At August 26 Abbott Park announced that FDA authorized their BinaxNOW COVID-19 Ag Card rapid test. The Emergency Use Authorization (EUA) were given through the context of still going coronavirus pandemic.
BinaxNOW is a fast test, that delivers results in 15 minutes and will be sold for $5, according to press relies. Abbott said that test is highly portable, and its size is close to the size of credit card. “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 important tool to manage risk by quickly identifying infectious people, so they don’t spread the disease to others,” – according to press relies.
NAVICA already have 500+ downloads on Google Play, and #32 in Medical at APP Store
In addition to the test Abbott creates the NAVICA free mobile app, that can be downloaded in iPhone and Android devices this app allows individuals who test negatively to display a temporary digital health pass that is renewed each time a person is tested through their health care 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.
NAVICA said that their Privacy Policy is safe for users. The app is not for contact tracing and only collects a person’s first and last name, email address, phone number, zip code, date of birth and test results
“While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know,” Robert B. Ford, president and chief executive officer of Abbot said. “We’re taking our know-how from our digitally connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible.”
Company will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October
The BinaxNOW Card is test that meant to search specific antigens to COVID-19 in nasal cavity. Nasal swab is used to collect specimens from people suspected of having an active infection. To date Abbott has provided more than 27 million COVID-19 tests in the U.S. to date, including 14 million detection tests and 13 million antibody tests.
“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.”
Need to remember The BinaxNOW COVID-19 Ag Test Card EUA has not been FDA cleared or approved. It has been by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings.