Status:
COMPLETED
Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
Lead Sponsor:
Sona Nanotech Inc
Collaborating Sponsors:
Nova Scotia Health Authority
Conditions:
Sars-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 R...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2022
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05256589
Start Date
April 19 2022
End Date
May 19 2022
Last Update
March 24 2023
Active Locations (1)
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1
COVID-19 Assessment centre @bayers lake
Halifax, Nova Scotia, Canada, B3s1c5