迈克F 580与Sysmex XS500i血细胞分析仪检测系统比对研究

Comparative Research on Detection System of Maccura’s F 580 and Sysmex’s XS-500i Automatic Hematology Analyzers

目的:以美国临床与实验室标准化委员会(CLSI)EP9-A3文件为依据,讨论了国产迈克F 580和日本Sysmex XS500i全自动血细胞分析仪结果的可接受性。方法:参照EP9-A3文件,以SysmexXS500i为参考系统,以迈克F580为实验系统,使仪器处于正常状态。测定40份新鲜抗凝全血标本的白细胞计(WBC)、红细胞计数(RBC)、血小板计数(PLT)、血红蛋白(Hb)和红细胞压积(HCT)。用ESD方法对测量结果进行离群值检验和评估偏移。利用最佳回归模型拟合回归方程,计算各项目医学决定水平处的偏移,并以1/2CLIA’88允许误差为标准,判断该偏移是否可接受。结果:Hb和Hct在两种血细胞分析仪的检测结果中偏移不被接受。WBC、RBC、PLT偏移均可接受。所有项目的偏移均小于允许误差。结论:根据CLSI EP9-A3标准,临床实验室血细胞分析仪定期比对试验是为临床使用提供准确可靠的试验数据的有力保证之一。

Objective:Based on the EP09-A3,a document issued by the Clinical and Laboratory Standards Institute(CLSI)in the U.S.,this paper discusses the acceptability of the test results of Maccura’s F 580 and Sysmex’s XS-500i automatic hematology analyzers.Method:Referring to EP09-A3,the paper takes Sysmex’s XS-500i as the reference system,takes Maccura’s F 580 as the experimental system,and keeps the instrument at the normal state.The white blood cell count(WBC),RBC count(RBC),platelet count(PLT),hemoglobin(Hb),and hematocrit(HCT)were determined in 40 fresh anticoagulated whole blood samples.Outlier test and offset evaluation were performed on these measurements by ESD method.The optimal regression model was used tofit the regression equation,calculate the offset at the level of medical decision for each item,and determine whether the deviation was acceptable,using 1/2 of allowable error value in the CLIA’88.Result:The deviations of Hb and Hct results in the two hematology analyzers are not acceptable.The deviations of WBC,RBC and PLT results are acceptable.Deviations of all items are less than the range of allowable error.Conclusion:According to the CLSI EP09-A3,performing comparative experiments on hematology analyzers regularly by clinical laboratories is one of the powerful guarantees to provide accurate and reliable test data for clinical use.