CDC scientists have developed a novel enzyme immunoassay for the simultaneous detection of hepatitis C virus (HCV) core antigen and circulating HCV antibodies. Serological testing procedures for HCV circulating antibodies are well established. There is, however, a window of time between HCV infection and seroconversion that generates an opportunity for false negative results. This period varies from two months in immunocompetent subjects to six to twelve months in immunodeficient patients. Combination testing, utilizing both serological testing and PCR-based techniques, can be used to overcome this limitation. PCR-based techniques, however, are costly and time-consuming and present considerable challenges to clinical laboratories, due to equipment requirements and sensitivity to cross-contamination.

This technology overcomes these challenges through simultaneous detection of both HCV core antigen and HCV antibody in an immunoassay format, which both significantly improves the sensitive diagnosis of hepatitis C among blood donors at any stage of infection and is also simpler to perform than combination testing utilizing PCR-based techniques.