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Journal of Clinical Microbiology, December 2001, p. 4407-4412, Vol. 39, No. 12
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.12.4407-4412.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

European Proficiency Testing Program for Molecular Detection and Quantitation of Hepatitis B Virus DNA

Elizabeth Valentine-Thon,1,* Anton M. van Loon,2 Jurjen Schirm,3 Jim Reid,4 Paul E. Klapper,5 and Graham M. Cleator5

Department of Molecular Biology, Laboratory Dr. Schiwara and Partners, 28357 Bremen, Germany1; Department of Virology, University Medical Center Utrecht, Utrecht,2 and Department of Virology, Regional Public Health Laboratory, Groningen,3 The Netherlands; and Shield Diagnostics Limited, Dundee,4 and Department of Virology, Manchester Royal Infirmary, Manchester,5 United Kingdom

Received 30 April 2001/Returned for modification 14 August 2001/Accepted 27 September 2001

External quality control of hepatitis B virus (HBV) DNA detection remains an important issue. This study reports and compares the results obtained from two different proficiency panels for both the qualitative and quantitative assessment of HBV DNA. The panels were designed by the European Union Quality Control Concerted Action, prepared by Boston Biomedica, Inc., and distributed in May 1999 (panel 1) and February 2000 (panel 2). Each contained two negative samples and six positive samples with 103 to 107 copies/ml (panel 1) or 103 to 2 × 106 copies of HBV DNA per ml (panel 2). For panel 1, 42 laboratories submitted 20 qualitative (all in-house PCRs) and 37 quantitative (87% commercial assays) data sets. For panel 2, 51 laboratories submitted 25 qualitative (all in-house PCRs) and 47 quantitative (94% commercial assays) data sets. Five data sets (8.8%) in panel 1 and two data sets (2.8%) in panel 2 contained totals of six and two false-positives, respectively, corresponding to false-positive result rates of 5.3% for panel 1 and 1.4% for panel 2. The false-negative result rates of 10.5% for panel 1 and 17.4% for panel 2 were dependent on the detection levels of the assays employed as well as panel composition. In the qualitative analysis of all data sets, 47.4% (panel 1) and 51.4% (panel 2) had all samples correct. An adequate or better score (all correct or only the weak-positive sample missed) was obtained with 77.2% of the panel 1 samples and 68.1% of the panel 2 samples. In the quantitative analysis, 57.1% (panel 1) and 42.6% (panel 2) of the data sets achieved an adequate or better score (positive results within the acceptable range of the geometric mean ± 0.5 log10 of all positive results). These results demonstrate that while the qualitative performance of HBV detection has considerably improved compared to that of a previously published HBV proficiency study, the detection levels of many commercial quantitative assays are still too high to allow adequate quantitation of all relevant clinical samples.

* Corresponding author. Mailing address: Department of Molecular Biology, Laboratory Dr. Schiwara and Partners, Haferwende 12, 28357 Bremen, Germany. Phone: 0049-421-20720. Fax: 0049-421-2072-167. E-mail: Elizabeth.Valentine-Thon{at}Schiwara.de.

Journal of Clinical Microbiology, December 2001, p. 4407-4412, Vol. 39, No. 12
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.12.4407-4412.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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Copyright © 2001 by the American Society for Microbiology. All rights reserved.