Abbott Receives FDA Authorization for a $5 App-Enabled 15-Minute COVID-19 Test

The biggest issues with COVID-19 testing have been speed and cost. Abbott Laboratories' (NYSE: ABT) newest offering seems to have those covered, and the healthcare company is even providing a phone app that will display negative results for customers who need to prove that they're not infected with the novel coronavirus that causes COVID-19.

Abbott's BinaxNOW COVID-19 Ag Card test, which is about the size of a credit card, can generate a result in 15 minutes and costs $5 per sample. The test, which was issued an emergency use authorization by the Food and Drug Administration, detects viral proteins to determine if the patient has been infected with the novel coronavirus. Results of the test will show up on Abbott's free Navica app, which will be available for both iPhone and Android devices.

Patient in a car getting a nasal swab

Image source: Getty Images.

Unlike molecular tests, which detect viral RNA, Abbott's test doesn't require additional hardware. The test can't be self administered, but a wide range of practitioners, including doctors, nurses, school nurses, medical assistants and technicians, pharmacists and employer occupational health specialists, are able to run the test.

The BinaxNOW COVID-19 Ag Card test isn't perfect. It has a sensitivity of 97.1%, meaning 2.9% of positive cases will be missed, and a specificity of 98.5%, meaning 1.5% of people will test positive even though they don't have COVID-19. Despite the small expected inaccuracies, the results are pretty good for a cheap test that only takes 15 minutes to run.

Abbott plans to ship tens of millions of tests in September and will ramp up to 50 million tests a month at the beginning of October.

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