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Antibody Tests Go To Market Largely Unregulated, Warns House Subcommittee Chair

A woman holds her hand out to have blood collected for a 15-minute test for coronavirus antibodies at a drive-through site in Hempstead, N.Y.
Seth Wenig
A woman holds her hand out to have blood collected for a 15-minute test for coronavirus antibodies at a drive-through site in Hempstead, N.Y.

Coronavirus antibody tests have garnered attention from officials as a potential tool to evaluate people's immunity to the illness. But the majority of companies creating the tests have had little to no regulatory oversight, according to the chair of the House Subcommittee on Economic and Consumer Policy.

Antibody tests, when accurate, can detect if someone has been exposed to the coronavirus in the past. More than 100 of these tests have been brought to market in the last several weeks, but the majority of them are not being tested by the Food and Drug Administration, said Raja Krishnamoorthi (D-Ill.) in an interview on Sunday with NPR's Weekend Edition.

Krishnamoorthi said that federal officials have told his subcommittee that companies selling antibody tests can go one of two routes as they seek to bring their products to market.

"One is to basically get authorization from the FDA to sell them, and four companies have taken advantage of that. And then the other is not to get any authorization from the FDA and go ahead and sell them, and 107 have taken advantage of that."

In lieu of mandatory FDA authorization, the majority of antibody test-makers are "self-validating," according to Krishnamoorthi.

"Because of this kind of voluntary compliance type of regimen," he said, "there is absolutely no incentive for a junk test-maker to actually produce their results to the FDA."

He added: "A Wild West of unregulated tests are now proliferating, and our biggest concerns are that they are unreliable, inaccurate and in many cases making fraudulent claims about their testing results."

Even if test results are accurate, scientists still have many questions about what the presence of coronavirus antibodies means.

Some officials have suggested that people who have coronavirus antibodies in their blood would be safe from reinfection, or immune from the disease.

But scientists have urged skepticism about this idea. In a brief dated Friday, the World Health Organization cautioned, "There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection."

A major challenge in the global pandemic has been timely, accurate testing. Without population-wide testing, there are looming questions around how prevalent the disease really is.

That's where accurate, widespread antibody testing could come in.

"Right now, only use a test that has been authorized by the FDA," Krishnamoorthi advised. "They've listed a handful of tests that have actually been authorized on their website."

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Hannah Hagemann is a 2019 Kroc Fellow. During her fellowship, she will work at NPR's National Desk and Weekend Edition.