Rapid Differential Diagnosis of COVID-19 and Common Respiratory Infections Fast Track SBIR NOT-AI-20-031The ongoing novel coronavirus disease (COVID-19) pandemic is spreading rapidly across the globe with over3.2 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 arelethal in an estimated 3-5% of confirmed cases. Influenza and respiratory syncytial virus (RSV) are the mostcommon 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 willbe an acute need to perform differential diagnosis of patients in distributed locations (e.g., urgent care, primarycare, pediatric physician offices, retail walk-in clinics, drive through testing sites, etc.). A differential diagnosis innon-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 platformwill be CLIA-waived for use in a distributed care setting and will provide diagnostic results within 10 minutes ofsample collection. The tests will be automated on our small footprint digital microfluidics testing platform, whichis currently CE marked and pending 510(k) clearance from the FDA. Our system will provide unique advantagesof integrated sample processing and will provide rapid results that easily fit within a typical urgent care, primaryor pediatric physician care, or retail walk-in clinic appointment. We are collaborating with the Duke HumanVaccine 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, identifymildly affected individuals and asymptomatic carriers to reduce community spread through appropriatequarantine, and ensure proper protective measures for critical patients requiring hospitalization. As our companymission is focused on pediatric care, we are especially interested in identifying newborns, infants, and olderchildren who may present at pediatric primary care clinics with symptoms indicative of COVID-19, influenza, orRSV. Our innovative digital microfluidics platform will remove the requirements for tedious manual sampleprocessing protocols and deliver the results while the patient is waiting. Future iterations of this technology willexpand the respiratory virus test panel to include over a dozen pathogens (i.e. parainfluenza viruses) and addserology testing to the same test cartridge to provide data on past viral exposure.
Public Health Relevance Statement: PROJECT NARRATIVE
The early symptoms of coronavirus disease 2019 (COVID-19) have similar symptomatic presentation
to those of common cold and flu viruses. Recurrent seasonal outbreaks of coronavirus are expected to
persist long after the initial COVID-19 pandemic wave, in patterns that coincide with seasonal outbreaks
of other respiratory viruses, including influenza A, influenza B, and respiratory syncytial virus (RSV).
We present an innovative, rapid, and multiplexed differential diagnostics panel to simultaneously test
for COVID-19, two influenza A subtypes, influenza B, and RSV from nasopharyngeal or oropharyngeal
swabs. The platform will be CLIA-waived for use in an urgent care or retail walk-in clinic setting and will
provide diagnostic results within 10 minutes of sample collection.
Project Terms: Affect ; Appointment ; Biological Assay ; Assay ; Bioassay ; Biologic Assays ; Child ; 0-11 years old ; Child Youth ; Children (0-21) ; youngster ; Common Cold ; Acute Nasopharyngitis ; Communities ; Coughing ; Differential Diagnosis ; Disease ; Disorder ; Disease Outbreaks ; Outbreaks ; Fever ; Pyrexia ; febrile ; febris ; Fluorescence ; Future ; Hospitalization ; Hospital Admission ; University Hospitals ; Human ; Modern Man ; Immunoglobulin A ; IgA ; Immunoglobulin G ; 7S Gamma Globulin ; IgG ; Immunoglobulin M ; 19S Gamma Globulin ; IgM ; Newborn Infant ; 0-4 weeks old ; Newborns ; newborn child ; newborn children ; Influenza ; Grippe ; Institutes ; Lung diseases ; Pulmonary Diseases ; Pulmonary Disorder ; Respiratory Disease ; Respiratory System Disease ; Respiratory System Disorder ; disease of the lung ; disorder of the lung ; lung disorder ; Manuals ; Methods ; Mission ; Names ; Nucleic Acids ; parainfluenza virus ; Patients ; Physicians ; Physicians' Offices ; Pneumonia ; 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Severe Acute Respiratory Distress Syndrome Corona Virus 2 ; Severe Acute Respiratory Distress Syndrome Coronavirus 2 ; Severe Acute Respiratory Syndrome CoV 2 ; Severe Acute Respiratory Syndrome-associated coronavirus 2 ; Severe Acute Respiratory Syndrome-related coronavirus 2 ; Severe acute respiratory syndrome associated corona virus 2 ; Severe acute respiratory syndrome corona virus 2 ; Severe acute respiratory syndrome coronavirus 2 ; Severe acute respiratory syndrome related corona virus 2 ; Wuhan coronavirus ; coronavirus disease 2019 virus ; hCoV19 ; nCoV2 ; COVID-19 pandemic ; COVID crisis ; COVID epidemic ; COVID pandemic ; COVID-19 crisis ; COVID-19 epidemic ; COVID-19 global health crisis ; COVID-19 global pandemic ; COVID-19 health crisis ; COVID-19 public health crisis ; COVID19 crisis ; COVID19 epidemic ; COVID19 global health crisis ; COVID19 global pandemic ; COVID19 health crisis ; COVID19 pandemic ; COVID19 public health crisis ; SARS-CoV-2 epidemic ; SARS-CoV-2 global health crisis ; 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