两套Beckman-Coulter血细胞分析系统间检测结果的偏差评估和可比性分析  

The bias estimation and comparative study on the results with two Beckman-Coulter hematology analyzers

作　　者：李仲笑[1] 陈嘉骥[1] 陈思颖[1] 潘连贞[1] 

机构地区：[1]广东省江门市中心医院检验科,广东江门529070

出　　处：《现代预防医学》2013年第7期1343-1344,1347,共3页Modern Preventive Medicine

摘　　要：目的通过对两套Beckman-Coulter血细胞分析系统的检测结果进行预期偏倚评估,探讨WBC、RBC、HGB、MCV、PLT在两套血细胞分析系统检测结果的可比性。方法参考美国临床实验室标准化委员会(NCCLS)EP9-A文件的要求,以Beckman-Coulter750血细胞分析仪为参比系统Beckman-CoulterLH500血细胞分析系统为实验系统,用患者样品对WBC、RBC、HGB、MCV、PLT进行了检测,以美国临床实验室修正法规(CLIA’88)规定的1/2允许误差范围为标准,判断两套血细胞分析系统的检验结果的可比性。结果所有测定WBC、RBC、HGB、MCV、PLT五项指标的相关系数(r)分别为0.9977,0.9969,0.9986,0.9966,0.9929,两者的相关性良好;在医学决定水平的系统误差(Bc)均小于允许误差(Ea)范围。结论当实验室内使用两套以上的血细胞分析系统,应对实验结果进行偏倚评估,以保证检测结果的可比性。OBJECTIVE To study the comparability of whole blood cell count results of WBC, RBC, HGB, MCV and PLT among two Beckman-Coulter systems. METHODS According to the profile NCCLS document Ep9-A, we used the BeckmanCoulter LH750 as a reference method to make comparison to the Beckman-Coulter LH500 （testing system） to detect WBC, RBC, HGB, MCV and PLT. We judged the comparability of the two systems according to CLIA’ 88 standard. RESULTS There was a good correlation between two hematology analyzers of whole blood cell count and the correlations （r） of WBC, RBC, HGB, MCV and PLT were 0.997 7, 0.996 9, 0.998 6, 0.996 6 and 0.992 9, and the systemic errors in medicine decide level were all below the Ea that was acceptable in clinic. CONCLUSION If the whole blood cell count test is determined by more than two systems, it is necessary to do bias estimation in order to insure the comparability.

关 键 词：血细胞分析仪 偏倚评估 对比分析 

分 类 号：R446.11[医药卫生—诊断学]