Abbott Laboratories Scores U.S. Authorization for a Rapid Covid-19 Antigen

On Wednesday medical devices and healthcare company Abbott Laboratories announced that it has won U.S. marketing authorization for a COVID-19 portable antigen test that can deliver results within 15 minutes. It also will sell for just $5.

According to company executives, the portable test is about the size of a credit card, requires no additional equipment to operate, and can be conducted using a less invasive nasal swab than traditional lab tests. Abbott is expecting to ship tens of millions of tests in September, ramping to 50 million tests a month from the beginning of October.

The test, BinaxNOW COVID-19 Ag Card, could be used to check that people participating in larger gatherings, such as those returning to schools or workplaces, do not have Covid-19 and could help aid the reopening of the U.S., said company executives.

The executives also added that there is a downloadable app that people who have taken the test could present before entering venues to show that they are Covid-19 free.

“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,” said Robert B. Ford, president and chief executive officer, Abbott. “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 the company’s press release, in data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, Ph.D., professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County.

“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.”

Disclaimer: We have no position in Abbott Laboratories (NYSE: ABT) and have not been compensated for this article.