June 28, 2021 – Abbott (Abbott Park, IL) announced it has received CE Mark for its Panbio COVID-19 Antigen Self-Test for sale directly to consumers for use in the detection of the SARS-CoV-2 virus in adults and children with or without symptoms.
This over-the-counter approval paves the way for critical access to fast, reliable self-testing throughout Europe.
Frequent rapid testing at work, school, home and other facilities makes it possible for people to know their infection status when it matters most – making mass screening an essential tool in the mitigation of COVID-19 as restrictions lift and vaccines roll out, the company says.
According to a recent study published in JAMA, at least 50% of COVID-19 infections are estimated to have originated from exposure to asymptomatic individuals.
Abbott’s Panbio COVID-19 Antigen Self-Test arms people with timely health information to help reduce further spread of infection. The test delivers results in 15 minutes and features a minimally invasive nasal swab for self-collection of specimens.
The test can be used on symptomatic or asymptomatic adults and children, including infants with an adult’s support.
The Panbio Self-Test is already authorized for use in Germany and France as part of national testing programs in schools, universities and workplaces. Abbott is the only diagnostics manufacturer to provide performance data on a rapid antigen test specific for use on children who are 15 years and younger, including infants.
Available in packages to support a variety of testing needs, the Panbio Self-Test comes in one, four, and 10 count test kits for individual and family or friends testing; it also comes in larger quantities of 20 test kits to meet school and workplace screening needs.