Back to resultsClinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
Primary Purpose
Sars-CoV-2 Infection
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sona Saliva C-19 Rapid Self-test
Sponsored by
About this trial
This is an interventional diagnostic trial for Sars-CoV-2 Infection focused on measuring Antigen, COVID19, Rapid Test, Saliva, Self-test
Eligibility Criteria
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
Sites / Locations
- COVID-19 Assessment centre @bayers lake
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SARS_CoV_2 Antigen Rapid Test
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent Positive Agreement (Sensitivity) and Negative Percent Agreement (Specificity)
Calculate the performance of the Sona Saliva C-19 Rapid Self Test when compared to RT- PCR
Secondary Outcome Measures
Full Information
NCT ID
NCT05256589
First Posted
February 16, 2022
Last Updated
March 22, 2023
Sponsor
Sona Nanotech Inc
Collaborators
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT05256589
Brief Title
Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
Official Title
Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
May 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sona Nanotech Inc
Collaborators
Nova Scotia Health Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Sona Saliva C-19 Rapid Self-Test is a lateral flow assay intended for detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to an RT-PCR reference method.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV-2 Infection
Keywords
Antigen, COVID19, Rapid Test, Saliva, Self-test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SARS_CoV_2 Antigen Rapid Test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sona Saliva C-19 Rapid Self-test
Intervention Description
Rapid Antigen diagnostic device performance comparative to RT-PCR
Primary Outcome Measure Information:
Title
Percent Positive Agreement (Sensitivity) and Negative Percent Agreement (Specificity)
Description
Calculate the performance of the Sona Saliva C-19 Rapid Self Test when compared to RT- PCR
Time Frame
35 days from last patient enrolment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
COVID-19 Assessment centre @bayers lake
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3s1c5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
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