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An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques

Authors

  • J. Saldanha,

    Corresponding author
    1. Division of Virology, National Institute for Biological Standards and Control, South Mimms, Herts, UK
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  • W. Gerlich,

    1. Institute of Medical Virology, Justus Liebig University Giessen, Giessen, Germany
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  • N. Lelie,

    1. CLB, PO Box 9190, Plesmanlaan 125, Amsterdam, the Netherlands
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  • P. Dawson,

    1. Standards Processing Division, National Institute for Biological Standards and Control, South Mimms, Herts, UK
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  • K. Heermann,

    1. Division of Medical Microbiology and National Reference Laboratory for Viral Hepatitis, University of Göttingen, Göttingen, Germany
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  • A. Heath,

    1. Informatics Division, National Institute for Biological Standards and Control, South Mimms, Herts, UK
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  • The WHO Collaborative Study Group

    1. Dr Albrecht, National Genetics Institute, Los Angeles, CA, USA; Dr Beck, Federal Institute for Medicine, Vienna, Austria; Mr Cleland, University of Edinburgh Medical School, Edinburgh, UK; Dr Chudy, Paul Ehrlich Institut, Langen, Germany; Dr Cuypers/Dr van Dyk, CLB, Amsterdam, the Netherlands; Dr Driesel, Institute of Laboratory Medicine, Recklinghausen, Germany; Dr Farrenkopf, Roche Molecular Systems, Sommerville, NJ, USA; Prof. Gerlich/Dr Klingerhöfer, Institute of Medical Virology, Giessen, Germany; Dr Gierman, Bayer Corporation, Raleigh, NC, USA; Dr Gröner, Centeon Pharma GmbH, Marburg, Germany; Ms Hallett, Central Public Health Laboratory, London, UK; Dr Misuzawa, National Institute of Infectious Diseases, Tokyo, Japan; Dr Murozuka, Japanese Red Cross Fractionation Center, Chitose, Japan; Dr Pisani/Dr Gentili, Istituto Superiore di Sanita, Rome, Italy; Dr Pichl, DRK Blutspendedienst NSOB, Springe, Germany; Dr Roth, Institut of Transfusion Medicine and Immunohaematology, Frankfurt, Germany; Dr Saldanha, NIBSC, South Mimms, UK; Dr Sawyer, Chiron Corporation, Emeryville, CA, USA; Dr Tabor/Dr Hsia/Dr Momosaki, CBER, Bethesda, MD, USA; Dr Thomas, Scientific Institute of Public Health, Brussels, Belgium; Dr York, University of Natal, Congella, South Africa; Dr Zerlauth, Baxter/Immuno, Vienna, Austria
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*Correspondence: J. Saldanha, Division of Virology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Herts EN6 3QG, UK E-mail: jsaldanha@nibsc.ac.uk

Abstract

Background and objectives

Twenty-two laboratories from nine countries participated in an international collaborative study to establish a World Health Organization (WHO) international standard for hepatitis B virus (HBV) DNA nucleic acid amplification techniques (NAT).

Materials and methods

Three samples, AA, BB (both of which were lyophilized) and CC (which was a liquid preparation), were analysed using several different NAT assays. The mean HBV DNA content of each sample was determined from the study.

Results

Despite the range of assays (commercial and in-house) used by participants, there was good agreement among the overall mean ‘equivalents’/ml obtained by the different assays, except for one laboratory (laboratory 4). The variation in estimates of log10‘equivalents’/ml was 1·75–1·25 for the three samples if results from laboratory 4 were excluded. The mean log10‘equivalents’/ml for all laboratories were 6·42 for sample AA, 6·30 for sample BB and 5·03 for sample CC (exclusion of results from laboratory 4 made little difference). The difference in titres between the two lyophilized samples (AA and BB) was not statistically significant but the titre of the frozen sample (CC) was significantly lower. Material AA (code 97/746) was accepted as the first WHO international standard for HBV DNA NAT assays and assigned a potency of 106 international units (IU)/ml.

Conclusions

The titres (genome equivalents/ml) of three HBV preparations were determined by several laboratories using different NAT assays. This study enabled the establishment of an international standard, 97/746, for HBV DNA NAT assays.

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