ISO15189认证中Sysmex UF-1000i尿沉渣分析仪的性能验证  

Performance Verification of Sysmex UF-1000i Urinary Sediment Analyzer in the ISO15189 Accreditation

作　　者：郑翠玲[1] 齐军[1] 王力[1] 许晓娜[1] 董波[1] 程焱[1] 韩晓红[1] 

机构地区：[1]中国医学科学院肿瘤医院检验科,北京100021

出　　处：《标记免疫分析与临床》2015年第7期690-693,共4页Labeled Immunoassays and Clinical Medicine

基　　金：国家自然科学基金(81201357);国家高技术研究发展(863)计划(2011AA02A110)

摘　　要：目的按ISO15189要求,评价Sysmex UF-1000i尿沉渣分析仪的性能。方法分别检测UF-1000i尿沉渣分析仪的精密度、准确度、携带污染率、线性范围并对生物参考区间进行验证。结果 UF-1000i的精密度、准确度、携带污染率、可报告范围均在厂家要求的范围内,并且生物参考区间验证结果符合要求。结论 Sysmex UF-1000i尿液沉渣分析仪各项性能均符合仪器要求范围,可用于临床尿液沉渣分析检测。Objective To evaluate the performance of Sysmex UF-lO00i urine sediment analyzer in order to meet the requirement of the ISO15189 laboratory accreditation. Methods A series of tests with UF-1000i sedimentary analyzer of precision, accuracy, carryover and linear range were detected, as well as the biological reference interval was verified. Results Precision, accuracy, carryover and reportable range of UF-IO00i were all in the allowable range supplied by factory authorities and the results of biological reference interval test met the requirements. Conclusion The performance of the Sysmex UF-1000i Urine Sedimentary analyzer was satisfied, it could be used for screening analysis of urine sedimentary.

关 键 词：ISO15189认证 尿沉渣分析仪 性能验证 

分 类 号：R446.12[医药卫生—诊断学]