The Hepatitis C (HCV) Antibody Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of anti-HCV antibodies IgG, IgM, and IgA in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of HCV infection.
HCV is a small, enveloped, positive-sense, single-stranded RNA virus. Anti-HCV antibodies are found in over 80% of patients with well-documented non-A, non-B hepatitis. Conventional methods fail to isolate the virus in cell cultures or by electron microscope visualization. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to the first generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity and to increase the sensitivity of the HCV antibody tests.