Abbott (NYSE:ABT) announced today that it received CE mark approval to market the Panbio COVID-19 test for over-the-counter use.
European approval covers direct-to-consumer sale of the Panbio COVID-19 antigen self-test for detecting the SARS-CoV-2 virus in adults and children both with or without symptoms.
Abbott Park, Ill.-based Abbott’s Panbio antigen self-test uses a minimally invasive nasal swab for self-collection of specimens and can be used with infants with the support of an adult, according to a news release.
The easy-to-use test delivers results in 15 minutes, Abbott said, and has already been approved in Europe for asymptomatic people and self-collection under healthcare worker supervision dating back to January.
“We need to remain vigilant in identifying and slowing the spread of the virus to be successful in winning the fight against COVID-19 even as vaccines roll out,” Abbott EVP of rapid & molecular diagnostics Andrea Wainer said in the release. “With CE Mark approval for the Panbio self-test, we are able to quickly get these critical rapid tests into the European countries and communities that need them to sustain the reopening of local economies and enable a safer return to work, school, sports, travel and other activities.”