Coronavirus: FDA gives cheap, quick antigen test EUA UPDATE

August 28, 2020

The $5 test takes 15 minutes to receive results and a phone app makes the results readily available.

The U.S. Food and Drug Administration (FDA) has given emergency use authorization (EUA) to a cheap, quick COVID-19 coronavirus antigen test developed by Abbott.

According to a news release, the BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infections will be sold for $5 and takes about 15 minutes to get results. It is about the size of a credit card and requires no equipment.

The rollout of the new test will also include the launch of a free mobile phone application for iPhone and Android devices called NAVICA which will allow patients who test negative to display a temporary digital health pass, renewed each time they are tested, to facilitate entry into businesses, the release says.

"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," Robert B. Ford, president and CEO of Abbott, says in the release. "BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives."

According to data submitted to the FDA from a clinical study, the new test demonstrated sensitivity of 97.1 percent and specificity of 98.5 percent in patients suspected of COVID-19 infection within the first seven days of symptom onset, the release says.

"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," Joseph Petrosino, Ph.D., professor and chairman of molecular virology and microbiology at Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County, says in the release. "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."

Abbott intends to ship millions of the tests in September and ramping up to 50 million tests a month beginning in October, the release says.

The U.S. Department of Health and Human Services (HHS) has announced a $760 million contract with Abbott to supply 150 million of the tests, according to a news release from the department.

“The introduction of Abbott’s antigen test is another incredibly valuable result of President Trump’s all-of-America approach to constructing our world-leading COVID-19 testing capacity,” HHS Secretary Alex Azar says in the release. “By strategically distributing 150 million of these tests to where they’re needed most, we can track the virus like never before and protect millions of Americans at risk in especially vulnerable situations.”