The U.S. Food and Drug Administration on Tuesday issued an emergency use authorization for the first at home COVID-19 test that provides rapid results.
The single-use Lucira COVID-19 All-In-One Test Kit has been authorize for home use in individuals over the age of 14 if their health care provider suspects they may have COVID-19. The test is also authorized for use in hospital settings. For individuals younger than 14-years-old, the test must be administered by a health care professional.
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The test works by swirling the self collected sample from a nasal swab in a vial which is then placed in a test unit. Results are ready in half an hour. Individuals who test positive should follow CDC guidelines and self- isolate. If an individual tests negative but is still experiencing COVID symptoms then that person should follow up with their health care provider. The test is currently authorized for prescription use only.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen Hahn said. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
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The test was produced by a California-based biotech company, Lucira Health. The FDA did not reveal the price of the test. But, the company’s website says the test is “intended to cost less than $50.”
