乙肝血源疫苗效力试验结果质量分析

Quality Analyse of Potency Test Results of Hepatitis B Vaccine

本文对６个厂家７年间生年的乙肝血源疫苗效力试验结果进行统计分析，结果表明各厂家的相对效价均值间有差异，各年度相对效价呈上升趋势，原因是试验条件不统一、试验误差大及参比苗效力的显著下降。结果提示应统一动物品系、试剂盒及严格操作并监测参比苗效力的下降趋势以便及时更换参比苗。

The data of hepatitis B vaccine potency test from 6 producers during 7 years was analized with biostatistic method.The relative potency was different in each of producer and had a upward trend.The reason appeared due to the difference of experiment animal,RIA reagent kit,experimental error and to the potency decline of reference vaccine. From the result, potency test conditions should be unified and the potency of ref. vaccine should be monitored constantly and changed timely.