FDA Approves New COVID-19 Home Test

The US Food and Drug Administration has approved the BinaxNOW COVID-19 Ag Card Home Test for prescription use in a new emergency use authorization.

The home test utilizes self-collected nasal swab samples to test for infection. Individuals using the test must be 15 years of age or older, be suspected of COVID-19 by their health care providers, and be within the first 7 days of symptom onset. The test is also authorized for use in individuals aged 4 years or older based on the same criteria, providing the nasal swab samples are collected by an adult. 

In addition to being available through prescription, the test will be offered in conjunction with a telehealth service. The telehealth service will include instructions for patients’ sample collection, provide assistance for understanding the results, and report relevant test results to the appropriate public health authorities with regard to law requirements.

However, a negative result does not mean a lack of a SARS-CoV-2 infection as antigen tests are not as sensitive or accurate as a molecular test, they noted. Negative test results may require additional testing.

This emergency use authorization follows the August 2020 approval of the BinaxNOW COVID-19 Ag Card, a separate product to be used at the point-of-care for patients. 

“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options. The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people,” said FDA Commissioner Stephen M. Hahn, MD.

—Leigh Precopio

Reference:

Coronavirus (COVID-19) update: FDA issues new authorization for the BinaxNOW COVID-19 Ag card home test. News release. December 16, 2020. US Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-authorization-binaxnow-covid-19-ag-card-home-test