The Wetherby-based firm’s AffiDX SARS-CoV-2 antigen lateral flow test is a 20-minute antigen test using patient-friendly nasal swabbing that is CE marked for professional use in the UK and EU.
The test has been shown by independent clinical evaluation to be 100 per cent sensitive for patient samples with a PCR Ct value below 27 - a high viral load, 98 per cent sensitive across a much wider range of viral loads and with 99 per cent specificity.
The test has also been shown to detect all the major variants of the virus including the delta variant.
Dr Alastair Smith, CEO of Avacta, said: “I am delighted that shipment of the AffiDX SARS-CoV-2 antigen lateral flow test has commenced.
“The excellent clinical performance and ease of nasal sampling, coupled with the fact that the AffiDX antigen test has been developed in the UK, and is based on UK technology and manufactured in the UK, are major points of differentiation.
"Manufacturing scale up continues to progress well and we remain focused on the challenge of being able to supply the clear demand in the market.
"We continue to see significant levels of commercial interest from around the world and are progressing a number of opportunities in a range of sectors. I look forward to updating the market on further developments."
The Wetherby-based firm recently appointed Calibre Scientific, a global distributor of diagnostic and life science products, as the first distributor for the test in the UK and European Union.
Avacta added that it is progressing multiple commercial opportunities with distributors and end users in Europe, UK, Asia and elsewhere.
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