The Food and Drug Administration has authorized the first diagnostic test where COVID-19 results can be read directly from a testing card.
The BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infection is about the size of a credit card, highly portable and can be read in similar fashion to a pregnancy test, according to the drug maker Abbott.
The test will sell for $5 and is designed to be fast and efficient for health care providers without the need of an analyzer.
“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,” Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health said. “This means people will know if they have the virus in almost real-time.
“Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic,” Shuren said.
Abbott will also launch a complementary mobile app named NAVICA for iPhone and Android devices.
This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their health care provider along with the date of the test result.
Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with handwashing, social distancing, enhanced cleaning and mask-wearing.
“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, Abbott president and chief executive officer. “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.”
How it works: A health care provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the health care provider reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result.
The FDA says this test can be used at doctor’s offices, emergency rooms or some schools. The test also has been authorized for use in patients suspected of COVID-19 by their health care provider within seven days of symptom onset.
Abbott plans to make up to 50 million tests available monthly in the U.S. at the beginning of October.
“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, chairman of the Molecular Virology and Microbiology Department at Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County, Texas.
“With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results,” Petrosino said. “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.”