The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to BinaxNOW™ COVID-19 Ag Self Test (Abbott), an over-the-counter (OTC) test to detect COVID-19 infection in individuals with or without symptoms.

The BinaxNOW COVID-19 Ag Card Self Test is a lateral flow immunoassay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in the human nasal cavity when tested twice over 3 days with at least 36 hours between tests. The test has been authorized for home use to collect nasal swab samples from individuals 2 years of age and older. 

The test includes a minimally invasive nasal swab (not the deep nasopharyngeal swab), test card, and reagent solution. Results are provided within 15 minutes and can be read directly from the testing card; 1 line indicates a negative result and 2 lines indicate a positive result.

The FDA has also authorized the BinaxNOW™ COVID-19 Ag Card test for point-of-care serial screening without a prescription. This authorization allows states, workplaces, schools and other organizations to streamline the process for testing without the need to use a medical provider to generate a prescription.


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Abbott is also offering a complementary mobile app, NAVICA, for individuals to obtain digitally verified test results.

“With the FDA’s authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “As we’ve said all along, if it’s a good test, we’ll authorize it.”

The FDA has also authorized the Quidel QuickVue At-Home OTC COVID-19 test for OTC at-home serial screening, along with the BD Veritor System for Rapid Detection of SARS-CoV-2 to be used for point-of-care serial screening with a prescription.

References

1.    Abbott’s BinaxNOW™ rapid antigen self test receives FDA Emergency Use authorization for asymptomatic, over-the-counter, non-prescription, multi-test use. [press release]. Abbott Park, IL: Abbott; March 31, 2021. 

2.    Coronavirus (COVID-19) update: FDA continues to advance over-the counter and other screening test development. [press release]. Silver Spring, MD: US Food and Drug Administration; March 31, 2021.