The federal government has received plenty of well-deserved flack for slow-rolling the national launch of diagnostic tests for Covid-19. First came the flawed swab-based tests from the Centers for Disease Control and Prevention, followed by a chaotic, lost month of regulatory tango that prevented independent tests from getting scaled and out the door. So when interest arose in a different kind of testing—antibody blood tests, which are used to find evidence of past infection, not a current diagnosis—the US Food and Drug Administration was under pressure to hurry things along. In mid-March, the agency loosened its rules, declaring via an update to its emergency use guidance that antibody tests could be sold without seeking the agency’s approval, provided that manufacturers did their own validation.
How Long Does the Coronavirus Live on Surfaces?
Plus: What it means to “flatten the curve,” and everything else you need to know about the coronavirus.
Now FDA officials are walking back that decision. Facing criticism that the loosened policy has undammed a flood of flawed tests and fraudulent marketing, agency officials revised their rules Monday to require manufacturers to submit their tests for validation and meet specific standards for accuracy.
“Flexibility never meant we would allow fraud,” wrote Anand Shah, an FDA deputy commissioner, and Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a blog post elaborating on the changes. They called out “unscrupulous actors” who were “using the pandemic as an opportunity to take advantage of Americans’ anxiety.”
So far, the FDA has approved 12 antibody tests through the emergency use process—including those from large manufacturers such as Roche, Ortho, and Abbott—and most of them only in the last few days. Yet agency officials say that more than 160 others are being sold in the US without the FDA’s authorization. They note that some companies have used the agency’s tacit allowance of the tests to market their tests as “FDA approved,” in explicit violation of the earlier guidance.
But fraud isn’t the only issue. One of the key performance problems with antibody tests has been false positives. That’s when a test erroneously signals that
