Lyng J, Heron I, Ljungqvist L
WHO International Laboratory for Biological Standards, State Serum Institute, Copenhagen S, Denmark.
Biologicals. 1990 Jan;18(1):3-9. doi: 10.1016/1045-1056(90)90062-5.
Two freeze-dried international reference tetanus toxoids of different origin and purified by different methods were compared in various potency assay systems, in vitro as well as in vivo. When the antigenic contents in the two toxoids are used as the basis for expressing the relative potency, different tests in animals gave different potencies. It is concluded that, as a result of such differences, tetanus vaccines can hardly be quantitated unambiguously in potency assays in animals. Since, however, a biological immunogenicity control seems necessary, a more simple type of test is suggested, which will require much less resources in terms of animals and manpower.
对两种来源不同且采用不同方法纯化的冻干国际参考破伤风类毒素，在多种体外和体内效力测定系统中进行了比较。当以两种类毒素中的抗原含量作为表达相对效力的基础时，在动物身上进行的不同试验得出了不同的效力结果。得出的结论是，由于存在这些差异，破伤风疫苗在动物效力测定中很难进行明确的定量。然而，鉴于似乎需要进行生物免疫原性控制，建议采用一种更简单的试验类型，这种试验在动物和人力方面所需资源要少得多。
