NCT04877002

Performance Study of SONA Saliva C-19 Rapid Test

Novel Salivary Rapid Testing of SARS_CoV_2

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sona Nanotech Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2021-04-29
• Primary completion: 2021-06-10
• Completion: 2022-01-05
• First posted: 2021-05-07
• Last updated: 2023-03-24

Locations

1 site across 1 country: Canada