方差成分模型在生物活性测定实验中间精密度分析中的应用  

Application of variance component model for calculating intermediate precision in bioassay

作　　者：冯国双[1] 谭德讲[2] 

机构地区：[1]中国疾病预防控制中心公共卫生监测与信息服务中心,北京102206 [2]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2013年第11期1835-1839,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：中检院学科带头人基金"统计学分析方法在药品检定中的应用研究"(课题编号2011X3)

摘　　要：目的:探讨方差成分模型在生物活性测定实验中间精密度分析中的应用。方法:细胞类生物活性测定实验中,考虑实验者、细胞基质、重复实验3个影响因素,利用方差成分模型计算各影响因素的变异,并具体计算中间精密度、操作模式变异等指标。结果与结论:方差成分模型分析结果显示,不同实验者、重复实验所造成的变异较大,而细胞基质因素造成的变异很小。操作模式变异提示,实验次数越多、每次实验样品重复数越多,变异越小。从本实例可以看到,可通过对实验者的统一培训、增加实验次数等措施,减少实验变异。方差成分模型在多变异来源的生物活性测定实验中具有较好的应用价值。To explore the application of variance component model for calculating intermediate preci- sion in bioassay. Methods：Three factors, i. e. , analyst, cell preparation, and run in a cell - based bioassay, were considered, and the variation caused by the three factors, the intermediate precision and format variability were cal- culated. Results and Conclusion： According to the results of the variance component model, the factors of ana- lyst and run lead to larger variation than the factor of cell preparation. The format variability indicated that the more runs or sample repetitions, the less variation. The variation could be decreased by training analysts, adding runs in the bioassay. The variance component model has a practical application in the bioassay with multi - source of variation.

关 键 词：生物活性测定实验 重复性 中间精密度 重现性 方差成分模型 影响因素 

分 类 号：R917[医药卫生—药物分析学]