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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronavirus, COVID

Intervention / Treatment
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* Diagnostic Test: RBA-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants can be patients or staff members at the testing site. Potential participants may be enrolled if: They are identified as requiring a standard diagnostic test for COVID-19 or are being treated after testing positive for COVID-19; They are age ≥ 18 years old; They are willing and able to provide verbal informed consent. Exclusion Criteria: Patients receiving active treatment with antivirals, chloroquine or immune modulators.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid +<br>Laboratory obtained Covid+ specimen results will be compared to saliva specimen | Diagnostic Test: RBA-2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |