雅培ARCHITECT i2000全自动免疫分析系统检测维生素B_(12)、叶酸及铁蛋白的性能验证  

A Performance Verification of Abbott i2000 Chemiluminescence System for the Detection of Vitamin B_(12),Folic Acid and Ferritin

作　　者：邵玲 张云丽 高世巍 曲波[1] 赵鸿梅[1] SHAO Ling;ZHANG Yunli;GAO Shiwei;QU Bo;ZHAO Hongmei(Department of Laboratory Medicine, The People’s Hospital of China Medical University, The People’s Hospital of Liaoning Province, Shenyang110016, China)

机构地区：[1]辽宁省人民医院暨中国医科大学人民医院检验医学科,辽宁沈阳110016

出　　处：《标记免疫分析与临床》2021年第4期671-675,共5页Labeled Immunoassays and Clinical Medicine

基　　金：辽宁省科学技术计划项目自然基金指导计划(编号:2019-ZD-0404)。

摘　　要：目的验证应用雅培ARCHITECT i2000SR全自动免疫分析系统对维生素B12、叶酸及铁蛋白的检测性能。方法依据CNAS GL037《临床化学定量检验程序性能验证指南》、美国临床实验室标准化协会(CLSI)系列指南文件及卫生行业标准进行正确度、精密度、线性范围及参考区间进行验证。结果维生素B12、叶酸及铁蛋白室间质评5个浓度样本检测结果均值与靶值之间的偏倚均<1/2 TEa,正确度符合要求;批内不精密度和总精密度均符合厂家说明书要求,重复性良好;维生素B12、叶酸及铁蛋白的最优拟合曲线为一阶方程,线性回归方程的斜率均在1.00±0.05范围内且满足R2≥0.95的要求;维生素B_(12)、叶酸及铁蛋白的测量值与厂家提供的参考区间符合率均≥95%。结论应用ARCHITECT i2000SR全自动免疫分析系统检测维生素B12、叶酸及铁蛋白的正确度、精密度、线性范围及参考区间均符合厂家和卫生行业标准的要求,可为临床提供可靠依据。Objective To verify the detection performance of the Abbott I2000 automatic chemiluminescence analyzer for vitamin B12,folic acid and ferritin.Methods The accuracy,precision,linear range and reference interval were evaluated based on the recommended methods of CNAS GL037,series of guidance documents of Clinical Laboratory Standards Institute(CLSI)and health industry standards.Results The bias%of vitamin B12,folic acid and ferritin were all<1/2TEa.The intra-assay imprecision and total imprecision were in line with the manufacturer requirements,which suggested a good repeatability.The optimal fitting curves of vitamin B12,folic acid and ferritin were first-order equations and the slopes ofthe linear regression equations were all within the range of(1.00±0.05)and met the requirements of R2≥0.95.The measured values of vitamin B12,folic acid and ferritin were consistent with the reference interval provided by the manufacturer at a rate of≥95%.Conclusion The accuracy,precision,linear range and reference interval of vitamin B12,folic acid and ferritin detected by Abbott I2000 automatic chemiluminescence analyzer meet the requirements of manufacturers and health industry standards,which can provide a reliable reference basis for clinical applications.

关 键 词：维生素B_(12) 叶酸 铁蛋白 性能验证 化学发光分析仪 

分 类 号：R392-33[医药卫生—免疫学]