Rapid Differential Diagnosis of COVID-19 and Common Respiratory Infections

ABSTRACT Rapid Differential Diagnosis of COVID-19 and Common Respiratory Infections Fast Track SBIR NOT-AI-20-031 The ongoing novel coronavirus disease (COVID-19) pandemic is spreading rapidly across the globe with over 3.2 million confirmed cases as of April 29, 2020. Most cases of COVID-19 have mild symptoms (fever, cough) or are asymptomatic, however severe complications including shortness of breath and bilateral pneumonia are lethal in an estimated 3-5% of confirmed cases. Influenza and respiratory syncytial virus (RSV) are the most common viral respiratory diseases and typically present with symptoms similar to those reported for COVID-19. There is no foreseeable eradication of COVID-19, and as the "flu season" arrives in the fall and winter, there will be an acute need to perform differential diagnosis of patients in distributed locations (e.g., urgent care, primary care, pediatric physician offices, retail walk-in clinics, drive through testing sites, etc.). A differential diagnosis in non-hospital settings will allow triaging of acute cases for hospitalization, provide appropriate targeted therapies, and decrease community spread. We outline an innovative, simple-to-use differential diagnostics panel that will simultaneously test for COVID-19, two influenza A subtypes (H1N1 and H3N2), influenza B, and RSV using nucleic acid based tests. The platform will be CLIA-waived for use in a distributed care setting and will provide diagnostic results within 10 minutes of sample collection. The tests will be automated on our small footprint digital microfluidics testing platform, which is currently CE marked and pending 510(k) clearance from the FDA. Our system will provide unique advantages of integrated sample processing and will provide rapid results that easily fit within a typical urgent care, primary or pediatric physician care, or retail walk-in clinic appointment. We are collaborating with the Duke Human Vaccine Institute, who are currently running COVID-19 tests, on the preclinical aims of this Fast Track project. Improved COVID-19 diagnostic assays are desperately needed to monitor the spread of the disease, identify mildly affected individuals and asymptomatic carriers to reduce community spread through appropriate quarantine, and ensure proper protective measures for critical patients requiring hospitalization. As our company mission is focused on pediatric care, we are especially interested in identifying newborns, infants, and older children who may present at pediatric primary care clinics with symptoms indicative of COVID-19, influenza, or RSV. Our innovative digital microfluidics platform will remove the requirements for tedious manual sample processing protocols and deliver the results while the patient is waiting. Future iterations of this technology will expand the respiratory virus test panel to include over a dozen pathogens (i.e. parainfluenza viruses) and add serology testing to the same test cartridge to provide data on past viral exposure.