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A medical worker dressed in PPE prepares to take a throat swab sample for a rapid antigen COVID test. Photo: Sean Gallup/Getty Images

The Food and Drug Administration granted emergency authorization Tuesday to Ellume's over-the-counter antigen COVID-19 test for fully at-home use.

Why it matters: Once available, a person in theory would be able to buy the test in a drug store, swab their nose, and run the test for results in about 20 minutes.

  • The company anticipates selling the test at about $30 or less. Ellume's goal is to produce 3 million tests by January and to deliver 20 million tests by the first of half of next year.

The big picture: Currently, home kits that test for the novel coronavirus either still need a prescription or require swabs be shipped to a lab, which could take days for results.

How it works: The rapid test can be used by symptomatic and asymptomatic users ages 2 years and above. This type of test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample.

  • A clinical study demonstrated overall sensitivity of 95% and specificity of 97%, according to Ellume.

Yes, but: Like all other antigen tests, "a small percentage of positive and negative results from this test may be false," the FDA notes.

  • "Patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible."

Go deeper

Miriam Kramer, author of Space
Jan 29, 2021 - Science

NASA will stage another test of its huge new rocket next month

An SLS engine firing. Photo: NASA TV

NASA is planning to re-do a major test of its Space Launch System rocket after the last test didn't go as planned earlier this month.

The big picture: The space agency hopes to launch the first uncrewed flight of the SLS by the end of the year, but having to re-run this test could put that timeline at risk.

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.

Jan 29, 2021 - Health

NYC set to restart indoor dining in February, weddings in March

Outdoor dining in New York City in January. Photo: Alexi Rosenfeld/Getty Images

Gov. Andrew Cuomo announced Friday that if the current coronavirus positivity in New York City holds, indoor dining will reopen at 25% capacity on Feb. 14, one of the busiest dining days of the year.

Why it matters: The forced closure of indoor dining in December caused major backlash, as New York's struggling restaurant industry had already been hit hard by pandemic restrictions. Restaurants will still be required to close at 1o p.m.