Abbott's Panbio rapid antigen test receives CE mark

Abbott has announced that 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.

Panbio COVID-19 Ag's label has been updated with clinical data on asymptomatic individuals, which enables mass testing (mass screening) of people who do not currently present symptoms of the disease. According to a recent study published in the Journal of the American Medical Association, 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."

From August 2020 until January 2021, 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.

Panbio COVID-19 Ag is not available in the U.S., where Abbott manufactures and sells the BinaxNOW™ COVID-19 Ag Card, which has received emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA). Abbott is in the process of pursuing FDA EUA of an asymptomatic indication for BinaxNOW.

Both Panbio and BinaxNOW rapid antigen tests use similar biologics and are highly portable, reliable and affordable.

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