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 吸附类毒素疫苗的破伤风成分。 ER 2（豚鼠 在破伤风ELISA测定中使用ELISA标准品10单位）以确定 常规批放行血清滴度。 来自DTP的血清，吸附，批次 因为它们是官方效力的边界样本， 比色法 收集添加样品以计算个体 和每只新DTP吸附免疫豚鼠的合并滴度。 的 在官方效价测定中检测合并物。 个体血清和 在ELISA测定中测试池。 之间的相关性 官方效价测定和ELISA结果良好。 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）。 有 ELISA中计算单位之间的差异约为200倍 对于豚鼠血清和美国标准（马），使用单位值时 从动物效力试验中。 正在评估这些结果， 确定使用美国标准与乘数的可行性。 如果不能使用美国标准，则使用几内亚制造的内部标准 将推荐使用猪血清，并根据美国标准进行验证。 的 破伤风毒素和几内亚的标准操作程序和样品 已将猪对照血清发送至其中一家获得许可的生产商。 将交换数据并审查功能特性。

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 of adsorbed toxoid vaccine. 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, adsorbed, 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, adsorbed 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.