Abbott Labs Receives FDA Approval For COVID-19 Rapid Test

news Aug 30, 2020

Published by Anthony Di Pizio

Abbott's Rapid Test Breakthrough

On August 26th Abbott Laboratories announced that its BinaxNOW COVID-19 test received Emergency Use Authorization (EUA) from the FDA. This is the first approved test that doesn't require laboratory instrumentation to detect active Coronavirus infections in patients, meaning it could be one key to reopening economies and borders.

The test is the size of a credit card and can deliver a result in 15 minutes. It requires a nasal swab which is then tested using Abbott’s proven lateral flow technology to detect antigens. If the patient is negative, they will receive a special QR code direct to an Abbott-designed app on their phone (called NAVICA) which organisations can scan for confirmation. The QR code will come with an expiration date determined by the requirements of the given organisation. 

Right now, the test only detects infections within 7 days of someone showing symptoms and may only be administered by a healthcare professional. However, it can be used in point-of-care settings that are operating under a CLIA (Clinical Laboratory Improvement Amendments) which broadens the scope of use to:

  • Doctors
  • Nurses
  • School nurses
  • Medical assistants and technicians
  • Pharmacists
  • Employer occupational health specialists

with minimal training and a prescription.

The test demonstrated a sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement). Abbott Labs is conducting further clinical trials on asymptomatic people in hopes of expanding its FDA authorisation.

The Key to Opening Economies and Borders?

Picture a situation where you can get a rapid COVID-19 test the day of your domestic or international flight, as required by the airline. If you're negative, your QR code is scanned at check-in time to prove it and you're allowed to board. In lieu of a vaccine, this is the technological bridge needed to prevent the spread of the virus which could allow us to return to normal much more quickly. 

The results from the ongoing clinical trial on asymptomatic people are absolutely key to this scenario, as these people spread the virus silently and unknowingly. A test that is effective on this portion of the population is imperative to further progress - this will allow the rapid test to become a mainstream weapon against the virus and not just a relief tool to ease pressure on laboratories. The ability to test everybody on a daily basis with immediate results is the best chance we have at the free movement of people prior to a widely administered vaccine. 

On that note, it’s important to remember that this doesn’t make the virus go away. It is not a vaccine or a silver bullet. However it will allow us to identify and isolate people much more quickly and effectively, helping to mitigate further spread in addition to green-lighting normalcy for healthy people.  

Abbott Laboratories will begin shipping the tests in September, with 50 million per month expected to be distributed from October onwards.

For the full press release by the company see here

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