FDA Authorizes Emergency Use of Antigen Test for COVID-19

August 28, 2020 Updated: August 28, 2020

The U.S. Food and Drug Administration (FDA) has authorized the emergency use of the first antigen test for COVID-19, it announced in a news release on Wednesday.

The FDA stated that the test will be administrated onto a card, and works similar to pregnancy tests, in which results can be seen on the testing card itself. It is an easy and simple test that can be administered to anyone and will not require the use of an analyzer.

The product, BinaxNOW COVID-19 Ag Card, was created by the company Abbott, and is marketed as a portable and cheap alternative to normal testing, according to the company press release.

“Our nation’s frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic. The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times, and greatly expand access to people who need it,” said Charles Chiu, professor of laboratory medicine at the University of California.

The test will require a nose swab, but the sample collected from the patients will be applied to the testing card, and that sample will be mixed together with a testing substance, the FDA stated. It takes 15 minutes for the card to deliver the results.

“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 Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health.

The results will be presented similar to pregnancy tests—one line means negative, two lines mean positive.

Abbott stated that the product should be used as a first line of defense to identify those who are infected, to quarantine or isolate them to prevent further spread of the disease.

“With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus,” said Joseph Petrosino, professor and chairman of molecular virology and microbiology at Baylor College of Medicine.

Abbott said it has partnered with several leading U.S. research universities to study the product and the product test card had shown a high degree of accuracy.

The study (pdf), which consisted of 102 sample swabs from patients and non-patients, was tested against the testing card product. The samples were broken up in 35 positive swabs and 67 negative swabs. Of all the swabs, the test card was able to correctly determine 34 out of 35 positive samples (97.1 percent) and 66 out of 67 negative samples (98.5 percent).

Because of its affordability and its portability, the test can be used at any point-of-care settings—such as doctor’s offices, emergency rooms, and certain schools—in which they can be administered to those suspected of being infected with the CCP virus, and has been cleared by the FDA.

The FDA also stated that though antigen tests are very specific, they might not be as sensitive as the current molecular tests out there. Therefore people who have received negative results may be required do another molecular test, depending on the patient’s medical history or condition, should they wish to undergo treatment.