Avacta has reported that data from the study of its AffiDX SARS-CoV-2 antigen lateral flow test showed a clinical sensitivity of 98% for Covid-19 samples.
The study was carried out at a single site in Europe on 98 Covid-19 positive samples with viral loads confirmed by polymerase chain reaction (PCR).
The results will be included in the technical report, along with stability and other performance data from ongoing studies, for CE marking the AffiDX SARS-CoV-2 antigen lateral flow test for professional use.
This will allow Avacta to commercially roll out the test across Europe from May.
Data showed that the test detected 96 out of 98 of the samples correctly as positive within a 20 minute read time, showing a 98% clinical sensitivity.
Furthermore, from a pool of 102 negative samples, the lateral flow device correctly detected 101 as negative, showing a 99% clinical specificity.
The AffiDX SARS-CoV-2 antigen lateral flow test showed a sensitivity of 100% in detecting infectious people with a viral load of Ct<27.
Avacta CEO Dr Alastair Smith 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.
“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.”
In another development, Empowered Diagnostics has received a CE mark for its CovClear COVID-19 Rapid Antigen Test.
This lower-cavity nasal swab test can identify an active Covid-19 infection within roughly two days of exposure to the SARS-CoV-2 virus, before individuals even become contagious.
The user-friendly test delivers precise results in minutes, with an accuracy of 99.7%, sensitivity of 98.5% and specificity of 100%.
Empowered Diagnostics president Barry Abraham said: “CovClear receiving a CE mark is an important step in delivering access to extremely accurate, affordable rapid testing throughout the European Union.
“Highly sensitive tests are essential for preventing the spread of Covid-19 by minimising false negatives and, therefore, the false confidence delays that discourage people from re-testing.”