Advancing COVID-19 Detection in a University Environment: Comprehensive Validation and Longitudinal Analysis of High-Throughput Breathalyzer Technology

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<sup>®</sup>), a Real-Time High-Throughput Breathalyzer, for SARS-CoV-2 detection. It aimed to validat...

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Main Authors: Khemraj Hirani, Joana R. N. Lemos, Maritza Suarez, Rahul Mittal, Jannet Yern, Giselle Wicks, Julio C. Pena, Eran Gabbai, Regina Aharonov-Nadborny, Iko Ben-Giat, Erin Kobetz, Roy E. Weiss
Format: Article
Language:English
Published: MDPI AG 2025-03-01
Series:Applied Microbiology
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Online Access:https://www.mdpi.com/2673-8007/5/2/35
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author Khemraj Hirani
Joana R. N. Lemos
Maritza Suarez
Rahul Mittal
Jannet Yern
Giselle Wicks
Julio C. Pena
Eran Gabbai
Regina Aharonov-Nadborny
Iko Ben-Giat
Erin Kobetz
Roy E. Weiss
author_facet Khemraj Hirani
Joana R. N. Lemos
Maritza Suarez
Rahul Mittal
Jannet Yern
Giselle Wicks
Julio C. Pena
Eran Gabbai
Regina Aharonov-Nadborny
Iko Ben-Giat
Erin Kobetz
Roy E. Weiss
author_sort Khemraj Hirani
collection DOAJ
description 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<sup>®</sup>), a Real-Time High-Throughput Breathalyzer, for SARS-CoV-2 detection. It aimed to validate and implement the TERA.Bio<sup>®</sup> 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<sup>®</sup> and mid-nasal swab RT-qPCR tests. The study evaluated TERA.Bio<sup>®</sup>’s accuracy, sensitivity, specificity, and its role for surveillance. A total of 27,445 breath samples were analyzed through the TERA.Bio<sup>®</sup>. In the validation phase, the TERA.Bio<sup>®</sup> demonstrated a sensitivity of 64% and a specificity of 85.1%. Longitudinal monitoring revealed no significant correlation between unclear TERA.Bio<sup>®</sup> results and smoking status. The TERA.Bio<sup>®</sup> 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<sup>®</sup> technology in broader public health scenarios.
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spelling doaj-art-32f9deb646a74f529b5b68e6cb283b2f2025-08-20T03:26:25ZengMDPI AGApplied Microbiology2673-80072025-03-01523510.3390/applmicrobiol5020035Advancing COVID-19 Detection in a University Environment: Comprehensive Validation and Longitudinal Analysis of High-Throughput Breathalyzer TechnologyKhemraj Hirani0Joana R. N. Lemos1Maritza Suarez2Rahul Mittal3Jannet Yern4Giselle Wicks5Julio C. Pena6Eran Gabbai7Regina Aharonov-Nadborny8Iko Ben-Giat9Erin Kobetz10Roy E. Weiss11Department of Medicine, University of Miami Miller School of Medicine, Miami, FL 33136, USADepartment of Medicine, University of Miami Miller School of Medicine, Miami, FL 33136, USADepartment of Medicine, University of Miami Miller School of Medicine, Miami, FL 33136, USADepartment of Medicine, University of Miami Miller School of Medicine, Miami, FL 33136, USADepartment of Medicine, University of Miami Miller School of Medicine, Miami, FL 33136, USAUHealth Information Technology, University of Miami, Miami, FL 33136, USAUHealth Information Technology, University of Miami, Miami, FL 33136, USATerahertz Group Ltd., Herzliya 4672517, IsraelTerahertz Group Ltd., Herzliya 4672517, IsraelTerahertz Group Ltd., Herzliya 4672517, IsraelDepartment of Medicine, University of Miami Miller School of Medicine, Miami, FL 33136, USADepartment of Medicine, University of Miami Miller School of Medicine, Miami, FL 33136, USAThe 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<sup>®</sup>), a Real-Time High-Throughput Breathalyzer, for SARS-CoV-2 detection. It aimed to validate and implement the TERA.Bio<sup>®</sup> 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<sup>®</sup> and mid-nasal swab RT-qPCR tests. The study evaluated TERA.Bio<sup>®</sup>’s accuracy, sensitivity, specificity, and its role for surveillance. A total of 27,445 breath samples were analyzed through the TERA.Bio<sup>®</sup>. In the validation phase, the TERA.Bio<sup>®</sup> demonstrated a sensitivity of 64% and a specificity of 85.1%. Longitudinal monitoring revealed no significant correlation between unclear TERA.Bio<sup>®</sup> results and smoking status. The TERA.Bio<sup>®</sup> 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<sup>®</sup> technology in broader public health scenarios.https://www.mdpi.com/2673-8007/5/2/35COVID-19 screeningbreath analyzernon-invasive diagnosticsuniversity health surveillancereal-time high-throughput breathalyzer
spellingShingle Khemraj Hirani
Joana R. N. Lemos
Maritza Suarez
Rahul Mittal
Jannet Yern
Giselle Wicks
Julio C. Pena
Eran Gabbai
Regina Aharonov-Nadborny
Iko Ben-Giat
Erin Kobetz
Roy E. Weiss
Advancing COVID-19 Detection in a University Environment: Comprehensive Validation and Longitudinal Analysis of High-Throughput Breathalyzer Technology
Applied Microbiology
COVID-19 screening
breath analyzer
non-invasive diagnostics
university health surveillance
real-time high-throughput breathalyzer
title Advancing COVID-19 Detection in a University Environment: Comprehensive Validation and Longitudinal Analysis of High-Throughput Breathalyzer Technology
title_full Advancing COVID-19 Detection in a University Environment: Comprehensive Validation and Longitudinal Analysis of High-Throughput Breathalyzer Technology
title_fullStr Advancing COVID-19 Detection in a University Environment: Comprehensive Validation and Longitudinal Analysis of High-Throughput Breathalyzer Technology
title_full_unstemmed Advancing COVID-19 Detection in a University Environment: Comprehensive Validation and Longitudinal Analysis of High-Throughput Breathalyzer Technology
title_short Advancing COVID-19 Detection in a University Environment: Comprehensive Validation and Longitudinal Analysis of High-Throughput Breathalyzer Technology
title_sort advancing covid 19 detection in a university environment comprehensive validation and longitudinal analysis of high throughput breathalyzer technology
topic COVID-19 screening
breath analyzer
non-invasive diagnostics
university health surveillance
real-time high-throughput breathalyzer
url https://www.mdpi.com/2673-8007/5/2/35
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