Sysmex XN-20型全血细胞分析仪的性能验证  

Performance verification of Sysmex XN-20 automatic hematology analyzer

作　　者：王文静[1] 沈琳[1] 魏红[1] 娄金丽[1] 

机构地区：[1]首都医科大学附属北京佑安医院临检中心,北京100069

出　　处：《医疗卫生装备》2016年第8期105-108,共4页Chinese Medical Equipment Journal

摘　　要：目的 :评价Sysmex XN-20型全血细胞分析仪的性能,以确定检验结果是否准确可靠。方法 :按照ISO 15189的要求,分别对Sysmex XN-20全血细胞分析仪的本底计数、携带污染率、精密度(包括批内精密度和日间精密度)、正确度、可报告范围进行测定,并对生物参考区间进行验证。结果:Sysmex XN-20型全血细胞分析仪的本底计数、携带污染率、精密度、正确度、可报告范围均在ISO 15189或行业标准的要求范围内,生物参考区间验证结果也符合要求。结论:Sysmex XN-20型全血细胞分析仪的各项性能均符合仪器要求范围,可用于临床全血细胞分析检测。Objective To evaluate the performance of Sysmex XN-20 automatic hematology analyzer in order to meet the requirement of ISO 15189 laboratory accreditation. Methods ISO 15189 was referred to detect the background count, carry pollution rate, within-run precision and day-to-day precision, accuracy and reportable range of Sysmex XN-20 automatic hematology analyzer, whose biological reference interval was also verified. Results The indexes such as background count,carry pollution, precision, accuracy, and reportable range of Sysmex XN-20 automatic hematology analyzer were all in the allowable range supplied by the ISO 15189 laboratory accreditation or factory authorities, and the results of biological reference interval test met the requirements. Conclusion The performance of Sysmex XN-20 automatic hematology analyzer satisfies the desired requirements, and can be used for clinical blood cell analysis and detection.

关 键 词：全血细胞分析仪 性能验证 ISO 15189认证 

分 类 号：R446.11[医药卫生—诊断学]