{ "ProductData": { "ID": "SYS_356", "ProductType": "System", "BrandName": "ePlex^® system", "ProductNameAddition": "", "RegulatoryDisclaimer1": "For in vitro diagnostic use.", "DisclaimerGroup1": "IVD", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "Genmark Customer Resource Center
Genmark Safety Data Sheets", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "GenMark ePlex system" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/ePlex_system_2.jpg", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "StructureNodeStatus": "valid", "NodeName": "Analyzer Instruments and Systems", "NodeID": "10-000-00" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "StructureNodeStatus": "valid", "NodeName": "Molecular Lab", "NodeID": "010-00" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "StructureNodeStatus": "valid", "NodeName": "Molecular", "NodeID": "100" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "999-00" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "999" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "09782702001", "MaterialDescription": "GM EPLEX 6 BAY TOWER KIT", "RegisteredProductName": "GM EPLEX 6 BAY TOWER KIT", "GTIN": "", "ProductCategoryText": "Instruments", "OldMaterialNumber": "RM007121", "PackSizePIM360": "Not Available", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "", "ReadyForUse": "", "OrderInformation": "" }, { "MaterialNum": "09556621001", "MaterialDescription": "GM EPLEX BASE", "RegisteredProductName": "GM EPLEX BASE", "GTIN": "00857167005009", "ProductCategoryText": "Instruments", "OldMaterialNumber": "RM003001", "PackSizePIM360": "Not Available", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "", "ReadyForUse": "", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "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.
 ", "Country": "XG", "Code": "Principle", "Name": "Principle" }, { "Language": "es", "Value": "El sistema ePlex es una plataforma de diagnóstico molecular de paneles sindrómicos basados en la reacción en cadena de la polimerasa (PCR). El sistema ePlex permite automatizar el flujo de trabajo desde el procesamiento de la muestra hasta el resultado final, incluyendo preparación de muestra, extracción de ácidos nucléicos, amplificación y detección. El sistema ePlex se basa en el procesamiento de cartuchos de un solo uso desarrollados y fabricados por GenMark Diagnostics. Cada cartucho contiene los parámetros y los reactivos específicos de la prueba. Por tanto, cada cartucho representa una prueba (análisis) independiente.\nEl sistema ePlex es modular y está compuesto por una base, que contiene la interfaz gráfica de usuario, y una o varias torres, que alojan tres o seis bandejas por torre. Cada bandeja admite cartuchos independientes, por lo que es posible realizar múltiples análisis en paralelo.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "Language": "es", "Value": "El sistema ePlex^® es un dispositivo automatizado de diagnóstico in vitro diseñado para realizar pruebas múltiples de ácidos nucleicos destinadas a la detección e identificación simultánea de dianas de ácidos nucleicos mediante el procesamiento de cartuchos de un solo uso desarrollados y fabricados por GenMark Diagnostics, Inc.", "Country": "XG", "Code": "Intended Use", "Name": "Intended Use" }, { "Language": "en", "Value": "System configurations

1-Tower System

• 1 Base (#09556621001)
• 1 Tower, 6-bay front tower fascia, 6 bays (#09782702001)
• 1 short tower bolts (#09792074001, 3 pieces)
• 1 Barcode scanner, Magnetic mount (#09792104001)

2-Tower System

• 1 Base (#09556621001)
• 2 Tower, 6-bay front tower fascia, 6 bays (#09782702001)
• 2 short tower bolts (#09792074001, 3 pieces) *
• 1 long tower bolts (#09792066001, 3 pieces) *
• 1 Barcode scanner, Magnetic mount (#09792104001)

* Note: Must order EITHER qty=2 short bolts OR qty=1 long bolts. The standard configuration is qty=2 short bolts. It is not necessary to order both.

3-Tower System

• 1 Base (#09556621001)
• 3 Tower, 6-bay front tower fascia, 6 bays (#09782702001)
• 1 short tower bolts (#09792074001, 3 pieces)
• 1 long tower bolts (#09792066001, 3 pieces)
• 1 Barcode scanner, Magnetic mount (#09792104001)

4-Tower System

• 1 Base (#09556621001)
• 4 Tower, 6-bay front tower fascia, 6 bays (#09782702001)
• 2 long tower bolts (#09792066001, 3 pieces)
• 1 Barcode scanner, Magnetic mount (#09792104001)

", "Country": "XG", "Code": "Background Information", "Name": "Background Information" } ] } } ] }