Materials and methods for assay of anti-hepatitis C virus (HCV) antibodies

摘要

A polypeptide comprising the contiguous amino acids 1-198 of SEQ ID NO: 2; a polypeptide, which comprises a contiguous amino acid sequence that is at least about 95% identical to the contiguous amino acids 1-198 of SEQ ID NO: 2, an epitope that is immunoreactive with an antibody that specifically binds to the core protein of hepatitis C virus (HCV), and an epitope that is immunoreactive with an antibody that specifically binds to the NS4 region of HCV; a nucleic acid encoding such a polypeptide; a host cell comprising such a nucleic acid; an immunodiagnostic reagent comprising such a polypeptide; a kit comprising such an immunodiagnostic reagent; and a method of determining the presence, amount, or concentration of anti-HCV antibodies in a test sample.

主权项

1. An immunodiagnostic reagent consisting essentially of
(a) an isolated or purified polypeptide consisting essentially of the contiguous amino acids 1-198 of SEQ ID NO:2 or a contiguous amino acid sequence that is at least 95% identical to the contiguous amino acids 1-198 of SEQ ID NO: 2 and (b) an isolated or purified polypeptide consisting essentially of (i) an epitope that is immunoreactive with an antibody that specifically binds to the NS3 region of HCV and (ii) an epitope that is immunoreactive with an antibody that specifically binds to the core region of HCV, wherein the isolated or purified polypeptide consists essentially of the contiguous amino acids 2-267 and 270-419 of SEQ ID NO:4, wherein (a) and (b) are co-coated on the same microparticles in a ratio of about 1:2 and concentration of (a) is at least about 40 μg/mL and the concentration of (b) is at least about 80 μg/mL.