1、,GeneXpert 技术及原理,马林 Feb 2016,真正的开始,2, Cepheid Proprietary and Confidential,重新定义分子诊断,The GeneXpert Family of SystemsGeneXpert Module GeneXpert Cartridge SmartCycler SmartCycler Tube System ICORE Module,Any Test Any Time Any Sample Any Place,3, Cepheid Proprietary and Confidential,分子诊断检测（PCR）,包含以下步骤：,
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3、号预防污染,一次性反应管,Large Surface Temperature Area with thin wall enclosure,Sealable pressure cap,Polished Optic windows (with 90 optics path),Optic Reflectors,8, Cepheid Proprietary and Confidential,PAGE9 | Cepheid Proprietary and Confidential 9,Disposable Tube compensates Clumsiness,固定的组件,PAGE12 | Cephei
4、d Proprietary and Confidential 12,BioRad,QIAGEN,Roche,系统模块任意配置,Multiple I-CORE Modules As System Building Blocks,11, Cepheid Proprietary and Confidential,Smart EBV,FCTC,灵活性: 荧光及模块,Smart CMV FCTC,ASR HSV,FATA,ASR EVFATA,12, Cepheid Proprietary and Confidential,Master Mix for a PCR assay,Buffer MgCl2
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6、Reference IVD,16, Cepheid Proprietary and Confidential, Cepheid Proprietary and Confidential,GeneXpert系统,GeneXpert 技术,18, Cepheid Proprietary and Confidential,整合的微流体技术，包括：仪器平台试剂盒运行程序和对照,实时荧光定量PCR (扩增和检测同时进行) 仪器和样品盒之间不存在湿式接触界面，以消除污染 反应体系完全内部质控-不需要设置独立的外部阳性和阴性对照 集成的细胞超声裂解释放DNA的装置 GeneXpert软件指示单个模块主板以协
7、调阀驱动和整体液压传动 精巧的流体学技术 液体流动由微型阀控制 适于试剂成分的微量反应 全自动的数据分析和结果解读,19, Cepheid Proprietary and Confidential,GeneXpert 设计,赛沛的技术,洗涤,DNA or RNA 提取,扩增,检测,分析,阳性,阴性,DNA or RNA 纯化,患者样本 PCR反应体系SmartCycler,GeneXpert,20, Cepheid Proprietary and Confidential,赛沛的技术,SmartCycler,GeneXpert,21, Cepheid Proprietary and Confi
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9、样品盒装载仓室,I-CORE,主板,阀驱动马达,超声变幅器,GeneXpert 模块 试剂盒仓室,26, Cepheid Proprietary and Confidential,阀驱动,超声装置,注射驱动,I-CORE,GeneXpert 试剂盒,27, Cepheid Proprietary and Confidential,GeneXpert 试剂盒,28, Cepheid Proprietary and Confidential,GeneXpert 试剂盒,基本特点 GX试剂盒有11个腔体 序号小的腔体用作样本处理 序号大的腔体用于试剂储存 试剂盒类型大致分为两类 Cartridge
10、A Cartridge C Cartridge A 和 C 有同样的主体。唯一的不同在于底部构成。,29, Cepheid Proprietary and Confidential,腔体通道,Reaction Tube,Chamber Port,Syringe Barrel,每个腔体的底部有通道用于腔体流动,30, Cepheid Proprietary and Confidential,试剂盒侧面图示,31, Cepheid Proprietary and Confidential,试剂盒分解图示,独特的灵活性: 从低到高的通量,Molecular Server Cabinet 系统上使得系
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12、系统 加载试剂盒，Infinity会自动完成剩余工作 更多模块容量, 更大的队列载量 无需等待以加载试剂盒 可连接LIS系统 无需人工获取数据 没有不必要的延迟空间 实验室所急缺 单位面积可获得的最高测试通量 Infinity-80 (270cm) /Infinity-48s (216cm),49, Cepheid Proprietary and Confidential,试剂盒准备,最简单的：,最复杂的：,无需实验室技术的特殊培训,52, Cepheid Proprietary and Confidential,软件步骤,点击 Create Test ,53, Cepheid Proprie
13、tary and Confidential,扫描试剂盒二维码,54, Cepheid Proprietary and Confidential,全自动的工作流程 整合了裂解、提取、扩增和实时检测的过程 快速获得结果 整合的超声裂解装置以快速获得核酸 特殊的PCR反应管设计可大大缩短PCR循环时间 自动结果解读 即时检测 无需批次检测 随时进行任意检测 即插即用 无需日常的设置和维护 通过整合LIS系统即时获得结果,GeneXpert 设计,55, Cepheid Proprietary and Confidential,支持多种样本类型 先进的微流体技术和样本处理 可靠和可重复的流程 高度自动化意味着不同用户和地点之间结果的一致性 结果的可信性 系统整合完全的内部质控 无需额外的外部对照及阴性对照,GeneXpert 设计,56, Cepheid Proprietary and Confidential,污染可能性降至最低 真正的封闭系统，避免样本残留 仪器与试剂盒间无湿式接触界面，消除了交叉污染的可能性优化的故障处理 模块化设计 更少的电子器件，最少的可移动组件 快速的模块校准流程,GeneXpert 设计,57, Cepheid Proprietary and Confidential,
