乙型脑炎减毒活疫苗原液的残余PHK细胞蛋白检测方法的验证

 目的   验证PHK细胞残余蛋白检测试剂盒检测乙型脑炎减毒活疫苗（乙脑疫苗）原液的残余PHK细胞蛋白的适用性。 方法   对PHK细胞残余蛋白检测试剂盒检测乙脑疫苗原液的残余PHK细胞蛋白的准确性、精密度、专属性、耐用性和线性进行验证。 结果   PHK细胞残余蛋白检测试剂盒检测乙脑疫苗原液的残余PHK细胞蛋白的准确性良好，PHK细胞蛋白标准品的回收率为96.16%~111.44%。该试剂盒在PHK细胞蛋白质量浓度为6.25~200.00 μg/L时呈现良好的线性，决定系数为0.997，最低检测限和最低定量限分别为6.70和22.33 μg/L。该试剂盒检测乙脑疫苗原液中的残余PHK细胞蛋白的专属性良好，而且操作人员、时间和试剂盒批号变化对检测结果没影响（相对标准偏差均≤15%）。 结论   PHK细胞残余蛋白检测试剂盒适用于乙脑疫苗中的残余PHK细胞蛋白检测。

Validation and application of a detection method for residual protein of PHK cell in bulk of Japanese encephalitis live attenuated vaccine

 Objective  To validate the applicability of a detection kit for residual protein of PHK cell in bulk of Japanese encephalitis live attenuated vaccine (JEV).  Methods   The accuracy, precision, specificity, durability and linearity of the detection kit for residual protein of PHK cell in bulk of JEV were validated.  Results   The accuracy of the detection kit  was good, the recoveries of PHK cell protein standard were 96.16% -111.44%. The detection kit showed good linearity when mass concentrations of PHK cell protein were 6.25-200.00 μg/L, and the coefficient of determination was 0.997. The limit of detection and the limit of quantification were 6.70 and 22.33 μg/L, respectively. The specificity of the detection kit was good. The changes of operator, time and kit lot had no effect on the detection results, and relative standard deviations were all ≤15%.  Conclusion   The detection kit for residual protein of PHK cell is suitable for detecting residual protein of PHK cell in bulk of JEV.