强生V-350全自动干式生化分析仪检测性能验证  

THE PERFORMANCE DEMONSTRATION OF VITROS 350 DRY-CHEMISTRY ANALYZER

作　　者：李磊[1] 王泓[1] 于凡[1] 凤婧[1] 甘春玉[1] 

机构地区：[1]四川大学华西第二医院医学实验中心,成都610041

出　　处：《现代预防医学》2009年第3期529-531,共3页Modern Preventive Medicine

摘　　要：[目的]通过实验全面验证美国强生公司的Vitros-350全自动干式生化分析仪的检测系统性能。[方法]根据美国临床实验室标准化委员会(The Clinical and Laboratory Standards Institute CLSI,原NCCLS)的检测仪器性能评价标准,对在V-350干化学分析仪上开展的10个生化检验项目的精密度、准确度和检测范围进行验证。[结果]10个项目的精密度、准确度、线性范围均能达到评价标准的要求,与仪器厂商提供的性能指标相符。[结论]实验表明,强生V-350干化学分析仪操作简便,快速准确,检测系统的精密度、准确度、检测范围均能满足临床检验的要求。[Objective ]To demonstrate the analytical performance of VITROS 350 Dry-Chemistry System by experiment. [Methods] The precision, accuracy and analytical measurement range （AMR） of 10 analytes in VITROS 350 Dry,Chemistry System Were demonstrated according to the protocols of The Clinical and Laboratory Standards Institute （CLSI）. [ Results] The precision, accuracy and AMR of 10 analytes could all meet the requirement and got satisfactory result which was consistent with the manufacture＇s claims. [Conclusion] The VITROS 350 Chemistry System offers easy operation, maintenance. The determination can be finished quickly and accurately and the precision, accuracy and AMR are satisfied with the clinical determination.

关 键 词：VITROS 350 干化学 生化分析仪 性能验证 

分 类 号：R446[医药卫生—诊断学]