同型号全自动血细胞分析系统检测结果的比对分析和偏倚评估  

Result comparison analysis and bias evaluation of the same type automatic hematocyte analyzer

作　　者：吴志平[1] 唐吉斌[1] 焦瑞宝[1] 王传发[1] 

机构地区：[1]安徽省铜陵市人民医院临床检验中心,244000

出　　处：《检验医学与临床》2014年第20期2830-2832,共3页Laboratory Medicine and Clinic

基　　金：安徽省铜陵市卫生局2013年资助项目[卫科研(2013)03号]

摘　　要：目的对两台同型号全自动血细胞分析系统Sysmex XT-2000i的检测结果进行比对分析和偏倚评估,实现结果的互通。方法参考美国临床实验室标准化委员会(NCCLS)EP9-A2文件的要求,采用参考仪器和测试仪器对患者新鲜全血白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、红细胞比容(HCT)、血小板(PLT)、红细胞平均体积(MCV)6项指标进行检测,制作散点图,计算回归方程、相关系数(r2)、预期偏倚和95%置信区间相对偏倚。以美国临床实验室改进法案修正案(CLIA′88)中规定允许误差(Ea)的1/2为标准,评估结果之间的可比性。结果两系统的批内精密度良好,WBC、RBC、HGB、HCT、PLT、MCV6项指标的r2分别为0.998 7,0.993 3,0.996 7,0.996 8,0.994 5,0.991 9,r2均大于0.95,两者总的相关性良好。检测系统各项目医学决定水平的相对偏倚均小于1/2Ea,结果可被临床接受。结论本实验室内两台同型号全自动血细胞分析系统Sysmex XT-2000i检测结果相关性良好,可实现检测结果的互通。Objective To analyze the results of two hematocyte analyzers Sysmex XT-2000i and evaluate the bias .Methods According to National Committee for Clinical Laboratory Standards （NCCLS） EP9-A2 ,the hemato-cyte analyzers were used to measure the white blood cell （WBC） ,red blood cell （RBC） ,platelet （PLT ） ,hemoglobin （HGB） ,hematocrit（HCT ） and mean corpuscular volume（MCV ）of fresh blood .The results in the reference instru-ment and test instrument were recorded ,and regression equations correlation coefficient （r2 ） ,predicted bias and 95%confidence interval were calculated .According to the ＆quot;Clinical Laboratory Improvement Amendments ＆quot; （CLIA′88） , half of allowable error（Ea）was applied as a standard to evaluated the comparability of results and clinical acceptabili -ty .Results The two systems had good intra batch precision .The r2 of WBC ,RBC ,HGB ,HCT ,PLT ,MCV were 0 .998 7 ,0 .993 3 ,0 .996 7 ,0 .996 8 ,0 .994 5 and 0 .991 9 respectively ,which were both more than 0 .95 .Therefore the overall correlation was good .The relative bias of the two systems were all less than 1/2 of CLIA′88 allowable error , which were clinically acceptable .Conclusion The two systems in the clinical laboratory of Tongling People＆#39;s Hospital exists well correlation .

关 键 词：全自动血细胞分析仪 比对试验 EP9-A2文件 

分 类 号：R446.112[医药卫生—诊断学]