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Journal of Clinical Microbiology, August 2000, p. 2897-2901, Vol. 38, No. 8
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Development of a Quantitative Real-Time Detection Assay for Hepatitis B Virus DNA and Comparison with Two Commercial Assays

Suzan D. Pas,1 Edwin Fries,1 Robert A. De Man,2 Albert D. M. E. Osterhaus,1 and Hubert G. M. Niesters1,*

Departments of Virology,1 and Gastroenterology,2 University Hospital Rotterdam, Rotterdam, The Netherlands

Received 2 March 2000/Accepted 1 June 2000

A highly reproducible and sensitive real-time detection assay based on TaqMan technology was developed for the detection of hepatitis B virus (HBV) DNA and compared with two commercially available assays. The assay was validated with the Viral Quality Control panel, which also includes EUROHEP HBV DNA standards. This real-time PCR detection system had a dynamic range of 373 to 1010 genome copies per ml and showed an excellent correlation with both the commercial HBV Digene Hybrid Capture II microplate assay (Digene Diagnostics) and the HBV MONITOR assay (Roche Diagnostics). To demonstrate its clinical utility, four chronically HBV-infected patients treated with lamuvidine were monitored using the three different assays. From the results we concluded that this assay is an excellent alternative for monitoring of HBV-infected patients in routine diagnostics and clinical practice, enabling the analysis of a large dynamic range of HBV DNA in a single, undiluted sample.

* Corresponding author. Mailing address: Department of Virology, University Hospital Rotterdam, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. Phone: 31-10-463.3431. Fax: 31-10-463.3441. E-mail: niesters{at}viro.fgg.eur.nl.

Journal of Clinical Microbiology, August 2000, p. 2897-2901, Vol. 38, No. 8
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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