不确定度评价血细胞分析仪间的比对

Application of measurement uncertainty in comparison of hematology analyzers

目的：探索测量不确定度在血细胞分析仪间比对的应用。方法以门诊 XE2100为参比仪器，对急诊 XE2100和 XN1000比对分析 WBC 、RBC 、Hb 、HCT 、PLT 五个项目。方案一：依据 EP9‐A2文件，每日重复测量8个样本两次，连续5天，仪器间测量值的相对偏移小于1／3CLIA＇88标准为比对合格。方案二：以 IQC 和校准品评定测量不确定度，计算仪器间相对差值的测量不确定度，以小于其差值为比对合格。结果方案一分析测量结果中仅有7．5％无可比性，方案二发现7．5％测量结果可比性差。结论两种比对方案结果一致，实验室内应定期以EP9文件进行仪器比对，日常工作中可通过不确定度监测仪器间的可比性。

Objective To explore the apply of measurement uncertainty in clinical laboratory for comparison of hematology analyzers .Methods Take the out‐patient XE2100 analyzer as comparative machine ,to compare with the emergency XE2100 analyzer and XN1000 analyzer by testing WBC ,RBC ,Hb ,HCT ,PLT .Scheme 1 ：Base on EP9‐A2 ,testing eight samples twice daily and last for five days ,only the relative bias smaller than one third of CLIA＇88 the comparison is on test ;Scheme 2 ：Using internal quality data （IQC） and calibrator to evaluate measurement uncertain‐ty ,only the bias smaller than the uncertainty of bias the comparison is on test .Results The results of Scheme 1 is 7 . 5% comparison is out of test ,while the results of Scheme 2 is also 7 .5% .Conclusion There is no difference between＆amp;nbsp;two Schemes .Laboratory should test the hematology analyzers periodically by Scheme 1 ,and using Scheme 2 to moni‐tor daily results .