UF-500i尿液分析仪的性能验证  

A Performance Verification of UF-500i Urine Analyzer

作　　者：李春梅 王建平[1] 孔莉[1] 张露[1] 童兰庭 张楠哲 梁巧玲 LI Chunmei;WANG Jianping;KONG Li;ZHANG Lu;TONG Lanting;ZHANG Nanzhe;LIANG Qiaoling(Department of Laboratory Medicine, The Second Affiliated Hospital , Nanjing Medical University, Nanjing 210011, China)

机构地区：[1]南京医科大学第二附属医院检验医学中心,江苏南京210011

出　　处：《标记免疫分析与临床》2020年第4期683-686,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的评价UF-500i尿液分析仪的性能指标。方法采用UF-500i尿液分析仪对尿液有形成分中高和低值的实验室标准差、总精密度、线性方程、携带污染率、准确度进行评价。结果尿液有形成分高和低值的实验室标准差分别为:红细胞4.78和1.72、白细胞11.96和3.28、上皮细胞8.57和2.77、管型4.44和1.74及细菌23.56和7.57;红细胞与白细胞线性回归方程及相关系数分别为:Y=1.0026X+56.14和0.9994、Y=1.0091X+79.52和0.9669;红细胞、白细胞及细菌的携带污染率(%)分别为:0.17、0.10、0.01;质控品测定值与理论值比较,其高值和低值的平均相对偏差(%)分别为:RBC 2.96和0.34、WBC 2.13和2.73、EC 1.59和-0.29、CAST 0.20和9.33、BACT 2.96和-5.81。结论UF-500i尿液分析仪在检测工作中大大节约了人力,降低了检测成本,提高了检测速度,经验证其检测指标(红细胞、白细胞和细菌)性能符合临床要求。Objective To evaluate the performance of UF-500i urine analyzer.Methods The UF-500i urine analyzer was used to evaluate the laboratory standard deviation,total precision,linear equation,carry pollution rate,and accuracy of high and low-end values from urine formed elements.Results The laboratory standard deviations of urine formed elements’high and low-end values were:red blood cells(4.78 and 1.72),white blood cells(11.96 and 3.28),epithelial cells(8.57 and 2.77),casts(4.44 and 1.74)and bacteria(23.56 and 7.57);The linear regression equations and correlation coefficients of red blood cells and white blood cells were:Y=1.0026X+56.14(0.9994)and Y=1.0091X+79.52(0.9669),respectively;The carry pollution rate of red blood cells,white blood cells and bacteria(%)were:0.17,0.10 and 0.01,respectively;When comparing the measured value by the urine analyzer with the theoretical value,the average relative deviations(%)of the high and low-end values were:RBC(2.96 and 0.34),WBC(2.13 and 2.73),EC(1.59 and-0.29),CAST(0.20 and 9.33),and BACT(2.96 and-5.81).Conclusion The UF-500i urine analyzer can greatly save manpower,reduce the cost of detection,and increase the speed of detection.Our results have verified that the performance of the instrument′s detection indicators(red blood cells;white blood cells and bacteria)meets clinical requirements.

关 键 词：总精密度 线性方程 携带污染率 准确度 

分 类 号：R-331[医药卫生]