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Journal of Clinical Microbiology, June 2005, p. 2991-2993, Vol. 43, No. 6
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.6.2991-2993.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Multicenter Evaluation of a Semiautomated, Standardized Assay for Detection of Hepatitis B Virus DNA in Blood Donations

Luisa Romanò,¹ Claudio Velati,^2* Lorella Baruffi,² Laura Fomiatti,² Giuseppe Colucci,³ Alessandro R. Zanetti,¹ and the Italian Group for the Study of Transfusion Transmissible Diseases

Institute of Virology, University of Milan, Milan,¹ Transfusion Medicine and Hematology Department, Hospital of Sondrio, Sondrio, Italy,² Scientific Affairs, Roche Molecular Systems, Rotkreuz, Switzerland³

Received 16 August 2004/ Returned for modification 14 November 2004/ Accepted 1 February 2005

We evaluated the COBAS Ampliscreen hepatitis B virus (HBV) test using standards, seroconversion panels, consecutive donations, and samples from patients with abnormal alanine aminotransferase and chronic hepatitis C. Specificity was 100% and sensitivity was 20 IU/ml. In seroconversion panels, HBV DNA was detected up to 4 to 18 days before HBsAg, suggesting that this assay is useful in shortening the infectious window phase.

Contributing members of the Italian Group for the Study of Transfusion Transmissible Diseases are listed in Acknowledgments.