Performance Study of SONA Saliva C-19 Rapid Test

Novel Salivary Rapid Testing of SARS_CoV_2

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

Study Overview

• Status: Terminated
• Conditions: Covid19; Corona Virus Infection; Sars-CoV-2 Infection
• Intervention / Treatment: Diagnostic test: Sona Saliva C-19 Rapid Test

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M3M 0B2
      • Humber River Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SARS_CoV_2 Antigen 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.	Diagnostic test: Sona Saliva C-19 Rapid Test; Rapid Antigen diagnostic device performance comparative to RT-PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	35 days from last patient enrolment

Collaborators and Investigators

• Sponsor: Sona Nanotech Inc
• Investigators: Principal Investigator: David Jacobs, Dr, Humber River Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): January 5, 2022

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: COVID19; Saliva; Antigen; Rapid Test
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: CT002-SalC19RT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No