Official Title
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device
Brief Summary

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.

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.

Not yet recruiting
Coronavirus
COVID

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.
Covid +

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Tampa General Hospital
Tampa, Florida, 33606

University of South Florida
Tampa, Florida, 33612

Investigator: Rachel Karlnoski, PhD
Contact: 813-974-8558
karlnosk@usf.edu

Investigator: Asa Oxner, MD

AdventHealth Tampa
Tampa, Florida, 33613

Investigator: Elsie Medina, MS
Contact: 813-615-7200

56514 elsie.medina@adventhealth.com

Investigator: Jose Tirado

Contacts

Janice Shirley, MPH MBA PA-C
813-919-8857
advancedclinicalresearch@yahoo.com

Fazal Fazlin
727-580-7013
ffazlin@kaligiabiosciences.com

Kaligia Biosciences, LLC
University of South Florida
NCT Number
MeSH Terms
Coronavirus Infections