Abbott has received the CE mark for its Panbio Covid-19 Antigen Self-Test, boosting the direct sale of the product to consumers in the UK and across Europe. 

The test detects the SARS-CoV-2 virus in adults and children, delivering results in 15 minutes. The company says interim study results show the test has an overall sensitivity of 76.3 per cent and specificity of 100 per cent. 

Abbott say it can can be used on symptomatic or asymptomatic adults and children, including infants with an adult’s support, adding that it arms people with timely health information to help reduce further spread of infection. 

"Alongside the roll-out of vaccines in the UK, testing plays a crucial part in getting our lives back to a closer version of normal," said Sam Lloyd, general manager of Abbott's rapid diagnostics business in the UK and Ireland.

"Rapid tests enable us to determine someone’s infection status, which in turn will indicate how likely they are to pass on the virus to someone who might be at risk. With this latest approval, our easy-to-use, reliable Panbio test will be more accessible to more people across the UK."

The company says many governments and employers are using the Panbio Covid-19 Ag Rapid Test Device for mass screenings in airports, sporting events and other activities where people congregate in order to safely reopen and sustain operations. Abbott has shipped 300 million tests for professional use to countries across Europe, the Americas, Asia and Africa.

The Panbio Self-Test comes in one, four, and 10 count test kits to support individual and family or friends testing, and comes in larger quantities of 20 test kits to meet school and workplace testing needs.

Abbott say that while the CE mark announced certifies the device is sage for use as part of self testing throughout the UK and Europe, the company will pursue new AKCA markings as per local requirements in the months ahead. Recommended retail prices for the OTC packs have not yet been announced.