1. Dynamic range of hepatitis C virus RNA quantification with the Cobas Ampliprep-Cobas Amplicor HCV Monitor v2.0 assay.
- Author
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Gourlain K, Soulier A, Pellegrin B, Bouvier-Alias M, Hézode C, Darthuy F, Rémiré J, and Pawlotsky JM
- Subjects
- Antiviral Agents therapeutic use, Automation, Drug Therapy, Combination, Hepacivirus genetics, Hepatitis C, Chronic drug therapy, Humans, Interferon alpha-2, Interferon-alpha therapeutic use, Nucleic Acid Amplification Techniques methods, RNA, Viral isolation & purification, Recombinant Proteins, Ribavirin therapeutic use, Viral Load, Hepacivirus isolation & purification, Hepatitis C, Chronic virology, Nucleic Acid Amplification Techniques standards, RNA, Viral blood, Reagent Kits, Diagnostic
- 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.
- Published
- 2005
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