A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
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Outcome Measures
Primary Outcome Measures
- Covid + [10 days]
The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2
Eligibility Criteria
Criteria
Inclusion Criteria:
Participants can be patients or staff members at the testing site.
Potential participants may be enrolled if:
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They are identified as requiring a standard diagnostic test for COVID-19 or are being treated after testing positive for COVID-19;
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They are age ≥ 18 years old;
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They are willing and able to provide verbal informed consent.
Exclusion Criteria:
- Patients receiving active treatment with antivirals, chloroquine or immune modulators.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tampa General Hospital | Tampa | Florida | United States | 33606 |
| 2 | University of South Florida | Tampa | Florida | United States | 33612 |
| 3 | AdventHealth Tampa | Tampa | Florida | United States | 33613 |
Sponsors and Collaborators
- Kaligia Biosciences, LLC
- University of South Florida
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KBS005