Clinical evaluation of the COBAS Ampliprep™/COBAS TaqMan™ for HCV RNA quantitation in comparison with the branched-DNA assay

✍ Scribed by Fabrizia Pittaluga; Tiziano Allice; Maria Lorena Abate; Alessia Ciancio; Francesco Cerutti; Silvia Varetto; Giuseppe Colucci; Antonina Smedile; Valeria Ghisetti

• Publisher: John Wiley and Sons
• Year: 2007
• Tongue: English
• Weight: 259 KB
• Volume: 80
• Category: Article
• ISSN: 0146-6615
• DOI: 10.1002/jmv.21073

✦ Synopsis

Abstract

Diagnosis and monitoring of HCV infection relies on sensitive and accurate HCV RNA detection and quantitation. The performance of the COBAS AmpliPrep™/COBAS TaqMan™ 48 (CAP/CTM) (Roche, Branchburg, NJ), a fully automated, real‐time PCR HCV RNA quantitative test was assessed and compared with the branched‐DNA (bDNA) assay. Clinical evaluation on 576 specimens obtained from patients with chronic hepatitis C showed a good correlation (r = 0.893) between the two test, but the CAP/CTM scored higher HCV RNA titers than the bDNA across all viral genotypes. The mean bDNA versus CAP/CTM log~10~ IU/ml differences were −0.49, −0.4, −0.54, −0.26 for genotype 1a, 1b, 2a/2c, 3a, and 4, respectively. These differences reached statistical significance for genotypes 1b, 2a/c, and 3a. The ability of the CAP/CTM to monitor patients undergoing antiviral therapy and correctly identify the weeks 4 and 12 rapid and early virological responses was confirmed. The broader dynamic range of the CAP/CTM compared with the bDNA allowed for a better definition of viral kinetics. In conclusion, the CAP/CTM appears as a reliable and user‐friendly assay to monitor HCV viremia during treatment of patients with chronic hepatitis. Its high sensitivity and wide dynamic range may help a better definition of viral load changes during antiviral therapy. J. Med. Virol. 80:254–260, 2008. © 2007 Wiley‐Liss, Inc.