Panbio COVID-19 Ag has received an updated label with clinical data on asymptomatic individuals to enable mass testing of people who do not currently present symptoms of the disease, according to a news release.
The other update allows for self-collection of nasal specimens under the supervision of a healthcare worker, offering improved patient comfort and reduced risk of accidental exposure to the virus for healthcare workers as they can maintain their distance during testing.
Abbott Park, Ill.-based Abbott has shipped 200 million Panbio rapid antigen tests across 120 countries in Europe, the Americas, Asia and Africa since August 2020. The company has coordinated with the Global Fund, the World Health Organization and the Bill & Melinda Gates Foundation to make the tests available to low- and middle-income countries.
Panbio is not avialable in the U.S. as Abbott manufactures and sells the BinaxNow COVID-19 Ag Card, which has FDA emergency use authorization (EUA). Abbott said it is in the process of pursuing EUA for an asymptomatic indication for BinaxNow, too.
Both Panbio and BinaxNow use similar biologics, the company said, and both provide portable, reliable and affordable options for COVID-19 testing.
“Rapid testing continues to be one of our most important tools for fighting this pandemic, and the ability to perform mass screening allows us to expand testing and reach more people in more places,” Abbott president & CEO Robert B. Ford said in the release. “Now that Abbott’s Panbio rapid antigen test has an asymptomatic indication, it becomes an even more valuable tool for enabling a safer return to work, school, travel and other activities of daily life.”