国产迈瑞EH-2080B全自动尿沉渣分析系统的性能评估  

Performance verification of Mindray EH-2080B fully automatic urinary sediment analysis system

作　　者：李宏杰[1] 陈飞群 张兴翔 鄢姣 王瑛[1] 郑月萍[1] 王倩倩[3] 应巧玲[1] 吕攀 胡苏球 王俊羽 应雄江 方杭 

机构地区：[1]杭州市西湖区第二人民医院检验科,310024 [2]浙江省永康市第一人民医院检验科 [3]安徽省淮南市第一人民医院检验科

出　　处：《中国医药》2015年第9期1381-1385,共5页China Medicine

摘　　要：目的 对国产迈瑞EH-2080B全自动尿沉渣分析系统的主要分析性能与功能扩展进行验证.方法 对该仪器检测白细胞、红细胞和上皮细胞等的主要分析性能进行验证;利用相对偏差对仪器间的结果比对以及利用假阳（阴）性率对人工镜检结果双重比对进行评价;利用目视低倍单视野对充液静置时间段,利用视觉暂留对低倍拍照和高倍拍照转换视野瞬间人工浏览视野,对可能成活的精子以及阴道毛滴虫补充动态观察进行功能扩展评价.结果 该仪器各检测项目的主要分析性能均在可接受范围;与室间质评各检测项目的相对偏差均≤仪器厂家提供的1/2允许总误差,符合仪器性能要求;该仪器各检测项目与人工镜检结果比对均存在一定程度的假阳（阴）性率,但临床尿液标本随机抽样的综合分析总体符合率在85％以上;人工浏览视野对可能成活的精予以及阴道毛滴虫补充动态观察可以捕捉到动态信息或可疑动态信息.结论 迈瑞EH-2080B全自动尿沉渣分析系统的主要分析性能及仪器间比对结果等基本符合实验诊断学实验室的要求,可用于临床标本的检测.该分析系统检测结果基本与人工镜检相符,相关性均较好.人工浏览视野对可能成活的精子以及阴道毛滴虫补充动态观察可以捕捉到的动态信息或可疑动态信息,结合可能的人工镜检综合审核红细胞的定量分析结果可作出滴虫感染的诊断.Objective To analyze the main analysis performance and function expansion of Mindray EH-2080B fully automatic urinary sediment analysis system made in China.Methods The main instrument detection projects,such as white blood cell（WBC）,red blood cell（RBC） and endothelial cell （EC）,were applied to analyze the equipment performance.The relative deviation was used to analyze the variance between different equipments,the positive （negative） rate was used to assess the instrument detection project compared with manual microscopy.The low power single view of the liquid filling static time period and visual persistence of low power and high power photographed conversion view instant were used to dynamically observe the living sperms and trichomonas vaginalis＆#39; messages by artificial browsing; the function extension of the instrument was observed accordingly.Results The main performance of the instrument detection projects was reasonable.The relative deviation of different equipments was ≤ 1/2 of total errors （TEa） provided by equipment production,which was consistent with the instrumental performance requirements.The instrument detection project comparison with manual microscopy results showed that WBC,RBC and fungi detections had a certain degree of false positive （negative） rate,but the comprehensive analysis coincidence rate of the overall clinical urine samples was more than 85%.The artificial browsing could be added to capture the dynamic information or suspicious information of living sperms or/and trichomonas vaginalis.Conclusions Mindray EH-2080B fully automatic urinary sediment analysis system made in China meet the requirements of the laboratories in clinical diagnosis.The results of the system and manual microcopy show a correlation; the artificial browsing may capture dynamic information or suspicious dynamic information of living sperms and/or trichomonas vaginal; according to the results of dynamic observation by using the equipment combined with RBC quantitative analysis resul

关 键 词：全自动尿沉渣分析系统 性能验证 结果比对 

分 类 号：R446.1[医药卫生—诊断学]