Becton, Dickinson and Company (BD) has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its rapid and point-of-care antigen SARS-CoV-2 diagnostic test.
Designed to be used with the BD Veritor plus system, the point-of-care antigen test will deliver results in 15 minutes.
The BD Veritor SARS-CoV-2 assay has been developed for use in health care settings to rapidly diagnose Covid-19 disease in symptomatic individuals.
The new assay allows detecting SARS-CoV-2 nucleocapsid antigens
BD’s assay secured EUA status only to identify SARS-CoV-2 nucleocapsid antigens for the diagnosis of SARS-CoV-2 virus infection.
The BD Veritor system, which is marginally larger than a cell phone, is presently in use at over 25,000 hospitals, clinician offices, urgent care centres and retail pharmacies in 50 states of the US.
BD’s system also provides customers with real-time reporting capabilities through the BD Synapsys informatics solution, helping to deliver data for disease monitoring and surveillance purposes.
The company is leveraging its global manufacturing network and scale, as well as aims to increase the capacity to produce two million tests per week by the end of September. BD is planning to produce up to 10 million tests from July through September
The new immunoassay test is an addition to the company’s other three molecular solutions for Covid-19 testing, which were registered for use with the BD MAX molecular system including two with EUAs and two with CE mark.
BD integrated diagnostic solutions president Dave Hickey said: “This will be a game-changer for frontline health care workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors’ offices.
“Such tests will also help communities be more informed and better prepared to help prevent new spikes and additional waves of COVID-19 by enabling public health workers to quickly identify infectious individuals and trace their contacts.”
In April, BD, along with BioGX, secured EUA status from the FDA for a new Covid-19 diagnostic test.
