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Establishment of the first World Health Organization International Standard for human parvovirus B19 DNA nucleic acid amplification techniques

Authors

  • J. Saldanha,

    Corresponding author
    1. 1Division of Virology, National Institute for Biological Standards and Controls, South Mimms, Herts., UK
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  • N. Lelie,

    1. 2CLB, Plesmanlaan 125, Amsterdam, the Netherlands
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  • M. W. Yu,

    1. 3Division of Hematology, CBER/FDA, Bethesda, Maryland, USA
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  • A. Heath,

    1. 4Informatics Division, National Institute for Biological Standards and Controls, South Mimms, Herts., UK
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  • the B19 Collaborative Study Group

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    • *

      Dr J. Albrecht, National Genetics Institute, Los Angeles, CA, USA; Dr S. Buhr/Professor W. Roth, Blood Donor Service Hesse, Frankfurt, Germany; C. Chaput, NIBSC, South Mimms, Herts., UK; Dr Chudy/I. Schmidt, Paul Ehrlich Institut, Langen, Germany; Dr B. Cohen, Central Public Health Laboratory, London, UK; Dr C. Defer/Dr C. Lefebvre, Laboratoire de Biologie Moleculaire des Virus CRTS, Lille, France; Dr S. Doyle/Dr P. Daly, National University of Ireland, Maynooth, Ireland; Dr J. Echevarria, Instituto de Salud Carlos III, Madrid, Spain; Dr D. Erdman/Dr B. Anderson, Center for Disease Control, Atlanta, GA, USA; R. Fang/D. Johnstone, CSL Bioplasma, Broadmeadows, Australia; Dr T. Gierman, Bayer Corporation, Raleigh, USA; Dr P. Gross, Baxter/Immuno AG, Vienna, Austria; Dr I. Held, BIFA, Vienna, Austria; Dr L. Jarvis/A. Cleland, SNBTS/PCR Unit, Royal (Dick) Veterinary College, Edinburgh, UK; Dr A. Lazo/Dr V. Gibaja, Vitex, Boston, MA, USA; Dr T. Murozuka, Japanese Red Cross Fractionation Center, Chitose, Japan; Dr Y. Okada, National Institute of Infectious Diseases, Tokyo, Japan; Dr L. Pedada/Dr A. Lou, Alpha Therapeutics Corporation, City of Industry, CA, USA; Dr Pisani/Dr Gentili, Istituto Superiore di Sanita, Rome, Italy; Dr Saldanha, NIBSC, South Mimms, Herts., UK; Dr M. Stolz, Blutspendedienst SRK, Berne, Switzerland; Dr I. Thomas/Dr E. Mathy, Scientific Institute of Public Health, Brussels, Belgium; Dr T. Weimer, Aventis Behring, Marburg, Germany; Dr M.-Y. Yu/Dr L. M. Shen/B. Mason, CBER, Bethesda, MD, USA; Dr D. York, University of Natal, Congella, South Africa; Dr H. Zhang, National Institute for the Control of Pharmaceutical and Biological Products, Beijing, China.


: J. Saldanha, Division of Virology, National Institute for Biological Standards and Controls, Blanche Lane, South Mimms, Herts. EN6 3QJ, UK E-mail: jsaldanha@nibsc.ac.uk

Abstract

Background and Objectives A collaborative study, involving 26 laboratories from 14 countries, was carried out in order to establish a World Health Organization (WHO) International Standard for human parvovirus B19 (B19) DNA nucleic acid amplification techniques (NAT).

Materials and methods Four samples: AA, BB (which were lyophilized), CC and DD (which were liquid preparations) were analysed using several different NAT assays. The mean B19 DNA content of each sample was determined for each laboratory using an end-point dilution method.

Results There was good agreement between the overall mean ‘equivalents’/ml obtained by the different assays. The mean log10‘equivalents’/ml were 5·76 for sample AA, 5·73 for sample BB, 5·82 for sample CC and 7·70 for sample DD. The differences in titre among samples AA, BB and CC were not statistically significant, but the titre of DD was significantly higher.

Conclusions Despite the range of NAT assays used in the study, it was possible to calculate the mean B19 DNA concentrations in the four preparations. Lyophilized preparation AA was established as the first International Standard for B19 DNA NAT assays and was assigned a concentration of 106 international units (IU)/ml.

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