Abbott Panbio SARS-CoV-2 Rapid Antigen Test Nabs CE Mark for Asymptomatic Screening, Self-Collection
Jan 26, 2021 | staff reporter
NEW YORK – Abbott announced on Tuesday its Panbio COVID-19 Ag Rapid Test Device received CE marking for the mass screening of asymptomatic people and self-swabbing.
The lateral flow test is CE-marked for self-collected samples with a nasal swab under a healthcare professional's supervision. The CE mark for use with asymptomatic patients will enable mass testing and screening, Abbott said. "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 Ford, Abbott's president and CEO.
Abbott's antigen test delivers results in 15 minutes and requires no instrumentation, the company said in a statement. Since August, Abbott said it has shipped 200 million Panbio tests to 120 countries globally, although it is not available in the US. The company said it has submitted documentation to the World Health Organization for Emergency Use Listing for Panbio's two new claims.
In conjunction with the antigen test, Abbott is also offering its Navica mobile app to show proof of negative results and its Sympheos data collection tool for surveillance management.
https://www.360dx.com/regulatory-news-fda-app...BVwY-hKiUk
Jan 26, 2021 | staff reporter
NEW YORK – Abbott announced on Tuesday its Panbio COVID-19 Ag Rapid Test Device received CE marking for the mass screening of asymptomatic people and self-swabbing.
The lateral flow test is CE-marked for self-collected samples with a nasal swab under a healthcare professional's supervision. The CE mark for use with asymptomatic patients will enable mass testing and screening, Abbott said. "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 Ford, Abbott's president and CEO.
Abbott's antigen test delivers results in 15 minutes and requires no instrumentation, the company said in a statement. Since August, Abbott said it has shipped 200 million Panbio tests to 120 countries globally, although it is not available in the US. The company said it has submitted documentation to the World Health Organization for Emergency Use Listing for Panbio's two new claims.
In conjunction with the antigen test, Abbott is also offering its Navica mobile app to show proof of negative results and its Sympheos data collection tool for surveillance management.
https://www.360dx.com/regulatory-news-fda-app...BVwY-hKiUk
