Across America, untold numbers of employers, employees and ordinary citizens are turning to a slew of sometimes pricey new COVID-19 blood tests. Knowing who’s already been infected could have important implications for understanding the spread of the disease, scientists say. But serious questions about the accuracy of some of the serology tests — and the usefulness of the results they provide — have prompted the federal Food and Drug Administration to try to rein in what several infectious disease experts described as “the wild, wild West” of antibody testing.
Unreliable results worry Dr. Jeff Duchin, the public health officer for Seattle and King County, Washington, where the first surge of COVID cases emerged in the U.S. A person who tests positive for antibodies that don’t exist may mistakenly believe he or she is free to ignore guidance about preventing infection, potentially spreading the disease. “Regardless of whether you test positive or negative, the workplace still needs to take steps,” he said. “They shouldn’t think a testing program in any way relieves them of that responsibility.”
FDA officials said they’re working now with the National Cancer Institute to independently validate serology tests on the market. Until that list is public, users must rely on the relatively few that have received the emergency-use authorizations to date.