Radio-immuno assay for hepatitis B virus PreS2 antibodies

• US 5,091,300 A
• Filed: 08/03/1989
• Issued: 02/25/1992
• Est. Priority Date: 08/03/1989
• Status: Expired due to Fees

• Current Assignee: Merck & Co., Inc.
• Original Assignee: Merck & Co., Inc.
• Inventors: Hurni, William M., Miller, William J.
• Primary Examiner(s): Ceperley, Mary E.
• Application Number:
  US07/389,207
• Time in Patent Office: 936 Days
• Field of Search: 435/5, 435/235.1, 435/948, 435/810, 436/501, 436/518, 436/534, 436/543, 436/547, 436/804, 436/808, 436/820
• US Class Current: 435/5
• CPC Class Codes: G01N 33/5764 Hepatitis B surface antigen
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• 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 436/808 Automated or kit
• CPC Class Codes: Y10S 436/82 Hepatitis associated antigens and antibodies

Abstract

Anti-hepatitis B virus surface protein (anti-HBS) antibody is adsorbed onto the surface of a substratum. Hepatitis B virus PreS2+S (PreS2+S) protein is then adsorbed onto the same surface through the interaction of the anti-HBS antibody with the "S" portion of the PreS2+S protein. The coated surface is then incubated concomitantly with the test sample and a radiolabelled antibody specific for the "PreS2" portion of the PreS2+S protein.

Claims

1. A method for the detection of anti-PreS2 antibodies in a biological fluid which comprises:

i) coating the surface of polystyrene beads with anti-HBS antibodies;

ii) adsorbing PreS2+S protein to the beads via interaction with anti-HBS antibody;

iii) separately preparing test samples, positive control and negative control samples by mixing each with about 3×

10⁵ cpm of ¹²⁵ I-labelled anti-PreS2 antibody;

iv) incubating the coated beads from (ii) with the samples prepared in (iii);

v) measuring the amount labelled anti-PreS2 antibody bound to said beads and calculating the level of anti-PreS2 antibodies in the sample.

2. A polystyrene bead coated with anti-HBS antibody and PreS2+S protein adsorbed to the anti-HBS antibody.

3. A package or kit containing the polystyrene beads of claim 2 which can be used for the detection of anti-PreS2 antibodies.