Saldanha, J. and Lelie, N. and Yu, M.W. and Heath, A. and Albrecht, J. and Buhr, S. and Roth, W. and Chaput, C. and Chudy, M. and Schmidt, I. and Cohen, B. and Defer, C. and Lefebvre, C. and Doyle, S. and Daly, P. and Echevarria, J. and Erdman, D. and Anderson, B. and Fang, R. and Johnstone, D. and Gierman, T. and Gross, P. and Held, I. and Jarvis, L. and Cleland, A. and Lazo, A. and Gibaja, V. and Murozuka, T. and Okada, Y. and Pedada, L. and Lou, A. and Pisani, G. and Gentili, A. and Stoltz, M. and Thomas, I. and Mathy, E. and Weimar, T. and Yu, M.-Y. and Shen, L.M. and Mason, B. and York, D. and Zhang, H.
(2002)
Establishment of the first World Health Organization
International Standard for human parvovirus B19 DNA nucleic
acid amplification techniques.
Vox Sanguinis, 82 (1).
pp. 24-31.
ISSN 0042-9007
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 log(10) '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 10(6) international units (IU)/ml.
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