USFDA has given its marketing authorizatiion for a portable antigen test developed by Abbott Laboratories.
The portable test which is just about the size of a credit card can deliver results within 15 minutes, says Abbott Laboratories. The company is planning to sell it in the US market for just $5.
As per the announcements made by the company this diagnostic test can be conducted using a less invasive nasal swab than traditional lab tests.
Abbott expects to ship tens of millions of tests in September, ramping to 50 million tests a month from the beginning of October.
The test, BinaxNOW COVID-19 Ag Card will be used in large gathering to find out whether people returning from schools or workplaces are infected with Covid-19 virus or not.
Abbott claims that this small kit will aid the reopening of the U.S. A downloadable app has also been created by the company. With this, people who have taken the test could present before entering venues to show that they are COVID-19 free.
The NAVICA app is optional and an easy-to-use tool that allows people to store, access and display their results with organizations that accept the results so people can move about with greater confidence.
The U.S. Food and Drug Administration granted the approval for this antigen test under its emergency use authorization program.
The result provided by the kit has a sensitivity (ability to detect true positives) of 97.1% and specificity (ability to detect true negatives) of 98.5% in clinical studies, making it a more accurate antigen-based test available in the market.
BinaxNOW is entirely self-contained and doesn’t need other equipment to get results, meaning large numbers of tests can be done simultaneously.
“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.”
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.
In India, ICMR has approved Abbott’s CLIA (Chemiluminescence immunoassay) antibody tests that are technologically advanced. According to experts technology used in these kits is more accurate than the rapid antibody test kits.
Due to its moderate sensitivity, experts in India have been critical of antigen-based testing.
