Abbott has secured CE mark approval for two new indications of its Panbio Covid-19 Ag rapid test device to detect the SARS-CoV-2 virus.
The Panbio Covid-19 Ag rapid test device is also now indicated for asymptomatic testing and self-swabbing.
The device’s label has been updated with clinical data on asymptomatic individuals, facilitating mass testing or mass screening of who do not currently present symptoms of the disease.
The other update enables self-collection of nasal specimens under the guidance of a healthcare worker.
According to the company, self-swabbing with a patient-friendly nasal swab enables to enhance patient comfort and minimise the risk of accidental exposure to the virus for healthcare workers.
Panbio COVID-19 Ag rapid test device is a lateral flow assay
Panbio COVID-19 Ag rapid test device is a lateral flow assay for a quick and qualitative detection of SARS-CoV-2 virus.
Specimens from individuals are collected from a nasal or nasopharyngeal swab for the test, which delivers results within 15 minutes without using any instrumentation.
Abbott stated that it has submitted documentation to the World Health Organisation for emergency use listing for the two new claims.
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.”
In December 2020, Abbott secured CE mark for its new lab-based quantitative Covid-19 IgG serology test, to measure the levels of IgG antibodies, produced against SARS-CoV-2 virus.
