Avacta Group has reported positive data from the clinical validation of its AffiDX SARS-CoV-2 antigen lateral flow test.
Data from the clinical study conducted in Europe on 98 positive COVID-19 samples demonstrate “excellent performance” in identifying the SARS-CoV-2 virus across a broad range of viral loads.
The AIM listed Wetherby-based life science business said this data will now be combined with stability and other performance data from ongoing studies to finalise the technical file for CE marking the AffiDX SARS-CoV-2 antigen lateral flow test for professional use. This will therefore allow the company to begin commercial roll-out in Europe in May.
The clinical evaluation of Avacta’s lateral flow test was carried out at a single site in Europe with patient samples with viral loads confirmed by PCR. The study tested 98 positive samples.
Avacta’s rapid antigen test identified 96/98 of these correctly as positive with a 20 minutes read time resulting in a clinical sensitivity of 98.0% for samples within this broad range down to low viral loads.
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 99.0%.
“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,” said Dr Alastair Smith, Chief Executive of Avacta Group.
“As part of the study the same clinical samples were tested with two leading, commercially available lateral flow antigen tests, and the data show that the AffiDX test had better clinical sensitivity across the range of Ct value and in particular at lower viral loads.
“We are completing the necessary assessment of the product from our manufacturing partner Global Access Diagnostics, including stability testing that will complete the technical file for CE marking, which we expect will happen in early May.
“We are very excited by the potential of this high quality SARS-CoV-2 rapid antigen test and we are looking forward to updating the market as we commercially roll-out the AffiDX® test in the coming months.”