FDA grants emergency use authorization for Abbott’s portable POC test
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.
