The primary objective of this effort will be to optimize and operationalize innovativepassive surveillance systems and in parallel, the effort will identify, evaluate, andtransition groundbreaking new technologies in diagnostics for operationalization.To meet the objective and execute the deliverables for this program of effort, the A&MBreathalyzer PROTECT Kiosk will be tested, modified and validated at Brooke Army MedicalCenter (BAMC). The collaborative efforts between the PI, Dr. Michael Morris at BAMC andCo-Investigator Dr. Tony Yuan at USU- Center for Biotechnology (4D Bio3) will assess thepassive detection technology and provide a capability survey of use-case scenarios fordifferent 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.
Emerging acute respiratory diseases (ARDs) pose a significant threat for the US military,
especially among those in training environments where crowded living conditions and
demanding multi-factorial stresses exacerbate infection exposure and suppress immunity,
respectively. Consequently, ARD rates are routinely reported higher in recruits than
older military personnel, which have a detrimental effect on operational readiness.
Although significant steps, such as surveillance and vaccine programs, have been taken to
minimize the impact that ARDs have on military recruits and newly mobilized troops,
hospitalizations among recruits still exceeds that of comparable civilian population in
the United States by at least 3- to 4-folds, accounting for almost 30% of all infectious
disease associated hospitalizations. In 2018, respiratory infections like respiratory
syncytial virus (RSV), accounted for an estimated 50,000 medical encounters affecting
about ~35,000 recruits that resulted in 1,000 hospital bed days leading to significant
loss in training time and cost. In addition to annual respiratory infections, the
on-going COVID-19 numbers rising again, continues to threaten to further degrade
operational readiness. Thus, inexpensive, rapid, and more reliable diagnostics are
continually required to better treat and prevent ARDs to preserve military readiness and
decrease disability adjusted life years.
Current CLIA laboratory diagnostic procedures, such Enzyme Linked Immunosorbent Assay
(ELISA), Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), and bacterial
cultures, are costly, time-consuming, and operator sensitive. It has become apparent that
during the COVID-19 pandemic, these approaches were and continue to be insufficient in
meeting diagnostic needs as they are difficult to scale-up and lack logistical
flexibility. Furthermore, due to the invasive nature of active clinical sampling, there
is a critical need for accurate and rapid passive surveillance as to screen for
SARS-CoV-19 as well as other hazardous chemical and biological agents. To address this
capability gap, the current project will: 1) modify and operationalize existing
innovative passive surveillance systems that can be deployed in the near-term; 2)
leverage revolutionary technologies that will enhance current diagnostic systems to meet
mid- and far-term gaps in CBRNE gaps.
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.
Other Name: Breathalyzer
Inclusion Criteria:
- Asymptomatic and symptomatic individuals 18 years and older
- Receiving standard COVID-19 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
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Investigator: Katherine Walker-Rodriguez, MSN
Contact: 210-378-3057
katherine.c.walker-rodriguez.ctr@health.mil
Investigator: Michael Morris, MD
Tony Yuan, PhD
214-292-0508
tony.yuan@usuhs.edu
Katherine Walker-Rodriguez
2103783057
katherine.c.walker-rodriguez.ctr@health.mil