GeneXpert技术与原理课件

1、GeneXpert 技术及原理马林 Feb 2016GeneXpert 马林 真正的开始2 Cepheid Proprietary and Confidential真正的开始2 Cepheid Proprietary 重新定义分子诊断The GeneXpertFamily of SystemsGeneXpert ModuleGeneXpert CartridgeSmartCyclerSmartCyclerTube SystemICOREModuleAny TestAny TimeAny SampleAny Place3 Cepheid Proprietary and Confidential重

2、新定义分子诊断Any Test3 Cepheid P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 System1 Cepheid Proprietary & ConfidentialGeneXpert System分子诊断检测（PCR）包含以下步骤：样本采集仪器平台, 耗材 Cepheid Proprietary and ConfidentialSmart Cycler Cepheid Proprietary and CoSmartCycler II6 Cepheid Proprietary and Confidentia

3、lSmartCycler II6 Cepheid ProSmartCycler 反应管25 l不会损坏！7 Cepheid Proprietary and ConfidentialSmartCycler 反应管25 l7 Cephei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 enclosureSealable pressure capPolished Opticwindows(with 90 optics path)OpticReflectors8 Cepheid Proprietar

4、y and Confidential最优化的设计:一次性反应管Large Surface TePAGE9 | Cepheid Proprietary and Confidential9Disposable Tube compensates ClumsinessPAGE9 | Cepheid Proprieta固定的组件PAGE12 | Cepheid Proprietary and Confidential12BioRadQIAGENRoche固定的组件PAGE12 | Cepheid Pr系统模块任意配置Multiple I-COREModules As System Building Bl

5、ocks11 Cepheid Proprietary and Confidential系统模块任意配置Multiple I-CORE11 CeSmart EBVFCTC灵活性: 荧光及模块Smart CMV FCTCASR HSVFATAASR EVFATA12 Cepheid Proprietary and ConfidentialSmart EBVFCTC灵活性: 荧光及模块Smart CMaster Mix for a PCR assayBufferMgCl2Taq PolymerasedNTP mixturePrimersProbeICPCR反应13 Cepheid Proprieta

6、ry and Confidential扩增/检测SmartMixTM HMMaster Mix for a PCR assayBuff预混珠14 Cepheid Proprietary and Confidential预混珠14 Cepheid Proprietary aReconstitute with WaterAdd the sampleStart the Run预混珠形式避免加样误差15 Cepheid Proprietary and ConfidentialReconstitute with WaterAdd th诊断软件 : DX 3.03 Assay TypesResearchR

7、eference IVD16 Cepheid Proprietary and Confidential诊断软件 : DX 3.03 Assay Types16 Cepheid Proprietary and ConfidentialGeneXpert系统 Cepheid Proprietary and CoGeneXpert 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GeneXpert 技术18 Cepheid Prop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

8、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 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 ConfidentialGeneXpert 设计实时荧光定量PCR (扩增和检测同时进行)19 Cephe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SmartCyclerGeneXpert20 Cepheid Proprieta

9、ry and Confidential赛沛的技术 洗涤DNA or RNA扩增检测分析 赛沛的技术SmartCyclerGeneXpert21 Cepheid Proprietary and Confidential赛沛的技术SmartCyclerGeneXpert21 CI-Core 模块模块化设计的SmartCycler 和 GeneXpert22 Cepheid Proprietary and ConfidentialI-Core 模块模块化设计的SmartCycler 和 GGeneXpert 6色荧光通道23 Cepheid Proprietary and Confidential通

10、道激发波长范围接收波长范围荧光染料1375-405 nm420-480 nmDye 12450-495 nm510-535 nmDye 23500-550 nm565-590 nmDye 34555-590 nm606-650 nmDye 45630-650 nm665-685 nmDye 56630-650 nm700 nmDye 6GeneXpert 6色荧光通道23 Cepheid 仪器平台I-CORE 模块SmartCycler GeneXpertGeneXpert 模块 BDS24 Cepheid Proprietary and Confidential仪器平台I-CORESmart

11、Cycler GeneXpeGeneXpert 模块30 Cepheid Proprietary and Confidential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GeneXpert 模块30 Cepheid PropGeneXpert 模块 试剂盒仓室26 Cepheid Proprietary and ConfidentialGeneXpert 模块 试剂盒仓室26 Cephei阀驱动超声装置注射驱动I-COREGeneXpert 试剂盒27 Cepheid Proprietary and Confidential阀驱动超声装置注射驱动I-COREGeneXpe

12、rt 试剂盒GeneXpert 试剂盒28 Cepheid Proprietary and ConfidentialGeneXpert 试剂盒28 Cepheid ProGeneXpert 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 有同样的主体。唯一的不同在于底部构成。29 Cepheid Proprietary and ConfidentialGeneXpert 试剂盒基本特点29 Cepheid 腔体通道Reaction TubeChamber Por

13、tSyringe Barrel每个腔体的底部有通道用于腔体流动30 Cepheid Proprietary and Confidential腔体通道Reaction TubeChamber PortS试剂盒侧面图示31 Cepheid Proprietary and Confidential试剂盒侧面图示31 Cepheid Proprieta试剂盒分解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CellChromosomeGenesGenes SequencemRNATranscriptionProt

14、eins46 46 CeCpehpehiedid Proprietary and Confidential独特的灵活性: 从低到高的通量Molecular Serv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RocheGenProbeQiagenBDAbbottCepheid47 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

15、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 ConfidentialInfinity: 更进一步时间49 Cepheid 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软件步骤点击 Create Test 53 Cepheid Propri

16、etary and Confidential软件步骤点击53 Cepheid Proprietar扫描试剂盒二维码54 Cepheid Proprietary and Confidential扫描试剂盒二维码54 Cepheid Propriet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全自动的工作流程GeneXpert 设计55 Cephe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