title: Performance characteristics of the VERSANT hepatitis C virus RNA 1.0 (kPCR) assay.
abstract: HCV RNA assays are of central importance for virological diagnostics and for clinical planning and monitoring of an antiviral combination treatment of chronic HCV infections. The objective of the pre-market evaluation of the VERSANT HCV RNA 1.0 Assay (kPCR) was to collect analytical performance data for this new method of HCV RNA quantification and to compare them with the high standards that exist in this context. The assay exhibited a specificity of 100%. The mean intra- and inter-assay imprecision was 14.1% and 14.6%, respectively. The detection limit was determined to be 16IU/ml (95% confidence interval: 11.9-30.6IU/ml) and consequently corresponded to the manufacturer's claims (i.e. 15IU/ml). The test exhibited linearity for all HCV genotypes in a broad range from 15 to 10(8)IU HCV RNA/ml. Hence, the kPCR assay in general is well suitable for HCV RNA determinations in clinical practice. However, in a methodological comparison, a considerable under-quantification of the concentrations of HCV genotype 2 and 3 isolates was detected. Provided that the assay's manufacturer will quickly remedy this shortcoming, the VERSANT HCV RNA 1.0 (kPCR) can be called a completely reliable technique for HCV RNA quantification in routine virological diagnostics.
authors.affiliation: Institute of Virology, National Reference Centre for Hepatitis C, Essen University Hospital, University of Duisburg-Essen, Hufelandstr., D-45122 Essen, Germany.
authors.forename: Nico
authors.initials: N
authors.lastname: Grüner
authors.affiliation: Institute of Virology, National Reference Centre for Hepatitis C, Essen University Hospital, University of Duisburg-Essen, Hufelandstr., D-45122 Essen, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Viazov
authors.affiliation: Institute of Clinical and Molecular Virology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Schlossgarten 4, D-91054 Erlangen, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Korn
authors.affiliation: Institute of Clinical and Molecular Virology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Schlossgarten 4, D-91054 Erlangen, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Knöll
authors.affiliation: Department of Gastroenterology and Hepatology, Essen University Hospital, University of Duisburg-Essen, Hufelandstr., D-45122 Essen, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Trippler
authors.affiliation: Department of Gastroenterology and Hepatology, Essen University Hospital, University of Duisburg-Essen, Hufelandstr., D-45122 Essen, Germany.
authors.forename: J F
authors.initials: JF
authors.lastname: Schlaak
authors.affiliation: Department of Gastroenterology and Hepatology, Essen University Hospital, University of Duisburg-Essen, Hufelandstr., D-45122 Essen, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Gerken
authors.affiliation: Institute of Virology, National Reference Centre for Hepatitis C, Essen University Hospital, University of Duisburg-Essen, Hufelandstr., D-45122 Essen, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Roggendorf
authors.affiliation: Institute of Virology, National Reference Centre for Hepatitis C, Essen University Hospital, University of Duisburg-Essen, Hufelandstr., D-45122 Essen, Germany. Electronic address: stefan.ross@uni-due.de.
authors.forename: R Stefan
authors.initials: RS
authors.lastname: Ross
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000175:diagnosis* / Q000188:drug therapy / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood*; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*; D055815:Young Adult
chemical_list: D012367:RNA, Viral
keywords: Antiviral combination therapy; HCV NS3 protease inhibitors; HCV NS5A inhibitors; Real-time polymerase chain reaction; Stopping rules; Transcription-mediated amplification