多仪器比对试验在不同血液分析系统质量调查中的应用

摘要

目的 探讨实验室间/内不同品牌血细胞分析系统检测结果可比性的方法.方法 对4家医院内两个品牌(Sysmex、迈瑞)的12 台不同型号血细胞分析系统,应用5 份新鲜血进行WBC、RBC、HGB、HCT、PLT比对;数据采用EP Evaluator软件多仪器比对模块进行统计分析,以12 台仪器测定均值作为靶值、WS/T406-2012"临床血液学检验常规项目分析质量要求"允许误差为可接受标准,结合EP软件中的误差指数,参照检验科建设管理规范要求进行评价;对不合格项进行调校.结果 12 台仪器WBC、RBC、HGB、HCT、PLT的相对误差大多在允许范围内,且仪器间的偏差同样在可接受范围.个别不合格项由科室会同厂商应用工程师进行调校改进.结论 新鲜血多台血细胞分析系统比对方案,经济实用、直观有效,完全能满足全血细胞分析的一致性要求.%Objective To explore the comparability of the results with different brands blood cell analysis systems in external quality assessment and internal quality control. Methods To explore a simple and easy comparison method, we used five fresh blood samples to compare the results of WBC, RBC, HGB, HCT and PLT in 12 different types blood cell analysis systems with two brands (Sysmex and Mindray) in four hospitals. The data were analyzed with multi-instrument comparison module by software EP Evaluator. The mean value of the results which were measured by 12 instruments was the target value. The allowable error of WS/T406-2012 "Quality Requirements for Analysis of Routine Items in Clinical Hematology Testing" was the acceptable standard. The evaluation was carried out according to the requirements of the construction and management specifications of department of clinical laboratory in combination with the error index in EP software. Unqualified items were adjusted. Results The relative errors of WBC, RBC, HGB, HCT and PLT of 12 instruments were mostly acceptable as far as the allowable range, and the deviations among those instruments were also acceptable. Individual unqualified items will be improved and adjusted by the departments with the manufacturer's application engineers. Conclusion The comparative study of multiple blood cell analysis systems for fresh blood is economical, practical, intuitive and effective, and was contented with the consistency requirements of whole blood cell analysis.