Is an assay for simultaneous detection of hepatitis C virus core antigen and antibody a valuable alternative to nucleic acid testing

摘要: BACKGROUND: A new enzyme immunoassay based on the simultaneous detection of nucleocapsid proteins hepatitis C virus (HCV) and anti-HCV (Monolisa HCV antigen-antibody Ultra, Bio-Rad) was evaluated as an alternative to nucleic acid testing (NAT) for diagnosis infection during window period in blood donations. STUDY DESIGN AND METHODS: The study included 107 sequential samples from 10 seroconversion commercial panels; 81 were preseroconversion phase, 26 collected after seroconversion. All tested with assay two minipool (MP) NAT procedures that are routinely used France (transcription-mediated amplification pools 8 COBAS AmpliScreen test [Roche Diagnostic] 24 donations). RESULTS: From 44 MP-NAT–positive, 31 (70.5%) also positive Monolisa assay. mean delay detecting between these methods 5.1 days (range, 0-24 days). led a reduction 26.8 days 0-72 days). detected specificity analyzed 2503 consecutive donations estimated at 99.88 percent. CONCLUSION: This developed presents improvement infection, especially early phase when antibodies undetectable. Although less sensitive than NAT, this could be suitable solution screening developing countries where (or core antigen–specific assay) is not affordable or its implementation feasible.