Tierney Rob, Stickings Paul, Hockley Jason, Rigsby Peter, Iwaki Masaaki, Sesardic Dorothea
Division of Bacteriology, National Institute for Biological Standards and Control, Health Protection Agency, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, United Kingdom.
Biologicals. 2011 Nov;39(6):404-16. doi: 10.1016/j.biologicals.2011.09.007. Epub 2011 Oct 8.
We present the results of a collaborative study for the establishment of a replacement International Standard (IS) for Tetanus Toxoid Adsorbed. Two candidate preparations were included in the study, one of which was established as the 4th IS for Tetanus Toxoid Adsorbed at the WHO Expert Committee on Biological Standardization meeting in October 2010. This preparation was found to have a unitage of 490 IU/ampoule, based on calibration in guinea pig challenge assays. Results from mouse challenge assays suggest that the relative performance of two candidate preparations may differ significantly between guinea pigs and mice. The authors note that the number of laboratories that performed guinea pig challenge assays, which are used to calibrate and assign IU, is much lower than in previous collaborative studies and this may have implications for calibration of replacement standards in the future. The issue of assigning separate units to the IS for guinea pig and mouse assays is discussed. The study also assessed performance of the replacement standard in serological assays which are used as alternative procedures to challenge assays for tetanus potency testing. Results suggest that the replacement standard is suitable for use as the reference vaccine in serological assays.
我们展示了一项合作研究的结果，该研究旨在建立吸附破伤风类毒素的替代国际标准品（IS）。该研究纳入了两种候选制剂，其中一种在2010年10月举行的世界卫生组织生物标准化专家委员会会议上被确立为第4个吸附破伤风类毒素国际标准品。根据豚鼠攻毒试验中的校准，该制剂的效价为490 IU/安瓿。小鼠攻毒试验的结果表明，两种候选制剂在豚鼠和小鼠中的相对性能可能存在显著差异。作者指出，用于校准和指定国际单位（IU）的豚鼠攻毒试验的实验室数量远低于以往的合作研究，这可能会对未来替代标准品的校准产生影响。文中讨论了为豚鼠试验和小鼠试验的国际标准品指定单独单位的问题。该研究还评估了替代标准品在血清学试验中的性能，血清学试验用作破伤风效力测试攻毒试验的替代方法。结果表明，该替代标准品适合用作血清学试验中的参考疫苗。
