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Journal of Clinical Microbiology, March 2006, p. 729-737, Vol. 44, No. 3
0095-1137/06/$08.00+0     doi:10.1128/JCM.44.3.729-737.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Comparison of Conventional PCR with Real-Time PCR and Branched DNA-Based Assays for Hepatitis C Virus RNA Quantification and Clinical Significance for Genotypes 1 to 5

Christoph Sarrazin,1* Barbara C. Gärtner,2 Dorothea Sizmann,3 Rainer Babiel,3 Ulrike Mihm,1 Wolf Peter Hofmann,1 Michael von Wagner,1 and Stefan Zeuzem1

Klinik für Innere Medizin II, Universitätsklinikum des Saarlandes, Kirrberger Str., 66421 Homburg/Saar, Germany,1 Abteilung für Virologie, Universitätsklinikum des Saarlandes, Kirrberger Str., 66421 Homburg/Saar, Germany,2 Roche Diagnostics, Molecular Diagnostics Development, Nonnenwald 2, 82372 Penzberg, Germany3

Received 16 August 2005/ Returned for modification 28 September 2005/ Accepted 1 December 2005

The key parameter for diagnosis and management of hepatitis C virus (HCV) infection is HCV RNA. Standardization of HCV RNA assays to IU is mainly based on genotype 1 panels. Little is known about the variability of commercially available HCV RNA assays for quantification of different genotypes. Two real-time reverse transcription (RT)-PCR assays (COBAS TaqMan HCV Test for use with the High-Pure System [HPS/CTM] and COBAS Ampliprep/COBAS TaqMan HCV Test [CAP/CTM]), one standard RT-PCR assay (COBAS Amplicor HCV Monitor 2.0 [CAM]), and one signal amplification assay (Versant Quantitative 3.0 [branched DNA {bDNA}]) were compared for quantification of genotypes 1 to 5 (n = 108). Using CAM as a reference assay for genotype 1-infected patients, the mean interassay differences compared with CAP/CTM, HPS/CTM, and bDNA were 0.16, –0.13, and –0.48 log10 IU/ml HCV RNA, respectively. Comparison of CAM with CAP/CTM, HPS/CTM, and bDNA for the remaining genotypes showed the following results, respectively: 2a/c, –0.24, –0.78, and –0.49; 2b, –0.21, –0.18, and –0.64; 3a, 0.13, –1.04, and –0.55; 4, –0.52, –1.51, and –0.05; and 5, –0.28, –1.00, and –0.24 log IU/ml HCV RNA. A correct decision for treatment discontinuation in genotype 1 patients at week 12 was possible only when the same assay was used at baseline and week 12. Comparison of CAM with the CAP/CTM assay showed equal quantifications of genotype 1, 2, 3, and 5 samples, while genotype 4 samples were slightly underestimated. For the HPS/CTM assay, a significant underestimation of the HCV RNA concentrations of genotypes 2a/c, 3, 4, and 5 was observed. For the bDNA assay, a constant lower quantification of genotypes 1 to 3 was detected.

* Corresponding author. Mailing address: Klinik für Innere Medizin II, Universitätsklinikum des Saarlandes, Kirrberger Str., D-66421 Homburg/Saar, Germany. Phone: 49-6841-16-23203. Fax: 49-6841-16-23264. E-mail: christoph.sarrazin{at}uniklinik-saarland.de.

Journal of Clinical Microbiology, March 2006, p. 729-737, Vol. 44, No. 3
0095-1137/06/$08.00+0     doi:10.1128/JCM.44.3.729-737.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



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