Chiron Corporation

Novartis Vaccines & Diagnostics, Gmbh

Phillip M Arcangel

David Y Chien

Angelica Medina-Selby

Doris Guenzi Coit

Carlos George-Nascimento

Laura Tandeske

Wanda Zeigler

Stephen Tirell

The invention relates to a method of detecting HCV infection in a biological sample, the method comprising providing an immunoassay solid support, comprising an HCV anti-core antibody, an antigen comprising an HCV NS3/4epitope, and an HCV multiple epitope fusion antigen, that can detect both HCV antigens and antibodies present in a sample. The invention also includes polynucleotides encoding multiple epitope fusion antigens for use in the assay, recombinant vectors and host cells comprising such polynucleotides, and methods of producing the multiple epitope fusion antigens.

Polynucleotides encoding a multiple epitope fusion antigen for use in an HCV antigen/antibody combination assay

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.

Immunoassays for anti-HCV antibodies

An HCV antigen/antibody/antigen assay is provided. The assay employs an isolated first antigen from a region of the HCV polyprotein, and an HCV multiple epitope fusion antigen that includes an epitope from the same region of the polyprotein as the first antigen. Both the first antigen and the multiple epitope fusion antigen bind antibodies present in an HCV-infected sample.

HCV assay

Immunoassays for detecting hepatitis C virus protein and immune complexes between hepatitis C virus protein and antibodies in biological samples, methods of screening blood products for hepatitis C virus, and kits employed therefor are provided.

Hepatitis C viral antigen immunoassay detection systems

Imnunoassays for detecting hepatitis C virus protein and immune complexes between hepatitis C virus protein and antibodies in biological samples, methods of screening blood products for hepatitis C virus, and kits employed therefor are provided.

Multiple fusion antigens for use in immunoassays for anti-HCV antibodies

An HCV core antigen and NS3/4a antibody combination assay that can detect both HCV antigens and antibodies present in a sample using a single solid matrix, is provided, as well as immunoassay solid supports for use in the assay.

HCV antigen/antibody combination assay

The present invention is directed to an antigen diluent or buffer for antigens, in particular HCV recombinant antigens, comprising a reducing agent. The antigen diluent or buffer serves as a stabilizing buffer for the antigens. The present invention is also directed to antigen diluents or buffers for use in an automated immunoassay.

Buffers for stabilizing antigens

The present invention is directed to assays for detecting antibodies in a sample in a single incubation step. The assays employ universal solid phases and/or universal detectable markers, and facilitate the detection and differentiation of antigens from the same source or from different sources in a single test sample. The present invention includes test kits for performing the methods according to the invention.

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Richmond, CA, United States of America

Phillip M Arcangel