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AB Molecular – GenMark ePlex® Multiplex PCR Respiratory Panel and SARS-CoV-2

D2

GenMark Responds to the SARS-CoV-2 Outbreak

On March 19, 2020, GenMark Diagnostics announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the company’s ePlex® SARS-CoV-2 Test. Read our press release to learn more.

The ePlex SARS-CoV-2 Test is an automated qualitative nucleic acid multiplex assay designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal swabs collected in viral transport media. This test is performed on the ePlex® Sample-to-Answer System capable of automating all aspects of nucleic acid testing including extraction, amplification, and detection in a single-use cartridge.

The ePlex System: The True Sample-to-Answer Solution®

Designed to improve true turnaround time, the ePlex® System automates the entire testing process from sample-to-report with the simplest workflow and shortest hands-on time.

ePlex SARS-CoV-2 Test Workflow

Less Than 2 Minutes Hands-On Time

  • Load Sample
  • Load Cartridge
  • Report Results

Respiratory Pathogen Panel

GenMark’s ePlex Respiratory Pathogen Panel (RP) detects and identifies the most common viral and bacterial organisms associated with upper respiratory infection.

>20 common respiratory pathogens

Validated clinical performance

Rapid, accurate, actionable results

Improve patient outcome

Reduce the cost of care

Influenza is often the first pathogen that comes to mind with a respiratory infection, but many other virus and bacteria have a similar clinical presentation.

Comprehensive detection of the most common viral and bacterial pathogens ensures that each patient is given the most appropriate treatment quicker.

Due to the simplicity of the ePlex® system it lends itself perfectly to point of care settings with only 2 minutes hands on time per sample.

Comprehensive Coverage of the Most Common Respiratory Pathogens

Viral Targets

  • Adenovirus
  • Coronavirus 229E
  • Coronavirus HKU1
  • Coronavirus NL63
  • Coronavirus OC43
  • Middle East Respiratory
  • Syndrome Coronavirus (MERS-CoV)
  • Human Bocavirus
  • Human Metapneumovirus
  • Human Rhinovirus/Enterovirus
  • Influenza A
  • Influenza A H1
  • Influenza A H1-2009
  • Influenza A H3
  • Influenza B
  • Parainfluenza 1
  • Parainfluenza 2
  • Parainfluenza 3
  • Parainfluenza 4
  • Respiratory Syncytial Virus A
  • Respiratory Syncytial Virus B

Bacterial Targets

  • Bordetella pertussis
  • Chlamydia pneumoniae
  • Legionella pneumophila
  • Mycoplasma pneumoniae

Have you validated this method, if so, how and what were the results of the validation?

The ePlex RP and SARS-CoV-2 panels are fully validated for clinical use.

Is the method already deployed in a UK hospital or clinical setting?

The GenMark Diagnostics ePlex system and Multiplex Respiratory Panels, SARS CoV-2 test, and BCID panels are already deployed in several UK hospitals. Current customers have shown a desire to transition from the stand-alone SARS-CoV-2 test to the full syndromic RP2 panel once launched.

Where is the kit manufactured?

The ePlex technology and panels are manufactured in the USA. 

What is the turn around time (sample-to-result) for this method?

True Sample-to-Answer Workflow

The ePlex® system is the only sample-to-answer solution on the market that streamlines the diagnostic workflow from physician order entry to the release of the final report in ~90 minutes.

  • 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
  • Independently validated shortest hands-on time in the lab
  • Remote alerts to notify practitioners 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

How will your solution communicate directly with the Laboratory Information Management System (LIMS)?

Laboratory Information System (LIS)

Bi-directional LIS integration improves result turnaround time and reduces risk of transcription errors

  • Pending test orders dashboard enables immediate visibility of incoming samples to determine daily workload
  • Integrated auto-validation control to manage automatic result release to LIS
  • Drivers available for all major LIS vendors
  • There is no limitation to HL7, ASTN, or third party middleware solutions

Software Designed to Improve Efficiency and Patient Care

The ePlex software combines major enhancements that incorporate customer feedback with the customization freedom and intuitive user interface required to support the diverse and changing needs of the laboratory and healthcare systems. With each release, we have introduced more enhancements to streamline tasks across the diagnostic process from order-to-report. The ePlex software is designed to improve productivity at every level. The newest version of the ePlex software offers a number of new features to help drive efficiency in the delivery of patient centered care.

How quickly could this be deployed and what are the dependencies?

The current ePlex RP panel and stand-alone SARS-CoV-2 test  are currently available to NHS hospitals in the UK.

What is the likely production volume?

To be announced.

What are the risks and barriers to using this at scale?

Modular and Scalable to Meet the Demands of Any Institution

The ePlex system offers a modular and scalable design that provides a simplified path to adding capacity. With five different instrument configurations that range from 3 to 24 test bays, ePlex delivers consistent order-to-report service levels across institutions of any size. ePlex NP (Near Patient) brings syndromic testing closer to the patient at institutions running as few as 12 patient samples per shift. The ePlex 4 Tower configuration outpaces any sample-to-answer platform in some of the world’s largest diagnostic laboratories.

Who are you already partnering with on this?

At present, AB Molecular, with the support of GenMark Diagnostics, are partnering with a number of public health bodies and NHS Trusts, along with private commercial pharmaceutical customers across the UK.

edited on Jun 16, 2020 by Christopher Rawlinson
Christopher Rawlinson

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Bev Matthews 6 months ago

Status label added: D2

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Bev Matthews 6 months ago

Thank you Christopher, your solution has been reviewed and will be shared with the relevant colleagues who are focusing on this issue. Thank you Bev

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