血清糖化清蛋白定量检测系统的性能验证  

Performance verification of the quantitative detection system in the detection of glycated albumin

作　　者：欧阳彬 李江[2] 魏玲玲 鄢盛恺[2,3] 

机构地区：[1]广东省河源市人民医院检验科,广东河源517000 [2]中日友好医院检验科,北京100029 [3]北京豪迈生物工程有限公司,北京101318

出　　处：《中国医药导报》2014年第11期82-85,共4页China Medical Herald

基　　金：科技部科技型中小企业创新基金项目(编号13C26211100122);北京市科技型中小企业创新基金项目(编号377);中日友好医院课题项目(编号2013-QN-02)

摘　　要：目的通过实验验证由北京豪迈生物工程有限公司（简称“豪迈”）生产的糖化清蛋白（GA）检测试剂盒和贝克曼库尔特AU2700全自动生化分析仪组成的检测系统的基本性能特征。方法收集2013年10～12月广东省河源市人民医院及中日友好医院门诊、住院患者和正常健康体检者的血清样本，混合成正常水平和异常水平的新鲜血清，参照CLSI—EP文件及其他文献，验证本检测系统的精密度、准确度、可报告范围和参考区间。结果2种水平样本的批内、批间变异系数均小于3％，符合厂家声明CV批内≤5％，CV批间≤15％。使用厂家的配套定值参考物质进行检测，GA校准品的相对偏差为2．4％。定值参考物质的回收试验，回收率为103．2％～107．9％．相对偏差在±15％之间和回收率为90％～110％，符合厂家声明。线性范围验证实验的分析测量范围为3．20％～68．00％．临床可报告范围为3．2％～68．0％，验证的厂家声明的参考区间为11％～16％，符合要求。结论由豪迈GA检测试剂盒和贝克曼库尔特AU2700全自动生化分析仪组成的检测系统的性能特征与豪迈公司声明一致，适合临床应用，本研究中所用性能验证的方案和方法简便、可行．Objective To verify the basic performance characteristics of the detection system composed of glycated al- bumin （GA） assay kit maked by Beijing Homa Biological Engineering Co.,LTD （＂HOMA＂for short） and Beckman-Coul- ter OLYMPUS AU2700 automatic biochemical analyzer. Methods Fresh serum samples of outpatients, in patients and healthy persons from October 2013 to December 2013 in the People＇s Hospital of Heyuan City and China-Japan Friendship Hospital were collected, and mixed into normal level and abnormal levels serum samples. The precision, trueness, reportable range and reference interval of the quantitative detection system were analyzed according to the guidelines of CLSI-EP. Results For the two different levels samples, the coefficients of variation of intra-assay and in- ter-assay were less than 3%, consistent with manufacturers statement （CVwithin≤ 5%, CVbetween≤ 15%）. The relative de- viations of the reference materials was 2.4%, the recovery tests were applied by using HOMA reference materials. The recoveries were 103.2%-107.9%. The relative deviations and the recoveries were consistent with manufacturers state- ment （the relative deviations within 15% and the recoveries between 90% and 110%）. The measurement range of linear range verified test was 3.20%-68.00%, the clinical reportable range was 3.2%-68.0%, the verified reference intervals of manufacturers were 11%-16% and consistent with requirement. Conclusion The performance characteristics of thequantitative detection system composed of GA assay kit made by HOMA and Beckman-Coulter OLYMPUS AU2700 automatic biochemical analyzer in the detection of GA are consistent with manufacturers statement, were suitable for clinical application, the performance verifi- cation procedures and methods are simple and practica- ble.

关 键 词：糖化清蛋白 性能验证 定量测定 

分 类 号：R446.1[医药卫生—诊断学]