Multicenter evaluation of a semiautomated, standardized assay for detection of hepatitis B virus DNA in blood donations

Luisa Romanò; Claudio Velati; Lorella Baruffi; Laura Fomiatti; Giuseppe Colucci; Alessandro R Zanetti; Italian Group for the Study of Transfusion Transmissible Diseases

doi:10.1128/JCM.43.6.2991-2993.2005

Multicenter evaluation of a semiautomated, standardized assay for detection of hepatitis B virus DNA in blood donations

J Clin Microbiol. 2005 Jun;43(6):2991-3. doi: 10.1128/JCM.43.6.2991-2993.2005.

Authors

Luisa Romanò¹, Claudio Velati, Lorella Baruffi, Laura Fomiatti, Giuseppe Colucci, Alessandro R Zanetti; Italian Group for the Study of Transfusion Transmissible Diseases

Affiliation

¹ Institute of Virology, University of Milan, Milan, Italy.

Abstract

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.

Publication types

Evaluation Study
Multicenter Study

MeSH terms

Blood Donors*
DNA, Viral / blood*
Hepatitis B / diagnosis*
Hepatitis B / virology
Hepatitis B Surface Antigens / blood
Hepatitis B virus / isolation & purification*
Humans
Nucleic Acid Amplification Techniques / methods*
Nucleic Acid Amplification Techniques / standards
Polymerase Chain Reaction / instrumentation
Polymerase Chain Reaction / methods
Sensitivity and Specificity

Substances

DNA, Viral
Hepatitis B Surface Antigens