FDA Clears Rapid OTC COVID Tests for Serial Asymptomatic Screening

Megan Brooks

April 01, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The US Food and Drug Administration (FDA) has authorized several rapid over-the-counter (OTC) tests for use at home, as well as point-of-care (POC) tests (with and without a prescription) to serially screen asymptomatic individuals for SARS-CoV-2 infection.

Serial SARS-CoV-2 testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always be detected with a single test.

Serial screening with OTC tests 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," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a statement. These authorizations are "massively important" and represent a "pivotal change in the testing landscape," Michael Mina, MD, PhD, with the Center for Communicable Disease Dynamics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, said during a call with reporters.

In mid-March, the FDA provided test developers with guidance designed to streamline the path to emergency use authorization of serial COVID-19 screening tests.

The three OTC tests authorized this week for at-home serial screening are the Quidel QuickVue At-Home OTC COVID-19 test; Abbott BinaxNOW COVID-19 Antigen Self Test; and the Abbott BinaxNOW COVID-19 Ag Card 2 Home Test (authorized for OTC at-home serial screening with telehealth proctor).

The FDA also authorized the Abbott BinaxNOW COVID-19 Ag 2 Card for POC screening without a prescription and the BD Veritor System for Rapid Detection of SARS-CoV-2 for POC screening with a prescription.

These tests had been previously authorized by FDA, some under different names, for use in people with COVID-19 symptoms, but the actions this week authorize testing of asymptomatic individuals when used for serial testing.

"The addition of the OTC and POC tests for screening will give schools, workplaces, communities, and others several options for serial screening tests that are accurate and reliable," the FDA said.

Mina also emphasized that these tests are effective. "There's been a lot of confusion about that," but they do work "very well" in asymptomatic people and have "very high sensitivity" when people are infectious, he said.

Once widely available, these tests will be "powerful tools" to help slow the spread of the virus, particularly now that the resurgence of cases in some parts of the US is starting to "eat away at many of the gains we've made recently," Mina added.

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