A digital test can detect COVID-19 antigens in symptomatic individuals in about 15 minutes at doctors' offices, urgent care centers, retail clinics, and other convenient points of care.

The BD Veritor System for SARS-CoV-2 from BD (Becton, Dickinson and Company, Franklin Lakes, NJ, USA) is a chromatographic, digital lateral flow immunoassay intended for the direct detection of the presence or absence of SARS-CoV-2 antigens in respiratory specimens taken from patients with signs and symptoms who are suspected of COVID-19, or taken from asymptomatic individuals being tested serially. The rapid chromatographic digital immunoassay provides results from nasal swab specimens from patients within six days of symptom onset.

The test delivers objective, easy-to-read results using the BD Veritor Plus Analyzer, which provides rapid diagnostic testing in a convenient, portable instrument. The BD Veritor Plus Analyzer delivers reliable results promptly, enabling quick diagnosis and treatment of patients with an easy-to-read, portable device. It provides diagnostic testing where and when patients need it, offering reliable, rapid results for a variety of respiratory tract infections.

BD has now received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor System for SARS-CoV-2. The test, which is intended for use in CLIA-waived environments, has been available under Emergency Use Authorization (EUA) from the FDA since September 2020. The new 510(k) clearance will eventually replace the current EUA version of the test, starting in early fall 2025.

"This FDA clearance is part of our ongoing commitment to support health care providers with reliable, rapid diagnostic tools," said Nikos Pavlidis, worldwide president of BD Diagnostic Solutions. "The BD Veritor System for SARS-CoV-2 has proven to be a reliable COVID-19 test with a streamlined workflow and clear digital results, helping clinicians make confident and timely decisions that can help improve patient outcomes."

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