Abbott’s Panbio Rapid Antigen Test Receives CE Mark for Asymptomatic Screening and Self-Administered Sample Collection with Nasal Swab

Abbott announced today it has received CE Mark for two new uses of its Panbio™ COVID-19 Ag Rapid Test Device for the detection of the SARS-CoV-2 virus: asymptomatic testing and self-swabbing.

Panbio COVID-19 Ag’s label has been updated with clinical data on asymptomatic individuals, which enables mass testing (mass screening1) of people who do not currently present symptoms of the disease. According to a recent study published in JAMA,2 at least 50% of COVID-19 infections are estimated to have originated from exposure to asymptomatic individuals.

The other update to the label allows self-collection of nasal specimens under the supervision of a healthcare worker. Self-swabbing with a patient-friendly nasal swab improves patient comfort and reduces the risk of accidental exposure to the virus for healthcare workers as they can maintain distance during the testing procedure.

“Rapid testing continues to be one of our most important tools for fighting this pandemic, and the ability to perform mass screening allows us to expand testing and reach more people in more places,” said Robert B. Ford, president and chief executive officer, Abbott. “Now that Abbott’s Panbio rapid antigen test has an asymptomatic indication, it becomes an even more valuable tool for enabling a safer return to work, school, travel and other activities of daily life.”

Read more about

Concrete Example of Transition to the Circular Economy

read more

Since last August, Abbott has shipped 200 million Panbio rapid antigen tests to 120 countries across Europe, the Americas, Asia and Africa. Healthcare professionals globally have seen the clinical utility of the test in detecting COVID-19 infections. In coordination with the Global Fund, the World Health Organization and the Bill & Melinda Gates Foundation, Abbott continues to make Panbio rapid antigen tests available to low- and middle-income countries.

Widespread, frequent and fast testing facilitates return to work

The large number of COVID-19 cases and fear of disease spread has resulted in a global economic recession, increased workplace absenteeism and the inability of employers to bring their employees back to the office. As a result, employers and governments around the world are looking for ways to ensure business continuity and restart their economies.

Frequent and fast screening of employees using rapid antigen tests such as Panbio COVID-19 Ag– along with preventative measures such as mask-wearing, social distancing, handwashing, disinfecting facilities and any other actions required by government – can support a safer return to work by quickly identifying and isolating infected and contagious individuals. Employees who test negative can be admitted to facilities and resume their work.

“Since October 2020, Abbott has used rapid antigen tests in a phased rollout of employee testing across multiple sites globally,” said Mary Moreland, executive vice president, Human Resources, Abbott. “Our experience proves that testing helps our employees feel safer and more comfortable coming into the office during this time, so they can more effectively collaborate with each other and perform their duties.”

Expanded rapid antigen testing plays critical role in restoring freedom of mobility Beyond workplace screening, the ability to conduct mass screenings at ports of entry using the Panbio rapid antigen test will facilitate the resumption of global travel. A number of governments now mandate proof of a negative COVID-19 viral test before entering the country.3,4

Additionally, various airlines and cruise ship companies require that passengers present negative test results before boarding. The International Air Transport Association (IATA) and the Airports Council International (ACI) have publicly called for a systematic approach to testing that is fast, accurate, affordable, easy-to-use, scalable and supported by public health authorities. Mass screening can help restore freedom of mobility across borders and will allow people to travel safely and with confidence.

“Being able to effectively screen asymptomatic people – along with other hygienic measures already in place – is the best way to ensure the safety of our passengers and all air transport workers,” said Olivier Jankovec, director general, Airports Council International Europe. “Over 100 airports across Europe are already providing COVID-19 testing facilities in close cooperation with their health authorities. Rapid screening using high-quality and affordable antigen tests is a crucial part of resuscitating global travel until the vast majority of the world’s travelers and crews are vaccinated.”

Since the pandemic began, Abbott has developed the most advanced and comprehensive portfolio of COVID-19 tests across its testing platforms — from high-throughput molecular tests on its m2000™ RealTime and Alinity™ m lab-based systems; to serology tests on its Alinity™ i and ARCHITECT® i1000SR and i2000SR instruments; to rapid molecular tests on the ID NOW™ instrument; to rapid antigen test options on BinaxNOW™ (available in the U.S. only) and the Panbio™ COVID-19 Ag Rapid Test Device (available in countries outside the U.S.).