CAJ | 학술논문

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U F-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U F-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。
목적：탐토겁차법비대험증방안재뇨침사분석의검측홍세포가비성험증중적응용。방법선택3태U F-1000i뇨침사분석의，계산련속6개월실내질공품홍세포검측적총균치화변이계수，학정가비성시험표본농도，선택부합농도요구적시험표본；설정비대험증결과가접수표준；학정시험표본중복검측차수，계산비대편차，병여가접수표준진행비교。결과3태분석의검측저치、고치질공품홍세포적결과합성불정밀도분별위4．26％화3．91％，총균치분별위41．17개／미승화189．42개／미승；선택적비대시험저치、고치표본홍세포농도분별위33．5、180．5개／미승，중복검측차수분별위4차화3차。비대험증결과가접수표준학정위비대편차불초과±10％。시험표본실제검측결과비대편차분별위4．5％화2．3％，균소우10％。결론3태U F-1000i뇨침사분석의검측홍세포비대험증통과。겁차법비대험증방안조작간단，괄합추엄응용。
Objective To verify the comparability of detected results of red blood cell between three UF-1000i urinal sediment analyzers according to the procedures of range test .Methods The total mean and coefficient of vari-ation(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 select-ed .Determining number of replicates was verified ,and the contrastive ranges and acceptance criteria were compared . Results Accumulated CV of low level and high level control materials were 4 .26% and 3 .91% ,and the total means were 41 .17 cells/μL and 189 .42 cells/μL respectively .Concentration of testing samples were set as 33 .5 cells/μL (sample 1) and 180 .5 cells/μL (sample 2) .The number of replicates of sample 1 and 2 were 4 and 3 times .The lev-el 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-1000i urinal sediment analyzers could be comparable .The method of range test comparable verification might be suit for compara-ble verification of urinal sediment analyzers .