Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2

POC Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2 Virus in Human Saliva

The Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. This test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of COVID-19.

The Therma COVID-19 Rapid Antigen Test will be compared to a Health Canada approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) samples will be collected at a COVID-19 Testing centre and saliva (for the rapid antigen test) samples will be collected and compared.

The prospective, observational, feasibility study will test 300 participants to establish the performance characteristics of the test on saliva specimens.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19
• Intervention / Treatment: Device: Theram COVID-19 Rapid Antigen Test

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Lisa Patterson, BA; Phone Number: 289-230-3605; Email: lisap1636@gmail.com
• Study Contact Backup: Name: Ira Price, MD; Email: ira.pmpc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential participants attending a COVID-19 testing centre for a PCR test will be approached to determine eligibility and obtain consent after they have had their PCR test completed. Three hundred participants will be recruited into the study.

Description

Inclusion Criteria:

1. Participant is willing to sign verbal informed consent form
2. Age 12 or older and parents or legal guardians must consent for children as required by law.
3. Participant is attending COVID-19 testing centre for a nasopharyngeal swab sample
4. Participant is willing to provide a self-collected saliva sample

Exclusion Criteria:

1. Participant has previously tested positive for COVID-19 within the past 90 days

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Rapid Antigen Saliva Test; Participants who have had a COVID-19 PCR test will self-administer the saliva test. The research team will conduct the processing of the test for the results of positive, negative or inconclusive

Device: Theram COVID-19 Rapid Antigen Test; The Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. This test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of COVID-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish Performance of Therma COVID-19 Rapid Antigen Test	To establish the performance characteristics of the Therma COVID-19 Rapid Antigen Test in a near-patient, point-of-care (POC) setting with lay users (no laboratory experience) testing a participant that has self-collected the saliva specimen. Clinical accuracy of the rapid antigen test compared to RT-PCR test results. Accuracy refers to the (PPA, positive percent agreement (sensitivity) and (NPA, negative percent agreement (specificity) between the results of the tests. The expected performance of the test for symptomatic participants shall be >90% PPA and >98% NPA.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Feedback	Evaluate participant feedback on the usability of the Therma COVID-19 Rapid Antigen Test and saliva collection device using the Participant Study Questionnaire Form (Ease of use 5-point scale from 5=Easy to 1=Hard)	1 day
User Feedback	Evaluate user feedback on the usability of the Therma COVID-19 Rapid Antigen Test and saliva collection device using the Therma Feasibility Study User Feedback Questionnaire (ease of use 5-point scale from Not at all to Very easy)	1 day

Collaborators and Investigators

• Sponsor: Cannabis Research Associates
• Investigators: Principal Investigator: Ira Price, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Saliva Antigen; Rapid Saliva Test
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: TB20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No