FDA Authorizes First Rapid, Simple COVID-19 Test

Aug. 27, 2020

The FDA approved emergency use authorization for the first rapid COVID-19 antigen test that displays results on a testing card in 15 minutes. Abbott Laboratories, based in Chicago’s northern suburbs, manufactured the BinaxNOW™ COVID-19 Ag Card test, which does not require the use of an analyzer.

Here’s how the test works:

  • A healthcare workers swabs the individual’s nose and places the sample on a specially coated strip about the size of the credit card.   
  • After 15 minutes, markings appear on the card: one line for a negative result, two lines for a positive result—similar to a pregnancy test.   
  • The test can be administered in point-of-care settings including a doctor’s office, emergency room or school, but not at home.

“This means people will know if they have the virus in almost real-time,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic.”

Starting in October, Abbott plans to make up to 50 million tests available monthly nationwide, with each test costing $5. The FDA notes that because antigen tests are not as sensitive as molecular tests, negative results should be considered in the context of clinical observations, patient history and epidemiological information.

More information is available in an Abbott news release.