病毒类疫苗Vero细胞宿主蛋白残留量检测试剂盒的适用性验证

Verification of Adaptivity of Detection Kit for Residual Vero Cell Host Protein in Viral Vaccines

目的对病毒类疫苗Vero细胞宿主蛋白残留量检测试剂盒进行适用性验证。方法将不同细胞基质制备的乙型脑炎灭活疫苗、人用狂犬病病毒疫苗共16批编盲后，每批疫苗均质等量分为44份，分别分发给3个实验室，用同批ELISA-Vero细胞宿主蛋白检测试剂盒进行检测，对试剂盒进行适用性验证，考核试剂盒的专属性、精密性、线性和范围等指标。结果3个实验室检测每批样品44次，原代地鼠肾细胞和鸡胚细胞为基质的疫苗检测结果均为阴性，以Vero细胞为基质的疫苗检测结果均为阳性。16份样本44次检测结果的变异系数在7．34％～14．77％之间，均低于15％；相对线性范围在12．5—400ng／ml之间。16份疫苗中6批Vero细胞乙脑疫苗和5批人用狂犬病病毒疫苗检出的细胞宿主蛋白残留量分别在153．3—5850．9ng／ml和1895．7～40625．1ng／ml之间。结论疫苗中Vero细胞宿主蛋白残留量检测试剂盒具有较好的专属性、精密性和线性，可用于Vero细胞为基质的病毒类疫苗宿主蛋白残留量的检测。

Objective To verify the adaptivity of detection kit for residual Vero cell host protein in viral vaccines. Methods A total of 16 batches of inactivated Japanese encephalitis （JE） vaccine and rabies vaccine for human use, prepared with various cell substances, were numbered randomly. Each batch was homogeneously and equally divided into 44 samples and distributed to 3 laboratories for detection by ELISA kit for Vero cell host protein of the same lot No. to verify the adaptivity. Results All the detection results of vaccines prepared with primary hamster kidney cells and with chick embryo cells were negative, while all those with Veto cells were positive. The CV value of detection results of all the 16 hatches of vaccines, each of which was detected for 44 times, was 7. 34% - 14. 77%, and the relative linear range was 12. 5 - 400 ng/ml. The residual Veto cell host protein content of 6 batches of JE vaccine prepared with Vero cells was 153. 3 - 5 850. 9 ng/ml, and that of 5 batches of rabies vaccine prepared with Veto cells was 1 895.7 - 40 625.1 ng/ml. Conclusion The detection kit for residual Veto cell host protein showed good specificity, precision and linearity, which was suitable for detection of residual host protein in viral vaccines prepared using Veto cells as substances.