Sysmex XE-2100血液分析仪临床应用评价

Clinical application evaluation of XE-2100 hematology analyzer

目的系统评价Sysmex XE-2100血液分析仪的性能。方法参照CLSI、ICSH相关文件,对XE-2100血液分析仪的精密度、携带污染率、稳定性、线性、可比性、白细胞分类相关性、正确度进行评价。结果 Sysmex XE-2100血液分析仪的精密度、携带污染率均在仪器要求范围内,标本在4℃保存条件下全血细胞计数与分类有良好的稳定性,WBC、RBC、HGB、PLT的线性范围宽,不同进样模式间的结果偏差均小于1%,与LH780、XT-1800i的检测结果具有良好的可比性,白细胞分类与人工分类具有良好的相关性,WBC、RBC、HGB、HCT、PLT正确度的偏移均小于1/4CLIA'88允许总误差。结论 XE-2100五分类血液分析仪的性能评价均达到了其技术指标,能满足临床对血液分析的需求。

Objective To evaluate the performance of Sysmex XE-2100 automated hematology analyzer. Methods According to CLSI, ICSH relevant documents, the performance of Sysmex XE-2100 was evaluated for precision, carryover rate, stability, lin-earity, comparability, correlation of leukocyte classification and accuracy. Results The results of precision and carryover rate were within the required range of instrument, complete blood count parameters and classification had good stability when the specimen were stored at 4℃. The WBC, RBC, HGB and PLT had wide linear range. The deviation of results detected with different measure modes were less than 1%. Compared with Beckman coulter LH780 and Sysmex XT-1800i, Sysmex XE-2100 had good comparabil-ity, leukocyte classification and artificial classification had good correlation. The bias of accuracy was less than a quarter CLIA＆#39;88 allow total error. Conclusion All the performance of Sysmex XE-2100 automated hematology analyzer has reached the technical indicators and meet the clinical demand for blood analysis.