STANDARDIZATION OF POTENCY TEST METHODS FOR IPV

世卫组织主持下的合作努力，以测试IPV的一致性 用单抗酶联免疫吸附试验测定14种不同血吸虫的效价 实验室，证明了不同的 实验室。在比较效力方面也注意到了类似的变异性 基于相同编码的内部ELISA法的测定 样本。这项合作研究的结果(Wood，D.J.，Heath， A.B.和Sawyer，L.A.，Biologals，1995；23：83-94)表示需要 基于酶联免疫吸附试验检测IPV效价的进一步改进。 此外，世卫组织随后进行的一项合作研究比较了IPV 小动物的免疫原性(Wood，D.J.和Heath，A.B.，生物制品 1995；23：301-311)也表现出显著的效力变异 来自10个参与实验室的检测结果。与之形成鲜明对比的是 在合作研究中看到的不同结果，单克隆性 继续进行脊髓灰质炎病毒D抗原的酶联免疫吸附试验 精密度和准确度作为CBER的一项实验测试。工作是 继续在本实验室改进单抗检测方法，评价 潜在的多克隆替代品，并促进对 合适的方法由CBER、制造商和其他监管机构提供。

Collaborative efforts under WHO auspices to test uniformity of IPV potency determinations by monoclonal ELISA in fourteen different laboratories, demonstrated unacceptable variability between the different laboratories. Similar variability was noted in comparing potency determinations based on in-house ELISA determinations of the same coded samples. The results of this collaborative study (Wood, D.J., Heath, A.B. and Sawyer, L.A., Biologicals, 1995;23:83-94) indicated the need for further improvements in ELISA based potency determinations of IPV. Moreover, results of a subsequent WHO collaborative study comparing IPV immunogenicity in small animals (Wood, D.J. and Heath, A.B., Biologicals 1995;23:301-311) also showed an significant variablity of potency determinations from the 10 participating laboratories. In contrast to the variable results seen in the collaborative study, the monoclonal ELISA assay for poliovirus D antigen continues to be performed with precision and accuracy as an experimental test at CBER. Work is continuing in this laboratory to improve the monoclonal assay, evaluate potential polyclonal alternatives, and promote the acceptance of a suitable method by CBER, manufacturers, and other regulatory agencies.