溯源性比对在血球分析仪间的实际应用  

THE NEW APPLICATION OF TRACEABILITY COMPARISON METHOD BETWEEN THE BLOOD CELL ANALYZERS

作　　者：李一龙[1] 刘鸿生[1] 谢国强[1] 

机构地区：[1]南京医科大学附属无锡人民医院医学检验科,江苏省无锡市214023

出　　处：《中国煤炭工业医学杂志》2012年第8期1139-1142,共4页Chinese Journal of Coal Industry Medicine

摘　　要：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,应用新鲜全血样本对我科的二台血细胞分析仪进行比对分析,使二台血细胞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"批准指南-第二版",以WBC、RBC、Hb、HCT、PLT等作为比对的主要项目;先对参比分析仪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、Hb、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、Hb、PLT的40个比对偏倚值中,有29个值(29/40,占72.5%)在控;比对后,WBC、RBC、Hb、PLT的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 To improve the detection quality of the blood analyzer,as well as to ensure the accuracy and reliability of the test results for using fresh whole blood samples to evaluate the comparability and traceability of two blood analyzers in author＇s laboratory.Methods Based on reference to NCCLS document EP9-A2,the test value of WBC,RBC,HGB,HCT,PLT as major targets for comparison,the ahthors 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） were all higher than 0.975.（r〉0.975）;and the system errors（BC） were all within the allowable total error range（Ea）.According to 1/2 of America＇s CLIA88 standard,29 values were in control out of the 40 biased samples before comparation;after analysis,39 out of the 40 values were in control.Consistency of test results had been ensured.Conclusion This method,which is comparable and traceable with a convenient and economic way,can help us to monitor the quality of different manufacturers and different models of the blood analyzer.

关 键 词：血液分析仪 比对 溯源性 EP9-A LH750 

分 类 号：R446.11[医药卫生—诊断学]