NCT05256589

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Sona Nanotech Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, non-randomized clinical evaluation study being carried out in the intended use population in which fresh saliva samples are collected, tested, and interpreted by lay-users and the results are compared to samples evaluated with an authorized high sensitivity molecular RT-PCR test. The device to be studied is the Sona Saliva C-19 Rapid Self Test. Participants will be recruited into the study who present at a NS Health Central Zone COVID-19 PCR testing site for COIVID-19 testing. This study does not involve any additional study visits, and all participants will receive the current standard of care. Patients will provide their RT-PCR sample as per the established testing processes at the health centre and will receive their results through the standard communication pathway. Self-testing using the Sona assay will be conducted at the COVID -19 testing center by individuals in real time. The participants will be instructed as to not act on the result of their Sona saliva assay, but rather await the gold standard result of RT-PCR. A usability questionnaire will also be completed by individuals.

Conditions

• Sars-CoV-2 Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sona Saliva C-19 Rapid Self-test	Rapid Antigen diagnostic device performance comparative to RT-PCR

Timeline

• Start date: 2022-04-19
• Primary completion: 2022-04-26
• Completion: 2022-05-19
• First posted: 2022-02-25
• Last updated: 2023-03-24

Locations

1 site across 1 country: Canada