A rapid, point-of-care, fingerstick test to identify HCV infection

Background: A rapid, point-of-care test that provides results in 20 minutes and does not require instrumentation, was recently approved by FDA to aid in the diagnosis of hepatitis C virus (HCV) infection using venous whole blood. We now report the results of a multi-center evaluation of this rapid HCV test using fingerstick whole blood. Methods: Performance of the OraQuick® HCV Rapid Antibody Test was evaluated at 8 sites within the US, in 1670 subjects with signs and symptoms of hepatitis or at risk for HCV infection. In addition, 608 subjects at low risk for HCV (2 sites) were also tested. Performance was compared to results of FDA approved laboratory-based HCV tests. Results: In the high risk population, the rapid test agreed with laboratory determined serostatus in 98.5% of HCV positive subjects (n=719) and in 99.7% of HCV negative subjects (n=926). In the low prevalence population, the rapid test generated 100% agreement in HCV positive subjects (21/21) and 99.8% agreement (582/583) in negative subjects. Positive predictive values (PPV) were 98% in the at-risk population and 95% in the low risk population. Conclusion: Clinical performance of the OraQuick® HCV Rapid Antibody Test was equivalent to that of currently approved laboratory based tests for the prospective diagnosis of HCV infection. Specificity and PPV was high in both high and low risk populations. Availability of a rapid HCV test utilizing fingerstick whole blood should increase testing opportunities and thereby identify previously undiagnosed disease in the US.