Abbott has announced that the US Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW Covid-19 Ag Card rapid test to detect Covid-19 infection. Abbott will sell this test for US$ 5.According to the company, it is highly portable (about the size of a credit card), affordable, and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an essential tool to manage risk by quickly identifying infectious people, so they don’t spread the disease to others.
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 and 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 and hand-washing, 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, 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.”
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 the 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 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, 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.”
Under FDA EUA, the BinaxNOW Covid-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.
AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are shipping about 1 million tests per day. Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October. Since April in two new US facilities, the company has invested hundreds of millions of dollars to manufacture BinaxNOW at a massive scale.
The BinaxNOW Covid-19 Ag Card can be used as the first line of defense to identify people who are currently infected and who should isolate themselves to help prevent the spread of the disease. 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.
As a near-person rapid antigen test, BinaxNOW was engineered for point-of-care settings, near-patient, and not for reference labs. Patient samples should be tested immediately and should not be diluted in viral transport media.