GeneXpert技術(shù)及原理課件

GeneXpert技術(shù)及原理?Cepheid–ProprietaryandConfidential2真正的開始?Cepheid–ProprietaryandConfidential3重新定義分子診斷TheGeneXpertFamilyofSystemsGeneXpertModuleGeneXpert?CartridgeSmartCyclerSmartCycler? TubeSystemICORE?ModuleAnyTestAnyTimeAnySampleAnyPlace?Cepheid–ProprietaryandConfidential4分子診斷檢測(cè)（PCR）包含以下步驟：樣本采集儀器平臺(tái),耗材&軟件樣本處理擴(kuò)增檢測(cè)報(bào)告結(jié)果SmartCyclerSystemGeneXpertSystem?Cepheid–ProprietaryandConfidentialSmartCycler?Cepheid–ProprietaryandConfidential6SmartCyclerII?Cepheid–ProprietaryandConfidential7SmartCycler

反應(yīng)管25

l不會(huì)損壞！?Cepheid–ProprietaryandConfidential8最優(yōu)化的設(shè)計(jì):快速溫度響應(yīng)最佳的熒光信號(hào)預(yù)防污染一次性反應(yīng)管LargeSurfaceTemperatureAreawiththinwallenclosureSealablepressurecapPolishedOpticwindows(with90°opticspath)OpticReflectorsPAGE9|?Cepheid–ProprietaryandConfidential9DisposableTubecompensatesClumsiness固定的組件PAGE12|?Cepheid–ProprietaryandConfidential12BioRadQIAGENRoche?Cepheid–ProprietaryandConfidential11系統(tǒng)模塊任意配置MultipleI-COREModulesAsSystemBuildingBlocks?Cepheid–ProprietaryandConfidential12SmartEBVFCTC靈活性:熒光及模塊SmartCMVFCTCASRHSVFATAASREVFATA?Cepheid–ProprietaryandConfidential13MasterMixforaPCRassayBufferMgCl2TaqPolymerasedNTPmixturePrimersProbeICPCR反應(yīng)擴(kuò)增/檢測(cè)SmartMixTMHM?Cepheid–ProprietaryandConfidential14預(yù)混珠?Cepheid–ProprietaryandConfidential15ReconstitutewithWaterAddthesampleStarttheRun預(yù)混珠形式避免加樣誤差?Cepheid–ProprietaryandConfidential16診斷軟件:DX3.03AssayTypesResearchReferenceIVD?Cepheid–ProprietaryandConfidentialGeneXpert系統(tǒng)?Cepheid–ProprietaryandConfidential18GeneXpert技術(shù)整合的微流體技術(shù)，包括：儀器平臺(tái)試劑盒運(yùn)行程序和對(duì)照?Cepheid–ProprietaryandConfidential19實(shí)時(shí)熒光定量PCR(擴(kuò)增和檢測(cè)同時(shí)進(jìn)行)儀器和樣品盒之間不存在濕式接觸界面，以消除污染反應(yīng)體系完全內(nèi)部質(zhì)控-不需要設(shè)置獨(dú)立的外部陽(yáng)性和陰性對(duì)照集成的細(xì)胞超聲裂解釋放DNA的裝置GeneXpert軟件指示單個(gè)模塊主板以協(xié)調(diào)閥驅(qū)動(dòng)和整體液壓傳動(dòng)

精巧的流體學(xué)技術(shù)

液體流動(dòng)由微型閥控制

適于試劑成分的微量反應(yīng)全自動(dòng)的數(shù)據(jù)分析和結(jié)果解讀GeneXpert設(shè)計(jì)?Cepheid–ProprietaryandConfidential20賽沛的技術(shù)洗滌DNAorRNA提取擴(kuò)增檢測(cè)分析陽(yáng)性陰性DNAorRNA純化患者樣本PCR反應(yīng)體系SmartCyclerGeneXpert?Cepheid–ProprietaryandConfidential21賽沛的技術(shù)SmartCyclerGeneXpert?Cepheid–ProprietaryandConfidential22I-Core模塊模塊化設(shè)計(jì)的SmartCycler和GeneXpert?Cepheid–ProprietaryandConfidential23GeneXpert6色熒光通道通道激發(fā)波長(zhǎng)范圍接收波長(zhǎng)范圍熒光染料1375-405nm420-480nmDye12450-495nm510-535nmDye23500-550nm565-590nmDye34555-590nm606-650nmDye45630-650nm665-685nmDye56630-650nm>700nmDye6?Cepheid–ProprietaryandConfidential24儀器平臺(tái)I-CORE模塊SmartCycler?GeneXpert?GeneXpert模塊BDS?Cepheid–ProprietaryandConfidentialGeneXpert模塊30柱塞桿馬達(dá)樣品盒裝載倉(cāng)室I-CORE主板閥驅(qū)動(dòng)馬達(dá)超聲變幅器?Cepheid–ProprietaryandConfidential26GeneXpert模塊–試劑盒倉(cāng)室?Cepheid–ProprietaryandConfidential27閥驅(qū)動(dòng)超聲裝置注射驅(qū)動(dòng)I-COREGeneXpert試劑盒?Cepheid–ProprietaryandConfidential28GeneXpert試劑盒?Cepheid–ProprietaryandConfidential29GeneXpert試劑盒基本特點(diǎn)GX試劑盒有11個(gè)腔體序號(hào)小的腔體用作樣本處理序號(hào)大的腔體用于試劑儲(chǔ)存試劑盒類型大致分為兩類Cartridge

ACartridge

CCartridgeA和C有同樣的主體。唯一的不同在于底部構(gòu)成。?Cepheid–ProprietaryandConfidential30腔體通道ReactionTubeChamberPortSyringeBarrel每個(gè)腔體的底部有通道用于腔體流動(dòng)?Cepheid–ProprietaryandConfidential31試劑盒側(cè)面圖示試劑盒分解圖示獨(dú)特的靈活性:從低到高的通量‘MolecularServerCabinet’系統(tǒng)上使得系統(tǒng)可隨檢測(cè)通量的增長(zhǎng)而增長(zhǎng)CellChromosomeGenesGenesSequencemRNATranscriptionProteins4646?C?eCpehpehiedid–ProprietaryandConfidential?Cepheid–ProprietaryandConfidential滿足多樣化測(cè)試需求的能力婦女健康危重感染院內(nèi)感染免疫缺陷性疾病腫瘤遺傳性疾病RocheGenProbeQiagenBDAbbottCepheid47?Cepheid–ProprietaryandConfidential35Infinity:更進(jìn)一步時(shí)間時(shí)間的重要性Infinity是市場(chǎng)上自動(dòng)化程度最高的系統(tǒng)加載試劑盒，Infinity會(huì)自動(dòng)完成剩余工作更多模塊容量,更大的隊(duì)列載量–

無(wú)需等待以加載試劑盒可連接LIS系統(tǒng)無(wú)需人工獲取數(shù)據(jù)沒(méi)有不必要的延遲空間實(shí)驗(yàn)室所急缺單位面積可獲得的最高測(cè)試通量Infinity-80(270cm)/Infinity-48s

(216cm)?Cepheid–ProprietaryandConfidential36試劑盒準(zhǔn)備最簡(jiǎn)單的：最復(fù)雜的：無(wú)需實(shí)驗(yàn)室技術(shù)的特殊培訓(xùn)?Cepheid–ProprietaryandConfidential37軟件步驟點(diǎn)擊?CreateTest??Cepheid–ProprietaryandConfidential38掃描試劑盒二維碼?Cepheid–ProprietaryandConfidential39全自動(dòng)的工作流程整合了裂解、提取、擴(kuò)增和實(shí)時(shí)檢測(cè)的過(guò)程快速獲得結(jié)果整合的超聲裂解裝置以快速獲得核酸特殊的PCR反應(yīng)管設(shè)計(jì)可大大縮短PCR循環(huán)時(shí)間自動(dòng)