Rapid At-Home Tests for COVID-19 Finally Get FDA Approval. But People Still Need a Prescription.
While coronavirus case counts keep rising and states keep imposing impractical new restrictions, this week also feels like a potential turning point in our pandemic experience. Initial COVID-19 vaccine trials from two different pharmaceutical companies—Pfizer and Moderna—have shown very promising results and the U.S. Food and Drug Administration (FDA) has finally approved an at-home rapid test for the virus. The single-use test, made by Lucira Health, can deliver results in 30 minutes.
Rapid results testing for COVID-19 is still scarce in a lot of places in the U.S., and at-home tests that don’t need to be mailed into a lab for processing have been banned, so the Lucira test’s approval is a big deal.
But at-home testing—and all its game-changing potential—is still being limited by government regulators, who will require people to get a prescription for the home test kit. Unless every single person gets prescribed the test via telemedicine, this ridiculous FDA rule has the potential to not only make at-home testing more difficult, less useful, and less widespread, but it could also put people at more risk.
Unfortunately, this sort of counterproductive meddling has been a recurring theme throughout the pandemic (and, well, always) for the FDA. The agency has so far been holding up at-home testing over paternalistic concerns that people would not be able to properly implement the tests or interpret results, reports the Associated Press:
More than two dozen companies have been racing for months to develop the first, rapid home-based test for COVID-19. However, the FDA outlined a number of study requirements for manufacturers.
These hurdles have less to do with COVID-19 specifically, and more to do with decades-long concerns about whether people without any medical training can accurately screen themselves and interpret the results.
The FDA has only ever approved one home test for an infectious disease—an HIV test. And even commonplace over-the-counter tests—such as home pregnancy kits—were subject to years of scrutiny before FDA allowed their use in the 1970s.
To the FDA, it is apparently preferable that a whole bunch of people don’t get tested at all, or risk infection waiting for hours in a doctor’s office or testing line, than for some small fraction of folks to somehow do their at-home tests wrong. Government math strikes again!
“To date, the FDA has authorized nearly 300 tests for coronavirus,” notes A.P.:
The vast majority require a nasal swab performed by a health professional and must be processed at laboratories using high-tech equipment. A handful of tests allow people to collect their own sample at home—a nasal swab or saliva—that’s then shipped to a lab, which usually means waiting days for results.
They also report that the Lucira at-home test kit “uses technology similar to genetic laboratory-based tests that are the standard tool for COVID-19 screening. That’s different than most rapid tests currently used in the U.S., which look for viral proteins called antigens—not
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