CHO细胞簇集法与小鼠体内法检测百日咳毒素残余毒性的相关性

A Study on the Relationship between CHO Cell Method and in Vivo Method to Detect the Residual Pertussis Toxin Activity

目的比较CHO细胞簇集试验、小鼠体内检测法(小鼠组胺致敏试验、小鼠白细胞增多试验)检测不同脱毒条件下的百日咳类毒素残余毒性的应用效果和相关性。方法以不同脱毒条件百日咳类毒素作为研究对象,用CHO细胞簇集试验、小鼠体内法检测百日咳毒素残余毒性,并进行相关性分析。结果白细胞增多实验与组胺致敏实验结果存在显著的正相关(r=0.881,P=0.00),CHO细胞法与白细胞增多实验呈负相关(r=0.630,P=0.028),CHO细胞法与组胺致敏实验呈负相关(r=-0.613,P=0.034)。结论分析了无细胞组分百日咳疫苗脱毒工艺中CHO细胞簇集试验和小鼠体内检测法2种检测试验的差异性和相关性,为百日咳毒素脱毒工艺的便捷检测开发提供重要参考。

Objective To compare the application and correlation between CHO cell method and in vivo detection（histamine sensitization test in mice, mouse leucocytosis test） in pertussis toxin toxicity test.Methods In the detoxification process,the detoxified pertussis toxoid was used as the research object and the residual pertussis toxin activity was detected by CHO cell method and mouse body method. We also have carried on the correlation analysis to the different test methods. Results Correlation analysis showed that there was a significant positive correlation between the experiment of leukocytosis and histamine sensitization test. There was a negative correlation between CHO cell assay and histamine sensitization test,so did CHO cell assay and leukocytosis test. Conclusion The experiment compared the detoxification effect of different concentrations of glutaraldehyde detoxification,and analyzed the difference and correlation between CHO method and histamine sensitization test and mouse leucocytosis test in mice,which may provide important reference for pertussis detoxification process.