D6-CRP型与XN-9000型血细胞分析仪比对的结果分析

Analysis on the comparison results of Dymind D6-CRP and Sysmex XN-9000 hematology Analyzer

目的:分析D6-CRP和XN-9000型血细胞分析仪检测结果的可比性。方法:按照国家卫生行业标准(WS/T406-2012要求,检测40份乙二胺四乙酸二钾(EDTA-K2)抗凝新鲜静脉全血标本,参照临床实验室标准化协会(CLSI)EP9-A2文件,以XN-9000型血细胞分析仪为对照仪器、D6-CRP型血细胞分析仪为待评仪器,统计2台仪器白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、血细胞比容(HCT)和血小板(PLT)5个检测结果的相对偏差符合度,计算相关系数和回归方程;在医学决定水平(Xc)处,计算2台仪器之间结果的偏倚,以美国临床实验室改进法案修正法案(CLIA’88)规定的允许总误差(TEa)的1/2作为评价标准,2台仪器检测的WBC、RBC、HGB、HCT和PLT比对的可接受范围依次为±7.5%、±3.0%、±3.5%、±3.0%和±12.5%。结果:两种血细胞分析仪5个检测项目的相对偏差符合要求的比例均≥80%,相关系数r均>0.975。在医学决定水平处,其中PLT为50×109/L的相对偏差Bc%>1/2TEa,但其Ea均落在95%CI内,表明是由抽样误差所造成,其待评方法的偏差可接受,其余检测项目均可接受。在各个医学决定水平处测定结果的偏倚均≤1/2TEa。结论:2台血细胞分析仪的检测结果具有较好的一致性,符合中国合格评定国家认可委员会(CNAS)对医学实验室质量和能力认可准则(ISO15189-2012),在临床应用时达到检验结果的互认,为临床可接受。

Objective:To analyze the comparability of the detection results of Dymind D6-CRP and Sysmex XN-9000 hematology analyzer.Methods:According to the requirement of health industrial standard(WS/T 406-2012),40 samples that were EDTA-K2 anticoagulation fresh venous bloods were used to detect.Referred to the EP9-A2 document of Clinical and Laboratory Standards Institute(CLSI),the XN-9000 hematology analyzer was used as the reference instrument,and D6-CRP hematology analyzer was used as the evaluated instrument.The conformities of the relative deviations of 5 detection results included white blood cell(WBC),red blood cell(RBC),hemoglobin(HGB),hematocrit(HCT)and platelet(PLT),and of the two instruments were calculated as statistic method,respectively,and the correlation coefficient and regression equation of them were calculated.The bias between the two instruments was calculated at the medical decision level,and the half of allowable total error which was stipulated by American Clinical Laboratory Improvement Act Amendments(CLIA’88)was used as the evaluation criterion,and the acceptable ranges of WBC,RBC,HGB,HCT and PLT of two instruments were±7.5%,±3.0%,±3.5%,±3.0%and±12.5%,respectively.Results:The ratios that the relative deviations of 5 detection items of two hematology analyzers met requirements were larger than or equal to 80%,and all the correlation coefficients(r)were larger than 0.975.At the medical decision level,the relative deviation(Bc%)was larger than 1/2 TEa when PLT was 50×109/L,but all of Ea were within the 95%CI.It means it was caused by sampling error,and the deviation of the method that was prepared to be evaluated was acceptable,and other detection items also could be accepted.Besides,the bias of detection results were less than or equal to 1/2 TEa at every medical decision level.Conclusion:There is a better consistency between the two hematology analyzers in the detection results,which conform to the Accreditation Criteria for Quality and Competence of Medical Laboratories(ISO15189-2012)of China National Accreditation Service for Conformity Assessment(CNAS).And the achieved mutual recognition of the test results in clinical application is acceptable by clinic work.