Rigsby Peter, Rijpkema Sjoerd, Guy Edward C, Francis Janet, Das Rose Gaines
Informatics Laboratory, National Institute for Biological Standards and Control, Hertfordshire, UK.
J Clin Microbiol. 2004 Nov;42(11):5133-8. doi: 10.1128/JCM.42.11.5133-5138.2004.
A freeze-dried human serum preparation containing immunoglobulin G (IgG) to Toxoplasma gondii was assessed for its suitability as an international reference reagent in an international collaborative study by 24 laboratories from 17 countries. This candidate standard was compared with the third international standard (IS) for human anti-Toxoplasma serum, TOXM, with the previous second IS, TOXS, and with a range of other serum samples. Samples were tested with the Sabin-Feldman dye test and a range of agglutination assays and enzyme immunoassays. This study emphasizes the need for appropriate standards if intermethod agreement of estimates is to be achieved. On the basis of the results of this study, the preparation was established by the World Health Organization as the first IS for human anti-Toxoplasma IgG, with an assigned potency of 20 IU per ampoule of total anti-Toxoplasma antibodies.
一种含有抗弓形虫免疫球蛋白G（IgG）的冻干人血清制剂，在一项由来自17个国家的24个实验室参与的国际协作研究中，被评估其作为国际参考试剂的适用性。该候选标准品与人类抗弓形虫血清的第三个国际标准品（IS）TOXM、之前的第二个IS TOXS以及一系列其他血清样本进行了比较。样本通过Sabin-Feldman染色试验以及一系列凝集试验和酶免疫测定法进行检测。这项研究强调，如果要实现不同方法估计值之间的一致性，就需要合适的标准品。基于这项研究的结果，世界卫生组织将该制剂确立为首个用于人类抗弓形虫IgG的国际标准品，每安瓿总抗弓形虫抗体的指定效价为20国际单位。
