Abbott has obtained CE mark for its Panbio COVID-19 Antigen Self-Test, developed to identify the SARS-CoV-2 virus in adults and children with or without symptoms.
The Panbio Self-Test, available in countries outside the US, is designed as a lateral flow assay for qualitative identification of SARS-CoV-2.
It involves the use of a minimally invasive nasal swab to collect samples and provides results in 15 minutes without any instrumentation.
The latest approval allows over-the-counter sales of the test directly to consumers in the European Union as well as other countries accepting the CE mark.
Self-testing is expected to mitigate the spread of Covid-19.
The company is making the test available in one, four and ten count kits, along with 20 count test kits for school and workplace screening requirements.
In April, the Panbio COVID-19 Ag Rapid Test Device received CE mark for use in children aged 15 years and below.
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.”
In clinical assessments by healthcare experts, Panbio Covid-19 Rapid Antigen detected 98.1% of positive samples and 99.8% of negative samples correctly.
All specimens were confirmed positive or negative using an approved reverse transcription-polymerase chain reaction (RT-PCR) test.
Meanwhile, clinical evaluations involving self-test users showed that the test correctly detected 95.2% and 100% of positive and negative samples, respectively.
The results were confirmed with the Panbio COVID-19 Antigen Rapid Test Device (nasopharyngeal).
Previously, the Panbio Self-Test received authorisation in Germany and France for use under national testing programmes in schools, universities and workplaces to prevent infection spread.
In addition, the Panbio COVID-19 Antigen Rapid Test Device is available for professional use to mass screen in airports, for cross-border travel, sporting events and various other activities.
Abbott has shipped 300 million Panbio COVID-19 Antigen Rapid tests since August last year for professional use in Europe, the Americas, Asia and Africa.