Development of at-Home, Self-Administered Test for COVID19 and Respiratory Viruses

Abstract

Rationale: We have proposed to develop an at-home breath collection device to diagnose and monitor patients with COVID-19. There is currently no method to track an individual's health outside of a hospital and predict if they might require clinical intervention. The present COVID19 diagnostic tests only look for direct evidence of the virus. We hypothesize that our method looks for the human body's response to infection. This allows us to not only determine whether an individual is infected or not, but also determine the severity of their health condition through chemical analysis of their metabolism. T Methods: COVID-19 infected patients are given a device that allows them to safely, non-invasively, and painlessly collect their own breath samples, which we are screening for not only COVID- 19 infection, but for other common respiratory viral infections, such as other coronaviruses, rhinovirus and influenza. We will compare the breath biomarkers of influenza with COVID-19 with that of our identified pattern of influenza. We are assessing the sensitivity of our test to diagnose COVID-19 and the specificity to not only diagnose COVID-19 from typical influenzas and rhinoviruses, but also the specificity to diagnose COVID-19 in patients with co-infections of other pulmonary viruses. Nasopharyngeal swab will be the gold standard. Results: We have collected exhaled breath condensate samples from patients with COVI19 infection. The device is can be used safely by the patient and does not require the participation of research coordinators during the breath collection phase. Symptomatic patients are able to use the device without excessive shortness of breath or other effects. The mass spectroscopy screening of the breath samples will look at a panel of eicosanoid biomarkers related to pulmonary infection and markers of oxidative stress. Patterns are being compared to prior breath profiles found with influenza infection. Conclusion: Our breath collection device could provide an “alarm” for individuals who are potentially facing a stark decline in health and should preemptively move into a hospital or clinical setting for closer monitoring. Because this method screens for a myriad of respiratory viruses and of pulmonary health simultaneously, its impact would extend far beyond the current COVID-19 pandemic.