Abbott 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 to reduce the spread of infection as economies reopen and daily life activities resume.
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. 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, is easy to use 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.
Rapid antigen testing is less expensive than PCR testing allowing people to test more frequently. While vaccines continue to roll out, the best way to curb the spread of infection is to regularly test people as they return to work or school and attend events and sports or opt to travel.
The Panbio Self-Test is already authorized for use in Germany and France as part of national testing programs in schools, universities and workplaces to test staff and students and restore continuity of in-person classes and safety. 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.
To help ensure business continuity and safety, many governments and employers are using the Panbio COVID-19 Antigen Rapid Test Device, for professional use, to facilitate mass screenings in airports, for cross-border travel, sporting events and other activities where people congregate in order to reopen and sustain operations.
Since last August to date, Abbott has shipped 300 million Panbio COVID-19 Antigen Rapid tests for professional use across Europe, the Americas, Asia and Africa.
In clinical evaluations of Panbio Covid-19 Rapid Antigen, performed by healthcare professionals, the test correctly identified 98.1% of positive specimens and 99.8% of negative specimens. All samples were confirmed negative or positive by an approved RT-PCR test.
In clinical evaluations with self-test users, the test correctly identified 95.2% of positive samples and 100% of negative samples. All samples were confirmed positive or negative by the Panbio COVID-19 Antigen Rapid Test Device (Nasopharyngeal).
With CE Mark, the availability of Panbio COVID-19 Antigen Self-Tests can be offered for sale direct-to-consumer, increasing access to fast, reliable testing for more people.
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.
Panbio COVID-19 Antigen Self-Test is available in countries outside of the U.S.
Negative results must be combined with clinical observations, patient history and epidemiological information. Negative results do not preclude COVID-19 infection and cannot be used as the sole basis for treatment or other management decisions.
The Panbio COVID-19 Antigen Rapid Test Device for professional use is CE-Marked and has received World Health Organization (WHO) Emergency Use Listing for use on asymptomatic individuals and for self-collection of samples using a nasal swab under the supervision of a healthcare professional.
The professional test has data to support use on children 15 years and younger, including infants. Abbott has updated its existing label for use to include performance data in children and has submitted the updated label to the WHO for EUL. ■