Saldanha J, Heath A, Lelie N, Pisani G, Yu M-Y
Roche Molecular Systems Inc., Pleasanton, CA 94588, USA.
Vox Sang. 2005 Jul;89(1):52-8. doi: 10.1111/j.1423-0410.2005.00633.x.
Sixteen laboratories from 10 different countries participated in an international collaborative study to evaluate candidate materials as the first World Health Organization (WHO) International Standard for hepatitis A virus (HAV) RNA nucleic acid amplification technology (NAT) assays.
Five candidate materials were analysed in this study: materials AA and BB were lyophilized, while materials CC, DD and EE were liquid preparations. Samples were diluted in pooled plasma or in pooled cryo-poor plasma (sample EE). Serial dilutions of the candidate materials were tested by each laboratory in four independent assays and the results were analysed statistically.
The mean log(10)'equivalents' per ml were 5.29 for sample AA, 5.07 for sample BB, 4.99 for sample CC, 5.40 for sample DD and 4.08 for sample EE.
Based on the results of this study, sample AA was established as the first International Standard for HAV RNA NAT assays at the WHO Expert Committee on Biological Standardizaton (ECBS) meeting held in February 2003. The code number of this preparation is 00/560 and the potency, based on the study, is 100 000 International Units (IU)/ml.
来自10个不同国家的16个实验室参与了一项国际合作研究，以评估候选材料作为世界卫生组织（WHO）甲型肝炎病毒（HAV）RNA核酸扩增技术（NAT）检测的首个国际标准。
本研究分析了5种候选材料：材料AA和BB为冻干品，而材料CC、DD和EE为液体制剂。样品在混合血浆或混合少冷沉淀血浆（样品EE）中进行稀释。各实验室在4次独立检测中对候选材料的系列稀释液进行检测，并对结果进行统计学分析。
样品AA每毫升的平均log(10)“当量”为5.29，样品BB为5.07，样品CC为4.99，样品DD为5.40，样品EE为4.08。
基于本研究结果，在2003年2月举行的WHO生物标准化专家委员会（ECBS）会议上，样品AA被确立为HAV RNA NAT检测的首个国际标准。该制剂的编号为00/560，根据研究，其效价为100 000国际单位（IU）/毫升。
