BD Receives FDA EUA for Asymptomatic Screening for SARS-CoV-2 Through Serial Rapid Antigen Testing
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By LabMedica International staff writers Posted on 02 Apr 2021 |
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Image: The BD Veritor Plus System for Rapid Detection of SARS-CoV-2 (Photo courtesy of Becton, Dickinson and Company)
Becton, Dickinson and Company (BD Franklin Lakes, NJ, USA) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) 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. The EUA for the BD Veritor Plus System includes SARS-CoV-2 screening through serial testing of asymptomatic individuals when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Serial testing on the BD Veritor Plus System can be performed in any setting with a CLIA certificate of waiver.
"BD is supporting the global efforts to return to normalcy as soon as possible, and this additional authorization for the BD Veritor System to be used in screening through serial testing of asymptomatic individuals is a large step forward," said Dave Hickey, president of Life Sciences for BD. "Frequent testing of individuals without symptoms will enable those with negative results to resume their normal school or work routines and will help to identify and isolate positive cases of COVID-19 as early as possible to prevent further spread. Screening through serial testing is an important part of any back-to-school or back-to-work program, along with additional measures such as mask wearing and social distancing."
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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. The EUA for the BD Veritor Plus System includes SARS-CoV-2 screening through serial testing of asymptomatic individuals when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Serial testing on the BD Veritor Plus System can be performed in any setting with a CLIA certificate of waiver.
"BD is supporting the global efforts to return to normalcy as soon as possible, and this additional authorization for the BD Veritor System to be used in screening through serial testing of asymptomatic individuals is a large step forward," said Dave Hickey, president of Life Sciences for BD. "Frequent testing of individuals without symptoms will enable those with negative results to resume their normal school or work routines and will help to identify and isolate positive cases of COVID-19 as early as possible to prevent further spread. Screening through serial testing is an important part of any back-to-school or back-to-work program, along with additional measures such as mask wearing and social distancing."
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