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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{dagger}

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.

* Corresponding author. Mailing address: Transfusion Medicine and Hematology Department, Ospedale "Civile", Via Stelvio 25, 23100 Sondrio, Italy. Phone: 39-0342-521298. Fax: 39-0342-515310. E-mail: claudio.velati{at}katamail.com.

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

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.





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