Immunoassays for anti-HCV antibodies
AssigneeChiron Corporation
InventorsDavid Y. Chien, Phillip Arcangel, Laura Tandeske, Carlos George-Nascimento, Doris Coit, Angelica Medina-Selby
Life of this patent
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Abstract
HCV immunoassays comprising an NS3/4a conformational epitope and a multiple epitope fusion antigen are provided, as well as immunoassay solid supports for use with the immunoassays.
Claims21
An immunoassay solid support consisting essentially of at least one HCV NS3/4a conformational epitope and a multiple epitope fusion antigen, bound to the support, wherein said NS3/4a epitope and/or said multiple epitope fusion antigen react specifically with anti-HCV antibodies present in a biological sample from an HCV-infected individual, and further wherein said NS3/4a epitope comprises the amino acid sequence depicted in FIGS. 3A-3D, or an amino acid sequence with at least 80% sequence identity thereto which has protease activity.
An immunoassay solid support consisting essentially of at least one HCV NS3/4a conformational epitope and a multiple epitope fusion antigen, bound to the support, wherein said NS3/4a conformational epitope comprises the amino acid sequence depicted in FIGS. 3A-3D, or an amino acid sequence with at least 80% sequence identity thereto which has protease activity, and said multiple epitope fusion antigen comprises the amino acid sequence depicted in FIGS. 5A-5F, or an amino acid sequence with at least 80% sequence identity thereto which reacts specifically with anti-HCV antibodies present in a biological sample from an HCV-infected individual.
An immunoassay solid support consisting essentially of at least one HCV NS3/4a conformational epitope and a multiple epitope fusion antigen, bound to the support, wherein said NS3/4a conformational epitope consists of the amino acid sequence depicted in FIGS. 3A-3D, and said multiple epitope fusion antigen consists of the amino acid sequence depicted in FIGS. 5A-5F.
A method of detecting hepatitis C virus (HCV) infection in a biological sample, said method comprising:
- (a) providing an immunoassay solid support consisting essentially of at least one HCV NS3/4a conformational epitope and a multiple epitope fusion antigen, bound thereto, wherein said NS3/4a conformational epitope consists of the amino acid sequence depicted in FIGS. 3A-3D, and said multiple epitope fusion antigen consists of the amino acid sequence depicted in FIGS. 5A-5F;
- (b) combining a biological sample with said solid support under conditions which allow HCV antibodies, when present in the biological sample, to bind to said NS3/4a epitope and/or said multiple epitope fusion antigen to form a first immune complex;
- (c) adding to the solid support from step (b) under complex forming conditions a detectably labeled antibody, wherein said labeled antibody is reactive with said immune complex;
- (d) detecting second immune complexes formed between the detectably labeled antibody and the first immune complex, if any, as an indication of HCV infection in the biological sample.
A method of producing an immunoassay solid support, comprising:
- (a) providing a solid support;
- and
- (b) binding to the solid support at least one HCV NS3/4a comformational epitope and a multiple epitope fusion antigen, wherein said NS3/4a epitope and/or said multiple epitope fusion antigen react specifically with anti-HCV antibodies present in a biological sample from an HCV-infected individual, and further wherein said NS3/4a conformational epitope comprises the amino acid sequence depicted in FIGS. 3A-3D, or an amino acid sequence with at least 80% sequence identity thereto which has protease activity, and said multiple epitope fusion antigen comprises the amino acid sequence depicted in FIGS. 5A-5F, or an amino acid sequence with at least 80% sequence identity thereto which reacts specifically with anti-HCV antibodies present in a biological sample from an HCV-infected individual.
Dependencies are inferred from the claim text.