红细胞沉降率标准物质均匀性和稳定性评价  

Homogeneity and stability analysis for reference material of erythrocyte sedimentation rate

作　　者：孙荣荣[1] 眭国平[1] 丁敏[1] 陆逊[1] 肖瑶[1] 王鹏德[1] 顾玮然[1] 

机构地区：[1]上海市计量测试技术研究院,上海201203

出　　处：《国际检验医学杂志》2015年第11期1535-1536,1539,共3页International Journal of Laboratory Medicine

摘　　要：目的对红细胞沉降率(ESR)标准物质的均匀性和稳定性进行评价。方法根据国际化标准组织GUIDE 35《标准物质定值的通用原则及统计学原理》对制备完成的标准物质随机抽取足够的样品,采用方差分析法进行均匀性评价,用线性趋势模型评价标准物质的稳定性。结果均匀性评价结果表明样品组内和组间方差差异无统计学意义(P>0.05);稳定性数据分析结果显示,标准物质ESR随存储时间的线性变化趋势稳定,差异无统计学意义(P>0.05)。结论制备的ESR标准物质均匀性、稳定性符合国家二级标准物质的要求。Objective To evaluate the homogeneity and stability analysis for reference material of erythrocyte sedimentation rate （ESR） .Methods After the reference material was prepared ,enough samples were extracted randomly according to ISO guide ＂35Reference materials‐General and statistical principles for certification＂ ,variance analysis method was used to estimate the homo‐geneity ,and linear trend model was used to estimate its stability .Results The variance within group and variance between group had no significant differences statistically （P〉 0 .05） .The linear change trend of the ESR value of reference material with storage time was not statistically significant （P〉 0 .05） .Conclusion The homogeneity and stability of ESR reference material accords with the criterion of national second‐level reference materials .

关 键 词：红细胞沉降率 标准物质 均匀性 稳定性 

分 类 号：R446.1[医药卫生—诊断学]