claim 7 which are immunoreactive with hepatitis B surface antigen.

9. The antibodies of claim 8 wherein said label is a radiolabel.