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.
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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.
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By GlobalDataIn 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.
