维护后比测法在血球分析仪中的应用

Application of Comparative Measurement Method in Blood Cell Analyzers after Maintenance

目的应用新鲜全血样本对我科的2台血球分析仪进行比对分析,使2台血球分析仪检测参数之间具有可比性与溯源性。方法参考NCCLS标准文件EP9-A2,先对参比分析仪LH750(Beckman Coulter公司)进行校准,并以此仪器作为基准仪器,与待评仪器SYSMEX XS-800iNO:1173进行比对分析。结果 LH750与XS-800i NO:1173间的白细胞数(WBC)、红细胞数(RBC)、血红蛋白(HGB)、红细胞压积(HCT)、血小板数(PLT)五项指标的相关系数r>0.975,系统误差(Se)均<规定的允许总误差(Ea)范围。按美国CLIA88比对标准,比对前的WBC、RBC、HGB、PLT的40个比对偏倚值中,有29个值(29/40,占72.5%)在控;比对后,这40个比对偏倚值中,有39个值(39/40,占97.5%)在控,检测结果的一致性得到了保证。结论该方法能对不同厂家、不同型号的血球分析仪进行有效的质量控制,且具有可比性与溯源性。

Objective To conduct comparative analysis with two blood cell analyzers using fresh whole blood samples in our department, so as to make comparability and traceability of test parameters between them. Methods With the reference of NCCLS standard EP9-A2 Approval guide - the second edition, we firstly calibrated reference analyzer of LH750 （Beckman - Coulter Inc）, which is treated as the reference instrument. And then, we do a comparative analysis between reference instrument and evaluating instrument SYSMEX XS-800i No：1173. Results The correlation coefficients of five indices （WBC, RBC, HGB, HCT, PLT） are all larger than 0.975, and the system errors（Bc）are all within the range of total error allowance（Ea）. According to 1/2 of American CLIA88 standard, 29 values are in control （29/40, 72.5%） before comparing 40 bias values of WBC, RBC, HGB, PLT; 39 values are in control （39/40, 97.5%） after the comparison. Consistency of test results has been ensured. Conclusion This method, which is comparable and traceable, can help us to monitor the quality of blood cell analyzers of different manufacturers and different models.