Performance Study of SONA Saliva C-19 Rapid Test
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Corona Virus Infection
- COVID-19
- SARS CoV-2 Infection
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The purpose of this study is to validate the performance of the Sona Saliva C-19 rapid Test for rapid detection of SARS_CoV_2 infection when using saliva specimens. A prospective randomized and blinded study to evaluate a rapid point of care antigen test for the detection of viral proteins and compared against an approved RT-PCR test. Saliva samples will be collected along with the current standard of care collection.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The clinical performance of the Sona Saliva C-19 Rapid Test will be evaluated in a prospective clinical study conducted at a single (1) investigational site in Toronto, Cananda. Consenting patients of ages 18+, any gender, or race/ethnicity who presents at the test site with COVID-19 like symptoms d...
The clinical performance of the Sona Saliva C-19 Rapid Test will be evaluated in a prospective clinical study conducted at a single (1) investigational site in Toronto, Cananda. Consenting patients of ages 18+, any gender, or race/ethnicity who presents at the test site with COVID-19 like symptoms during the 2021 COVID-19 season will be asked to take part in the study, will be sequentially enrolled and tested. Trained operators with laboratory experience who have received training on the use of the Sona Saliva C-19 Rapid Test will conduct the testing and represent the intended users. A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process, study questionnaire and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number, be asked to provide a sample for testing.
Tracking Information
- NCT #
- NCT04877002
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Jacobs, Dr Humber River Hospital
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