- For immediate release:
Today, the U.S. Food and Drug Administration issued a new Emergency Use License (EUA) for the BinaxNOW COVID-19 Ag Card Home Test, which is prescription-approved for use by patients at home.
The BinaxNOW COVID-19 Ag Card Home Test is authorized for prescription home use with self-collected nasal swabs from individuals 15 years of age or older who are suspected by their healthcare provider of COVID-19 symptoms within the first seven days of onset. It is also approved for use with adult nasal swabs from individuals four years or older who are suspected by their healthcare provider of COVID-19 symptoms within the first seven days of developing symptoms.
The test will be offered in conjunction with a tele-health service that will guide users step-by-step through the sample collection process and provide assistance in reading and understanding the results. The telecare provider will also report all test results to the relevant public health authorities in accordance with local, state and federal requirements.
“FDA continues to approve COVID-19 tests that will give more Americans access to more testing flexibility and options,” said FDA Commissioner Stephen M. Hahn, MD. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”
In general, antigen tests are very specific for COVID-19, but are not as sensitive as molecular PCR tests. This means that there is a greater chance of false negatives than many molecular tests. Positive results from antigen tests, while generally very accurate, can be subject to false positive results, especially in areas with fewer infections.
Individuals with positive results should isolate themselves and seek additional care from their healthcare provider. Negative results do not preclude a person from developing a SARS-CoV-2 infection. Individuals who test negative may need additional testing, especially those who continue to experience COVID-like symptoms.
“With today’s approval of the BinaxNOW COVID-19 Ag Card Home Test, there are now three tests that can be used entirely at home,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We will continue to work with test developers to support the availability of more innovative test options.”
The Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card, which is a different product from this home test, is authorized for use at the point of care under an EUA issued in August 2020.
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.