The test is a "game changer," according to Brett Giroir, the US assistant secretary for health in the Department of Health and Human Services.
Investors sure think so: Abbott's stock was up about 8% Thursday morning.
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The FDA's emergency use authorization is for Abbott's BinaxNOW COVID-19 Ag Card. The size of a credit card, BinaxNOW will cost $5 and will come with a free mobile app that will let people who test negative display a temporary, date-stamped health pass that is renewed each time a new test is taken.
The antigen test, in which involves a nasal swab, uses the same type of technology as a flu test. Abbott says it anticipates producing 50 million BinaxNOW tests a month by October.
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"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," said Joseph Petrosino, a professor of virology at Baylor College of Medicine, in a statement released by Abbott.
Petrosino's labs have been leading efforts to provide COVID-19 testing for the college and Harris County, which includes Houston.
"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," he said.
The BinaxNOW COVID-19 Ag Card is the fourth antigen test to receive an emergency use authorization from the FDA.
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Antigen tests, which look for pieces of the virus, are not as reliable as traditional Polymerase chain reaction tests, which look for the virus' genetic material. However they are a quicker, less expensive and less invasive. PCR tests have been beset by supply chain problems as well as back-ups at labs which have delayed results and frustrated patients, doctors and public health experts alike.