Performance Study of SONA Saliva C-19 Rapid Test

NCT ID: NCT04877002

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2022-01-05

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sona Saliva C-19 Rapid Test

Intervention Type: DIAGNOSTIC_TEST

Rapid Antigen diagnostic device performance comparative to RT-PCR

Interventions

Sona Saliva C-19 Rapid Test

Rapid Antigen diagnostic device performance comparative to RT-PCR

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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:

1. Presenting to the Emergency Department at HRH.

2. Receiving a COVID-19 RT-PCR test as per standard pathway of care.

3. Provide written informed consent.

4. Patients must be presenting or have experienced at least one (1) or more signs or symptoms of COVID-19 within ≤ 7 days:

1. Fever as self-described or measured ≥ 38 °C (100.4°F)

2. Chills

3. Cough

4. Shortness of breath

5. Congestion or runny nose

6. Difficulty Breathing

7. Muscle or Body Aches

8. Vomiting

9. Diarrhea

10. New loss of sense of taste or smell

11. Headache

12. General malaise

13. Sore Throat

Exclusion Criteria

1. Asymptomatic patients.

2. Patients unable to provide a saliva sample.

3. Patients unable to give consent.

4. Patients who will not be receiving a nasopharyngeal RT-PCR test.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sona Nanotech Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Jacobs, Dr

Role: PRINCIPAL_INVESTIGATOR

Humber River Hospital

Locations

Humber River Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CT002-SalC19RT

Identifier Type: -

Identifier Source: org_study_id