The Food and Drug Administration on Tuesday approved the first rapid at-home COVID-19 test.
The FDA granted emergency use authorization to the 30-minute test kit from California-based manufacturer Lucira Health. The test is prescription-only and solely approved for those 14 and older.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Dr. Stephen Hahn said in a statement.
“Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
The test works with just a couple of steps. First, users take a nasal swab, which they then place into a vial that plugs into a portable testing unit.
Within 30 minutes, the device interprets the results and displays whether the person tested positive or negative for COVID-19.
The FDA has authorized nearly 300 coronavirus tests to date. Previously, a handful allowed people to collect their own nasal or saliva sample at home, which they then shipped to a lab, usually having to wait days to get back their results.
Experts say allowing people to test themselves at home will help reduce turnaround times and curb the possible spread of the virus to healthcare workers.
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