The FDA issued a letter to BD (NYSE:BDX) to confirm the emergency use authorization of its Veritor system for detecting COVID-19 and flu.
According to the letter, dated last week, the Veritor system was authorized for the simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and/or influenza A and B nucleoprotein antigens directly from anterior nasal swab samples taken from those suspected of a viral respiratory infection.
Use of the test under the EUA is limited only to authorized laboratories, which will analyze tests for those suspected of the infection by a healthcare provider within the first six days of symptom onset.
BD’s Veritor diagnostic analysis platform has been a mainstay in the COVID-19 testing space over the past year. The company received several government contracts to produce various tests, including rapid, point-of-care antigen diagnostics.
Issues did arise with reports of false-positive results with certain antigen tests using the BD Veritor system in September 2020, followed by further reports earlier this week claiming that BD’s antigen test was among those distributed to nursing homes but going unused due to fears over accuracy. However, there have been no such public complaints over the past several months.