双抗夹心ELISA法在无细胞百日咳疫苗生产质控中的应用

Monitoring the process optimization of an acellular pertussis vaccine by a sandwich ELISA

实验中对无细胞百日咳疫苗的脱毒工序优化后,采用双抗夹心ELISA法来检测百日咳有效组分含量,同时采用效价试验方法来验证结果。ELISA法定量测定有效成分的结果和效价试验结果均证明达到《中国药典》三部2005版的要求。由于双抗夹心ELISA法特异性强,灵敏度高,适用于无细胞百日咳疫苗生产各个环节的质量控制。

After optimizing the process of acellular pertussis vaccine（APV）,Two Sandwish ELISA methods were used to detect the effective component content of APV.The results of ELISA were validated with those of potency test.All of results of this two methods meet is in line with the standard requirement of ＂The Chinese Pharmacopoeia,Section Ⅲ,2005＂.Since the Sandwith ELISA method are of the excellent specificity and sensitivity,this method can be applied to the quality control of APV.