Corona Virus Infection, Covid19, Sars-CoV-2 Infection
Conditions
Keywords
Antigen, COVID19, Rapid Test, Saliva
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTSona Saliva C-19 Rapid Test
Rapid Antigen diagnostic device performance comparative to RT-PCR
Sponsors
Sona Nanotech Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Presenting to the Emergency Department at HRH. 2. Receiving a COVID-19 RT-PCR test as per standard pathway of care. 3. Provide written informed consent. 4. Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 days: 1. Fever as self-described or measured ≥ 38 °C (100.4°F) 2. Chills 3. Cough 4. Shortness of breath 5. Congestion or runny nose 6. Difficulty Breathing 7. Muscle or Body Aches 8. Vomiting 9. Diarrhea 10. New loss of sense of taste or smell 11. Headache 12. General malaise 13. Sore Throat
Exclusion criteria
1. Asymptomatic patients. 2. Patients unable to provide a saliva sample. 3. Patients unable to give consent. 4. Patients who will not be receiving a nasopharyngeal RT-PCR test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Positive Agreement and Negative Percent Agreement | 35 days from last patient enrolment | Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens. |
Countries
Canada
Outcome results
None listed