FDA authorizes several OTC COVID-19 tests for routine screening

Brittany A. Roston - Apr 1, 2021, 6:52pm CDT
FDA authorizes several OTC COVID-19 tests for routine screening

The FDA has authorized multiple over-the-counter (OTC) COVID-19 tests that will enable 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, COVID-19 testing has become more available but is still tricky for those who require routine screening. Appointments are often necessary and a trip to a testing center, such as a local pharmacy, is required. Over-the-counter tests change this.

Prescriptions aren’t necessary to get 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 has also been authorized for use at point-of-care facilities sans a prescription.

In a statement about the new authorizations, the FDA’s Center for Devices and Radiological Health Director Jeff Shuren, MD, JD, said:

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.

The tests can be used in a variety of situations, such as at schools and businesses where it may be necessary to determine whether someone is infected. The agency notes that it had previously authorized some of these tests, but that this new authorization covers serial testing for asymptomatic people.


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