The Wetherby-based group said its rapid antigen test was used in a clinical study in Europe on 98 positive Covid-19 samples across a broad range of viral loads.
The test correctly identified 96 of the 98 as positive within a 20 minutes read time, resulting in a clinical sensitivity of 98 per cent.
Out of a total of 102 negative samples tested with the lateral flow device, the test correctly identified 101 as negative, giving a clinical specificity of 99 per cent.
As part of the study, the same clinical samples were tested with two leading, commercially available lateral flow antigen tests, and the data showed that the AffiDx test had better clinical sensitivity across the range of viral loads, and in particular at lower levels.
Avacta said the new data will now be combined with other performance data from ongoing studies to finalise the technical file for CE marking Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test for professional use, allowing the company to begin commercial roll-out in Europe in May.
Lateral flow rapid antigen tests provide a low cost means of identifying individuals with a high viral load that means they are more likely to infect others.
Many factors affect whether an individual will infect others or not, as well as viral load, such as the circumstances and length of exposure.
However, there is a growing consensus that a viral load of Ct<27 should be considered as infectious.
The clinical data for Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test demonstrated 100 per cent sensitivity for identifying infectious individuals in this range.
Dr Alastair Smith, chief executive of Avacta Group, said: “I am delighted with the clinical data from this larger clinical study, which has robustly evaluated the AffiDX antigen test with lower viral loads of Ct>26 as well as with higher viral load samples.
“The results are very impressive and marks a major step in obtaining a CE mark for professional use.”