Performance Study of SONA Saliva C-19 Rapid Test

Study Overview
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Brief Summary
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The Sona Saliva C-19 Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to a RT-PCR reference method

Detailed Description
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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.

Official Title
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Novel Salivary Rapid Testing of SARS_CoV_2

Conditions
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Covid19, Sars-CoV-2 Infection, Corona Virus Infection

Intervention / Treatment
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* Diagnostic Test: Sona Saliva C-19 Rapid Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Up to 500 subjects will be screened, consented, and enrolled to obtain a minimum of 50 eligible candidates. In order to be eligible to participate in this study, an individual must meet all of the following criteria: Presenting to the Emergency Department at HRH. Receiving a COVID-19 RT-PCR test as per standard pathway of care. Provide written informed consent. Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 days: Fever as self-described or measured ≥ 38 °C (100.4°F) Chills Cough Shortness of breath Congestion or runny nose Difficulty Breathing Muscle or Body Aches Vomiting Diarrhea New loss of sense of taste or smell Headache General malaise Sore Throat Exclusion Criteria: Asymptomatic patients. Patients unable to provide a saliva sample. Patients unable to give consent. Patients who will not be receiving a nasopharyngeal RT-PCR test.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SARS_CoV_2 Antigen Rapid Test<br>The same group of patients participated in two arms of the study: One arm was for obtaining performance data of the Sona Saliva C-19 Rapid test and the comparator arm was to obtain data from the primary care route using approved RT-PCR testing. | Diagnostic Test: Sona Saliva C-19 Rapid Test<br>* Rapid Antigen diagnostic device performance comparative to RT-PCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Positive Agreement and Negative Percent Agreement | Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens. | 35 days from last patient enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Saliva, Antigen, COVID19, Rapid Test