统计分析在疫苗国家参考品研制中的应用  

The Application of Statistical Analysis in the Preparation of National Reference Material for Vaccine

作　　者：温芳[1] 关孚时[1] 江波[1] 戴志红[1] 李翠[1] 蒋卉[1] 王在时[1] 

机构地区：[1]中国兽医药品监察所,北京10081

出　　处：《中国兽药杂志》2013年第12期32-35,共4页Chinese Journal of Veterinary Drug

摘　　要：根据国内及国际标准物质相关规范和指南要求,按照统计学原理对鸡新城疫(La Sota株)国家参考品均匀性进行F检验,稳定性进行t检验,协作标定数据进行狄克逊检验,并对总不确定度进行合成,最终定值结果为:lgEID50=6.5±0.33。由此可见,应用统计分析方法对疫苗国家参考品进行定值增加了结果判定的准确性和可控性。According to relevant national and international norms and guidelines of reference materials, statistical analysis was carried out with national reference material for newcastle disease live vaccine （La Sota strain）. The uniformity was conducted with F - test, the stability was conducted with t - test, and the data of collaboration study were conducted with Dixon test. Then, the combined uncertainty was evaluated. The certification of the reference material was that ： IgEID50/0.1 mL = 6.5 ± 0.33. This article hopes to clarify the role of statistical analysis in the preparation and characterization of veterinary biological reference materials.

关 键 词：统计分析 疫苗 国家参考品 应用 

分 类 号：S859.797[农业科学—临床兽医学]