Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19
Sars-CoV-2 Infection
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
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.