FDA Approves 15-Minute COVID-19 Antigen Test

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the first antigen test capable reading of coronavirus 2019 (COVID-19) results directly from the testing card.

The authorization, granted to Abbott Diagnostics Scarborough’s BinaxNow COVID-19 Ag Card, will allow for in-person results within minutes from the device. The FDA likened its design and immediate convenience to some pregnancy tests.

The test requires a healthcare provider swap the patient’s nose and place samples on a test card with an attached testing reagent. After 15 minutes, the provider is able to read results directly—1 line indicating negative, 2 indicating positive.

In a statement accompanying the authorization, Jeff Shurden, MD, JD, director of the FDA’s Center for Devices and Radiological Health, noted the FDA anticipates a greater rate of COVID-19 tests in coming months. He praised the new antigen test as an “an important advancement in our fight against the pandemic.”

Abbott anticipates to produce 50 million tests monthly in the US starting October 2020.

The test available for use at point-of-care settings, including physician’s offices, emergency settings, or certain schools. It’s been authorized for use in patients with suspected COVID-19 as advised by their healthcare provider within 7 days of symptom onset.

Advising on the use of antigen tests, the FDA emphasized they are very specific—but lack molecular tests’ sensitivity.

“Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the FDA wrote. “Negative results from an antigen test should be considered in the context of clinical observations, patient history and epidemiological information.”