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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

Jan 29, 2021 - Health

J&J says its one-shot vaccine is 66% effective against moderate to severe COVID

Photo: Thiago Prudêncio/SOPA Images/LightRocket via Getty Images

Johnson & Johnson announced Friday that its single-shot coronavirus vaccine was 66% effective in protecting against moderate to severe COVID-19 disease in Phase 3 trials, which was comprised of nearly 44,000 participants across eight countries.

Between the lines: The vaccine was 72% effective in the U.S., but only 57% effective in South Africa, where a more contagious variant has been spreading. It prevented 85% of severe infections and 100% of hospitalizations and deaths, according to the company.

Jan 30, 2021 - World

Germany to impose travel restrictions to curb spread of coronavirus variants

Border police officers check passports and COVID-19 tests at Frankfurt Airport. Photo: Thomas Lohnes via Getty Images

Germany announced Friday that it was imposing new travel restrictions in an effort to curb the spread of more contagious coronavirus variants.

Details: All non-German residents traveling from countries deemed "areas of variant concern," including the United Kingdom, South Africa, Portugal, Ireland, Brazil, Lesotho and Eswatini, will be banned from entering the country, even if they test negative for the coronavirus.

Updated 10 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Vaccines: Key FDA committee takes on the big booster question — Los Angeles County to require vaccination proof at indoor bars — France suspends 3,000 unvaccinated health workers without pay.
  2. Health: Worsening crisis at Rikers Island jail spurs call for action — 1 in 500 Americans has died — Cases are falling, but deaths are rising.
  3. Politics: White House invites call with Nicki Minaj to discuss vaccine — Gottlieb says CDC hampered U.S. response — 26 states have limited state or local officials' public health powers.
  4. Education: Denver looks to students to close Latino vaccination gap — Federal judge temporarily blocks Iowa's ban on mask mandates in schools — Massachusetts activates National Guard to help with school transportation.
  5. Variant tracker: Where different strains are spreading.