The United States Food and Drug Administration has approved the first at-home kit that tests for COVID-19, the disease caused by the novel coronavirus. The device, called the Lucira COVID-19 All-In-One Test Kit, provides results in under 30 minutes by testing a self-collected nasal swab sample, and then a light on the display indicates whether the result is positive or negative.
Previously, people had to visit a doctor’s office, hospital or testing site to have a COVID-19 test done, or a sample could be collected at home to be mailed into a laboratory for analysis. It’s hoped that an at-home kit will facilitate wider testing across the country.
“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen M. Hahn said. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.” The single-use kit is currently only available by prescription to those 14 and older whose health care provider suspects they have COVID-19. The test can be conducted on younger patients at a doctor’s office or hospital.
“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said. “A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”
Experts generally believe that this type of test is less accurate than PCR testing - which is the test required to be taken by travelers heading to a number of popular tourist destinations - but it produces results faster. Lucira has said that its test accurately detected 94% of infections and 98% of healthy people, but the study was small and only included those with COVID-19 symptoms. It’s expected that the test will cost about $50 and will be available from health care providers across the country by spring.
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