COVID-19 Rapid Response: Development of a Coronavirus Antigen Early Diagnostic Detection Platform: Point-of-Need, Fast, Easy-to-Use with Integration into Contact Tracing

The goals of this project are both broad and technical in orientation. The board-minded objectives include:Dailyscreening until the pandemic is deemed under control nationally but particularly locally in rural communities...To couple monitoring temperatures of all employees before entering facility withFollow-up screening of those employees with elevated temperatures with a sensitive diagnostic test designed to detect a coronavirus analyte at early stage after exposure, NOT an antibody test.Additional statistical sampling of employees to capture asymptomatic infections.Link test results to contact tracing to immediately screen all other individuals potentially exposed to the individual screened positive for coronavirus.And with this above process,To most effectively minimize or eliminate the spread of the infection.To identify and monitor asymptomatics a mechanism through which they can be identified and isolated as necessary.To close the gap in meat packing facilities between operational shutdowns and business as normal.To recapture more of the economic health in rural communities experienced before the coronavirus pandemic spreads further.From a technical perspective, the goals of this project are to:Establish ApolloDx&#39;s platform&#39;s capability to detect the SARS-CoV-2 virus&#39; antigenThis will require purchasing matched pairs of antibodies that have already been utilized for producing working ELISA (central laboratory) tests.Immobilize the primary (capture) antibody to graphene oxide deposited on a carbon electrochemical electrode - just as ApolloDx has initiated work on already with a model system for an unrelated virus.Either directly conjugate the secondary (reporter) antibody to an enzyme (horseradish peroxidase or lactate dehydrogenase) or use a generic anti-specie-enzyme conjugate. (In other words, if a mouse monoclonal demonstrates the best results (good limit of detection sensitivity) in this diagnostic mechanism, an anti-mouse antibody-enzyme conjugate will be used. Perform optimizations across a wide range for the critical variables (concentration of primary and second antibodies used, incubation times, pH, concentration of electrochemically (redox) species (e.g. methylene blue), peroxidase substrate concentration (e.g. hydrogen peroxide) etc.) to obtain an electrochemical signal sufficient to demonstrate assay detection feasibility. In their latest advisory, the FDA does not set a quantitative limit of detection (LOD) for coronavirus tests but that the quantitative performance of the test be documented as described in this recommendation. ApolloDx will follow this recommendation.Demonstrate feasibility of coronavirus detection by testing a serial dilution series of the recombinant spike protein target sample in a) first, buffer and b) second, resuspension in nasopharyngeal eluate from non-infected people.Establish specificity of developed test versus common recombinant respiratory viruses.Secure three non-infectious recombinant or biologically inactivated respiratory virus samples from among influenza viruses, respiratory syncytial virus (RSV), parainfluenza viruses, and respiratory adenoviruses.Test these samples at equimolar concentrations with the SARS-CoV-2 antigen in ApolloDx&#39;s assay and examine results for interference from these samples. As described above for sensitivity analysis, this specificity will be documented. Evaluate a range of nasopharyngeal swab eluates equivalent to 1x, 3x, 5x and 7x the normal concentration of eluate in 500µL of elution buffer. Look for interference in the electrochemical signal with increasing eluate concentration.?Endeavor to reduce test performance for <10&#39; TAT (turnaround time). This is a &#39;nice to have&#39; not a &#39;must have&#39;.Write a downloadable smart device app to collect test subject information that will a) merge with sample and consumable test device barcode information, b) the coronavirus antigen test results and c) connect this de-identified information with iOS and Android operating systems to enable contact tracing.