Performance Study of SONA Saliva C-19 Rapid Test

Not Applicable

Terminated

• Conditions: Sars-CoV-2 Infection; Corona Virus Infection; Covid19
• Interventions: Diagnostic Test: Sona Saliva C-19 Rapid Test

• Registration Number: NCT04877002
• Lead Sponsor: Sona Nanotech Inc

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.

Study Timeline

• Study Start: 2021-04-29
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-07
• Primary Completion: 2021-06-10
• Study Completion: 2022-01-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SARS_CoV_2 Antigen Rapid Test	Sona Saliva C-19 Rapid Test	The same group of patients participated in two arms of the study: One arm was for obtaining performance data of the Sona Saliva C-19 Rapid test and the comparator arm was to obtain data from the primary care route using approved RT-PCR testing.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Humber River Hospital; 🇨🇦 Toronto, Ontario, Canada