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Journal of Clinical Microbiology, April 2005, p. 1669-1673, Vol. 43, No. 4
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.4.1669-1673.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Dynamic Range of Hepatitis C Virus RNA Quantification with the Cobas Ampliprep-Cobas Amplicor HCV Monitor v2.0 Assay

Karine Gourlain,1 Alexandre Soulier,1 Bertrand Pellegrin,1 Magali Bouvier-Alias,1 Christophe Hézode,1,2 Françoise Darthuy,1 Jocelyne Rémiré,1 Jean-Michel Pawlotsky,1* the DITTO Group,{dagger}

Department of Virology, INSERM U635,1 Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, Université Paris XII, Créteil, France2

Received 1 August 2004/ Returned for modification 18 November 2004/ Accepted 15 December 2004

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.

* Corresponding author. Mailing address: Service de Virologie, Hôpital Henri Mondor, 51 avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France. Phone: 33 1 4981 2827. Fax: 33 1 4981 4831. E-mail: jean-michel.pawlotsky{at}hmn.aphp.fr.

{dagger} Contributing members (or participants) of the DITTO Group are listed in Acknowledgments.

Journal of Clinical Microbiology, April 2005, p. 1669-1673, Vol. 43, No. 4
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.4.1669-1673.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

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  • Colson, P., Motte, A., Tamalet, C. (2006). Broad Differences between the COBAS Ampliprep Total Nucleic Acid Isolation-COBAS TaqMan 48 Hepatitis C Virus (HCV) and COBAS HCV Monitor v2.0 Assays for Quantification of Serum HCV RNA of Non-1 Genotypes. J. Clin. Microbiol. 44: 1602-1603 [Full Text]  


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