Abbott’s Covid-19 antigen test device receives CE Mark

27 January 2021 (Last Updated January 27th, 2021 12:35)

Abbott has received CE Mark for its Panbio COVID-19 Ag Rapid Test Device to detect SARS-CoV-2 virus for two new uses of asymptomatic testing and self-swabbing.

Abbott’s Covid-19 antigen test device receives CE Mark
The latest development follows clinical data on asymptomatic people. Credit: Waldemar Brandt on Unsplash.

Abbott has received CE Mark for its Panbio COVID-19 Ag Rapid Test Device to detect SARS-CoV-2 virus for two new uses of asymptomatic testing and self-swabbing.

The lateral flow assay uses nasal or nasopharyngeal swab for collecting specimens from people.

Utilising Abbott lateral flow technology provides results in 15 minutes without the need for instrumentation.

The latest development follows clinical data on asymptomatic people and will aid in mass testing congregate populations of people who do not show Covid-19 symptoms.

Furthermore, Panbio COVID-19 Ag Rapid Test Device’s label update permits self-collection of nasal specimens supervised by a healthcare professional.

Abbott president and CEO Robert Ford 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.

“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.”

The test’s performance was analysed in a clinical study by testing 483 asymptomatic individuals for SARS-CoV-2 antigen and the results were compared with a PCR reference method.

The test showed a sensitivity of 93.8% and specificity of 100% in asymptomatic individuals with high viral loads.

Abbott noted that the company shipped 200 million Panbio rapid antigen tests to 120 countries across Europe, the Americas, Asia and Africa since last August.

Furthermore, along with the Global Fund, the World Health Organisation and the Bill & Melinda Gates Foundation, it continues to provide these tests to low and middle-income nations.

Abbott produces and markets BinaxNOW COVID-19 Ag Card in the US, where Panbio COVID-19 Ag is not available.

Last month, the US Food and Drug Administration (FDA) issued Emergency Use Authorisation (EUA) for Abbott’s virtually guided at-home use of its BinaxNOW COVID-19 Ag Card rapid test for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.