【摘要】 目的对实验室内不同血液分析仪检测白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、红细胞比容(HCT)和血小板(PLT)的检测结果进行偏倚评估,确保同一实验室内不同仪器间检验结果的一致性,为临床提供准确可靠的检验结果。方法参照美国临床实验室标准化协会(CLSI)《EP9-A2》文件,先使用配套的具有溯源性的校准品和质控品对Sysmex XE-2100、XT-1800i和Beckman Coulter LH780血液分析仪进行校准和精密度评价;在校准和精密度均合格后,用患者EDTA-K2抗凝新鲜全血,以XE-2100为比较方法,XT-1800i、LH780为实验方法,对WBC、RBC、Hb、HCT及PLT的检测结果进行比对分析,计算医学决定水平(Xc)处的预期偏倚(Bc)及Bc95%的可信区间,以美国临床实验室改进修正法案"88(CLIA"88)的1/3允许总误差(TEa)为判断标准,判断不同仪器间检验结果的一致性。结果各仪器测定WBC、RBC、Hb、HCT和PLT的CV均小于CLIA"88的1/3允许总误差,精密度符合要求;XT-1800i、LH780的检测结果与XE-2100具有良好的相关性,各比对项目在医学决定水平处的预期偏倚均在临床可接受范围内。结论本科室内应用不同检测系统检测WBC、RBC、Hb、HCT和PLT的检测结果具有一致性,差异无统计学意义。更多还原

【Abstract】 Objective To estimate the bias of WBC,RBC,HGB,HCT and PLT results measured by different automated hematology analyzers in the lab,ensure the consistency of the results and provide accurate and reliable test results for clinical.Methods According to Clinical and Laboratory Standards Institute(CLSI) document EP9A2,we first adjusted Sysmex XE-2100,XT-1800i and Beckman Coulter LH780 automated hematology analyzers with traceability calibrator,then evaluated precision with supporting quality control.Under satisfactory precision and calibration,the EDTA-K2 anticoagulated blood was measured by XE-2100(as comparison method),XT-1800i and LH780(as experiment method).Then we evaluated the bias of WBC,RBC,Hb,HCT and PLT tests results in different analyzers,calculated the expected bias and the 95% confidence interval of expected bias at medical decision levels and compared to 1/3 allowed total error of CLIA"88 to inspect comparability between different analyzers.Results The CV of WBC,RBC,Hb,HCT and PLT tested by different analyzer were less than 1/3 CLIA88 allowed total error,and the precision conformed the requirements.The correlation of the test results between XT-1800i,LH780 and XE-2100 was good and the expected bias of all projects were acceptable.Conclusion The results of WBC,RBC,Hb,HCT and PLT measured by different analyzers have a good consistency,and the differences of them have no statistical significance.更多还原