Abbott designed the rapid antigen test kit to deliver the results within 15 minutes and facilitate serial (frequent) Covid-19 testing
Abbott has secured the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for its BinaxNOW Covid-19 Ag self-test to detect Covid-19 infection in asymptomatic individuals.
The authorisation allows the rapid antigen test for over-the-counter, non-prescription use in asymptomatic individuals aged two years and older when samples are collected by adults.
The US-based medical device maker intends to start shipping its new rapid antigen test kit to major food, drug and mass merchandiser retailers in few weeks.
Abbott president and chief executive officer Robert Ford said: “We’ve now accomplished what we set out to do when we launched BinaxNOW, which is to bring an accurate, affordable and readily available test to the American people that they can have on hand, whether they want to test frequently or in certain circumstances.
“Together with vaccines, the BinaxNOW self-test will help Americans get back to doing what they want and need to do, like going to work and school or seeing friends and family, with greater confidence.”
Abbott designed the rapid antigen test kit to deliver the results within 15 minutes and facilitate serial (frequent) testing for asymptomatic individuals.
The test uses a minimally invasive nasal swab and comes with all the required materials, including swab, test card, and reagent solution included in the box.
In August last year, Abbott has introduced the BinaxNOW professional test, which showed 84.6% sensitivity (positive agreement) and 98.5% specificity (negative agreement).
The US Department of Health and Human Services (HHS) has purchased the first 150 million test kits for distribution among schools and nursing homes.
The company said that the BinaxNOW self-test leverages the same technology as the existing BinaxNOW professional test, but facilitates serial testing of asymptomatic individuals.
Also, it intends to offer the new BinaxNOW self-test at low-price, similar to common OTC tests, to make it more accessible for US citizens.
Furthermore, the authorisation allows the use of the BinaxNOW Covid-19 Ag Card test for professionals, without any prescription.