乙型脑炎减毒活疫苗皮下感染入脑试验半定量检测法的方法学验证

Validation of semi-quantitative determination method for neurotropism test on live attenuated Japanese encephalitis vaccine for subcutaneous injection in mice

目的采用半定量法对乙型脑炎减毒活疫苗皮下感染入脑动物试验进行方法学验证。方法引入逐日观察打分的方法,将皮下感染入脑试验由定性转变为半定量动物试验,验证该方法的精密度(重复性)、中间精密度、准确度、特异性。结果皮下感染入脑试验半定量检测方法具有良好的精确度(重复性),中间精密度及特异性。各项验证参数均达到预先设定的可接受标准。结论该方法与用途一致,且与供试品相适宜,可用于乙型脑炎减毒活疫苗的质量控制。

Objective To validate the neurotropism test on live attenuated Japanese encephalitis（JE） inoculated for subcutaneous injection by semi-quantitative method.Methods The neurotropism test on JE vaccine for s.c.injection was changed into semi-quantitative test by introducing score method,and verified for precision（reproducibility）,intermedia precision,accuracy and specificity.Results The semi-quantitative method for neurotropism test showed high precision（reproducibility）,intermedia precision,accuracy and specificity,of which all the validation parameters reached the acceptable criteria designed.Conclusion Validation result showed that the semi-quantitative method was appropriate for its intended use and suitable for the test samples,which might be used for the quality control of live attenuated JE vaccine.