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方法研究

ISO15189认证中Sysmex UF-1000i尿沉渣分析仪的性能验证

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  • (中国医学科学院肿瘤医院检验科,北京 100021)
郑翠玲,博士,副主任技师,目前从事临床基础检验工作。 Tel:010-87787621;Email:zicel@126.com

收稿日期: 2015-01-30

  网络出版日期: 2015-09-16

基金资助

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

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

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  • (Department of Clinical Laboratory,Cancer Hospital, Chinese Academy of Medical Science,Beijing 100021, China)

Received date: 2015-01-30

  Online published: 2015-09-16

摘要

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。

本文引用格式

郑翠玲,齐 军,王 力,许晓娜,董 波,程 焱,韩晓红 . ISO15189认证中Sysmex UF-1000i尿沉渣分析仪的性能验证[J]. 标记免疫分析与临床, 2015 , 22(7) : 690 . DOI: 10.11748/bjmy.issn.1006-1703.2015.07.031

Abstract

Abstract: Objective To evaluate the performance of Sysmex UF-1000i 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-1000i 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.
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