UF5000尿有形成分分析仪检测尿红细胞的性能评价和准确性评估  

Performance Evaluation and Accuracy Assessment of UF5000 Urine Sediment Analyzer for Detecting Urinary Red Blood Cells

作　　者：侯江雪 赵世首 陈雅斌[2] HOU Jiang-xue;ZHAO Shi-shou;CHEN Ya-bin(Department of Clinical Laboratory,Nan’an Maternal and Child Health Hospital,Fujian Nan’an 362300;Department of Clinical Laboratory,Quanzhou First Hospital Affiliated to Fujian Medical University,Fujian Quanzhou 362000)

机构地区：[1]南安市妇幼保健院检验科,福建南安362300 [2]福建医科大学附属泉州第一医院检验科,福建泉州362000

出　　处：《中国医疗器械信息》2024年第22期78-81,共4页China Medical Device Information

摘　　要：目的:评价UF5000尿有形成分分析仪(UF5000)检测尿红细胞(red blood cell,RBC)的性能和准确性。方法:选取2023年9月~2023年10月福建医科大学附属泉州第一医院检验科常规检测的尿液标本1200例作为研究对象,对UF5000检测尿红细胞的能力进行性能验证,包括批内精密度、日间精密度、正确度、携带污染率和线性范围。以人工镜检作为金标准,计算UF5000检测RBC与人工镜检的符合率,并分析引起UF5000检测RBC假阳性的影响因素。结果:UF5000检测尿RBC的批内精密度CV:低浓度6.60%、高浓度3.63%;日间精密度CV:低浓度6.06%、高浓度3.26%;正确度符合要求;携带污染率0;线性范围回归方程y=1.0068x+64.021,r=0.9991;人机比对符合率94.58%;均符合厂家规定要求。假阳性标本中影响因素以结晶和细菌为主。结论:UF5000检测尿RBC的性能评价和准确性评估符合厂家和实验室规定,能用于临床的标本检测。Objective:Evaluate the performance and accuracy of the UF5000 urine sediment analyzer(UF5000)in detecting red blood cells(RBC)in urine.Methods:1200 urine samples routinely tested by the Department of Clinical Laboratory,Quanzhou First Hospital Affiliated to Fujian Medical University from September 2023 to October 2023 were selected as the research subjects to verify the performance of UF5000 in detecting urine red blood cells,including intra batch precision,inter day precision,accuracy,contamination rate,and linear range.Using manual microscopy as the gold standard,calculate the conformity rate between UF5000 detection of RBC and manual microscopy,and analyze the influencing factors that cause false positives in UF5000 detection of RBC.Results:The intra batch precision CV of low concentration 6.60%,high concentration 3.63%;Daytime precision CV:low concentration 6.06%,high concentration 3.26%;Accuracy meets the requirements;Carrying pollution rate of 0;The linear range regression equation y=1.0068x+64.021,r=0.9991;The conformity rate of human-machine comparison was 94.58%;All comply with the manufacturer’s requirements.The main influencing factors in false positive specimens are crystal and bacteria.Conclusion:The performance evaluation and accuracy evaluation of UF5000 for detecting urinary RBC comply with the manufacturer and laboratory regulations,and can be used for clinical specimen testing.

关 键 词：UF5000 尿红细胞 性能评价 准确性评估 

分 类 号：R446.1[医药卫生—诊断学]