Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
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|ClinicalTrials.gov Identifier: NCT05256589|
Recruitment Status : Not yet recruiting
First Posted : February 25, 2022
Last Update Posted : March 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Sars-CoV-2 Infection||Diagnostic Test: Sona Saliva C-19 Rapid Self-test||Not Applicable|
This is a prospective, non-randomized clinical evaluation study being carried out in the intended use population in which fresh saliva samples are collected, tested, and interpreted by lay-users and the results are compared to samples evaluated with an authorized high sensitivity molecular RT-PCR test.
The device to be studied is the Sona Saliva C-19 Rapid Self Test.
Participants will be recruited into the study who present at a NS Health Central Zone COVID-19 PCR testing site for COIVID-19 testing. This study does not involve any additional study visits, and all participants will receive the current standard of care.
Patients will provide their RT-PCR sample as per the established testing processes at the health centre and will receive their results through the standard communication pathway. Self-testing using the Sona assay will be conducted at the COVID -19 testing center by individuals in real time.
The participants will be instructed as to not act on the result of their Sona saliva assay, but rather await the gold standard result of RT-PCR.
A usability questionnaire will also be completed by individuals.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
The purpose of this study is to validate the performance of the Sona Saliva C-19 rapid Self-Test for detection of SARS_CoV_2 infection when using saliva specimens. A prospective 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)|
|Official Title:||Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19|
|Estimated Study Start Date :||March 2022|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||April 2022|
Experimental: SARS_CoV_2 Antigen Rapid Test
The same group of patients participate in two arms of the study:
One arm is for obtaining performance data of the Sona Saliva C-19 Rapid self test and the comparator arm is to obtain data from the primary care route using approved RT-PCR testing.
Diagnostic Test: Sona Saliva C-19 Rapid Self-test
Rapid Antigen diagnostic device performance comparative to RT-PCR
- Percent Positive Agreement (Sensitivity) and Negative Percent Agreement (Specificity) [ Time Frame: 35 days from last patient enrolment ]Calculate the performance of the Sona Saliva C-19 Rapid Self Test when compared to RT- PCR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05256589
|Contact: Glenn Patriquin, MD||+1 firstname.lastname@example.org|