Clinical Evaluation of the SONA Saliva C-19 Rapid Self-Test for the Detection of COVID-19

NCT05256589 | Completed

• 1 other identifier: DHF009 - NSHCT
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The Sona Saliva C-19 Rapid Self-Test is a lateral flow assay intended for detection of the SARS-CoV-2 virus. Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to an RT-PCR reference method.

Conditions

Sars-CoV-2 Infection

Keywords

Antigen; COVID19; Rapid Test; Saliva; Self-test

Outcome Measures

Primary Outcomes (1)

• Percent Positive Agreement (Sensitivity) and Negative Percent Agreement (Specificity)

  Calculate the performance of the Sona Saliva C-19 Rapid Self Test when compared to RT- PCR

  35 days from last patient enrolment

Study Arms (1)

SARS_CoV_2 Antigen Rapid Test

EXPERIMENTAL

The same group of patients participate in two arms of the study: One arm is for obtaining performance data of the Sona Saliva C-19 Rapid self test and the comparator arm is to obtain data from the primary care route using approved RT-PCR testing.

Diagnostic Test: Sona Saliva C-19 Rapid Self-test

Interventions

Sona Saliva C-19 Rapid Self-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:

• Aged ≥ 18+ years
• Presenting at designated NS Health Central Zone COVID-19 PCR testing sites.
• Receiving a RT-PCR COVID-19 test as per standard of care (nasopharyngeal/mid-turbinate swabs).
• Unvaccinated, partially vaccinated, fully vaccinated and fully vaccinated-boosted patients
• Provide written informed consent..
• Patients may have recently been exposed, in close contact, show no symptoms or may be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 6 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
• Diarrhoea

You may not qualify if:

• All patients from whom a non-valid result is obtained from either or both the RT-PCR testing and Sona Saliva C-19 Rapid Self-test will be excluded in the analysis for sensitivity and specificity and will be noted as a test error.
• Any rapid tests that produced an invalid test result will be noted as a test error and secondary analysis will be conducted on this cohort of patients to understand any underlying causation.
• Patients recruited into the study that are recorded to have consumed anything orally within 30 minutes of conducting a rapid self-test, as per the warnings laid out in the IFU, may be excluded from the analysis to mitigate any interference risks relating to test outcome.
• Also, the following:
• Patients unable to provide a saliva sample for rapid testing
• Patients unable to provide written consent.
• Patients previously enrolled in the study
• Patients undergoing treatment currently and/or within the past thirty (30) days of the study with prescription medication to treat novel Coronavirus SARS-CoV-2 infection

Sponsors & Collaborators

• Sona Nanotech Inc: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

COVID-19 Assessment centre @bayers lake

Halifax, Nova Scotia, B3s1c5, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

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 Self-Test for detection of SARS\_CoV\_2 infection when using saliva specimens. A prospective 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: February 16, 2022
• First Posted: February 25, 2022
• Study Start: April 19, 2022
• Primary Completion: April 26, 2022
• Study Completion: May 19, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)