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.
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.
Diagnostic Test: RBA-2
Collection of 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.
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.
Tampa General Hospital
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
Janice Shirley, MPH MBA PA-C
813-919-8857
advancedclinicalresearch@yahoo.com
Fazal Fazlin
727-580-7013
ffazlin@kaligiabiosciences.com