FDA issues emergency approval for first at-home COVID-19 diagnostic test

The FDA has issued an emergency authorization for the first at-home COVID-19 test that can deliver results in less than 30 minutes. 

The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test that uses a self-collected nasal swab. People 14 and older can give the test to themselves, but healthcare providers must administer it on those younger than 14. 

The tests are prescription only, and healthcare providers are required to report all test results to public health agencies. Lucira Health makes the tests, which can return results in 30 minutes or less.

"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," said Jeff Shuren, MD, director of the FDA’s center for devices and radiological health. 

Read the FDA's full news release here.


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