Clinical trial and detection of SARS-CoV-2 by a commercial breath analysis test based on Terahertz technology.

ABSTRACT

Public health threats such as the current COVID-19 pandemics have required prompt action by the local, national, and international authorities. Rapid and noninvasive diagnostic methods may provide on-site detection and immediate social isolation, used as tools to rapidly control virus spreading. Accordingly, the aim of the present study was to evaluate a commercial breath analysis test (TERA.Bio®) and deterministic algorithm for detecting the SARS-CoV-2 spectral signature of Volatile Organic Compounds present in exhaled air samples of suspicious persons from southern Brazil. A casuistic total of 70 infected and 500 non-infected patients were sampled, tested, and results later compared to RT-qPCR as gold standard. Overall, the test showed 92.6% sensitivity and 96.0% specificity. No statistical correlation was observed between SARS-CoV-2 positivity and infection by other respiratory diseases. Further studies should focus on infection monitoring among asymptomatic persons. In conclusion, the breath analysis test herein may be used as a fast, on-site, and easy-to-apply screening method for diagnosing COVID-19.