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

NCT04357977 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-04-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of South Florida

    collaborator OTHER

  • Kaligia Biosciences, LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2020-08-31
Completion
2020-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04357977 on ClinicalTrials.gov