title: Evaluation of the VERSANT HCV RNA 3.0 assay for quantification of hepatitis C virus RNA in serum.
abstract: We assessed the performance of a new assay (VERSANT HCV RNA 3.0 [bDNA 3.0] assay [Bayer Diagnostics]) to quantitate HCV RNA levels and compared the results of the bDNA 3.0 assay to results of the Quantiplex HCV RNA 2.0 (bDNA 2.0) assay. Samples used in this study included 211 serum specimens from hepatitis C virus (HCV)-infected persons from two sites (Bordeaux and Marseille, France) with different genotypes; 383 serum specimens from HCV antibody-negative, HCV RNA-negative persons; and serial dilutions of World Health Organization (WHO) HCV RNA standard at a titer of 100,000 IU/ml. The specificity of the bDNA 3.0 assay was 98.2%. A high correlation was observed between expected and observed values in all dilutions of WHO standard (r = 0.9982), in serial dilutions of pooled samples (r = 0.9996), and in diluted sera from different HCV genotypes (r = 0.9930 to 0.9995). The standard deviations (SD) for the within-run and between-run reproducibility of the bDNA 3.0 assay were <or=0.2 and <or=0.14, respectively. The intersite SD ranged from 0.03 to 0.14. The bDNA 3.0 assay results were positively correlated with the bDNA 2.0 assay results (r = 0.9533). Taking in account the overall performance, this assay could be used as a routine tool for the HCV RNA quantification.
authors.affiliation: Laboratoire de Virologie, Centre Hospitalier Régional et Université Victor Segalen, CHU de Bordeaux, Bordeaux, France. pascale.trimoulet@chu-bordeaux.fr
authors.forename: Pascale
authors.initials: P
authors.lastname: Trimoulet
authors.forename: Philippe
authors.initials: P
authors.lastname: Halfon
authors.forename: Eric
authors.initials: E
authors.lastname: Pohier
authors.forename: Hacène
authors.initials: H
authors.lastname: Khiri
authors.forename: Geneviève
authors.initials: G
authors.lastname: Chêne
authors.forename: Hervé
authors.initials: H
authors.lastname: Fleury
mesh_terms: D021121:Branched DNA Signal Amplification Assay / Q000379:methods* / Q000592:standards; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000821:virology*; D006801:Humans; 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