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Results from the BinaxNOW COVID-19 Ag Card test will be available in roughly 15 minutes. Photo: Courtesy of Abbott Laboratories.

Abbott Laboratories said Wednesday it received emergency use authorization (EAU) from the Food and Drug Administration for its COVID-19 test that works without lab equipment.

The big picture: Abbott said it will ramp up production of its "highly portable," $5 tests to 50 million by the beginning of October.

  • The tests, about the size of a credit card, use similar technology to at-home pregnancy tests, per Bloomberg.
  • Results from the tests, called the BinaxNOW COVID-19 Ag Card, are available in roughly 15 minutes, the company said.
  • Abbott added that the tests "demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset."
  • Abbott will also launch a "first-of-its-kind" mobile app to "allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result."

What they're saying: "The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," Joseph Petrosino, professor at Baylor College of Medicine, said in a statement released by Abbott.

  • "With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus," Petrosino added.

The state of play: The EUA comes as cities and states scramble to secure enough tests, and overcome long wait times for results.

Go deeper: Coronavirus dashboard

Go deeper

Dec 4, 2020 - Health

CDC: It's time for "universal face mask use"

Photo: Paul Hennessy/SOPA Images/LightRocket via Getty

The CDC is urging “universal face mask use” for the first time since the coronavirus pandemic began, citing recent case spikes as the U.S. has entered a phase of “high-level transmission” before winter officially begins.

Why it matters: Daily COVID-related deaths across the U.S. hit a new record on Wednesday. Face coverings have been shown to increase protection of the wearer and those around them, despite some Americans' reluctance to use them.

Dec 4, 2020 - Health

Bay Area counties to enact stay-at-home order ahead of state mandate

Golden Gate Park. Photo: Justin Sullivan via Getty

Counties around the San Francisco Bay Area will adopt California’s new regional stay-at-home order amid surges in cases and ICU hospitalizations, health officials said Friday.

The big picture: California Gov. Gavin Newsom announced a three-week stay-at-home order on Thursday that would go into effect in regions with less than 15% ICU capacity. Despite the Bay Area’s current 25.3% ICU capacity, health officials from Alameda, Contra Costa, Marin, Santa Clara, San Francisco and the city of Berkeley are moving ahead with a shelter-in-place mandate in the hopes of reducing risk.

Dec 4, 2020 - World

UN: "2021 is literally going to be catastrophic"

David Beasley, executive director of the World Food Programme. Photo: Souleymane Ag Anara/AFP via Getty Images

Next year is "going to be catastrophic" in terms of worldwide humanitarian crises, World Food Program executive director David Beasley warned on Friday, per Reuters.

Driving the news: The stark outlook comes as many countries contend with not only the coronavirus pandemic, but also possible famine, economic instability, conflict and other humanitarian crises. A record 235 million people will need humanitarian assistance and protection next year, a nearly 40% increase from 2020, the UN projected earlier this week