Approved for use with a minimally invasive nasal swab, Panbio Covid-19 Ag test device offers results within 15 minutes
Abbott's Panbio rapid antigen test receives CE Mark. (Credit: Abbott.)
Abbott has received CE Mark approval for its lateral flow assay Panbio Covid-19 Ag Rapid Test Device, intended for the rapid, qualitative detection of SARS-CoV-2 virus, for asymptomatic testing and self-swabbing.
The label of Panbio Covid-19 Ag, which delivers test results within 15 minutes, has been updated with clinical data on asymptomatic individuals, which enables mass testing of people with no active symptoms of the disease.
Also, the label is updated to enable the self-collection of nasal specimens by users under the guidance of a healthcare worker.
Abbott said that self-swabbing with a patient-friendly nasal swab will enhance comfort for patients and reduces the risk of accidental exposure to the virus.
Abbott president and chief executive officer 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 clinical efficacy of the device was determined through a testing programme, in 483 people asymptomatic for SARS-CoV-2 antigen and the results are compared against PCR reference method.
Positive results were stratified by cycle threshold (Ct) counts in order to understand the correlation between product performance and the amount of virus present in the clinical sample. A lower Ct value corresponds to a higher concentration of the virus.
The test offered 100% specificity across 433 negative samples, which indicated that no identified false positives, and 66% sensitivity at all Ct counts.
Abbott said that it has shipped 200 million Panbio rapid antigen tests to 120 countries across Europe, the Americas, Asia and Africa, since August last year.
Abbott human resources executive vice president Mary Moreland said: “Since October 2020, Abbott has used rapid antigen tests in a phased rollout of employee testing across multiple sites globally.
“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.”