The Food and Drug Administration has given emergency use authorization for a low-cost, rapid-response COVID-19 test that can produce results on a small card.

The FDA said it authorized Abbott Laboratories' BinaxNOW COVID-19 Ag Card, which the company says can give test results in 15 minutes and costs $5 each.

A clinical study showed the BinaxNOW card has a sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in suspected COVID-19 patients within the first seven days, Abbott said in a statement.

"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," Dr. Jeff Shuren, director of the FDA Center for Devices and Radiological Health, said in a statement. "This means people will know if they have the virus in almost real-time."

With the BinaxNOW test, a health worker swabs a patient's nose and puts the sample onto the test card. Results then appear on the card -- a single line for a negative result and two lines for a positive result.

Abbott said it will ship tens of millions of the tests next month, and 50 million per month starting in October. The company will also launch a companion app, NAVICA, which allows those who test negative to display a temporary digital health pass to enter restricted facilities.

"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 Abbott President and CEO Robert Ford.

Copyright 2020 United Press International, Inc. (UPI). Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent., source US Top News