A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device
Purpose
The current available diagnostic methods used for the detection of COVID-19 takes up to 4 hours. In some cases, these diagnostics tests make take up to a couple of days. As it is highly contagious, people who are in close contact with the infected person are at high risk of being infected. COVID-19 is transmitted through respiratory droplets produced when an infected person coughs or sneezes. The desire for rapid detection of COVID-19 has become an immediate necessity. The purpose of Kaligia Biosciences' saliva monitoring device (RBA-2) is to detect the presence of the COVID-19 virus in human saliva. The RBA-2 uses Raman Spectros-copy to detect the coronavirus. Once the sample is scanned successfully, the spectra contains the response of the component present in human saliva and provide results in a matter of minutes, rather than hours or days.
Conditions
- Coronavirus
- COVID
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
Participants can be patients or staff members at the testing site. Potential participants may be enrolled if: 1. They are identified as requiring a standard diagnostic test for COVID-19 or are being treated after testing positive for COVID-19; 2. They are age ≥ 18 years old; 3. They are willing and able to provide verbal informed consent.
Exclusion Criteria
- Patients receiving active treatment with antivirals, chloroquine or immune modulators.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Ecologic or Community
- Time Perspective
- Cross-Sectional
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Covid + | Laboratory obtained Covid+ specimen results will be compared to saliva specimen |
|
Recruiting Locations
More Details
- NCT ID
- NCT04357977
- Status
- Unknown status
- Sponsor
- Kaligia Biosciences, LLC
Detailed Description
The purpose of this study is to calibrate the performance of RBA-2 using people by comparing the results against a standard diagnostics test. The objective of this study is to collect non-invasive in vivo saliva from confirmed cases of both infected and non-infected COVID-19 patients or site staff at the testing site and compare the test results using the RBA-2 against the standard test results used for diagnosis. The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2.