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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 determine the subcutaneous infection of live attenuated Japanese encephalitis patients into brain by semi-quantitative method. Methods A daily scoring method was introduced. The subcutaneous infection into the brain was qualitatively transformed into semi-quantitative animal experiments to verify the precision (repeatability), intermediate precision, accuracy and specificity of the method. Results Subcutaneous infection into the brain test semi-quantitative detection method with good accuracy (repeatability), the intermediate precision and specificity. The verification parameters have reached the pre-set acceptable standards. Conclusion The method is consistent with the purpose and suitable for the test sample, and can be used for quality control of live attenuated JE vaccine.