FDA grants emergency use authorization for Abbott coronavirus antibody test
Microscopic image of an isolate from the first U.S. case of COVID-19. Photo: Smith Collection/Gado/Getty Images
The FDA granted Monday an emergency use authorization for a new coronavirus antibody test by Abbott Laboratories.
Why it matters: Companies are pushing to create antibody tests, which indicate whether a person had the coronavirus in the past, including those who were asymptomatic.
- The company wants to ship nearly 30 million tests in May and 60 million by June, per a press release.
- Abbott says the test can give results of 99.6% specificity and 100% sensitivity for patients tested 14 days after symptoms began.
The big picture: The Trump administration has recommended that these tests be offered as states begin to reopen some businesses so Americans can feel confident about returning to work.
- Abbott's antibody test is its fourth coronavirus-linked emergency use authorization from the FDA.
- Its rapid test for coronavirus infections, which produces results in just minutes, is used at the White House.
Worth noting, via Axios' Caitlin Owens: We don't actually know whether antibodies are necessarily indicative of immunity — or how strong that immunity might be.
- The best value here is in understanding the virus' true spread and helping the highest-risk workplaces operate more safely — not as any kind of universal, nationwide get-back-to-normal permit.