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(R) HCV Te st (Roche), a total of 1,204 serum samples from 888 patients was exami ned, Seven out of 443 anti-HCV-negative samples, 638 out of 729 anti-H CV-positive samples and four out of 32 anti-HCV-indeterminate samples tested HCV RNA positive by Amplicor(R) in initial testing. One false-n egative and five false-positive Amplicor(R) results were found in init ial testing, giving an overall sensitivity and specificity of the Ampl icor(R) HCV Test of 99.8% and 99.1%, respectively, Our study confirmed that the Amplicor(R) HCV Test is a practical, rapid, sensitive and sp ecific assay for detection of HCV RNA. However, the results must be in terpreted with some caution and with the patient's anti-HCV status and clinical data in mind.