Avacta Group has announced significant progress in the development of a highly scalable manufacturing process for a lateral-flow SARS-CoV-2 antigen test, currently being carried out with BBI Solutions, and that the test shows very good sensitivity.
Avacta is developing several coronavirus tests using Affimer binders that are highly specific to the SARS-CoV-2 virus spike protein. A highly scalable test device using readily available components and routine manufacturing processes has now been shown to have a sensitivity for coronavirus spike protein in laboratory samples better than 300 pg/mL, which is in the range expected for spike protein in clinical samples.
In preparation for clinical validation of the lateral-flow test, Avacta is working on both saliva and anterior nasal swab samples. Anterior nasal swabs sample the easily accessible parts of the nose and are therefore painless and straightforward to administer, unlike nasopharyngeal swabs which are generally regarded as painful and unpleasant. Avacta and its partners will continue to develop both sampling methods in parallel in order to bring high-performance COVID-19 tests to market quickly to suit a range of cases.
The performance of the test with clinical samples will now be evaluated as a precursor to a much larger clinical study with COVID-19 patients of known viral load to determine the clinical sensitivity of the test. In parallel, BBI Solutions is working to finalise and validate the manufacturing process so that the group can carry out a full clinical validation on the final product to support the regulatory approval process.