两种血细胞分析系统测定结果的可比性研究

Comparison and bias estimation on the results produced by different hematology testing systems

目的探讨不同血细胞分析系统间测定结果的可比性。方法参考美国临床实验室标准化协会(CLSI)的EP9-A2文件,以已经过比对的、可溯源的XT-4000i血细胞分析系统为目标,用患者新鲜全血对XS-800i血细胞分析系统的白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、血小板(PLT)4项参数测定结果进行比对,计算两个系统之间的相对偏差(SE%),以美国临床实验室修正法规(CLIA′88)规定的室间质量评价允许误差(TEa)范围的1/2为标准,判断测定结果的可比性。结果两个血细胞分析系统各项目的批内精密度和批间精密的变异系数均不大于5%,显示两个分析系统重复性好、在试验期间性能稳定。在仪器的偏倚评估和可比性评价方面,检测系统的WBC、PLT在低值时1/2CLIA′88TEa<SE%<CLIA′88TEa,其他4个参数在其余各医学决定水平处的SE%均小于1/2CLIA′88TEa。结论当同一项目用不同检测系统检验时,应进行方法比对和偏倚评估,判断其临床可接受性能,以保证检验结果的可比性。

Objective To study the result comparability of different hematology testing systems by bias estimation and method comparison.Methods According to document EP9-A2 of Clinical Laboratory Standards Institute（CLSI）,four items（include WBC,RBC,Hb and PLT） in different hematology testing systems and aim system were tested respectively to obtain the correlation coefficient and the linear equation.Then the system bias between hematology testing systems and aim system could be evaluated by obtained equation.The comparability of different investigated system was judged by the half of clinical laboratory improvement amendment 88（CLIA 88） allowed total error.Results There are comparabilities between system 800i and aim system in all items.The WBC and PLT showed no comparabilities with aim system in the low level.Conclusion If the same item is tested in more than two systems,it is necessary to judge clinical acceptability by method comparison and bias estimation so as to insure the comparability.