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Laura Robles, 14, takes a swab at a COVID-19 testing site in Los Angeles on Nov. 11. The Lucira test kit is a nasal swab to be used by people aged 14 or older. Photo: Irfan Khan/Los Angeles Times via Getty Images

The Food and Drug Administration announced in a post Tuesday night that it has issued an emergency use authorization for the first COVID-19 test for self-testing at home — and it returns rapid results.

Why it matters: Coronavirus cases, hospitalizations and deaths from the virus are accelerating across the U.S. This rapid home test could help reduce testing delays.

  • Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement the development is "a significant step toward FDA’s nationwide response to COVID-19."

Yes, but: This molecular single use test kit developed by Lucira Health is currently available by prescription only.

Of note: Point-of-care settings including doctor's offices, hospitals, urgent care centers and emergency rooms are also authorized to have this nasal swab testing kit, to be used by people aged 14 or older.

  • Lucira said in a statement it anticipates the test will "cost around $50."

For the record: Rapid tests have generally been less accurate. Lucira describes the test's accuracy as having a 94% positive percent agreement, with a 98% negative percent agreement.

  • Lucira Health CEO Erik Engelson noted in a statement that while antigen rapid response tests "are more likely to miss an active coronavirus infection," the company's kit is a molecular test, which is "50 to 60 times more sensitive" and considered the ‘gold standard’ for determining if someone is infected."

How it works: The Lucira COVID-19 All-In-One Test Kit "works by swirling the self-collected sample swab in a vial that is then placed in the test unit," the FDA said in a statement.

  • "In 30 minutes or less, the results can be read directly from the test unit's light-up display that shows whether a person is positive or negative for the SARS-CoV-2," the virus that causes COVID-19, the FDA added.

What they're saying: FDA commissioner Stephen Hahn noted in a statement that 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."

  • "This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission," he said.

Editor's note: This article has been updated with new details throughout.

Go deeper

20 hours ago - Politics & Policy

California governor and family in quarantine after coronavirus exposure

California Gov. Gavin Newsom. Photo: Justin Sullivan/Getty Images

California Gov. Gavin Newsom (D) tweeted late Sunday that he and his family are quarantining after being exposed to COVID-19.

Details: Newsom said they learned Friday that three of his children had come into contact with a California Highway Patrol officer who tested positive for the coronavirus. "Thankfully, the entire family tested negative today," Newsom said.

Kendall Baker, author of Sports
14 hours ago - Sports

Coronavirus precautions leave college basketball schedule in flux

Illustration: Eniola Odetunde/Axios

With the college basketball season slated to begin on Wednesday, 35 men's teams are currently in "pause" and quarantining, per Stadium's Jeff Goodman.

Details: Schedules are in constant flux as schools prepare to fly across the country. Take Illinois State, which was supposed to be in Lincoln, Nebraska, on Wednesday, but will now be in Columbus, Ohio.

11 hours ago - Health

U.S. coronavirus hospitalizations keep breaking records

Data: The COVID Tracking Project; Chart: Axios Visuals

The number of people hospitalized with COVID-19 in the U.S. has reached new record highs every day since Nov. 10.

Why it matters: Governors in states like North Dakota and Illinois have been warning about overburdened hospitals and limited beds for weeks.