Abbott has announced it has received CE Mark for its Panbio™ COVID-19 Antigen Self-Test for sale direct-to-consumers for use in the detection of the SARS-CoV-2 virus in adults and children with or without symptoms. The approval paves the way for critical access to fast, reliable self-testing throughout the United Kingdom (UK) and Europe to reduce the spread of infection as economies reopen and daily life activities resume.
Self-testing is a key aspect of the UK government’s national testing strategy, making testing widely available in order to facilitate activities of daily life.
Frequent rapid testing at work, school and home makes it possible for people to know their infection status when it matters most. According to a recent study published in JAMA.1 at least 50% of COVID-19 infections are estimated to have originated from exposure to asymptomatic individuals. Further, a University College London study2 during lockdown last year, showed in the UK 86% of people who tested positive for COVID-19 did not have symptoms.
Abbott’s Panbio COVID-19 Antigen Self-Test arms people with timely health information at a critical point 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.
"Alongside the roll-out of vaccines in the UK, testing plays a crucial part in getting our lives back to a closer version of normal," said Sam Lloyd, general manager of Abbott's rapid diagnostics business in the UK and Ireland. "Rapid tests enable us to determine someone’s infection status, which in turn will indicate how likely they are to pass on the virus to someone who might be at risk. With this latest approval, our easy-to-use, high-performing and reliable Panbio COVID-19 Antigen Self-Test will be more accessible to more people across the UK."
Restoring freedom and peace of mind through frequent, regular rapid testing
Rapid antigen testing is less expensive than PCR testing allowing for more 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, school, travel and before large family gatherings and events.
Globally, the large number of COVID-19 cases and fear of disease spread has resulted in restrictions on travel, increased workplace absenteeism and the inability of employers to bring their employees back to the office. To help ensure business continuity and safety, many governments and employers are extensively using the Panbio COVID-19 Ag Rapid Test Device (professional use) to facilitate mass screenings in airports, for cross-border travel, sporting events and other activities where people congregate in order to safely reopen and sustain operations.
Since last August to date, Abbott has shipped 300 million Panbio COVID-19 Antigen Rapid tests for professional use to countries across Europe, the Americas, Asia and Africa.
Bringing affordable, reliable tests closer to home for more people
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 to support individual and family or friends testing; it also comes in larger quantities of 20 test kits to meet school and workplace testing needs.
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).
About Panbio COVID-19 Antigen Tests
Panbio COVID-19 Ag Rapid Self-Test is a lateral flow assay for rapid, qualitative detection of SARS-CoV-2 virus. A nasal swab is used for collection of specimens from individuals. Test results are delivered in as early as 15 minutes with no instrumentation.
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.
The Abbott Panbio COVID-19 Ag Rapid Test Device and Panbio COVID-19 Ag Self-Test are available in countries outside of the U.S. and subject to local regulatory and commercialization requirements.
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1. JAMA, SARS-CoV-2 Transmission from People Without COVID-19 Symptoms, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2774707.