Abbott's USD 5, 15-Minute BinaxNOW COVID-19 Ag Card Becomes First Diagnostic Test with Read-Result Test Card to Receive FDA EUA

The test uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. It is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people who are currently infected and who should isolate themselves to help prevent the spread of the disease.

In data submitted to the FDA from a clinical study conducted by Abbott with several leading US 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 BinaxNOW COVID-19 Ag Card is the sixth test that Abbott is launching in the US to help fight the coronavirus pandemic.

Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA. 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 healthcare provider together with the date of the test result. If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass. If test results are positive, people receive a message to quarantine and talk to their doctor. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing. The app is supported by Apple and Android digital wallets and will be available from public app stores in the US.

Additionally, Abbott has entered into a deal worth USD 750 million with the US government to supply 150 million BinaxNOW COVID-19 Ag Card rapid tests for the detection of COVID-19 infection, substantially expanding the nation’s capacity for rapid testing.

"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."

"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."