Author: Seme, Katja; Poljak, M.
Title: Evaluation of the amplicor HCV test: Experiences after 1 year of routine use in a diagnostic laboratory Cord-id: tko3k0nf Document date: 1996_1_1
ID: tko3k0nf
Snippet: 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,
Document: 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.
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