May 11, 2020 - Health

FDA grants emergency use authorization for Abbott coronavirus antibody test

Marisa Fernandez

Transmission electron microscopic image of an isolate from the first US case of COVID-19 — 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.

Go deeper: U.S. doubles payment for some coronavirus tests

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FDA grants emergency use authorization for Abbott coronavirus antibody test

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