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BD Gets Emergency Use Authorization For Asymptomatic Screening For SARS-CoV-2

Becton, Dickinson and Company (BDX) said that it has received an emergency use authorization from the U.S. Food and Drug Administration for its rapid antigen test to be used for SARS-CoV-2 screening through serial testing of asymptomatic individuals.

The BD Veritor Plus System for Rapid Detection of SARS-CoV-2 is intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in direct anterior nasal swabs from individuals who are either suspected of COVID-19 by their health care provider within the first five days of the onset of symptoms, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

On Wednesday, Abbott said that it received U.S. Food and Drug Administration Emergency Use Authorization for over-the-counter, non-prescription, asymptomatic use of its BinaxNOW COVID-19 Ag Self Test for detection of COVID-19 infection.

The new indication allows individuals with or without symptoms to have access to the test without a prescription.

The BinaxNOW Self Test is the same technology as the existing BinaxNOW test that has been available since August 2020 but is indicated by the FDA for serial asymptomatic testing, meaning that people should test themselves frequently.

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