BIOSYSTEM BA400全自动特定蛋白仪检测尿微量白蛋白的性能测定  

Performance Study of BIOSYSTEM BA400 Automatic Specific Proein Analyzer for Detecting Urinary Microalbulmin

作　　者：刘斌[1] 王勇[2] 张炳昌[2] 栾芳[2] LIU Bin;WANG Yong;ZHANG Bingchang;LUAN Fang(Department of Biomedical Engineering,Shandong Provincial Hospital affiliated to Shandong University,Jinan Shandong 250021,China;Department of Clinical Laboratory,Shandong Provincial Hospital affiliated to Shandong University,Jinan Shandong 250021,China)

机构地区：[1]山东大学附属省立医院医学工程部,山东济南250021 [2]山东大学附属省立医院临床医学检验部,山东济南250021

出　　处：《中国医疗设备》2018年第4期50-52,68,共4页China Medical Devices

基　　金：国家自然科学基金青年基金项目(81101484);山东省优秀中青年科学家奖励基金(BS2011SW035);山东省科技发展计划(2016GSF201154)

摘　　要：目的 BIOSYSTEM BA400全自动特定蛋白仪(以下简称"BA400特定蛋白仪")检测尿微量白蛋白的性能。方法评估BA400特定蛋白仪检测尿液标本中微量白蛋白的准确度、精密度、线性范围、可报告范围、参考区间、携带污染率,评价尿微量白蛋白试剂在BA400特定蛋白仪上的分析性能。结果 BA400特定蛋白仪检测尿微量白蛋白的准确度、精密度、线性范围、参考区间验证均在允许的范围内;可报告范围为5.0~16000.0 mg/L;携带污染率为0.12%,符合仪器要求。结论 BA400特定蛋白仪测定尿微量白蛋白准确度高、重复性好,线性范围能满足临床所需,携带污染率极低,检测快速方便,结果可靠,特别适用于肾内科、内分泌科、心内科对早期肾脏疾病的筛查,是临床测定尿微量白蛋白的理想分析仪器。Objective To study the performance of BIOSYSTEM BA400 automatic specific protein analyzer(“BA400 specific protein analyzer”for short)for detecting urinary microalbumin.Methods The accuracy,precision,linearity,clinical report range,reference intervals and contamination rate of urinary microalbumin were verified by BA400 specific protein analyzer to evaluate the analytical performance of urinary microalbumin reagent.Results The accuracy,precision,linear range and reference interval of urinary microalbum verified by BA400 specific protein analyzer were all within the allowable range.The clinical report range was 5.0-16000.0 mg/L,and the contamination rate was 0.12%.Conclusion BA400 specific protein analyzer behaves well in accuracy,repeatability,linear range and residual contamination rate.For its convenient detection and reliable results,it is suitable for urinary microalbum detection in nephrology,endocrinology,cardiology departments in early screening kidney disease.

关 键 词：全自动特定蛋白仪 尿微量白蛋白 性能评价 

分 类 号：R33[医药卫生—人体生理学]