title: Performance evaluation of the new Roche cobas AmpliPrep/cobas TaqMan HCV test, version 2.0, for detection and quantification of hepatitis C virus RNA.
abstract: To evaluate the analytical performance and explore the clinical applicability of the new Roche cobas AmpliPrep/cobas TaqMan HCV test, v2.0 (CAP/CTM v2.0), a platform comparison was performed on panels and diagnostic samples with the Roche cobas AmpliPrep/cobas TaqMan HCV test (CAP/CTM v1.0), the Siemens Versant HCV RNA 3.0 branched DNA (bDNA) test, the Abbott m2000 RealTime HCV assay (Realtime assay), and the Siemens Versant HCV transcription-mediated amplification (TMA) test (TMA assay). The analytical performance of the CAP/CTM v2.0 on WHO and Acrometrix panels and clinical specimens of patients infected with HCV genotype 1, 2, 3, 4, 5, or 6 relative to that of the CAP/CTM v1.0 was significantly improved. In a qualitative comparison of the CAP/CTM v2.0 relative to the TMA assay on genotype 1 to 4 samples, the two tests proved to be almost equally sensitive. Response-guided therapy in one of five HCV genotype 4-infected patients previously tested with the CAP/CTM v1.0 would have significantly changed if tested with the CAP/CTM v2.0. In conclusion, the Roche CAP/CTM v2.0 has significantly better performance characteristics than the former CAP/CTM HCV v1.0 and the bDNA assay and performance characteristics comparable to those of the Realtime assay.
authors.affiliation: Erasmus MC, Department of Virology, Rotterdam, the Netherlands.
authors.forename: S
authors.initials: S
authors.lastname: Pas
authors.forename: R
authors.initials: R
authors.lastname: Molenkamp
authors.forename: J
authors.initials: J
authors.lastname: Schinkel
authors.forename: S
authors.initials: S
authors.lastname: Rebers
authors.forename: C
authors.initials: C
authors.lastname: Copra
authors.forename: S
authors.initials: S
authors.lastname: Seven-Deniz
authors.forename: D
authors.initials: D
authors.lastname: Thamke
authors.forename: R J
authors.initials: RJ
authors.lastname: de Knegt
authors.forename: B L
authors.initials: BL
authors.lastname: Haagmans
authors.forename: M
authors.initials: M
authors.lastname: Schutten
mesh_terms: D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000821:virology*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral