Panbio Covid-19 Antigen Self-Test leverages Abbott lateral flow technology and is intended for use in adults and children with or without symptoms
Abbott headquarters. (Credit: Abbott.)
Abbott has received CE Mark approval for Panbio Covid-19 Antigen Self-Test, its lateral flow assay for rapid, qualitative detection of SARS-CoV-2 virus in symptomatic and asymptomatic adults and children.
The easy-to-use rapid antigen Covid-19 self-test features a minimally invasive nasal swab for self-collection of specimens and delivers results in 15 minutes with no instrumentation.
In January this year, Abbott has received CE Mark approval for its Panbio Covid-19 Ag Rapid Test Device, intended for asymptomatic testing and self-swabbing.
Sold directly to the consumers as an over-the-counter product, the self-test facilitates access to rapid and reliable self-testing to reduce the spread of infection, said the company.
Abbott rapid and molecular diagnostics executive vice president Andrea Wainer said: “We need to remain vigilant in identifying and slowing the spread of the virus to be successful in winning the fight against Covid-19 even as vaccines roll out.
“With CE Mark approval for the Panbio Self-Test, we are able to quickly get these critical rapid tests into the European countries and communities that need them to sustain the reopening of local economies and enable a safer return to work, school, sports, travel and other activities.”
The company noted that rapid antigen testing is less expensive compared to PCR testing, and more frequent testing would help limit the spread of infection.
Its Panbio self-test was already authorised in Germany and France as part of national testing programmes in schools, universities and workplaces.
The test accurately identified 98.1% of positive specimens and 99.8% of negative specimens in clinical evaluations, confirmed by an approved RT-PCR test.
It identified 95.2% of positive samples and 100% of negative samples in clinical studies on self-test users, as confirmed by the Panbio Covid-19 Antigen Rapid Test Device.
Abbott is commercialising the Panbio Covid-19 Antigen Rapid Test Device and Panbio Covid-19 Antigen Self-Test in countries outside of the US, subject to local regulatory and commercialisation requirements.
The company claimed that since August last year, it has shipped 300 million Panbio Covid-19 Antigen Rapid tests for professional use across Europe, the Americas, Asia and Africa.