Sabin S, Schwanig M
Zentralbl Bakteriol Orig A. 1979 Jul;244(2-3):268-74.
A reproducible method for potency-testing of pertussis-sera and - immunoglobulines in a neutralisation test in the mouse is described. The tests were done on two human immunoglobulines, one crude immune serum from the rabbit, and two purified resp. concentrated rabbit immune sera, one of which - the US-Standard for Pertussis Sera - was used as the standard preparation for the potency evaluation. There is no correlation between the results of the neutralisation test and the agglutination titer among the different preparations. That means, the agglutination titer is not suitable for comparing the potency of pertussis sera resp. - immunoglobulines. It seems necessary to establish a uniforme method as well as a standard preparation for potency testing of pertussis sera and - immunoglobulines on the basis of the neutralisation test in the mouse - at least on the European level.
本文描述了一种在小鼠体内进行百日咳血清和免疫球蛋白中和试验效价检测的可重复方法。对两种人免疫球蛋白、一种兔粗免疫血清以及两种纯化的或浓缩的兔免疫血清进行了检测,其中一种(美国百日咳血清标准品)用作效价评估的标准制剂。不同制剂的中和试验结果与凝集效价之间没有相关性。这意味着,凝集效价不适用于比较百日咳血清或免疫球蛋白的效价。似乎有必要在小鼠中和试验的基础上,至少在欧洲层面,建立一种统一的方法以及用于百日咳血清和免疫球蛋白效价检测的标准制剂。