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Characterization of a New Sensitive PCR Assay for Quantification of Viral DNA Isolated from Patients with Hepatitis B Virus Infections

Laboratoire de Virologie-CERVI, Hôpital de la Pitié-Salpêtrière, 83 Bd. de l'Hôpital, 75651 Paris Cedex 14, France,¹ INSERM, U871, 69003 Lyon, Université Lyon 1, IFR62 Lyon-Est, 69008 Lyon, and Hospices Civils de Lyon, Hôtel Dieu, Service d'Hépatologie et de Gastroentérologie, 69002 Lyon, France,² Abbott Molecular Inc., 1300 East Touhy Ave., Des Plaines, Illinois 60018-3315³

Received 12 June 2007/ Returned for modification 19 July 2007/ Accepted 9 October 2007

Sensitive and accurate quantification of hepatitis B virus (HBV) DNA is necessary for monitoring patients with chronic hepatitis receiving antiviral therapy in order to determine treatment response and to adapt therapy in case of inadequate virologic control. The development of quantitative PCR assays has been crucial in meeting these needs. The objective of this study was to compare the performance of a new real-time PCR assay (Abbott RealTime) for HBV DNA with that of three other commercial assays for the detection of HBV DNA. These were the Versant 3.0 branched-chain DNA assay, the Cobas Amplicor HBV Monitor test, and the Cobas AmpliPrep-Cobas TaqMan hepatitis B virus assay (CAP-CTM). HBV DNA was measured in blood samples taken from two cohorts of patients with chronic hepatitis. HBV DNA levels measured with the Abbott RealTime assay were highly correlated with those measured with the other three tests over their respective dynamic ranges (r, 0.88 to 0.96). The sensitivity (detection limit, 10 IU/ml) and dynamic range of the Abbott RealTime assay (10¹ to 10⁹ IU/ml) was superior to that of the Versant assay. The RealTime assay recognized both HBV strains belonging to genotypes A to G and those bearing polymerase gene mutations equivalently. In conclusion, this study demonstrates the utility of the Abbott RealTime assay for monitoring HBV DNA levels in patients with chronic hepatitis B. Its sensitivity and wide dynamic range should allow optimal monitoring of antiviral therapy and timely treatment adaptation.

Published ahead of print on 17 October 2007.