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Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine
A Prospective, Non-interventional, Observational Clinical Validation Study to Analytically Validate the A&M Breathalyzer PROTECT Kiosk Breath Capture System.
Who can join
Ages 18 to 89 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Asymptomatic and symptomatic individuals 18 years and older * Receiving standard COVID-19, Flu and/or RSV screening and testing at BAMC * Do not have to be diagnosed with SARS-CoV-19 (COVID-19) but only be screened * Ability to understand consent Exclusion Criteria: * Any individual under age of 18 * Anyone unable to comply (or be assisted) with study procedures * Anyone not able to provide temperature thermal scan, and/or perform exhaled breath for approximately 8 seconds
About the study
The primary objective of this effort will be to optimize and operationalize innovative passive surveillance systems and in parallel, the effort will identify, evaluate, and transition groundbreaking new technologies in diagnostics for operationalization.
To meet the objective and execute the deliverables for this program of effort, the A\&M Breathalyzer PROTECT Kiosk will be tested, modified and validated at Brooke Army Medical Center (BAMC). The collaborative efforts between the PI, Dr. Michael Morris at BAMC and Co-Investigator Dr. Tony Yuan at USU- Center for Biotechnology (4D Bio3) will assess the passive detection technology and provide a capability survey of use-case scenarios for different operational settings.
Goals:
1. Optimization and operationalize the A\&M Breathalyzer PROTECT Kiosk, portable mass spectrometer (MS) Detector for Deployment in Military Operational Medicine Environments. The Breathalyzer will be deployed to BAMC to test its detection capabilities of COVID-19 among symptomatic and asymptomatic COVID-19 carrier vs. those not infected compared to gold standard RT-PCR. 2. Evaluate the passive sensing, breath capture system, built within the A\&M Breathalyzer PROTECT Kiosk. The conversion of the active breath capture system, currently requires a straw that the subject breaths into, where then a series of sensors built in the Breathalyzer would automatically sample the exhaled breath within proximity for recent COVID-19 exposure. This task would conclude with a set of sensors and sensor inputs that would be analyzed by the Atomic AI platform built in the device. Field testing at BAMC is planned to determine the level of detection and discrimination for sensor combinations to SARS-CoV2 components and biomarkers detected. This testing would update the Atomic AI algorithm, within the device, to understand the accuracy of positive detection and the resulting sensitivities.
What is being tested
- A&M Breathalyzer PROTECT Kiosk (device)
Sponsor: The Geneva Foundation · Participants: 100 · Started: Dec 27, 2023
Contact the study team
- Tony Yuan, PhD · Phone: 214-292-0508
- Katherine Walker-Rodriguez · Phone: 2103783057
Official record on ClinicalTrials.gov — NCT06402318
Locations in the U.S.
| Texas | Brooke Army Medical Center, Fort Sam Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.