BD announced that the FDA has granted Emergency Use Authorization (EUA) for its BD Veritor Plus System for Rapid Detection of SARS-CoV-2, to screen through serial testing of asymptomatic individuals.
Articles and studies in multiple peer-reviewed publications including, the New England Journal of Medicine and the British Medical Journal have touted the benefits of serial, rapid antigen testing. Additionally, a recent landmark RADx-funded study demonstrated that the serial use of diagnostic tests includes rapid antigen tests and increases the ability to detect infection. The BD Veritor Plus System supports this approach in everyday locations such as schools and businesses, along with serial testing in other situations, such as athletes and teams to ensure safe games and competitions.
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 within 48 hours between the tests. Serial testing on the BD Veritor Plus System can be performed, in any setting with a CLIA certificate of waiver.
Dave Hickey, President of Life Sciences, BD, said: “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. 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.”