Abbott's rapid antigen COVID-19 test cleared in Europe for at-home, direct-to-consumer sales

Even as Abbott continues to anticipate a steep drop-off in its COVID-19 testing sales boom—and recently updated its financial projections for the year to reflect that—testing demand has yet to completely dissipate.



Far from it, in fact: The diagnostics giant recently received the go-ahead to make its Panbio rapid antigen test even more widely available in Europe. The newly granted CE mark allows the at-home test to be sold directly to European consumers, regardless of whether they’re showing any COVID symptoms.




The Panbio test was previously cleared for professional use in about 120 countries around the world (excluding the U.S.), with about 300 million tests shipped to Europe, Asia, Africa and North and South America since August, according to Abbott. Those tests have been used by governments and employers for mass screenings at airports, borders, sporting events and more.



In Europe, for example, it was authorized by German and French authorities for use in their national testing efforts in schools, universities and workplaces.



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The lateral flow test, similar to Abbott's BinaxNOW test in the U.S., requires only a single nasal swab and returns results in about 15 minutes. It can be used by patients of all ages, including infants and children with the help of an adult, and is now available over the counter in a range of quantities from one to 20.



Clinical evaluations found that the self-administered test correctly identified more than 95% of positive COVID cases and 100% of negative samples, according to Abbott.



“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,” Andrea Wainer, executive vice president of Abbott’s rapid and molecular diagnostics business, said in a statement.



“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,” Wainer continued.



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In the U.S., Abbott has received emergency use authorization from the FDA for several of its COVID-19 tests, including the BinaxNOW rapid antigen diagnostic.

Though originally available only with a prescription, the BinaxNOW kit was given the regulatory go-ahead for direct-to-consumer sales at the end of March. Since then, Abbott has teamed up with United Airlines to make the kit available to American travelers planning international roundtrips who need a negative COVID test to return home. The test can be ordered directly through United while passengers are booking travel, and it must be administered with the virtual supervision of a telehealth provider.




The FDA’s expanded green light of the BinaxNOW tests arrived not long after a study from the Centers for Disease Control and Prevention found that the diagnostic could miss as many as two-thirds of asymptomatic cases.



Still, the study confirmed that the test performed much better at identifying samples containing live, culturable virus, indicating the most contagious cases. In those cases, the test spotted more than 92% of those with symptoms and just under 80% of those without.