The FDA announced today that it authorized several COVID-19 tests for over-the-counter use in asymptomatic screening.
Among the tests authorized were the BinaxNow Ag card from Abbott (which includes point-of-care screening), the Quidel Quick-View at-home test and the BD Veritor Plus system, which was authorized for POC screening with a prescription.
“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,” BD life sciences president Dave Hickey said in a news release. “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.”
The FDA said the addition of the OTC and POC tests for screening will offer schools, workplaces, communities and others several options for serial screening tests that are both accurate and reliable.
“Screening testing, especially with the over-the-counter tests authorized today, is an important part of the country’s pandemic response—many schools, workplaces, communities, and other entities are setting up testing programs to quickly screen for COVID-19. With the FDA’s authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization. As we’ve said all along, if it’s a good test, we’ll authorize it,” FDA Center for Devices & Radiological Health director Dr. Jeff Shuren said. “The FDA has taken many steps to support test development throughout the pandemic, including authorizing tests quickly, offering many avenues for test developers to work with us to get their tests on the market, if shown to be accurate and reliable, and issuing enforcement policies for COVID-19 tests. As the pandemic has progressed, we have worked with test developers wishing to add screening claims.”