Recently, Abbott announced that the U.S. Food and Drug Administration has granted emergency use authorization for the BinaxNOWCOVID-19AgCard, a COVID-19 rapid antigen test card developed by the company. This test card qualitatively detects the novel coronavirus nucleocapsid protein antigen in nasal swabs from patients with suspected COVID-19.
The test card uses Abbott's proven lateral flow technology, which eliminates the need for any instrumentation and produces results in just 15 minutes. In data submitted to the FDA, a clinical study conducted by Abbott and several top U.S. research universities showed that the BinaxNOW COVID-19 AgCard test had a sensitivity of 97.1% and specificity of 98.5% within the first 7 days of symptoms in people suspected by healthcare providers of being infected with COVID-19.
Priced at $5, this test card is highly portable and affordable. Because it requires no equipment, the card will be an important tool for managing risk during a COVID-19 pandemic, serving as a first line of defense to quickly identify and isolate infected people so they don't spread the disease to others.
Abbott is also launching a complementary mobile app for iPhone and Android devices, NAVICA, the first of its kind, which will be available for free. At crowd gatherings, when asked by organizations such as workplaces and schools, the app will allow people who test negative to display a temporary digital health pass that shows the BinaxNOW test results to the organization's personnel and updates that pass, along with the date of the test results, each time the test is administered through a healthcare provider. Organizations will be able to view and verify the information displayed on the mobile device, incorporating measures such as hand washing, social distancing, enhanced cleaning and masking to facilitate personnel access to the facility.
Abbott plans to distribute tens of millions of test cards in September, reaching 50 million per month by early October. Since April, the company has invested hundreds of millions of dollars to mass-produce BinaxNOW at two new facilities in the U.S.
Robert B. Ford, Abbott's president and chief executive officer, said, "We've purposely designed the BinaxNOWtest and the NAVICA apps to provide a comprehensive testing solution to help Americans feel more confident about their health and their lives.The BinaxNOW and NAVICA apps provide us with an affordable, easy-to-use, scalable test, as well as a complementary digital wellness tool to help us have more normalcy in our daily lives."
Dr. Joseph Petrosino, chair of molecular virology and microbiology at Baylor College of Medicine, said, "The mass rollout of this test card and app will give tens of millions of people access to fast and reliable testing. With lab-based tests, you can get excellent sensitivity, but it can take days or longer to get results. Whereas with rapid antigen testing, you get results right away and get infectious people off the streets and into quarantine areas so they don't spread the virus."
Original source:AbbottsFast, $5, 15-Minute, Easy-to-UseCOVID-19AntigenTestReceivesFDAEmergencyUseAuthorization. MobileappDisplaysTestResultstoHelpOurReturntoDailyLife;RampingProductionto50MillionTestsaMonth