Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine

Summary

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.

Conditions

• COVID-19
• SARS CoV 2 Virus
• COVID-19 Pneumonia
• COVID-19 Respiratory Infection
• COVID-19 Acute Respiratory Distress Syndrome

Interventions

DEVICE

A&M Breathalyzer PROTECT Kiosk

The A\&M Breathalyzer PROTECT Kiosk will collect the mass spectrum breath readings from each participant, scan speed, and will autoanalyze noise and scan thresholds and sensitivity data.

Sponsors & Collaborators

• Brooke Army Medical Center

  collaborator FED

• Uniformed Services University of the Health Sciences

  collaborator FED

• Level 42 AI, Inc.

  collaborator INDUSTRY

• The Geneva Foundation

  lead OTHER

Principal Investigators

• Tony Yuan, PhD · Uniformed Services University of the Health Sciences (USUHS)

• Michael Morris, MD · Brooke Army Medical Center

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-27

Primary Completion

2025-12-31

Completion

2026-03-30

Countries

• United States

Study Locations