ABSTRACT:

COVID-19 disease is a pandemic currently, according to the World Health Organization (WHO) caused by the SARS-CoV-2 virus. Without innate immunity to the novel virus and with the lack of therapeutic means to treat it, the only way to contain the spread of this disease further is through early diagnosis. However, for many infected individuals the disease remains asymptomatic, yet they can potentially transmit COVID-19 and unknowingly infect more of the population. The early stages of infection cannot be detected for the most part by the molecular tests used currently for screening individuals for this disease. This work features a new and revolutionary approach to diagnose COVID-19 infection from sampling a single human (breath) exhale. This disruptive approach to infectious disease diagnosis and to the detection of COVID-19 specifically involves sampling the breath of human subjects for gaseous signaling metabolites that signal the disease, that is COVID-19 biomarkers. The relative change in the concentration of these biomarkers upon the subject’s infection with the SARS-CoV-2 virus provides an early and distinct signal of this infection. The COVID-19 breath test utilizes selective resistive gas sensors based on binary nanostructured metal oxides, and by testing the breath of humans infected by COVID-19 and comparing it to the breath signal pattern from controls, a distinct signature of acute COVID-19 disease has been identified. This signal pattern has the shape of the small Greek letter omega (ω) and the mechanism behind its formation will be discussed in this talk. Measurements were made repeatedly on infected subjects to map the severity of the disease and to identify when the subject had recovered. Thus, a novel screening/diagnostic tool for the pandemic infection has been developed. The diagnostic device prototype that was developed and used for the clinical testing allowed for the detection of the disease within 15 seconds. This breath test is a rapid, point-of-care, detection tool. In summary, we have established the pathway for the effective diagnosis of the novel coronavirus disease through biomarker monitoring and establishing the specifications required for the early detection of COVID-19. Promoting breath analysis as a first response, on-site, point-of-care, personalized diagnostics method is envisioned. Fast and ubiquitous deployment of the device upon being granted an EUA (our application is still pending at FDA) is anticipated. This is an interdisciplinary project also involving clinicians and infectious disease experts from the Colleges of Medicine and Veterinary Medicine. Support has been provided by the National Science Foundation, the Orton Chair funds and CCTS.

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