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Performance Evaluation of the New Roche cobas AmpliPrep/cobas TaqMan HCV Test, Version 2.0, for Detection and Quantification of Hepatitis C Virus RNA

2012; American Society for Microbiology; Volume: 51; Issue: 1 Linguagem: Inglês

10.1128/jcm.01729-12

1098-660X

Suzan D. Pas, Richard Molenkamp, Janke Schinkel, Sjoerd Rebers, Cedrick Copra, Sevgi Seven-Deniz, Diana Thamke, Robert J. de Knegt, Bart L. Haagmans, Martin Schutten,

Hepatitis B Virus Studies

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 m 2000 RealTi m e HCV assay (Real time 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 Real time assay.