The test, called the BinaxNOW COVID-19 Ag Card, is roughly the size of a credit card and is administered by a healthcare professional using a nasal swab. BinaxNow uses lateral flow technology, similar to an at-home pregnancy test, to search for virus proteins and is intended to be used for patients within seven days of feeling coronavirus symptoms. The test can provide results in up to 15 minutes.
According to Abbott, the test has a demonstrated sensitivty, or the percent of positive cases that it can accurately detect, of about 97%.
In addition to increasing overall testing capabilities and result turnaround times, BinaxNow is aimed at helping bring employees back to work and children back to school.
BinaxNow can be linked to a free app called NAVICA, which allows those who are given the "all clear" to display a digital health pass via a QR code that displays their negative test result.
"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," Abbott president and chief executive officer, Robert B. Ford, said in a press release Wednesday evening.
The combination of the BinaxNOW test and the NAVICA app Ford added should help provide "a bit more normalcy in our daily lives."
The FDA's emergency use authorization will allow doctors, nurses, school nurses, medical assistants and technicians, pharmacists and employer occupational health specialists to administer the test with minimal training and a patient prescription.
Abbott will ship tens of millions of tests starting in September, with plans to ramp up to 50 million tests a month at the beginning of October.
BinaxNOW is the sixth test that Abbott has launched in the U.S. to help fight the coronavirus pandemic. To date, the company has provided more than 27 million COVID-19 tests in the United States, including 14 million detection tests and 13 million antibody tests.
Shares of Abbott surged more than 11% in after-hours trading Wednesday evening on the news.