- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05256589
Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Glenn Patriquin, MD
- Phone Number: +1 902-473-7493
- Email: glenn.patriquin@nshealth.ca
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3s1c5
- COVID-19 Assessment centre @bayers lake
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged ≥ 18+ years
- Presenting at designated NS Health Central Zone COVID-19 PCR testing sites.
- Receiving a RT-PCR COVID-19 test as per standard of care (nasopharyngeal/mid-turbinate swabs).
- Unvaccinated, partially vaccinated, fully vaccinated and fully vaccinated-boosted patients
- Provide written informed consent..
Patients may have recently been exposed, in close contact, show no symptoms or may be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 6 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
- Diarrhoea
- New loss of sense of taste or smell
- General malaise All patients in whom a test result (positive or negative) is obtained from both the RT-PCR testing and Sona Saliva C-19 Rapid Self-test, will be included in the performance analysis.
Exclusion Criteria:
All patients from whom a non-valid result is obtained from either or both the RT-PCR testing and Sona Saliva C-19 Rapid Self-test will be excluded in the analysis for sensitivity and specificity and will be noted as a test error.
Any rapid tests that produced an invalid test result will be noted as a test error and secondary analysis will be conducted on this cohort of patients to understand any underlying causation.
Patients recruited into the study that are recorded to have consumed anything orally within 30 minutes of conducting a rapid self-test, as per the warnings laid out in the IFU, may be excluded from the analysis to mitigate any interference risks relating to test outcome.
Also, the following:
- Patients unable to provide a saliva sample for rapid testing
- Patients unable to provide written consent.
- Patients previously enrolled in the study
- Patients undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Rapid Antigen diagnostic device performance comparative to RT-PCR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
35 days from last patient enrolment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DHF009 - NSHCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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