For in vitro diagnostic use. System GenMark ePlex system IVD ePlex® system SYS_356 RM007103 GM EPLEX SHORT TOWER BOLTS Not Available GM EPLEX SHORT TOWER BOLTS 09792074001 Not Available Accessories general (hardware) RM007121 GM EPLEX 6 BAY TOWER KIT Not Available GM EPLEX 6 BAY TOWER KIT 09782702001 Not Available Instruments RM003001 GM EPLEX BASE 00857167005009 Not Available GM EPLEX BASE 09556621001 Not Available Instruments RM007102 GM EPLEX LONG TOWER BOLTS Not Available GM EPLEX LONG TOWER BOLTS 09792066001 Not Available Accessories general (hardware) RM007001 GM EPLEX BARCODE SCANNER AND MOUNT Not Available GM EPLEX BARCODE SCANNER AND MOUNT 09792104001 Not Available Accessories general (hardware) en The True Sample-to-Answer Solution® ePlex Instrument automates all aspects of nucleic acid testing including extraction, amplification, and detection, combining electrowetting and GenMark’s eSensor® technology in a single-use cartridge. eSensor technology is based on the principles of competitive DNA hybridization and electrochemical detection, which is highly specific and is not based on fluorescent or optical detection.Electrowetting, or digital microfluidics, uses electrical fields to directly manipulate discrete droplets on the surface of a hydrophobically coated printed circuit board (PCB). Sample and reagents are moved in a programmable fashion in the ePlex cartridge to complete all portions of the sample processing from nucleic acid extraction to detection.A sample is loaded into the ePlex cartridge and the cartridge is placed into the ePlex Instrument. Nucleic acids are extracted and purified from the specimen via magnetic solid phase extraction. PCR is used to create double-stranded DNA, which is treated with exonuclease to create single-stranded DNA in preparation for eSensor detection.The target DNA is mixed with ferrocene-labeled signal probes that are complementary to the specific targets on the panel. Target DNA hybridizes to its complementary signal probe and capture probes, which are bound to gold-plated electrodes, as shown below in Figure 1. The presence of each target is determined by voltammetry which generates specific electrical signals from the ferrocene-labeled signal probe.Figure 1: Hybridization complex. Target-specific capture probes are bound to the gold electrodes in the eSensor microarray on the ePlex cartridge. The amplified target DNA hybridizes to the capture probe and to a complementary ferrocene-labeled signal probe. Electrochemical analysis determines the presence or absence of targets using voltammetry.  fr Le système ePlex est utilisé pour les essais multiplexes basés sur microréseau développés par GenMark. Ce type d’essai est basé sur les principes d’hybridation compétitive des acides nucléiques au moyen d’un format d’essai en « sandwich » dans lequel une cible à simple brin se lie simultanément à une sonde de signalisation en phase soluble spécifique à la séquence et à une sonde de capture en phase solide liée à une électrode. Le test emploie l’extraction d’acides nucléiques, l’amplification en chaîne par polymérase (PCR) cible ou l’amplification en chaîne par polymérase à transcription inverse (RT-PCR), et l’hybridation de l’ADN cible. En cours de processus, les amplimères de la PCR à double brin sont digérés avec une exonucléase pour générer de l’ADN à simple brin adapté à l’hybridation.