FDA authorizes Abbott's $5 rapid COVID-19 test
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.
- More than 73 million tests have been performed in the U.S., according to Johns Hopkins University.
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