Murata R, Perkins F T, Pittman M, Scheibel I, Sladký K
Bull World Health Organ. 1971;44(5):673-87.
Because of wide variations in the methods used to assay the potency of pertussis vaccine, the effect of the type of challenge used in the mouse-protection test was studied. Eight laboratories took part in a collaborative investigation and the potencies of 4 pairs of vaccines were estimated. Two methods were used, a "local method" using local strains and procedures for challenge, and a "study method" using a distributed strain and a specified procedure. For both methods the challenge level (mouse LD(50)) and the number of colony-forming units per challenge dose varied greatly between laboratories.The results of the collaborative assay show that the use of a common challenge, Bordetella pertussis strain 18-323, and a uniform method for preparing the challenge did not reduce the heterogeneity of the results. Other factors influencing the results of potency assays, such as the use of different strains of mice and the effect of levels of challenge, have still to be investigated.
由于用于检测百日咳疫苗效力的方法存在很大差异，因此对小鼠保护试验中所用攻击类型的影响进行了研究。八个实验室参与了一项协作调查，并对4对疫苗的效力进行了评估。使用了两种方法，一种是“本地方法”，使用本地菌株和攻击程序，另一种是“研究方法”，使用分发的菌株和特定程序。对于这两种方法，各实验室之间的攻击水平（小鼠半数致死量）和每剂攻击剂量中的菌落形成单位数量差异很大。协作检测结果表明，使用共同的攻击菌株百日咳博德特氏菌18 - 323以及统一的攻击制备方法并没有降低结果的异质性。影响效力检测结果的其他因素，如使用不同品系的小鼠以及攻击水平的影响，仍有待研究。
