For in vitro diagnostic use. System GenMark ePlex system IVD ePlex® system SYS_356 09782702001 GM EPLEX 6 BAY TOWER KIT GM EPLEX 6 BAY TOWER KIT Instruments RM007121 Not Available Not Available 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.  en El sistema ePlex se utiliza para realizar pruebas múltiples basadas en micromatrices desarrolladas por GenMark. Este tipo de prueba con un formato de sándwich se basa en los principios de hibridación competitiva de ácidos nucleicos: una diana monocatenaria se une simultáneamente a una sonda indicadora (en fase disuelta) específica de la secuencia y a una sonda de captura (en fase sólida) unida a un electrodo. La prueba consiste en la extracción del ácido nucleico, la amplificación de la diana mediante la reacción en cadena de la polimerasa (PCR) o la PCR con transcripción inversa (RT-PCR) y la hibridación del ADN diana. Durante el proceso, los amplicones bicatenarios de la PCR se digieren con exonucleasa para generar un ADN monocatenario adecuado para la hibridación. es