Covid: Wetherby firm’s rapid test edges closer to roll-out

The Wetherby-based firm said the results showed “excellent performance” of the test in identifying patients with an infectious viral load and no false positive results.

The group’s founder and CEO, Dr Alastair Smith, said the findings were “extremely encouraging”.

Avacta developed its SARS-CoV-2 rapid antigen test to identify infectious individuals so that they can isolate promptly and reduce the spread of Covid-19.

A recent report from the Liverpool Covid SMART Pilot Study indicated that people with Covid-19 infection had a significant chance of infecting their contacts if they had a viral load – called the Ct value – of about 25 or lower.

The initial evaluation of Avacta’s test involved 30 positive samples with Ct values of 26 and below; the test identified 29 of these correctly as positive, indicated a clinical sensitivity of 96.7 per cent for Ct values below 26.

Importantly, the test correctly identified every negative sample it was applied to, with no false positives, giving a clinical specificity of 100 per cent. High specificity is critical for mass screening, as false positives can create a major burden on follow-on testing resources, and cause people to isolate unnecessarily.

Based on the data, Avacta said it would now progress to a full clinical validation with a larger number of patient samples to CE mark the test for professional use. It aims to bring the test to market in Europe around the end of the first quarter of this year.

Dr Smith said: “I am delighted with the performance of the test with clinical samples which is extremely encouraging.

“These data from the first clinical studies will allow us to quickly progress with confidence into the full clinical validation of the test, manufactured at scale, at our clinical trial sites in the UK and the EU.

“I am confident that these data will accelerate our commercial discussions regarding the roll-out of the test when it is approved for professional use.”