For in vitro diagnostic use. System GenMark ePlex system IVD ePlex® system SYS_356 09 792 074 001 9 792 074 001 09792074001 9792074001 09792074001 GM EPLEX SHORT TOWER BOLTS GM EPLEX SHORT TOWER BOLTS Accessories general (hardware) RM007103 Not Available Not Available 09 782 702 001 9 782 702 001 09782702001 9782702001 09782702001 GM EPLEX 6 BAY TOWER KIT GM EPLEX 6 BAY TOWER KIT Instruments RM007121 Not Available Not Available 09 792 066 001 9 792 066 001 09792066001 9792066001 09792066001 GM EPLEX LONG TOWER BOLTS GM EPLEX LONG TOWER BOLTS Accessories general (hardware) RM007102 Not Available Not Available 09 792 104 001 9 792 104 001 09792104001 9792104001 09792104001 GM EPLEX BARCODE SCANNER AND MOUNT GM EPLEX BARCODE SCANNER AND MOUNT Accessories general (hardware) RM007001 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 The ePlex system is used to run multiplex microarray-based assays developed by GenMark. This type of assay is based on the principles of competitive nucleic acid hybridization using a sandwich assay format, wherein a single-stranded target binds concurrently to a sequence-specific solution-phase signal probe and a solid-phase electrode-bound capture probe. The test employs nucleic acid extraction, target amplification via polymerase chain reaction (PCR) or reverse transcription PCR (RT-PCR) and hybridization of target DNA. In the process, the double-stranded PCR amplicons are digested with exonuclease to generate single-stranded DNA suitable for hybridization. en

cobas® eplex system

IVD

True sample-to-answer solution

The cobas® eplex system sample-to-answer solution streamlines the diagnostic workflow from your order entry to the release of the final report.

cobas® eplex system improvements

Leveraging 7 years of continuous input and 24 months of direct customer engagement through interviews and concept modeling

Improved user workflows
Refined reporting capabilities
Concurrent run serviceability
Direct connect support emails
Enhanced responsiveness
Field repairable
Improved reliability
Sustainable packaging

True sample-to-answer workflow

Bi-directional LIS to automate and accelerate order entry and results reporting
Random and continuous access and a modular, scalable design to
ensure capacity that meets peak season demand
Less than 1 minute hands-on time
Remote alerts to notify when test results are available
Intuitive user interface with guided workflows to enable operation on every shift
Remote service capability to minimize system downtime and ensure patients and physicians have access to rapid test results

Order-to-report is what matters most

The cobas® eplex system is designed for order-to-report with a lean workflow by eliminating manual steps and staging of samples that often delay and complicate efficient test processing and results reporting.

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Designed for the patient, optimized for the lab

The cobas® eplex system sample-to-answer capabilities integrate the whole process from order-to-report to better realize the patient and laboratory benefits of rapid, multiplex molecular diagnostics.

The ePlex^® System offers many unique solutions that were thoughtfully engineered to address the biggest challenges you face in the clinical laboratory and to support hospital systems in delivering patient centered, value-based care.

Designed for the patient to reduce avoidable medical errors

Preventable medical errors are now the third leading cause of death in the United States at more than 250,000 per year.¹ Automating information transfer has been shown to be effective in reducing many common errors, including patient identity checking and order transcription.²

The ePlex^® System is uniquely designed with patient safety features in mind so that labs and physicians can have the confidence that they have the right patient, with the right test, and the right result, every time.

Reduce the chance of pre-analytical errors with less than 1 minute hands-on time and guided workflows
Transcription errors can be eliminated in both order entry and result reporting with bi-directional LIS

Optimized for the lab to maximize lab efficiency by reducing administrative overhead

Monitoring and reporting quality control testing is both a requirement and a best practice to ensure accuracy of patient results and compliance with lab standards. With on-board QC tracking capabilities and safeguards, you can not only run controls when required, you can also easily track and report compliance.

In addition to automated control tracking, the ePlex^® System provides the following compliance and data management tools:

Integrated data analytics to easily monitor lab performance
On-demand epidemiology reports for export and simplified analysis
Fully configurable, auto-release of test results

All of these unique capabilities of the ePlex^® System allow you to reduce the time spent on routine administrative tasks and focus your limited resources on high-value activities that impact patient care and the bottom line.

cobas® eplex system: Sample-to-answer solution

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A modular and scalable system

cobas® eplex system NP

3 test bays
Throughput (24 hours): 36 patient samples per day*
Physical dimensions (H x D x W): 23.5" x 19.0" x 21.3",
59cm x 48cm x 54cm

cobas® eplex system 1 tower

6 test bays
Throughput (24 hours): 72 patient samples per day*
Physical dimensions (H x D x W): 23.5" x 19.0" x 21.3",
59cm x 48cm x 54cm

cobas® eplex system 2 tower

12 test bays
Throughput (24 hours): 144 patient samples per day*
Physical dimensions (H x D x W): 23.5" x 19.0" x 28.5",
59cm x 48cm x 72cm

cobas® eplex system 3 tower

18 test bays
Throughput (24 hours): 216 patient samples per day*
Physical dimensions (H x D x W): 23.5" x 19.0" x 35.8",
59cm x 48cm x 91cm

cobas® eplex system 4 tower

24 test bays
Throughput (24 hours): 288 patient samples per day*
Physical dimensions (H x D x W): 23.5" x 19.0" x 43.0",
59cm x 48cm x 109cm

^*Based on 24 hour day

Specifications

Weight 1-tower system

49kg (108 lbs)
Dimensions 1-tower system

59 cm x 48 cm x 54 cm (24.0” x 19.0” x 21.0”)
LIS compatibility

ASTM LIS 1-A & LIS 2-A2 (Bi-directional); HL7 v2.3 (Bi-directional); Flat file (.csv, .xml and .txt)
Supported barcodes

Aztec, Codabar, Code 39, Code 93, Code 128, Data Matrix, EAN, Interleaved 2 of 5, JAN, MaxiCode, UPC
Power requirements

100-240 Vac, 50/60 Hz
Environmental conditions

Ambient temperature: 15 – 30°C; relative humidity: 15 – 85% (non-condensing)
Noise generation

≤ 60dBA

Intended use

The cobas® eplex system is an automated in vitro diagnostic device designed to perform multiplexed nucleic acid tests for the simultaneous detection and identification of nucleic acid targets by processing single-use cartridges.

Registration status

US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics local website.

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