title: Dynamic range of hepatitis C virus RNA quantification with the Cobas Ampliprep-Cobas Amplicor HCV Monitor v2.0 assay.
abstract: Accurate quantification of hepatitis C virus (HCV) RNA is needed in clinical practice to decide whether to continue or stop pegylated interferon-alpha-ribavirin combination therapy at week 12 of treatment for patients with chronic hepatitis C. Currently the HCV RNA quantification assay most widely used worldwide is the Amplicor HCV Monitor v2.0 assay (Roche Molecular Systems, Pleasanton, Calif.). The HCV RNA extraction step can be automated in the Cobas Ampliprep device. In this work, we show that the dynamic range of HCV RNA quantification of the Cobas Ampliprep/Cobas Amplicor HCV Monitor v2.0 procedure is 600 to 200,000 HCV RNA IU/ml (2.8 to 5.3 log IU/ml), which does not cover the full range of HCV RNA levels in infected patients. Any sample containing more than 200,000 IU/ml (5.3 log IU/ml) must thus be retested after dilution for accurate quantification. These results emphasize the need for commercial HCV RNA quantification assays with a broader range of linear quantification, such as real-time PCR-based assays.
authors.affiliation: Department of Virology, INSERM U635, Créteil, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Gourlain
authors.forename: Alexandre
authors.initials: A
authors.lastname: Soulier
authors.forename: Bertrand
authors.initials: B
authors.lastname: Pellegrin
authors.forename: Magali
authors.initials: M
authors.lastname: Bouvier-Alias
authors.forename: Christophe
authors.initials: C
authors.lastname: Hézode
authors.forename: Françoise
authors.initials: F
authors.lastname: Darthuy
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Rémiré
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Pawlotsky
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use; D001331:Automation; D004359:Drug Therapy, Combination; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000188:drug therapy / Q000821:virology*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D021141:Nucleic Acid Amplification Techniques / Q000379:methods / Q000592:standards*; D012367:RNA, Viral / Q000097:blood* / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic; D011994:Recombinant Proteins; D012254:Ribavirin