Abstract
The COVID-19 pandemic has underscored the need for efficient and non-invasive diagnostic tools for early detection and management. This study evaluated the TERA breath analyzer (TERA.Bio®), a Real-Time High-Throughput Breathalyzer, for SARS-CoV-2 detection. It aimed to validate and implement the TERA.Bio® for the detection of SARS-CoV-2 within a university population compared to RT-qPCR testing. Conducted at the University of Miami, this observational study consisted of two phases: a validation phase and a longitudinal monitoring phase, using cross-sectional and prospective cohort designs, respectively. Participants, including symptomatic individuals and those in close contact with confirmed cases, underwent simultaneous testing with the TERA.Bio® and mid-nasal swab RT-qPCR tests. The study evaluated TERA.Bio®’s accuracy, sensitivity, specificity, and its role for surveillance. A total of 27,445 breath samples were analyzed through the TERA.Bio®. In the validation phase, the TERA.Bio® demonstrated a sensitivity of 64% and a specificity of 85.1%. Longitudinal monitoring revealed no significant correlation between unclear TERA.Bio® results and smoking status. The TERA.Bio® is a viable tool for COVID-19 screening in university environments, providing rapid, cost-effective, apt extensive screening and monitoring in a dense academic setting. Its non-invasive nature, high throughput, and electronic health system compatibility make it an essential addition to existing COVID-19 diagnostic strategies. This study highlights the critical role of innovative diagnostic tools in pandemic management and suggests potential applications of TERA.Bio® technology in broader public health scenarios.