Performance Study of SONA Saliva C-19 Rapid Test

Sponsor

Sona Nanotech Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04877002

Collaborator

(none)

500

Enrollment

Location

Arm

Anticipated Duration (Days)

7609.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Sars-CoV-2 Infection Corona Virus Infection	Diagnostic Test: Sona Saliva C-19 Rapid Test	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Novel Salivary Rapid Testing of SARS_CoV_2

Actual Study Start Date :

Apr 29, 2021

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percent Positive Agreement and Negative Percent Agreement [35 days from last patient enrolment]
Calculate the performance of the Sona Saliva C-19 Rapid Test when compared to RT- PCR using nasopharyngeal swab specimens.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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
Headache
General malaise
Sore Throat