ICS07.080 CCSA40 CITS 团 体 标 准 T/CITS651—2025 分子克隆试剂盒质量评价技术规范 Technicalspecificationonqualityevaluationofmolecularcloningkit 2025-11-05发布 2025-11-05实施 中国检验检测学会  发布 全国团体标准信息平台 T/CITS651—2025 I目次 前言.................................................................................III 引言..................................................................................IV 1范围................................................................................1 2规范性引用文件......................................................................1 3术语和定义..........................................................................1 4评价指标............................................................................1 4.1核酸纯度........................................................................1 4.2连接效率........................................................................1 4.3克隆阳性率......................................................................2 4.4稳定性..........................................................................2 4.5批间差异........................................................................2 4.6灵敏度..........................................................................2 4.7兼容性..........................................................................2 5评价方法............................................................................2 5.1基本要求........................................................................2 5.2核酸纯度........................................................................2 5.3连接效率........................................................................2 5.4克隆阳性率......................................................................2 5.5稳定性..........................................................................2 5.6批间差异........................................................................2 5.7灵敏度..........................................................................3 5.8兼容性..........................................................................3 6评价结果判定........................................................................3 6.1基本要求........................................................................3 6.2核酸纯度........................................................................3 6.3连接效率........................................................................3 6.4克隆阳性率......................................................................3 6.5稳定性..........................................................................4 6.6批间差异........................................................................4 6.7灵敏度..........................................................................4 6.8兼容性..........................................................................4 7评价报告............................................................................4 附录A（规范性）核酸纯度测定方法.....................................................5 A.1试剂和材料......................................................................5 A.2仪器设备........................................................................5 A.3操作步骤........................................................................5 A.4结果计算和纯度判断..............................................................5 全国团体标准信息平台 T/CITS651—2025 II附录B（规范性）连接效率测定方法.....................................................6 B.1试剂和材料......................................................................6 B.2仪器设备........................................................................6 B.3操作步骤........................................................................6 B.4结果计算........................................................................6 B.5结果分析........................................................................7 附录C（规范性）克隆阳性率测定方法....................................................8 C.1试剂和材料......................................................................8 C.2仪器设备........................................................................8 C.3快速筛选阶段：菌落PCR和酶切验证...........................................