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© Abbott General | March 31, 2020

Abbott gets OK for fast, portable COVID-19 test

Abbott has been granted emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a rapid molecular point-of-care test for the detection of novel coronavirus (COVID-19).

The test is capable of delivering positive results in five minutes and negative results in 13 minutes and differs from other accelerated tests under development because of its ability to be used outside of a hospital setting, such as doctors’ offices and urgent care clinics. The test runs on Abbott’s ID NOWTM platform, and is conducted within a lightweight, tabletop box about the size of a toaster, a press release said. In the statement, Abbott said, “We're ramping up production to deliver 50,000 ID NOW COVID-19 tests per day, beginning next week, to the U.S. healthcare system.” Also in the statement, Abbott emphasized that ID NOW COVID-19 EUA has not been FDA cleared or approved; it has FDA authorization for emergency use by authorized laboratories and patient care settings in response to the current coronavirus pandemic. Last week, Abbott announced the availability of the Abbott RealTime SARS-CoV-2 EUA test under FDA EUA, which runs on m2000 RealTime molecular system for centralized lab environments. Combined with ID NOW, Abbott expects to produce about five million tests in April.
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May 12 2020 12:15 pm V18.6.4-2