title: COBAS ® AmpliPrep/COBAS ® Taqman ® HCV Quantitative Test, version 2.0: an in vitro test for hepatitis C virus RNA quantification.
abstract: 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.
authors.affiliation: Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand, demail@springer.com.
authors.forename: Emma D
authors.initials: ED
authors.lastname: Deeks
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D021141:Nucleic Acid Amplification Techniques; D012367:RNA, Viral / Q000235:genetics*; D012680:Sensitivity and Specificity; D016896:Treatment Outcome; D019562:Viral Load / Q000235:genetics
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral