U.S. FDA Advances OTC and Other Coronavirus Screening Tests

The U.S. Food and Drug Administration (FDA) announced on March 31, 2021, new authorizations of several tests for over-the-counter (OTC) use without a prescription when used for coronavirus serial screening.

In addition to the tests authorized for OTC use, one serial screening test was authorized for use in a point-of-care (POC) setting without a prescription, and an additional screening test was authorized for POC use with a prescription.

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 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," stated Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a press statement.

"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 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," concluded Dr. Shuren's comments.

As of March 31, 2021, the U.S. CDC reported about 371 million RT-PCR diagnostic tests, excluding antibody and antigen tests, have been performed to confirm SARS-CoV-2 virus infections during the COVID-19 pandemic.

The specific tests authorized by the FDA this week are as follows:

• Quidel QuickVue At-Home OTC COVID-19 test - authorized for OTC at-home serial screening
• Abbott BinaxNOW (multiple configurations)
• Abbott BinaxNOW COVID-19 Antigen Self Test – authorized for OTC at-home serial screening
• Abbott BinaxNOW COVID-19 Ag Card 2 Home Test - authorized for OTC at-home serial screening with telehealth proctor
• Abbott BinaxNOW COVID-19 Ag 2 Card – authorized for POC serial screening without a prescription 
• BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for POC serial screening with a prescription

These tests had been previously authorized by the FDA (some under different names) to test those with COVID-19 symptoms. Still, the actions this week authorize testing of asymptomatic individuals when used for serial testing.

As of March 30, 2021, the FDA announced it had authorized 349 coronavirus diagnostic tests, including 258 molecular tests, 74 antibody tests, and 17 antigen tests during the COVID-19 pandemic. Furthermore, 42 molecular authorizations can be used with home-collected samples.

The FDA is an agency within the U.S. Department of Health and Human Services that protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.