Holmes H, Davis C, Heath A, Hewlett I, Lelie N
Division of Retrovirology, National Institute of Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, EN6 3QG, Herts, UK.
J Virol Methods. 2001 Apr;92(2):141-50. doi: 10.1016/s0166-0934(00)00283-4.
Twenty-six laboratories from 10 different countries participated in a collaborative study to establish the 1st International Standard for HIV-1 RNA for use in nucleic acid-based techniques (NAT). Three candidate preparations were tested all based on genotype B viruses. The candidates were tested by each laboratory at a range of dilutions in four independent assays and the results collated and analysed statistically. All three candidates gave results that were tightly grouped, with little difference between the results from different laboratories or from the use of different assays. Studies of relative potency showed good agreement between laboratories. There were no significant differences between five commercial assay types, except that candidate XX showed a slightly lower potency compared to YY and ZZ with a single commercial assay. The reason for this was not established. Degradation studies showed that the freeze-dried preparations were stable at -20,4 and 20 degrees C for 26 weeks, the longest period studied, but that they became difficult to reconstitute after 3 weeks at 45 degrees C and 9 weeks at 37 degrees C. As a result of the study, the World Health Organisation (WHO) Expert Committee on Biological Standardisation (ECBS) established the preparation referred to as candidate YY (NIBSC Code No. 97/656) as the 1st International Standard for HIV-1 RNA for use with NAT with an assigned potency of 100000 International Units per vial.
来自10个不同国家的26个实验室参与了一项合作研究，以建立首个用于基于核酸技术（NAT）的HIV-1 RNA国际标准品。对三种候选制剂进行了测试，所有制剂均基于B基因型病毒。各实验室在四种独立检测中对不同稀释度的候选制剂进行了测试，并对结果进行了整理和统计分析。所有三种候选制剂的结果都紧密聚集，不同实验室的结果之间或使用不同检测方法的结果之间差异很小。相对效价研究表明各实验室之间具有良好的一致性。五种商业检测类型之间没有显著差异，只是在单一商业检测中，候选XX与YY和ZZ相比效价略低。其原因尚未明确。降解研究表明，冻干制剂在-20℃、4℃和20℃下26周内稳定，这是研究的最长时间，但在45℃下3周和37℃下9周后难以重新溶解。作为该研究的结果，世界卫生组织（WHO）生物标准化专家委员会（ECBS）将称为候选YY（NIBSC编号97/656）的制剂确定为首个用于NAT的HIV-1 RNA国际标准品，每瓶指定效价为100000国际单位。
