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| Name | Class |
|---|---|
| University of South Florida | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Covid + | Laboratory obtained Covid+ specimen results will be compared to saliva specimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBA-2 | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Covid + | The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2 | 10 days |
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Inclusion Criteria:
Participants can be patients or staff members at the testing site.
Potential participants may be enrolled if:
Exclusion Criteria:
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Participants will be recruited from patients and study staff at the testing site who have been flagged for COVID-19 testing or who are being treated for COVID-19.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janice Shirley, MPH MBA PA-C | Contact | 813-919-8857 | advancedclinicalresearch@yahoo.com | |
| Fazal Fazlin | Contact | 727-580-7013 | ffazlin@kaligiabiosciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Tampa | Florida | 33606 | United States | ||
| University of South Florida |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Tampa |
| Florida |
| 33612 |
| United States |
|
| AdventHealth Tampa | Tampa | Florida | 33613 | United States |
|
| D007239 |
| Infections |