A-ROAD TRL4 to TRL7 prototype to commercial ready

Following the government's well publicised finding that current SARS-CoV-2 antibody assays were inadequate, the case for a reliable and robust test was made by Sir John Bell, Regius Professor of Medicine at the University of Oxford and a government adviser on life sciences stating, how "We see many false negatives (tests where no antibody is detected despite the fact we know it is there) and we also see false positives". In fact, most tests analysed failed to detect antibodies half the time they were known to be present with the best tests managing 70%, falling well short of the required 95% success.

Despite the improved confidence available with recent Abbot and Roche antibody tests, home finger-prick testing has been removed from the market until the MHRA is able to ensure test stability and ease of use. Consequently, the only resultant testing available still depends heavily on the labour intensive Test and Trace program that requires PCR analysis in a centralised laboratory.

Our test is designed to detect antibodies against Covid-19 in blood samples, and will be adapted to detect evidence of the virus itself ('antigens') in saliva samples. The test can be performed at home, in the workplace, in hospitals and schools and even at airports, at costs that we hope will make routine testing affordable. Early experiments suggest that our test may be 200-fold more sensitive than current antibody tests, and we aim to achieve to achieve 98% detection (within a 95% confidence interval). If we are able to reproduce this for antigen detection, we may be able to replace PCR testing with a more delocalised approach.

In contrast to other LFAs, the result will be confirmed electrically as a binary positive or negative to remove any ambiguity. This allows us to digitise the test and display the result on a smartphone for real-time interpretation by the patient, as well as transmitting the result instantaneously to the employer, a government body or healthcare provider. For the first time, people will know where and when Covid-19 is encountered in real time.

The assay will take the format of a home finger-prick LFA because of its familiarity which requires no further equipment, specialist training and, which is already able to be mass manufactured. The test will use a new electrical platform which will be reusable. Using Innovate UK funding to address the immediate and urgent need for response to the current pandemic, we are building SARS-CoV2 specific assays. In the future, our ground-breaking technology will be a generic platform for the detection of other pathogens and environmental contaminants.