FDA authorizes 1st fully at-home COVID-19 test

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It allows people to test themselves and get the results at home, within 30 minutes.

Sign outside the FDA headquarters.
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The Food and Drug Administration (FDA) has authorized the first fully at-home rapid COVID-19 test.

The test, made by Lucira Health in California, requires a prescription and provides results within 30 minutes, according to a statement from the FDA.

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According to Lucira, a study of the test's accuracy found that it correctly identified 94% of people with the virus, and correctly ruled out infection in 98% of healthy people. 

The test detects genetic material from SARS-CoV-2, the virus that causes COVID-19, through a method known as loop mediated amplification reaction, or LAMP. This method is similar to PCR, the gold-standard for COVID-19 testing; however, LAMP is generally considered less accurate than PCR, according to The New York Times.

Lucira anticipates that each test will cost about $50, according to a statement from the company. The test should be available in the near future to patients in Northern California served by Sutter Health, and to patients of the Cleveland Clinic Florida in Miami-Ft. Lauderdale, the statement said. The company expects the test to be available nationally by early spring 2021.

Originally published on Live Science.  

Rachael Rettner
Rachael Rettner
Contributor

Rachael is a Live Science contributor, and was a former channel editor and senior writer for Live Science between 2010 and 2022. She has a master's degree in journalism from New York University's Science, Health and Environmental Reporting Program. She also holds a B.S. in molecular biology and an M.S. in biology from the University of California, San Diego. Her work has appeared in Scienceline, The Washington Post and Scientific American.