Performance Study of SONA Saliva C-19 Rapid Test

NCT04877002 | Terminated

• 1 other identifier: CT002-SalC19RT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19; Sars-CoV-2 Infection; Corona Virus Infection

Keywords

Antigen; COVID19; Rapid Test; Saliva

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SARS_CoV_2 Antigen Rapid Test

EXPERIMENTAL

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

Interventions

Sona Saliva C-19 Rapid Test DIAGNOSTIC_TEST

Rapid Antigen diagnostic device performance comparative to RT-PCR

SARS_CoV_2 Antigen Rapid Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Presenting to the Emergency Department at HRH.
• Receiving a COVID-19 RT-PCR test as per standard pathway of care.
• Provide written informed consent.
• Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 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
• Diarrhea
• New loss of sense of taste or smell

You may not qualify if:

• Asymptomatic patients.
• Patients unable to provide a saliva sample.
• Patients unable to give consent.
• Patients who will not be receiving a nasopharyngeal RT-PCR test.

Sponsors & Collaborators

• Sona Nanotech Inc: lead

Study Sites (1)

Humber River Hospital

Toronto, Ontario, M3M 0B2, Canada

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David Jacobs, Dr

  Humber River Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 7, 2021
• Study Start: April 29, 2021
• Primary Completion: June 10, 2021
• Study Completion: January 5, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)