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Journal of Clinical Microbiology, September 2009, p. 2931-2936, Vol. 47, No. 9
0095-1137/09/$08.00+0     doi:10.1128/JCM.00532-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Quantification of Hepatitis C Virus (HCV) RNA in a Multicenter Study: Implications for Management of HCV Genotype 1-Infected Patients{triangledown}

Giulio Pisani,* Karen Cristiano, Francesco Marino, Francesca Luciani, Guillermo M. Bisso, Claudio Mele, Daniela Adriani, Giuliano Gentili, and Maria Wirz

Biologicals Unit, Center for Immunobiologicals Research and Evaluation, Istituto Superiore di Sanità, Viale Regina Elena, 299, 00161 Rome, Italy

Received 16 March 2009/ Returned for modification 29 May 2009/ Accepted 10 July 2009

Assessment of the viral load in hepatitis C virus (HCV) genotype 1-infected patients is critical before, during, and after antiviral therapy. In patients achieving a rapid virological response at week 4 of treatment, the viral load at the baseline is considered a predictive criterion of a sustained virological response 24 weeks after the discontinuation of treatment. A ≥2-log10 drop in the viral load at week 12 of treatment (early virological response) triggers the continuation of therapy. We organized a multicenter study (MS) for diagnostic laboratories involved in the quantification of HCV RNA. Commercial assays, including two based on real-time reverse transcription-PCR (TaqMan system), and in-house methods, were used by the 61 participants. The overall reproducibility of the commercial quantitative nucleic acid amplification techniques (qNAT) was acceptable. As the intermethod variability among commercial qNAT for HCV RNA was still present, the manufacturers of these test kits should join efforts to harmonize the means of quantification of HCV RNA. This study also shows that caution should be exercised when the baseline viral load is evaluated and when the 2-log10 reduction after 12 weeks of therapy is interpreted. Finally, this MS confirms the higher sensitivity of the commercial qNAT based on the TaqMan system, making them the elective assays for the monitoring of therapy.

* Corresponding author. Mailing address: Biologicals Unit, Center for Immunobiologicals Research and Evaluation (CRIVIB), Istituto Superiore di Sanità, Viale Regina Elena, 299, 00161 Rome, Italy. Phone: 39-06-49902346. Fax: 39-06-49902964. E-mail: giulio.pisani{at}iss.it

{triangledown} Published ahead of print on 15 July 2009.

Journal of Clinical Microbiology, September 2009, p. 2931-2936, Vol. 47, No. 9
0095-1137/09/$08.00+0     doi:10.1128/JCM.00532-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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