COBAS® AmpliPrep/COBAS® Taqman® HCV Quantitative Test, Version 2.0: An In Vitro Test for Hepatitis C Virus RNA Quantification

The COBAS® AmpliPrep/COBAS® Taqman® HCV Quantitative Test, version 2.0, is an in vitro, fully automated, real-time, nucleic acid amplification test indicated for quantifying hepatitis C virus (HCV) RNA levels in the plasma/serum of patients infected with HCV of genotypes 1–6 who are receiving anti-viral therapy. By quantifying levels of HCV RNA in these patients, the test can be used early in the course of treatment to predict the likelihood of a sustained virologic response being achieved and can also be used to assess virologic response during treatment as part of response-guided therapy. The test has excellent sensitivity, high specificity and a broad linear range of quantitation. It correlates well with version 1.0 of the same test, but has the benefit of better sensitivity and genotype inclusivity and a smaller sample input volume. It also correlates well with other available HCV tests, including other quantitative real-time PCR tests (specifically the COBAS® Taqman® HCV Test, version 2.0, used with the high pure system, and the Abbott Realtime and Artus HCV QS-RGQ tests), the Versant® branched DNA quantitative test, the COBAS® Amplicor HCV Qualitative PCR Test and the Versant® HCV qualitative transcription-mediated amplification assay. The test is not indicated for HCV infection diagnosis or to screen for the presence of HCV in blood/blood products.