Blood tests for the coronavirus could play a key role in getting Americans back to school and work. But public health officials warn that the current “Wild West” of unregulated tests is creating confusion that could ultimately slow the path to recovery.
could play a key role in deciding whether millions of Americans can safely return to work and school. But public health officials warn that the current “Wild West” of unregulated tests is creating confusion that could ultimately slow the path to recovery.
Because of the relative simplicity of the technology, the Food and Drug Administration decided to waive initial review of the tests as part of its emergency response to the coronavirus outbreak. Members of Blank’s group, which represents state and local lab officials, have urged the FDA to revisit its lax approach toward the tests. That approach essentially allows companies to launch as long as they notify the agency and include disclaimers. Companies are supposed to state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected.
Dr. Allison Rakeman of New York City’s Public Health Laboratory says some local hospitals are assuming the tests, which are listed on FDA’s website, “have been vetted, when they have not.” For many infections, antibody levels above a certain threshold indicate that the person’s immune system has successfully fought off the virus and is likely protected from reinfection. For COVID-19, it’s not yet clear what level of antibodies render patients immune or how long immunity might last.
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