NEW YORK – Abbott announced on Monday that its Panbio COVID-19 Antigen Self-Test received CE marking.
The rapid antigen test is approved for sale directly to consumers and can be used for adults and children both with and without symptoms, the company said in a statement. It can also be used on infants with an adult's support.
The lateral flow test uses a nasal swab and can deliver results in 15 minutes without an instrument. According to Abbott, the test correctly identified 95.2 percent of positive samples and 100 percent of negative samples in clinical evaluations with self-test users.
The test was previously authorized for use in Germany and France as part of national testing programs in schools, universities, and workplaces. It has also received World Health Organization Emergency Use Listing for use on asymptomatic individuals and for self-collection of samples under the supervision of a healthcare professional.
In January, Abbott's Panbio COVID-19 Ag Rapid Test Device received CE marking for the mass screening of asymptomatic people and self-swabbing.
Since last August, Abbott has shipped more than 300 million Panbio tests to countries outside of the US, the firm said.