Redhead K, Das R E
National Institute for Biological Standards and Control, Hertfordshire, U.K.
Biologicals. 1991 Apr;19(2):107-11. doi: 10.1016/1045-1056(91)90008-8.
A collaborative assay has been carried out to estimate the mouse protective potency of a freeze-dried preparation of Bordetella pertussis (88/522) intended to serve as the third British Reference Preparation for Pertussis Vaccine (third BRP). The opportunity was also taken of reassessing the relationship between the second International Standard for Pertussis Vaccine and the second British Reference Preparation for Pertussis Vaccine (second BRP). Workers in nine laboratories took part in the study and together completed 19 assays which were considered to be statistically valid. Based on the results of the study it is proposed that ampouled preparation code number 88/522 be established as the third BRP with an assigned potency of 50 IU per ampoule. The evidence of this study also suggests that the relationship between the second International Standard for Pertussis Vaccine and the second BRP has not changed significantly since they were originally established.
已开展一项协作试验，以评估用作英国百日咳疫苗第三参考制剂（第三BRP）的冻干百日咳博德特氏菌制剂（88/522）的小鼠保护效力。同时，还重新评估了百日咳疫苗第二国际标准品与百日咳疫苗第二英国参考制剂（第二BRP）之间的关系。九个实验室的工作人员参与了该研究，共完成了19项被认为具有统计学有效性的试验。根据研究结果，建议将安瓿制剂编号88/522确立为第三BRP，每安瓿指定效力为50 IU。该研究的证据还表明，自最初确立以来，百日咳疫苗第二国际标准品与第二BRP之间的关系并未发生显著变化。
