FDA grants EUA for Abbott’s 5-minute COVID-19 POC test

March 30, 2020

Abbott has received an emergency use authorization (EUA) from the Food and Drug Administration (FDA) for a molecular point-of-care (POC) test for the detection of the novel coronavirus, which causes COVID-19.

The test delivers positive results in as little as five minutes and negative results in 13 minutes, the company said in a news release. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2.

The new Abbott ID NOW COVID-19 test runs on Abbott's ID NOW platform—a lightweight box (6.6 pounds and the size of a small toaster) that can be used in a variety of non-traditional locations, such as physician’s offices or urgent care centers.

Abbott said it is ramping up production to deliver 50,000 ID NOW COVID-19 tests per day, beginning this week. Several weeks ago, Abbott received an EUA from the FDA for a RealTime SARS-CoV-2 test, which runs on m2000 RealTime molecular system for centralized lab environments.

Abbott has the announcement.

More COVID-19 coverage HERE.