SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies (Level42)

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 such as influenza, on-going COVID-19, which has claimed the lives of 210,000 Americans, 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. Regaining American technological supremacy will require a pivot from the large, exquisite, hardware- defined systems that won us the conflicts of last century to larger numbers of lower-cost, attritable,smaller, software-defined systems. This is particularly critical as the country reopens, and life returns to normal, thus long-term technological technology platforms must be able to secure entry to workplaces, airplanes, schools, stadiums, theaters, mass transit center, ports-of-entry, malls and restaurants. 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 dynamic COVID-19 pandemic, these approaches are 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- modify and operationalize existing innovative passive surveillance systems that can be deployed in the near-term. The Level 42 AI imPulseTM UNA and TOR are both over-clothing e-stethoscope and stand-off systems which are intended to be used to identify characteristic and subtle changes in audible and inaudible sounds changes in the upper and lower respiratory tract driven by airflow velocity, hydration, pressure, and wall shear stress for both inspiration (velocity splitting) and expiration (velocity merging) during active infection vs. health. The Level 42 AI imPulseTM TOR improves upon the UNA and adds the capabiliy to perform non-contact, alternating multi-lead electrocardiogram (ECG) and electromyography (EMG) sensors along with existing broad-spectrum vibroacoustic biosignature sensors. This allows the TOR to collect six types of inaudible vibrations and audible sounds as i) Korotkoff sounds and murmurs, ii) heartbeat, iii) respiratory rhythm, iv) gut motility, v) carotid tree blood flow and resistance, and vi) Traube-Hering waves, which measure states of stress tension.