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1、,GeneXpert 技术及原理,马林 Feb 2016,Cepheid Proprietary and Confidential,2,真正的开始,Cepheid Proprietary and Confidential,3,重新定义分子诊断,The GeneXpertFamily of SystemsGeneXpert ModuleGeneXpert CartridgeSmartCyclerSmartCyclerTube SystemICOREModule,Any TestAny TimeAny SampleAny Place,Cepheid Proprietary and Confiden
2、tial,4,分子诊断检测（PCR）,包含以下步骤：,样本采集,仪器平台,耗材&软件,样本处理,扩增,检测,报告结果,SmartCycler System,GeneXpert System,Cepheid Proprietary and Confidential,Smart Cycler,Cepheid Proprietary and Confidential,6,SmartCycler II,Cepheid Proprietary and Confidential,7,SmartCycler 反应管,25 l不会损坏！,Cepheid Proprietary and Confidential
3、,8,最优化的设计:快速温度响应最佳的荧光信号预防污染,一次性反应管,Large Surface Temperature Area with thin wall enclosure,Sealable pressure cap,Polished Opticwindows(with 90 optics path),OpticReflectors,PAGE9|Cepheid Proprietary and Confidential9,Disposable Tube compensates Clumsiness,固定的组件,PAGE12|Cepheid Proprietary and Confiden
4、tial12,BioRad,QIAGEN,Roche,Cepheid Proprietary and Confidential,11,系统模块任意配置,Multiple I-COREModules As System Building Blocks,Cepheid Proprietary and Confidential,12,Smart EBV,FCTC,灵活性:荧光及模块,Smart CMV FCTC,ASR HSV,FATA,ASR EVFATA,Cepheid Proprietary and Confidential,13,Master Mix for a PCR assay,Buff
5、erMgCl2Taq PolymerasedNTP mixture,PrimersProbeIC,PCR反应,扩增/检测,SmartMixTM HM,Cepheid Proprietary and Confidential,14,预混珠,Cepheid Proprietary and Confidential,15,Reconstitute with Water,Add the sample,Start the Run,预混珠形式避免加样误差,Cepheid Proprietary and Confidential,16,诊断软件:DX 3.0,3 Assay TypesResearchRef
6、erence IVD,Cepheid Proprietary and Confidential,GeneXpert系统,Cepheid Proprietary and Confidential,18,GeneXpert 技术,整合的微流体技术，包括：仪器平台试剂盒运行程序和对照,Cepheid Proprietary and Confidential,19,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调阀驱动和整体液压传动
7、 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,GeneXpert 设计,Cepheid Proprietary and Confidential,20,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,Cepheid Proprietary and Confidential,21,赛沛的技术,SmartCycler,GeneXpert,Cepheid Proprietary and Confidential,22,I-Core 模块,
8、模块化设计的SmartCycler 和 GeneXpert,Cepheid Proprietary and Confidential,23,GeneXpert 6色荧光通道,Cepheid Proprietary and Confidential,24,仪器平台,I-CORE 模块,SmartCycler,GeneXpert,GeneXpert 模块 BDS,Cepheid Proprietary and Confidential,GeneXpert 模块,30,柱塞杆马达,样品盒装载 仓室,I-CORE,主板,阀驱动马达,超声变幅器,Cepheid Proprietary and Confi
9、dential,26,GeneXpert 模块 试剂盒仓室,Cepheid Proprietary and Confidential,27,阀驱动,超声装置,注射驱动,I-CORE,GeneXpert 试剂盒,Cepheid Proprietary and Confidential,28,GeneXpert 试剂盒,Cepheid Proprietary and Confidential,29,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 ACartridge CCartridge A 和 C
10、 有同样的主体。唯一的不同在于底部构成。,Cepheid Proprietary and Confidential,30,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,Cepheid Proprietary and Confidential,31,试剂盒侧面图示,试剂盒分解图示,独特的灵活性:从低到高的通量,Molecular Server Cabinet 系统上使得系统可随检测通量的增长而增长,Cell,Chromosome,Genes,Genes Sequence,mRNATranscription,Prot
11、eins,46 46 CeCpehpehiedid Proprietary and Confidential,Cepheid Proprietary and Confidential,满足多样化测试需求的能力,妇女健康,危重感染,院内感染,免疫缺陷性疾病,肿瘤,遗传性疾病,Roche,GenProbe,Qiagen,BD,Abbott,Cepheid,47,Cepheid Proprietary and Confidential,35,Infinity:更进一步,时间时间的重要性Infinity是市场上自动化程度最高的系统加载试剂盒，Infinity会自动完成剩余工作更多模块容量,更大的队列载
12、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),Cepheid Proprietary and Confidential,36,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,Cepheid Proprietary and Confidential,37,软件步骤,点击 Create Test,Cepheid Proprietary and Confidential,38,扫描试剂盒二维码,Cepheid Proprietary and
13、 Confidential,39,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,Cepheid Proprietary and Confidential,40,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,Cepheid Proprietary and Confidential,41,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,
