Story at a glance

  • The FDA issued emergency use authorization for the test kit Tuesday.
  • The single-use test has been authorized for home use with self-collected nasal swab samples in people aged 14 and older who are suspected of being infected with the virus.
  • Lucira Health said the tests are expected to initially roll out in California and Florida and will then be widely available nationwide in spring 2021 with a price tag of $50.

The U.S. Food and Drug Administration (FDA) has authorized the first COVID-19 self-testing kit for home use capable of producing results in 30 minutes or less.

The agency on Tuesday issued an emergency use authorization for the Lucira COVID-19 All-In-One Test Kit. The single-use test has been authorized for home use with self-collected nasal swab samples in people aged 14 and older who are suspected of being infected with the virus. Testing of people younger than 13 should be performed by a health care provider, the FDA says. 


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The test is also authorized to be used at point-of-care settings, such as doctors' offices, hospitals, urgent care centers and emergency rooms, but swabs must be collected by a health care provider. 

“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 Hahn said in a statement. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.” 

The test involves swabbing the inside of the nose and placing the sample swab in a vial that is then inserted in the test unit. Within half an hour, results are shown from the test unit’s display that shows whether a person is positive or negative for the coronavirus. 

Lucira Health said the tests are expected to initially roll out in California and Florida and will then be widely available nationwide in spring 2021 with a price tag of $50. The FDA said the test is currently authorized for prescription use only. 

Public health officials and experts have maintained over the course of the pandemic that widespread testing and contact tracing is key to controlling the spread of the virus.

The U.S. is currently experiencing the worst outbreak since the pandemic began, averaging more than 154,000 new cases per day and 1,160 deaths, according to The Covid Tracking Project


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Published on Nov 18, 2020