酶联免疫吸附法测定破伤风人免疫球蛋白效价的试验研究

目的: 为建立破伤风人免疫球蛋白(HTIG)效价测定的动物替代方法奠定基础。 方法: 选取7家企业生产的9批HTIG待检品,分别用酶联免疫吸附法(ELISA)和小鼠毒素中和试验法(TNT)测定其效价,并对2种方法检测结果的一致性进行评价。 结果: ELISA法测定结果的回收率达到95%~105%,RSD在10%以内,配对t检验、直线回归和Bland-Altman分析表明ELISA法与TNT法的检测结果具有良好的一致性和相关性。 结论: 为ELISA法替代TNT法用于HTIG效价测定提供了数据支持。

Objective: To provide a basis for establishment of an alternative method to the animal tests for potency assay of human tetanus immunoglobulin (HTIG). Methods: Nine lots of HTIG final products from seven manufacturers were selected for testing.Potency assays were conducted by enzyme-linked immunosorbent assay (ELISA) and mice toxin neutralization test (TNT),respectively.The results of the two methods were then evaluated for consistency. Results: The recovery rate of ELISA was 95%-105%,and the RSD was below 10%.Good consistency and relation of ELISA and TNT method was shown by paired t-test,linear regression and Bland-Altman analysis. Conclusion: Our results support the replacement of TNT method in HTIG potency assay by ELISA.

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