FDA tightens rules on coronavirus antibody tests after accuracy concerns

The Food and Drug Administration on Monday tightened rules for coronavirus antibody tests, ordering manufacturers to submit emergency use authorization forms and data proving the tests work within 10 days or face possible removal. 

So-called serological, or antibody, tests can indicate whether a person has had Covid-19 in the past and was either asymptomatic or recovered.

So far, 12 antibody tests have been authorized by the FDA for emergency use, and more than 250 tests are currently the subject of a pre-EUA, FDA Commissioner Stephen Hahn told reporters Monday during a press briefing. 

The agency is also providing performance threshold recommendations for antibody test developers and is introducing a streamlined process to support EUA submission forms, Hahn said. 

“High-quality antibody tests or serologic tests can help us understand a person and population’s exposure to Covid-19,” he added.

U.S. officials and corporations across America are pouring money into antibody testing, hoping it will give people the confidence to return to work and reopen parts of the economy. President Donald Trump has recommended states use the tests as they start relaxing some of the strict social distancing measures imposed to combat the pandemic.

This is a developing story. Please check back for updates.