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Journal of Clinical Microbiology, August 2007, p. 2529-2536, Vol. 45, No. 8
0095-1137/07/$08.00+0     doi:10.1128/JCM.00058-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Comparison of Performance Characteristics of Three Real-Time Reverse Transcription-PCR Test Systems for Detection and Quantification of Hepatitis C Virus

Molecular Diagnostics Laboratory, Department of Pathology, Virginia Commonwealth University, Richmond, Virginia,¹ Section of Hepatology, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia,² Molecular Genetics Laboratory, University of North Carolina, Chapel Hill, North Carolina³

Received 8 January 2007/ Returned for modification 20 February 2007/ Accepted 4 June 2007

We evaluated the performance characteristics of three real-time reverse transcription-PCR test systems for detection and quantification of hepatitis C virus (HCV) and performed a direct comparison of the systems on the same clinical specimens. Commercial HCV panels (genotype 1b) were used to evaluate linear range, sensitivity, and precision. The Roche COBAS TaqMan HCV test for research use only (RUO) with samples processed on the MagNA Pure LC instrument (Roche RUO-MPLC) and Abbott analyte-specific reagents (ASR) with QIAGEN sample processing (Abbott ASR-Q) showed a sensitivity of 1.0 log₁₀ IU/ml with a linear dynamic range of 1.0 to 7.0 log₁₀ IU/ml. The Roche ASR in combination with the High Pure system (Roche ASR-HP) showed a sensitivity of 1.4 log₁₀ IU/ml with a linear dynamic range of 2.0 to 7.0 log₁₀ IU/ml. All of the systems showed acceptable reproducibility, the Abbott ASR-Q being the most reproducible of the three systems. Seventy-six clinical specimens (50 with detectable levels of HCV RNA and various titers and genotypes) were tested, and results were compared to those of the COBAS Amplicor HCV Monitor v2.0. Good correlation was obtained for the Roche RUO-MPLC and Abbott ASR-Q (R² = 0.84 and R² = 0.93, respectively), with better agreement for the Abbott ASR-Q. However, correlation (R² = 0.79) and agreement were poor for Roche ASR-HP, with bias relative to concentration and genotype. Roche ASR-HP underestimated HCV RNA for genotypes 3 and 4 as much as 2.19 log₁₀ IU/ml. Our study demonstrates that Roche RUO-MPLC and Abbott ASR-Q provided acceptable results and agreed sufficiently with the COBAS Amplicor HCV Monitor v2.0.

Published ahead of print on 13 June 2007.