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FDA grants emergency authorization to over-the-counter, at-home COVID test

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."

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Jacob Knutson
Sep 5, 2020 - Economy & Business

Scammers have stolen over $130 million in coronavirus-related schemes

Photo: Chip Somodevilla/Getty Images

Over 100,000 Americans have collectively reported roughly $132 million in fraud losses from scams related to the coronavirus and government stimulus checks since the March start of the pandemic, according to the Federal Trade Commission.

Why it matters: Coronavirus-related fraud complaints peaked in May when the IRS began sending its first round of stimulus checks. Congress recently proposed a second round of stimulus.

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Orion Rummler
Jan 26, 2021 - Health

Biden admin to boost COVID vaccine delivery to states for at least 3 weeks

Vice President Harris receives her second COVID-19 vaccine dose in Bethesda, Maryland, on Jan. 26. Photo: Brendan Smialowski/AFP via Getty Images

The Biden administration plans to increase its COVID-19 vaccine shipments to states and tribes from 8.6 million doses per week to 10 million for at least the next three weeks, as part of an effort to vaccinate the majority of the U.S. population by the end of this summer.

Why it matters: Hospitals in states across the U.S. say they are running out of vaccines and the country's death toll is sharply rising.

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Oriana Gonzalez
Jan 26, 2021 - Health

U.K. surpasses 100,000 COVID-19 deaths

Photo: Owen Humphreys/PA Images via Getty Images

The U.K. on Tuesday surpassed 100,000 coronavirus deaths almost a year after the first two cases were reported in the country, according to government figures.

Why it matters: It is the first European country and fifth country in the world to reach the threshold. The country reported 100,162 deaths on Tuesday.

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