IN VITRO POTENCY ASSAY DEVELOPMENT FOR TETANUS ANTITOXIN

本研究的目的是开发一种体外效价测定方法， 取代正式放行试验的豚鼠死亡试验部分 破伤风成分 ER2（豚鼠ELISA标准品10单位）为 用于破伤风ELISA测定，以测定常规批次的滴度 释放血清。 保存来自DTP吸附批次的血清，因为它们 官方效价测定中的临界样品。 添加样品为 收集以计算每个新抗体的个体和合并液滴度。 DTP吸附免疫豚鼠。 这些游泳池在官方的 效价测定 在ELISA中检测个体血清和合并液 比色法 官方效价测定与ELISA之间的相关性 是好的. 将美国标准抗破伤风（E134和E135）与 豚鼠血清（ER 2和ER 3，替代ELISA标准品，8单位）， 破伤风ELISA。 两者之间大约有200倍的差异， 豚鼠血清和美国标准品ELISA中的计算单位 （马），当使用动物效价试验的单位值时。 这些 正在评估结果，以确定使用美国 带乘数的标准。 如果无法使用美国标准，则在内部 由豚鼠血清制成的标准品，并根据美国 将推荐标准。 标准操作程序和 破伤风毒素和豚鼠对照血清的样本已被送往 给一个有执照的制造商 数据将被交换， 将检查功能特性。

The object of this study is to develop an in vitro potency assay to replace the guinea pig death test portion of the official release test for the tetanus component. ER2 (Guinea Pig ELISA standard 10 units) was used in the Tetanus ELISA assay to determine the titer of routine lot release serum. Sera from DTP adsorbs lots were saved, because they were borderline samples in the official potency assay. Addition samples were collected to calculate both the individual and pool titers of each new DTP adsorbs immunized guinea pig. The pools were tested in the official potency assay. The individual sera and pools were tested in the ELISA assay. The correlation between the official potency assay and the ELISA was good. A US Standard Antitetanus (E134 and E135) was compared to Guinea Pig serum (ER2 and ER3 the alternate ELISA standard 8 units) in the Tetanus ELISA. There is approximately 200 fold difference between the calculated units in ELISA for Guinea Pig serum and US Standard (horse), when using the unit value from the animal potency assay. These results are being evaluated to determine the feasibility of using the US Standard with a multiplier. If the US Standard cannot be used, in house standards made from Guinea Pig serum and validated against the US Standard will be recommended. The Standard Operating Procedure and samples of the tetanus toxin and Guinea Pig control sera have been sent to one of the licensed manufacturers. Data will be exchanged and functional characteristics will be examined.