The FDA has authorized several over-the-counter COVID-19 (OTC) tests that will allow asymptomatic people to be routinely screened for the coronavirus. The authorization covers multiple varieties of Abbott BinaxNOW, as well as the Quidel QuickVue At-Home OTC COVID-19 test and the BD Veritor system for rapid detection of SARS-CoV-2.
A year after the pandemic was declared, the COVID-19 test became more available, but it is still complicated for those who need routine tests. Often, appointments are required and a visit to an examination center, such as a local pharmacy, is required. Over-the-counter tests change that.
No prescriptions are required to obtain one of these newly authorized OTC COVID-19 tests, which can be used for serial screening – the FDA’s term for routine testing of asymptomatic individuals. One of the tests was also authorized for use in point-of-care facilities without a prescription.
In a statement about the new authorizations, the FDA’s Center for Devices and Radiological Health Director Jeff Shuren, MD, JD, said:
The screening test, 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 creating testing programs to quickly track COVID-19. With FDA authorization for various tests, the public can be assured that these tests have met our scientific standards for emergency use authorization. As we have always said, if it is a good test, we will authorize it.
The tests can be used in a variety of situations, such as in schools and businesses, where it may be necessary to determine whether someone is infected. The agency notes that it has already authorized some of these tests, but that this new authorization covers serial testing for asymptomatic people.