Performance Study of SONA Saliva C-19 Rapid Test

Sona Nanotech Inc20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Covid19 Sars-CoV-2 Infection Corona Virus Infection

Interventions

Sona Saliva C-19 Rapid TestDIAGNOSTIC_TEST

Rapid Antigen diagnostic device performance comparative to RT-PCR

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Humber River Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Percent Positive Agreement and Negative Percent Agreement

Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens.

Time frame: 35 days from last patient enrolment

Data from ClinicalTrials.gov

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