Saldanha J, Lelie N, Yu M W, Heath A
Division of Virology, National Institute for Biological Standards and Controls, South Mimms, Herts., UK.
Vox Sang. 2002 Jan;82(1):24-31. doi: 10.1046/j.1423-0410.2002.00132.x.
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).
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.
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.
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.
开展了一项涉及14个国家26个实验室的合作研究，以建立世界卫生组织（WHO）人细小病毒B19（B19）DNA核酸扩增技术（NAT）国际标准品。
使用几种不同的NAT检测方法对四个样本：AA、BB（冻干样本）、CC和DD（液体制剂）进行分析。每个实验室采用终点稀释法测定每个样本的平均B19 DNA含量。
不同检测方法获得的总体平均每毫升“当量”之间具有良好的一致性。样本AA的平均log(10)每毫升“当量”为5.76，样本BB为5.73，样本CC为5.82，样本DD为7.70。样本AA、BB和CC之间的滴度差异无统计学意义，但样本DD的滴度显著更高。
尽管本研究中使用了多种NAT检测方法，但仍有可能计算出四种制剂中的平均B19 DNA浓度。冻干制剂AA被确立为首个B19 DNA NAT检测国际标准品，并被赋予10(6)国际单位（IU）/毫升的浓度。
