title: Clinical evaluation of a new polymerase chain reaction assay (Amplicor HCV) for detection of hepatitis C virus.
abstract: Direct detection of hepatitis C virus (HCV) by reverse transcription (RT) and polymerase chain reaction (PCR) has clinical impact on diagnosis and the assessment of anti-viral therapy. However, recent results of a quality control study on the detection of HCV-RNA by RT-PCR revealed inappropriate sensitivity and specificity in the majority of participating laboratories. In this study we evaluated the first standardized RT-PCR-assay (Amplicor HCV) for routine detection of hepatitis C virus in serum samples from patients with hepatitis C (n = 111), patients with resolved acute hepatitis C (n = 7) and controls (n = 101). The Amplicor HCV assay was convenient to handle, detected all genotypes of the hepatitis C virus commonly present in Europe (type 1, 2 and 3 according to Simmonds et al.) and had a lower detection limit of 10(2)-10(3) copies as assessed by quantifiable HCV-specific RNA templates. In the clinical evaluation the Amplicor HCV system reached a sensitivity of 100% and a specificity of 97%.
authors.affiliation: Medizinische Klinik II, Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt.
authors.forename: S
authors.initials: S
authors.lastname: Zeuzem
authors.forename: B
authors.initials: B
authors.lastname: Rüster
authors.forename: W K
authors.initials: WK
authors.lastname: Roth
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000175:diagnosis* / Q000188:drug therapy; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods*; D011237:Predictive Value of Tests; D011786:Quality Control; D012367:RNA, Viral / Q000097:blood / Q000235:genetics*; D012194:RNA-Directed DNA Polymerase / Q000235:genetics*
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral; D012194:RNA-Directed DNA Polymerase