应用EP6-A2方案评价自建检测系统中尿蛋白的线性范围  

Application of EP6-A2 protocol for evaluating linear range of U-pro testing in self-built test system

作　　者：周远青[1] 梁瑞莲[1] 吕伟标[1] 梁玉全[1] 陈映慧[1] 

机构地区：[1]南方医科大学附属顺德第一人民医院检验科,广东顺德528300

出　　处：《检验医学与临床》2015年第13期1898-1899,1901,共3页Laboratory Medicine and Clinic

摘　　要：目的建立自建检测系统中尿蛋白的线性范围,以供临床检验做参考。方法根据美国临床和实验室标准化协会（CLSI）颁发的EP6-A2文件,配制11组U-pro浓度为等间距排列的试验标本,每个样本重复测定2次,用SPSS软件对数据进行多项式回归,得出该项目的线性范围。结果自建检测系统检测尿蛋白重复性CV为1.59%,小于实验室所规定的重复性目标2%,数据重复性好,符合实验要求。实验数据经多项式回归分析后得出的最适模型为三次多项式,通过对其非线性度分析,判断其为临床可接受的线性,对应的自建检测系统中检测尿蛋白线性范围为5.2-1 355.15mg/L。结论自建检测系统中尿蛋白的线性范围为5.2-1 355.15mg/L,小于试剂盒说明书上的线性范围0-2 000mg/L。临床实验室应对检测系统的分析性能进行评价,以保证其检测结果的准确可靠。Objective To establish the linear range of U-pro in the self-built test system for clinical laboratory to provide reference for clinical detection.Methods 11 groups of sample were prepared according to the EP6-A2 document issued by the Clinical and Laboratory Standard Institute（CLSI）,which had equal interval U-pro concentrations,every sample was tested twice.The data were conducted the polynomial regression for obtaining the linear range of U-pro by the SPSS software.Results The CVof repeat test in the self-built test system was 1.59%,less than 2% which was ruled in the laboratory,the data were repeatable.After regression analysis on the data,the optimal model was the cubic polynomial,but through analyzing its nonlinearity,it was judged as the acceptable linearity for clinic.The corresponding linear range of U-pro in the self-built test system was 5.20-1 355.15mg/L.Conclusion The linear range of U-pro in the self-built test system is 5.20-1 355.15mg/L,which is less than the linear range of 0-2 000 mg/L provided by the kit instruction.Clinical laboratory should evaluate the analytical performance of testing systems to ensure the accuracy and reliability in the detection results.

关 键 词：尿蛋白 线性范围 EP6-A2方案 自建检测系统 

分 类 号：R446.11[医药卫生—诊断学]