NCCLS EP9-A2方法在血球分析仪间的应用

Application of the NCCLS EP9-A2 Method in Hemantology Analyzers in the Infectious Laboratory

目的:为更好地提高血液分析仪的检测质量,确保检测结果的准确性和可靠性。方法:参考NCCLS标准文件EP9-A2"批准指南—第二版",以WBC、RBC、HGB、HCT、PLT等作为比对的主要项目;先对感染科参比分析仪LH750(Beckman-Coulter公司)进行校准,并以此仪作为基准仪器,与待评仪器SYSMEX XS-800i NO:1173进行比对分析。结果:LH750与XS-800i NO:1173间的WBC、RBC、HGB、HCT、PLT五项指标的相关系数r>0.975,系统误差(Bc)均小于规定的允许总误差(Ea)范围。按1/2美国CLIA88比对标准,比对前的WBC、RBC、HGB、PLT的四十个比对偏倚值中,有29个值(29/40,占72.5%)在控;比对后,WBC、RBC、HGB、PLT的四十个比对偏倚值中,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:该方法能方便、经济地对不同厂家、不同型号的血液分析仪进行有效的质量控制,且具有可比性与溯源性。

Objective：In order to improve the quality of the blood analyzer test,as well as to ensure the accuracy and reliability of the test results,we conducted comparative analysis with our department’s two blood cell analyzers using fresh whole blood samples.These experiments have also helped us make the results of the two blood analyzers comparable and traceable.Methods：With reference to NCCLS document EP9-A2,we made WBC,RBC,HGB,HCT,PLT our major targets for comparison.We firstly calibrated LH 750（Beckman-Coulter Inc）,and then did a comparative analysis between this reference instrument and the targeted SYSTEM XS-800i No：1173.Results：The correlation coefficients between LH 750’s and SYSSTEM XS-800i’s five indices（WBC,RBC,HGB,HCT,PLT）are all larger than 0.975（r〉0.975）;and the system errors（BC）are all within the allowable total error range（Ea）.According to1/2 of America’s CLIA88 standard,29values were in control out of the 40 biased samples before the comparative analysis;after he analysis,39 out of the 40 values were in control.Consistency of test results has been ensured.Conclusion：This method,which is comparable and traceable,can help us the monitor the quality of different manufacturers and different models of the blood analyzer blood analyzer tests in a convenient and economic way.