应用CLSI系列文件对XE-2100全自动血细胞分析仪进行性能验证及评价

目的对SYSMEX XE-2100全自动血细胞分析仪性能进行验证及评价。方法参考美国临床和实验室标准化协会（CLSI）系列文件和相关文献,结合工作实际,对XE-2100的精密度、正确度、可报告范围、携带污染率、仪器间的比对等分析性能进行验证和评价,并将实验结果与卫生部临检中心的要求进行比较。结果 Sysmex XE-2100的本底计数均达到厂商设计规定的要求,检测白细胞、红细胞、血红蛋白含量、红细胞压积、血小板五项精密度、正确度、线性范围良好,携带污染率低;其白细胞分类计数与显微镜分类的相关性不同细胞有差异。结论 Sysmex XE-2100分析性能良好,可以较好的满足临床血液常规检测要求,在批量筛检的基础上需要结合显微镜复检。

Evaluation of sysmex XE-2100 hematology analyzer by using CLSI documents

Objective To evaluate the performance of Sysmex XE-2100 Hematology Analyzer.Methods The evaluation was performed by using guideline established by the International Committee for Standardization Hematology（ICSH）.Precision,linearity,carryover and the contrast were analyzed.Results The background counts were lower than the design.Precision,linearity,carryover of the WBC,RBC,HGB,HCT,PLT were good,the carryover was low,the results were different for Leukocyte Differential Count.Conclusion The performance of Sysmex XE-2100hematology analyzer is adequate for clinical demand,so it can be used for the blood samples analysis,and the microscopic reexamination is necessary.