The rapid antigen self-test will help detect SARS-CoV-2 virus in adults and children with or without symptoms
Healthcare company Abbott has secured CE mark approval for its Panbio Covid-19 rapid antigen self-test to commercialise across Europe.
The Panbio rapid antigen self-test facilitates the detection of the SARS-CoV-2 virus in adults and children with or without symptoms.
Designed to deliver results in 15 minutes, the lateral flow assay uses a minimally invasive nasal swab for self-collection of specimens.
In clinical evaluations with self-test users, the Panbio self-test is said to have correctly identified 95.2% of positive samples and 100% of negative samples.
Abbott rapid and molecular diagnostics executive vice president Andrea Wainer said: “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.
“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.”
Abbott has already secured authorisation for the Panbio self-test in Germany and France for use in schools, universities and workplaces.
According to the company, several governments and employers are using the Panbio Covid-19 antigen rapid test device for mass screenings in airports, cross-border travel, sporting events and other activities.
The CE Mark allows the availability of the self-tests for sale direct-to-consumer.
Abbott is offering Panbio self-test in packages, including one, four, and 10 count test kits for individual needs. It is also available in larger quantities of 20 test kits to meet school and workplace screening requirements.
In December last year, Abbott secured CE mark approval for its new lab-based quantitative Covid-19 IgG serology test.