Sysmex UF5000尿液有形成分分析仪性能验证及比对方法的探索  

An Exploration on Performance and Comparison Method of Sysmex UF5000 Urine Sediment Analyzer

作　　者：金晶[1] 杨琼 吴卫[1] JIN Jing;YANG Qiong;WU Wei(Department of Clinical Laboratory,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking UnionMedical College,Beijing 100730,China;Department of Clinical Laboratory,National Center for Cardiovascular Diseases and Fuwai Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100037,China)

机构地区：[1]中国医学科学院北京协和医学院北京协和医院检验科,北京100730 [2]中国医学科学院国家心血管病中心北京阜外医院检验科,北京100037

出　　处：《标记免疫分析与临床》2022年第5期867-872,900,共7页Labeled Immunoassays and Clinical Medicine

基　　金：北京市临床重点专科医学检验科卓越项目(编号:2K201000)。

摘　　要：目的对Sysmex UF5000全自动尿有形成分分析仪的5项主要参数进行临床应用性能评价,建立一种同一检测系统仪器更新比对的方法,方便临床的使用。方法采用仪器配套尿沉渣质控品评价Sysmex UF5000的精密度及正确度;筛选不同浓度范围及数量的新鲜尿标本,分别用于Sysmex UF5000仪器携带污染率、临床可报告范围及参考区间的验证,以及与旧仪器Sysmex UF1000i进行仪器间检测结果的比对。结果Sysmex UF5000全自动尿有形成分分析仪的精密度、正确度及携带污染率均符合厂家说明书规定标准,临床可报告范围及参考区间均在新鲜尿标本中验证通过。Sysmex UF5000与旧仪器Sysmex UF1000i间比对的一致率:红细胞及细菌在仪器间一致率均为100%,白细胞在仪器间一致率为98.39%,上皮细胞在仪器间一致率均为94.44%,管型在仪器间一致率为96%。结论Sysmex UF5000全自动尿有形成分分析仪性能良好,可应用于临床标本检测。建立的仪器间比对新方法能提高比对工作效率,保证同一检测系统仪器更换时对于检验结果的一致性。Objective To evaluate the clinical application performance of five main parameters of Sysmex UF5000 automatic urine sediment analyzer,and to establish a new method for instrument comparison to improve the comparison efficiency of the same detection system when the instrument is updated.Methods The precision and accuracy of UF5000 were evaluated with urinary sediment quality control.Fresh urine samples with different concentration ranges were screened for the verification of contamination rate,clinically reportable range and reference interval of UF5000 instrument,as well as the comparison of test results between UF5000 and UF1000i.Results The precision,accuracy and contamination rate of Sysmex UF5000 automatic urine composition analyzers were all in line with the manufacturer’s specifications.The clinical reportable range and reference interval were verified in fresh urine samples.The consistency of the test results between UF5000 and the old UF1000i were 100%for red blood cells and bacteria,98.39%for white blood cells,94.44%for epithelial cells,and 96%for casts,respectively,which met the manufacturer’s recommended acceptance standard.Conclusion Sysmex UF5000 automatic urine sediment analyzer has a good performance and can be used in clinical sample detection.The new method of inter-instrument comparison can improve the efficiency of comparison and is able to verify the accurate transmission ability of the updated instrument for clinical test results.

关 键 词：尿沉渣分析仪 临床应用 仪器间比对 

分 类 号：R-331[医药卫生]