Evaluation of the Amplicor HCV test: experiences after 1 year of routine use in a diagnostic laboratory.

To evaluate the usefulness of a standardized commercial amplification assay for detection of hepatitis C virus (HCV) RNA, Amplicor HCV Test (Roche), a total of 1,204 serum samples from 888 patients was examined. Seven out of 443 anti-HCV-negative samples, 638 out of 729 anti-HCV-positive samples and four out of 32 anti-HCV-indeterminate samples tested HCV RNA positive by Amplicor in initial testing. One false-negative and five false-positive Amplicor results were found in initial testing, giving an overall sensitivity and specificity of the Amplicor HCV Test of 99.8% and 99.1%, respectively. Our study confirmed that the Amplicor HCV Test is a practical, rapid, sensitive and specific assay for detection of HCV RNA. However, the results must be interpreted with some caution and with the patient's anti-HCV status and clinical data in mind.