The FDA is trying to rein in the chaos it created by allowing companies to flood the market with COVID-19 antibody tests of questionable accuracy.
warning that, given the low prevalence of the virus in the general population, even the most accurate tests could be wrong half of the time.“Serologic test results should not be used to make decisions about grouping persons residing in or being admitted to congregate settings, such as schools, dormitories, or correctional facilities,” the guidelines state.
“Serologic test results should not be used to make decisions about returning persons to the workplace.” Such tests are most useful for understanding the epidemiology of the virus, not for making individual decisions, said Dr. Mary Hayden, director of the division of clinical microbiology at Rush Medical Laboratories in Chicago. Even the best tests can’t yet answer the crucial question about whether antibodies confer immunity from future COVID infections, Hayden said. “The best possible scenario is that people get infected and they have protective immunity for a long time,” she said. “That would be awesome. But we just don’t have [evidence of] that right now.” But a plethora of tests being pitched to consumers explicitly promise results aimed at allowing a return to work, school and other social arenas.The tests offered by Because Health are among hundreds churned out since March from a variety of commercial labs, academic research centers and small developers seeking a toehold in the lucrative market spurred by the global pandemic. Because Health is using two antibody tests in tandem, one of which received emergency-use authorization on May 29; that authorization for the other is still pending. Anders Boman, the son of the medical director and co-founder of Because Health, said that until the COVID-19 crisis occurred, the company that launched in Seattle last year was focused on “a niche of integrative care and sexual health,” including hormone treatments for men and women. “Consumers are not concerned about sexual health right now,” Boman said, explaining the change in focus. “They’re concerned about how to get back to work, how to return to normal and are they safe?” The FDA normally follows a stringent approval process for tests to detect diseases, often a costly effort that can take months or years. That typically requires independent validation of the accuracy of the tests. But after being criticized for the fumbled rollout of diagnostic tests during the start of the current pandemic, the FDA swung hard in the other direction, waiving its usual requirements and letting firms rush self-validated tests onto the market.Several experts interviewed by Kaiser Health News said the FDA faced tremendous political pressure to make antibody tests available. “It was really a single pressure — and that was the fact that the original inability to get a [diagnostic] test on the market in the U.S. as the outbreak escalated means they were trying to do basically everything they could to get these out,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. The relaxed rules drew concern from Congress, where a subcommittee of the House Committee on Oversight and Reformthe FDA’s failure to “police the test market.” Groups such as the Assn. of Public Health Laboratories also raised questions. Scott Becker, the APHL’s chief executive, said he spoke to top officials at the U.S. Department of Health and Human Services in early April.“We just let loose and we said, ‘This is a really bad policy,’” Becker said. “‘We’re going to get flooded and we’re going to lose control of quality. We’re not going to know what to do with the results.’” That’s exactly what has happened, said Osterholm. “The FDA needs to bring much more discipline to this area and they need to articulate it clearly,” he said.
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