An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques
An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques
复制标题
DOI：
10.1046/j.1423-0410.2001.00003.x
复制
发表时间：
2001-01-01
期刊：
影响因子：
2.7
通讯作者：
Heath, A
中科院分区：
文献类型：
--
作者：
Saldanha, J;Gerlich, W;Heath, A
背景和目的来自9个国家的22个实验室参加了一项国际合作研究，以建立一个世界卫生组织（WHO）的B肝炎病毒（HBV）DNA核酸扩增技术（NAT）的国际标准。材料和方法三个样品，AA，BB（两者都是冻干）和CC（这是一种液体制剂），分析使用几种不同的NAT检测。每个样本的平均HBV DNA含量测定从study.Results的范围内使用的检测（商业和内部）的参与者，有很好的协议之间的整体平均“当量”/毫升获得不同的检测，除了一个实验室（实验室4）。如果排除实验室4的结果，则三份样本的log（10）“当量”/ml估计值的变化为1.75-1.25。所有实验室的平均log（10）“当量”/ml分别为6.42（样本AA）、6.30（样本BB）和5.03（样本CC）（排除实验室4的结果几乎没有差异）。两种冻干样品（AA和BB）之间的滴度差异无统计学显著性，但冷冻样品（CC）的滴度显著较低。材料AA（代码97/746）被接受为第一个WHO HBV DNA NAT检测的国际标准品，并指定效价为10（6）国际单位（IU）/ml。结论3种HBV制剂的滴度（基因组当量/ml）由多个实验室使用不同的NAT检测法测定。本研究建立了HBV DNA NAT检测的国际标准97/746。
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 log(10) 'equivalents'/ml was 1.75-1.25 for the three samples if results from laboratory 4 were excluded. The mean log(10) '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 10(6) 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.