极差法比对验证方案在尿沉渣分析仪检测红细胞比对中的应用

Application of range test comparable verification method of RBC detection between different urinal sediment analyzers

目的探讨极差法比对验证方案在尿沉渣分析仪检测红细胞可比性验证中的应用。方法选择3台UF-1000i尿沉渣分析仪,计算连续6个月室内质控品红细胞检测的总均值和变异系数,确定可比性试验标本浓度,选择符合浓度要求的试验标本;设定比对验证结果可接受标准;确定试验标本重复检测次数,计算比对偏差,并与可接受标准进行比较。结果 3台分析仪检测低值、高值质控品红细胞的结果合成不精密度分别为4.26%和3.91%,总均值分别为41.17个/微升和189.42个/微升;选择的比对试验低值、高值标本红细胞浓度分别为33.5、180.5个/微升,重复检测次数分别为4次和3次。比对验证结果可接受标准确定为比对偏差不超过±10%。试验标本实际检测结果比对偏差分别为4.5%和2.3%,均小于10%。结论 3台UF-1000i尿沉渣分析仪检测红细胞比对验证通过。极差法比对验证方案操作简单,适合推广应用。

Objective To verify the comparability of detected results of red blood cell between three UF-1000 i urinal sediment analyzers according to the procedures of range test.Methods The total mean and coefficient of variation（CV）of six months were calculated.An approximate concentration of comparison testing samples was verified,and samples were selected according to verified concentration.The appropriate level of acceptance criteria was selected.Determining number of replicates was verified,and the contrastive ranges and acceptance criteria were compared.Results Accumulated CVof low level and high level control materials were 4.26%and 3.91%,and the total means were 41.17cells/μL and 189.42cells/μL respectively.Concentration of testing samples were set as 33.5cells/μL（sample 1）and 180.5cells/μL（sample 2）.The number of replicates of sample 1and 2were 4and 3times.The level of acceptance criteria was±10%.The contrastive ranges of two testing samples were 4.5% and 2.3%,which were less than the critical differences.Conclusion The detected results of red blood cells by three UF-1000 iurinal sediment analyzers could be comparable.The method of range test comparable verification might be suit for comparable verification of urinal sediment analyzers.