Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19
The COVID-19 pandemic has challenged the health systems worldwide. Many tools have been developed in response to the pandemic, but there is no current way to quickly screen multiple people for the disease. Research has shown that people with COVID-19 have higher levels of some proteins involved in the immune response and inflammation. These proteins can be detected in sweat using a special camera. Researchers want to see if analysis of sweat from fingerprints could be used to detect COVID-19 infection in people.
To test a new technology to detect COVID-19 infection based on an analysis of sweat from fingerprints.
Adults ages 18 and older who tested positive or negative for COVID-19 within the last 7 days.
Participants will visit the NIH Clinical Center for one day within 7 days from COVID-19 testing. The visit will last for 3 to 4 hours.
Participants who show symptoms for COVID-19 with a positive test will give blood samples to correlate with the sweat markers. About 1/2 tablespoon of blood will be drawn.
For sweat markers, 10 fingers will be imaged by a camera using a touchless system. This will be repeated 3 times. It will take about 15 minutes. Participants will use the device. They will get instructions and watch a short video on how to use the device.
|Condition or Disease||Intervention/Treatment||Phase|
The new COVID19 pandemic has challenged the health system worldwide. Massive testing contact tracing and social distancing proved to be the most effective tools to fight the pandemic in absence of an effective vaccine.
Despite the effort to develop rapid diagnostic testing, we still don t have an available large population screening modality. Hyperspectral analysis of sweat metabolites from fingerprint has the potential to be a valid clinic strategy to detect COVID19 infected individuals.
COVID19 infection has shown higher levels of inflammatory proteins like IL6, LDH, CRP, and d-dimer which have been implicated with severe COVID-19 induced pneumonitis and coagulopathy. These molecules can be detected as sweat metabolites and used as a biomarker for viral infection detection.
Identify a pattern classifier to distinguish between COVID19 positive and COVID19 negative human subjects by hyperspectral analysis of sweat metabolites.
Individuals must all be >=18 years old
Must have standard of care molecular testing for COVID19 within 7 days from study enrollment. Those individuals who tested positive will be enrolled in cohort 1 and those who tested negative will be enrolled in cohort 2
This is an exploratory multisite study to evaluate the use of biometric analysis of sweat metabolites to detect COVID19 infection. Center for Cancer research (CCR), NCI will be the coordinating center.
All adult subjects that have available testing for COVID-19 completed within 7 days from the study enrollment are eligible for this study. The study will have two cohorts, cohort 1 (COVID19 positive), and cohort 2 (COVID19 negative). Fifty participants will be enrolled in each cohort to receive additional COVID19 testing based on the hyperspectral analysis of fingerprint sweat metabolites.
Every participant will have all ten fingers imaged by the camera with a touchless system. The ten fingers imaging will be repeated three times. This imaging will take about 15 minutes.
The hyperspectral instruments will be used directly by the participants without any additional human resources to carry out this data collection.
The data obtained by the digital analysis will be compared to the result of the standard COVID19 test in use at the National Institute of Health and Inova Fairfax Medical Campus.
Arms and Interventions
|Cohort 1/COVID19 positive|
Participants with molecular testing positive for COVID19
|Cohort 2/COVID19 negative|
Participants with molecular testing negative for COVID19
Primary Outcome Measures
- Hyperspectal Analysis [One day]
Identify a pattern classifier to distinguish between COVID19 positive (cohort 1) and COVID 19 negative (cohort 2) human subjects by hyperspectral analysis of sweat metabolites.
- INCLUSION CRITERIA:
Eligible subjects must meet the following inclusion criteria:
Age >=18 years.
Must have a standard of care molecular testing positive for COVID19 to be enrolled in cohort 1 or a standard of care molecular testing negative for COVID19 to be enrolled in cohort 2 done within 7 days
Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document
Subjects with the following characteristics will be excluded from the study:
-Participants started on treatment with remdesivir and/or dexamethasone for the treatment of COVID19
Contacts and Locations
|1||National Institutes of Health Clinical Center||Bethesda||Maryland||United States||20892|
|2||INOVA Fairfax Hospital||Falls Church||Virginia||United States||22042|
Sponsors and Collaborators
- National Cancer Institute (NCI)
- Principal Investigator: James L Gulley, M.D., National Cancer Institute (NCI)
Study Documents (Full-Text)None provided.