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ISO15189认证中Sysmex UF-1000i尿沉渣分析仪的性能验证 被引量:10

Performance Verification of Sysmex UF-1000i Urinary Sediment Analyzer in the ISO15189 Accreditation
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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.
出处 《标记免疫分析与临床》 CAS 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)
关键词 ISO15189认证 尿沉渣分析仪 性能验证 IS015189 accreditation Urine sedimentary analyzer Performance evaluation
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