2. What’s the government doing to ensure the tests are accurate?
The FDA said in March that it would allow companies to develop and distribute validated antibody tests without review under certain circumstances — including that test-makers notify the agency and include disclaimers in test results.
More than 90 tests are now on the market, and most have bypassed FDA review. Diagnostic manufacturers, public health labs and commercial labs have raised concerns about the accuracy of these tests. They want the FDA to take a tougher regulatory approach to ensure the quality of antibody tests.
Top government officials, including HHS testing “czar” Brett Giroir and Hahn, have said the public should only rely on antibody tests reviewed by the FDA. But the agency has given emergency authorization to only one such test, manufactured by Cellex.
“There should be a strong evaluation process that goes on ahead of getting these tests out there,” APHL CEO Scott Becker told POLITICO.
The National Institutes of Health, Centers for Disease Control and Prevention and the FDA are each working to assess the accuracy of antibody tests that haven’t yet undergone FDA review.
“There has been some concern about the accuracy of at least some of these tests, so the FDA in collaboration with other agencies is standing up a voluntary program to help address and verify their accuracy,” FDA diagnostics chief Tim Stenzel said on a webinar last week.
3. Will widespread antibody testing be available soon?
The Trump administration said over the weekend that it would require most private insurers to cover coronavirus antibody testing at no cost to consumers. But so far, very few Americans have undergone such testing.
Giroir and other members of the administration have predicted that “tens of millions” of antibody tests will soon be under production, but it is unclear how soon they will reach the public.
“I think we’re still weeks away from the logistical aspects of this kind of mass testing program,” Becker said. “We in public health are looking for a high-quality test that can be used for serology studies to understand the dynamics of immunity within each community.”
Once the logistics of administering tests are resolved, frontline health care workers should have priority, said former acting CMS Administrator Andy Slavitt. That can help workers who suspect they’ve been exposed to the virus return to work if they have antibodies.
“It will be important in the future and at least important for health care workers in New York and other places,” Slavitt told POLITICO. But until more is understood about potential immunity gained after being exposed to the virus, he added, antibody tests are “unlikely to be a game changer.”