IN VITRO POTENCY ASSAY DEVELOPMENT FOR TETANUS ANTITOXIN

本研究的目的是建立一种体外效力测定方法，以 更换官方放行试验中的豚鼠死亡试验部分 用于破伤风成分。ER2(豚鼠EL ISA标准10单位)为 用于破伤风酶联免疫吸附试验测定常规批次效价 释放血清。DTP吸附的血清保存了很多，因为它们是 官方效价分析中的临界样品。添加的样本是 收集以计算每个新的 DTP对免疫豚鼠的吸附作用。这些泳池在官方网站上进行了测试 效价分析。在酶联免疫吸附试验中检测了单个血清和池 化验。官方效价测定与酶联免疫吸附试验的相关性 很不错。美国标准安蒂塔努斯(E134和E135)与 豚鼠血清(ER2和ER3为交替的ELISA8单位) 破伤风EL ISA。两者之间大约有200倍的差异 豚鼠血清酶联免疫吸附试验中的计算单位及美国标准 (马)，当使用动物效力分析的单位值时。这些 正在对结果进行评估，以确定使用美国 带乘数的标准。如果不能使用美国标准，在内部 用几内亚猪血清制成的标准并与美国进行了验证 标准将被推荐。标准操作程序和 破伤风毒素和几内亚猪控制血清的样本已经发送 卖给了一家有执照的制造商。将交换数据并 我们将研究其功能特性。

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.