FDA Grants EUA for Abbott’s Card-Based COVID-19 Antigen Test

The FDA has granted Abbott Laboratories an Emergency Use Authorization for its COVID-19 antigen test, a diagnostic that provides fast, readable results on a card similar to some pregnancy tests.

The COVID-19 diagnostic, BinaxNOW, is the first one granted emergency clearance by the FDA that prints results on a testing card. It is designed for fast and efficient use and does not require an analyzer.

The test is conducted using a nasopharyngeal swab. The healthcare provider twirls the sample on the test card after adding a testing reagent, and results appear in 15 minutes. One line indicates a negative result, while two lines indicate a positive result.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card. This means people will know if they have the virus in almost real-time,” said Jeff Shuren, director of the Center for Devices and Radiological Health. “Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement.”

Abbott said it plans to produce up to 50 million tests monthly in the U.S., starting in October.