The United States Food and Drug Administration (USFDA) has issued an emergency use authorisation (EUA) for Abbott’s rapid test for Covid-19 detection.
The rapid antigen test named BinaxNOW COVID-19 Ag Card is about the size of a credit card and can help detect Covid-19 infection within 15 minutes, Abbott said. The company has priced the test at $5.
The company will also launch a complementary mobile app for iPhone and Android devices called NAVICA. The app will provide a temporary digital health pass to people who have tested negative for Covid-19. The health pass will be renewed each time a person is tested through their healthcare provider together with the date of the test result.
President and Chief Executive Officer, Abbott, Robert B. Ford said, "BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complimentary digital health tool to help us have a bit more normalcy in our daily lives."
Abbott had submitted data from a clinical study conducted by Abbott with several leading US research universities to the FDA as proof of efficacy. According to the study, the test showed a sensitivity of 97.1 per cent (positive per cent agreement) and specificity of 98.5 per cent (negative per cent agreement) in patients suspected to have Covid-19 infection by their healthcare provider within the first seven days of symptom onset.
The test uses nasal swabs to detect nucleocapsid protein antigen from SARS-CoV-2, the virus that causes Covid-19.
“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 operate under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation,” Abbott said.
A prescription will be required to use the test.
“Abbott will ship tens of millions of tests in September, ramping up the number to 50 million tests a month at the beginning of October,” it said.