GeneXpert技术及原理学习课件

GeneXpert技术及原理真正的开始2©Cepheid–Proprietaryand

Confidential重新定义分子诊断The

GeneXpertFamilyof

SystemsGeneXpertModuleGeneXpert®CartridgeSmartCyclerSmartCycler®

TubeSystemICORE®ModuleAny

TestAny

TimeAny

SampleAny

Place3©Cepheid–Proprietaryand

Confidential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©Cepheid–Proprietaryand

ConfidentialSmart

CyclerSmartCycler

II6©Cepheid–Proprietaryand

ConfidentialSmartCycler

反应管25

l不会损坏！7©Cepheid–Proprietaryand

Confidential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LargeSurfaceTemperatureArea

withthinwall

enclosureSealablepressurecapPolished

Opticwindows(with90°optics

path)OpticReflectors8©Cepheid–Proprietaryand

ConfidentialPAGE9|©Cepheid–Proprietaryand

Confidential9DisposableTubecompensates

Clumsiness固定的组件PAGE12|©Cepheid–Proprietaryand

Confidential12BioRadQIAGENRoche系统模块任意配置MultipleI-COREModules

AsSystemBuildingBlocks11©Cepheid–Proprietaryand

ConfidentialSmart

EBVFCTC灵活性:荧光及模块Smart

CMVFCTCASR

HSVFATAASR

EVFATA12©Cepheid–Proprietaryand

ConfidentialMasterMixforaPCR

assayBufferMgCl2Taq

PolymerasedNTP

mixturePrimersProbeICPCR反应13©Cepheid–Proprietaryand

Confidential扩增/检测SmartMixTM

HM预混珠14©Cepheid–Proprietaryand

ConfidentialReconstitutewith

WaterAddthe

sampleStartthe

Run预混珠形式避免加样误差15©Cepheid–Proprietaryand

Confidential诊断软件:DX

3.03Assay

TypesResearchReferenceIVD16©Cepheid–Proprietaryand

Confidential©Cepheid–Proprietaryand

ConfidentialGeneXpert系统GeneXpert

技术18©Cepheid–Proprietaryand

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–Proprietaryand

ConfidentialGeneXpert

设计赛沛的技术洗涤DNAor

RNA提取扩增检测分析阳性阴性DNAor

RNA纯化患者样本PCR反应体系SmartCyclerGeneXpert20©Cepheid–Proprietaryand

Confidential赛沛的技术SmartCyclerGeneXpert21©Cepheid–Proprietaryand

ConfidentialI-Core

模块模块化设计的SmartCycler和

GeneXpert22©Cepheid–Proprietaryand

ConfidentialGeneXpert6色荧光通道23©Cepheid–Proprietaryand

Confidential通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

nm>700

nmDye

6仪器平台I-CORE模块SmartCycler®

GeneXpert®GeneXpert模块BDS24©Cepheid–Proprietaryand

ConfidentialGeneXpert

模块30©Cepheid–Proprietaryand

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–试剂盒仓室26©Cepheid–Proprietaryand

Confidential阀驱动超声装置注射驱动I-COREGeneXpert试剂盒27©Cepheid–Proprietaryand

ConfidentialGeneXpert

试剂盒28©Cepheid–Proprietaryand

ConfidentialGeneXpert

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

CCartridgeA和C有同样的主体。唯一的不同在于底部构成。29©Cepheid–Proprietaryand

Confidential腔体通道Reaction

TubeChamber

PortSyringe

Barrel每个腔体的底部有通道用于腔体流动30©Cepheid–Proprietaryand

Confidential试剂盒侧面图示31©Cepheid–Proprietaryand

Confidential试剂盒分解图示独特的灵活性:从低到高的通量‘MolecularServerCabinet’系统上使得系统可随检测通量的增长而增长CellChromosomeGenesGenesSequencemRNATranscriptionProteins4646©C©eCpehpehiedid–Proprietaryand

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RocheGenProbeQiagenBDAbbottCepheid47©Cepheid–Proprietaryand

ConfidentialInfinity: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–Proprietaryand

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–Proprietaryand

Confidential软件步骤点击«CreateTest

»53©Cepheid–Proprietaryand

Confidential扫描试剂盒二维码54©Cepheid–Proprietaryand

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–Proprietaryand

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