title: Performance of an automated system for quantification of hepatitis C virus RNA.
abstract: The Amplicor HCV Monitor test for quantitative determination of serum or plasma hepatitis C virus (HCV) RNA was modified recently and introduced onto the Cobas Amplicor instrument to automate fully amplification, detection and calculation of results. This new version (v2.0) was evaluated in a routine diagnostic laboratory. The sensitivity and reproducibility were assessed on well-characterized panels (Eurohep) and clinical samples. HCV RNA levels measured by the v2.0 Monitor test were about 1log(10) higher than those detected by the previous version test, and genotypes 1 and 3 were quantified with equal sensitivity. Within the linear dynamic range of 10(3) to 10(6) copies/ml, the coefficients of variation for both intra- and inter-assay reproducibility ranged from 1.9 to 2.95%. This test system was found to be a reliable and labor saving assay for the quantification of HCV RNA.
authors.affiliation: Laboratoire de Virologie, UPRES EA 1596, Hopital Paul Brousse, 12 avenue Paul Vaillant Couturier, 94804, Villejuif, France. anne-marie.roque@pbr.ap-hop-paris.fr
authors.forename: A M
authors.initials: AM
authors.lastname: Roque Afonso
authors.forename: J
authors.initials: J
authors.lastname: Didier
authors.forename: E
authors.initials: E
authors.lastname: Plouvier
authors.forename: B
authors.initials: B
authors.lastname: Falissard
authors.forename: M P
authors.initials: MP
authors.lastname: Ferey
authors.forename: M
authors.initials: M
authors.lastname: Bogard
authors.forename: E
authors.initials: E
authors.lastname: Dussaix
mesh_terms: D001331:Automation; D005069:Evaluation Studies as Topic; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods*; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic