Wearable Diagnostics for Detection of COVID-19 Infection

This program is focused on the development a wearable diagnostic capability for the pre-/very early-symptomatic detection of COVID-19 infection.

The pandemic COVID-19, a disease caused by a novel coronavirus, continues to spread worldwide. There is a dire and urgent need for development of rapid, accurate wearable diagnostics to identify and isolate pre-symptomatic COVID-19 cases and track/prevent the spread of the virus.

Some of the ideal capabilities or specifications of a wearable diagnostic for COVID-19 infection are:

  • • Platform must be designed for pre-detection (e.g., physiological monitoring of readiness) and early detection of infection and pathogenic response that can be utilized pre-clinically leading to use at point-of-need role of care 1/2, local doctor’s office, emergency departments, urgent care centers and immediate care clinics.
  • • The capability should be “wearable”, non- or minimally-invasive and be able to assess physiological markers to monitor the health state of the user. A single device is preferred, but a combination of technologies is acceptable.
  • • Device(s) should be designed to be worn for continuous physiological monitoring in a non-obtrusive manner and should not affect the daily activity of the wearer. Sampling of physiological markers/antibodies/biomarkers can occur “on demand” to conserve power. Device should be worn until exposure has been verified or until a medical professional has deemed the device is no longer needed.
  • • Results should be easy to interpret by non-laboratory personnel and results should be collected and able to be saved and shared in a standard and secure format.
  • • The device must be able to be stored and operated between 4°C to 45°C.
  • • Physiologic surveillance for COVID-19 positive individuals that do not yet show clear medical symptoms is an ultimate goal. Physiological signatures therefore must produce predictive algorithms that can be tied into validated and relevant antibody/molecular measurements.
  • • Must have an established manufacturing capability for the platform and assay kits on a large-scale.

The deliverable at the end of the project is to obtain Emergency Use Authorization for the new wearable capability and be ready to distribute the device and test kits. The research project award recipients were selected from the Offerors who responded to MTEC’s Request for Project Proposals (20-12-COVID-19_Diagnostics).