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

ArmDescriptionAssigned Intervention
Covid + Laboratory obtained Covid+ specimen results will be compared to saliva specimen
  • 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.

Recruiting Locations

More Details

NCT ID
NCT04357977
Status
Unknown status
Sponsor
Kaligia Biosciences, LLC

Study Contact

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

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.