团 体 标 准 基于固体培养基的结核分枝杆菌比例法 药物敏感性试验操作规范 Theguidelineonoperationofsolidmedium-basedproportion methodfordrugsensitivitytestingofmycobacteriumtuberculosis 中国防痨协会发布ICS11.020 CCSC05 T/CHATA037—2024 2024-06-11 发布 2024-06-11 实施 全国团体标准信息平台 全国团体标准信息平台 T/CHATA037—2024 I目次 前言............................................................................III 1范围.............................................................................1 2规范性引用文件...................................................................1 3术语和定义.......................................................................1 4对象与样本........................................................................2 5设施与设备.......................................................................2 6试剂与耗材.......................................................................2 7培养基、药物纯品、药物溶液保存...................................................2 7.1培养基保存.................................................................2 7.2药物纯品保存...............................................................2 7.3药物溶液保存...............................................................3 8受试菌选择.......................................................................3 8.1总体原则...................................................................3 8.2直接应用初代分离菌株.......................................................3 8.3需要二次传代培养的菌株.....................................................3 9菌悬液制备与菌液稀释.............................................................4 9.1菌悬液制备.................................................................4 9.2菌液稀释...................................................................4 10接种与培养......................................................................5 10.1接种......................................................................5 10.2培养......................................................................5 11结果记录、判读与报告............................................................5 11.1结果记录..................................................................5 11.2结果判读..................................................................5 11.3结果报告..................................................................6 12质量控制........................................................................6 全国团体标准信息平台 T/CHATA037—2024 II12.1人员培训和技能考核...........................................................6 12.2仪器设备的质量控制...........................................................6 12.3DST前质量控制...............................................................6 12.4DST中质量控制...............................................................7 12.5DST后质量控制...............................................................7 12.6质控参考菌株的使用..........................................................7 13实验室生物安全...................................................................7 附录A(规范性)结核分枝杆菌固体培养基比例法DST操作流程图..........................8 附录B(资料性)L-J对照培养基和含药培养基制备......................................9 附录C(资料性)7H10/7H11对照培养基和含药培养基制备..............................111 附录D(资料性)结核分枝杆菌体外药物敏感性试验测试药物溶液配制....................133 附录E(资料性)ATCC耐药结核分枝杆菌质控株........................................155 参考文献............................................................................16 全国团体标准信息平台