使用毒素结合抑制(ToBI)试验来估计疫苗中白喉成分的效力

C.F.M. Hendriksen , J.W.v.d. Gun , J.G. Kreeftenberg
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引用次数: 19

摘要

毒素结合抑制(ToBI)试验以前是为估计人血清中的白喉和破伤风抗毒素而开发的,现已用于估计疫苗中白喉成分的效力。数据显示,通过ToBI试验获得的小鼠个体血清的抗毒素效价与Vero细胞试验获得的抗毒素效价很好地一致。此外,通过ToBI试验估计了12批不同成分疫苗的白喉效力和95%置信区间,并将结果与Vero细胞的结果进行了比较。一个显著的相关性可以被证明。本研究认为ToBI试验是基于小鼠抗毒素诱导的白喉类毒素效价测定的一种有价值的模型。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The use of the Toxin Binding Inhibition (ToBI) test for the estimation of the potency of the diphtheria component of vaccines

The Toxin Binding Inhibition (ToBI) test, previously developed for the estimation of diphtheria and tetanus antitoxin in human sera, was adapted for the estimation of the potency of diphtheria components in vaccines. Data are presented to show that antitoxin titres of individual sera of mice obtained by the ToBI test are in good agreement with those obtained in the Vero cell test.

In addition, diphtheria potency and 95% confidence interval of twelve batches of vaccine in different compositions were estimated by the ToBI test and the results were compared with those obtained in Vero cells. A significant correlation could be demonstrated. It is concluded from this study that the ToBI test is a valuable model in the potency assay of diphtheria toxoids, based on antitoxin induction in mice.

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