团 体 标 准 T/CITS124—2024ICS11.040 CCSC44 糖化血红蛋白检测系统性能验证 PerformanceverificationforhemoglobinA1ctestsystem 2024-08-09发布 2024-08-09实施T 中国检验检测学会发布 全国团体标准信息平台 全国团体标准信息平台 T/CITS124—2024 I目次 前言.......................................................................................................................................................................II 1范围...................................................................................................................................................................1 2规范性引用文件...............................................................................................................................................1 3术语和定义.......................................................................................................................................................1 4概述...................................................................................................................................................................2 4.1检测系统的分类...........................................................................................................................................2 4.2检测方法.......................................................................................................................................................2 5一般要求...........................................................................................................................................................3 5.1性能验证的时机...........................................................................................................................................3 5.2性能验证的质量保证...................................................................................................................................3 5.3性能验证的结果...........................................................................................................................................3 6性能验证前准备...............................................................................................................................................3 6.1人员...............................................................................................................................................................3 6.2标本...............................................................................................................................................................4 6.3检测系统.......................................................................................................................................................4 6.4设施和环境条件...........................................................................................................................................4 7验证内容...........................................................................................................................................................4 7.1精密度...........................................................................................................................................................4 7.2正确度...........................................................................................................................................................5 7.3线性...............................................................................................................................................................6 7.4特异性验证（适用时）...............................................................................................................................7 附录A（资料性）糖化血红蛋白即时检验检测系统性能验证实例.............................................................8 参考文献...............................................................................................................................................................13 全国团体标准信息平台 T/CITS124—2024 II前言 本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规 定起草。 请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。 本文件由首都医科大学附属北京地坛医院、国军标（北京）标准化技术研究院提出。 本文件由中国检验检测学会归口。 本文件起草单位：首都医科大学附属北京地坛医院、首都医科大学附属北京朝阳医院/北京市临床 检验中心、国军标（