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17th August 2020  Product update: rapidmicrobiology staff writer

RT-PCR & MALDI-TOF COVID-19 Assay Receives FDA Authorization


Ethos Laboratories has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SARS-CoV-2 MALDI-TOF Assay.

The SARS-CoV-2 MALDI-TOF Assay is a high-throughput molecular SARS-CoV-2 panel that tests for the novel coronavirus that causes COVID-19.

Ethos is the first laboratory in the nation to receive EUA for this technology and workflow. The matrix-assisted laser desorption ionization-time of flight mass spectrometry or (MALDI-TOF MS) in this authorization allows Ethos to process a sample in 12 hours.

The majority of samples are processed, and results are released within one business day of receipt at the lab.

The wide availability of this testing and the one-day turnaround will greatly benefit the following:

  • Public Health, with contact tracing efforts to help limit the spread of infection in communities

  • The travel industry, where carriers, hospitality organizations, and state and county governments require travelers to have recent negative COVID-19 tests to conduct business and personal travel safely.

  • Health providers, who need patients to provide current COVID-19 status to perform required procedures safely.

  • Businesses, which need reliable, available testing with prompt results to initiate safe return-to-work programs for their offices

  • Back to school preparation and ongoing surveillance to ensure a safe learning environment for faculty and students.

Ethos is working with local community leaders and health care providers to ensure access to this FDA-authorized testing.

"We evaluated several different technologies to meet the demands of this pandemic best. Ethos' FDA-authorized test uses technology that limits supply chain issues related to reagents while still providing high throughput and fast turnaround time," said Joshua Gunn, CSO of Ethos Research and Development.

The Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay is also authorized for use with the Ethos Laboratories U-Collect At Home Collections kit for self-collection of nasal swab specimens at home by individuals when determined and prescribed by a healthcare provider to be appropriate based on the results of an online COVID-19 questionnaire or scheduled visit.

This testing is currently available at Ethos Laboratories in Newport, Kentucky and select pop-up locations. To schedule a test, please visit www.ethos-labs.com


    

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Date Published: 17th August 2020

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.


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