Design of novel conformational and genotype-specific antigens for improving sensitivity of immunoassays for hepatitis C virus-specific antibodies.

The current commercially licensed enzyme-linked immunosorbent assays (ELISAs) for hepatitis C virus (HCV) mainly use recombinant proteins containing linear epitopes. There is evidence, however, that conformational epitopes of HCV are more immunoreactive. Thus, we have designed an HCV antibody assay that employs a conformational protein, NS3NS4a PI (with functional protease and helicase activities), and a linear fusion protein, multiple-epitope fusion antigen 7.

Assessment of the target-capture PCR hepatitis B virus (HBV) DNA quantitative assay and comparison with commercial HBV DNA quantitative assays.

Recent clinical studies suggest that hepatitis B virus (HBV) load and genotype may be independent predictors of responses to antiviral therapies. However, it is difficult for clinicians to accurately determine viral loads in patient samples because results--both the values and the units of measure--can vary greatly among different tests. Accordingly, the World Health Organization (WHO) has produced the first international standard for HBV DNA for nucleic acid amplification technology (NAT) assays.

Detection and quantitation of HBV DNA in the WHO International Standard for HIV-1 RNA (NIBSC code: 97/656).

Nucleic-acid amplification technology (NAT) assays have been implemented for HCV and HIV-1 in the United States, and many parts of Europe, Australia and Asia. Nucleic acid detection assays utilize many different technologies, and the WHO International Standards for nucleic acid tests are widely used to compare them. Currently, several laboratories are developing an assay for simultaneous detection of HCV RNA, HIV-1 RNA and HBV DNA.