Abbott Laboratories' 15-Minute COVID-19 Test Receives FDA's Approval

By Mary Anne R. First Posted: Aug 27, 2020 02:44 AM EDT

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization to another rapid COVID-19 test from Abbott Laboratories.

The COVID-19 test BinaxNow COVID-19 Ag Card can show results in 15 minutes that appear directly on the card. Abbott has paired it with an app called Navica that is intended to work as a "temporary digital health pass" for people who test negative.

Abbott said it is increasing its productions by up to 50 million COVID-19 tests per month and will provide it for $5.

The COVID-19 test BinaxNow works with a nasal swab sample and a credit card-sized reactive card, where it would detect the antigen from SARA-CoV-2.Abbott said health professionals could use it at any location.

A company's executive officer said it could be used at a massive scale to help overcome the current waiting game for COVID-19 test results. This is if Abbott's COVID-19 test lives up to its promises.

"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 chief executive officer of Abbott, said in a statement.

Ford noted that BinaxNow and the Navica app give people an affordable, easy-to-use, portable, with digital health tools to help people have a bit of normalcy in their lives.

The COVID-19 test BinaxNow demonstrated a sensitivity of 97.1 percent, which is a positive percent agreement, and 98.5 percent negative percent agreement in patients suspected of being infected by the disease.

Joseph Petrosino, Ph.D., who is a virology expert, said the massive scale of this COVID-19 test and app would let tens of millions of people to have access to rapid COVID-19 testing.

Petrosino said with lab-based tests, you get excellent sensitivity but might have to wait days or longer for 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," Petrosino said.

BinaxNow can be used as the first line of defense to identify people who are currently infected and those who should isolate themselves.

Navica Mobile App

Aside from the COVID-19 test, Abbott is also offering a mobile app with no charge. It will allow people to display their results obtained through a healthcare provider when entering facilities needing proof of testing.

Abbott's mobile app allows people to store, access, and display their results with organizations that accept the results.

The app can be used by both Android and iOS users. Navica will also be available in public stores across the country.

Ford said they are taking their know-how from their digitally connected devices and applying it to their diagnostics at a time that people expect their diagnostics.

Navica would display a digital health pass via a QR code if the results came back negative. If it is positive, people will receive a message to quarantine and they should talk to their doctor immediately.