FDA tightens enforcement on Covid-19 antibody tests

15 Apr, 2020

After loosening restrictions on antibody tests, the US Food and Drug Administration has decided government scientists will review data on lab tests that claim they can detect if someone has antibodies to Covid-19, according to the CEO of a lab association who was on a call with FDA officials Tuesday morning.


On March 16, the FDA loosened its standards and allowed companies to sell antibody tests without submitting any evidence that they worked.
That led to "crappy" tests flooding the market, according to Scott Becker, CEO of the Association of Public Health Laboratories.

Dr. Deborah Birx, the response coordinator for the White House coronavirus task force, has called antibody tests "critical" in the response to the pandemic.
If someone has antibodies, they could be immune to the disease. On a small scale, if someone is immune, it can help them make decisions about going back to work and back out into the community. On a larger scale, knowing what percent of the population is immune can help officials make decisions about re-opening the country.

It's crucial that the tests work properly. A false positive -- telling someone they have antibodies when they don't -- could have grave consequences, since that person would then think they're immune to Covid-19 when they're not.
"A test is only as good as its result," said Kelly Wroblewski, director of infectious disease programs for the lab association, which represents more than 125 state, county and municipal public health labs in the US. "Having many inaccurate tests is worse than having no tests at all."

On Tuesday's call, Becker said FDA Commissioner Stephen Hahn told him and members of his association that the National Cancer Institute (NCI) would start reviewing tests that are on the market to see if they obtain correct results.
"I'm happy they've taken these steps," Becker told CNN after the call.
"We're hopeful that the evaluation will be completed very soon and that that data is going to be made available, so that we can get a sense of the quality of these tests," Wroblewski added.

In recent interviews, Hahn has talked about the need to review the tests.
"I am concerned that some of the antibody tests that are on the market that haven't gone through the FDA scientific review may not be as accurate as we'd like them to be," he told NBC's "Meet the Press" on Sunday. "I can assure the American people that what we're doing is using data and science to look at those tests to make sure they're valid, they're accurate, and they're reproduceable."

More than 90 companies have informed the FDA that they're selling antibody tests. Becker said it's not clear how many tests the NCI will be reviewing to see if they work.
He said members of his association, which represents more than 125 state, county and municipal public health labs in the US, would have preferred that the FDA change the rules to make it so that companies have to provide data showing that their tests work.
"The floodgates were opened and now the consequences of that are becoming apparent," he said. "Now they're putting in some flood control measures to verify accuracy. It would have been ideal if these measures were in place in the first place, but this is a good step given where we are in this pandemic."
The FDA did not respond to questions for this story, referring CNN to the NCI.