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.
Seme
K
K
Institute of Microbiology, Medical Faculty of Ljubljana, Slovenia.
Poljak
M
M
D001782:Blood Donors; D005188:False Negative Reactions; D005189:False Positive Reactions; D016174:Hepacivirus / Q000235:genetics* / Q000302:isolation & purification; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis*; D006801:Humans; D011446:Prospective Studies; D012367:RNA, Viral / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic; D012307:Risk Factors; D012680:Sensitivity and Specificity
D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic