Comparison of qualitative (COBAS AMPLICOR HCV 2.0 versus VERSANT HCV RNA) and quantitative (COBAS AMPLICOR HCV monitor 2.0 versus VERSANT HCV RNA 3.0) assays for hepatitis C virus (HCV) RNA detection and quantification: impact on diagnosis and treatment of HCV infections.

Quantitative measurements of serum hepatitis C virus (HCV) RNA are becoming increasingly important in the management of HCV-infected patients. Here we compared two quantitative assays, the COBAS AMPLICOR HCV Monitor 2.0 assay (Roche Diagnostics) and the branched DNA-based VERSANT HCV RNA 3.0 assay (Bayer Diagnostics) for HCV RNA measurement in 344 samples derived from 120 patients with chronic genotype 1 HCV infection. The overall concordance between the results of the two tests was 95%, and the HCV RNA titers within the dynamic ranges of the assays correlated very well (r2=0.86). Furthermore, both tests performed equally well in determining an early viral response at week 1 or 4 during antiviral therapy. We also compared two qualitative HCV RNA detection assays: the COBAS AMPLICOR HCV 2.0 assay versus the transcription-mediated amplification (TMA)-based VERSANT HCV RNA qualitative assay. Stored samples from sustained responders to interferon-ribavirin therapy were retested by the HCV TMA assay and were found to contain no detectable HCV RNA, demonstrating complete concordance between the results of PCR and TMA. However, HCV RNA was detected by the TMA assay in end-of-treatment (ETR) samples from 33% of patients with relapses who were HCV RNA negative according to the COBAS AMPLICOR assay. This observation suggests that a TMA assay can lead to a more correct definition of the ETR response.