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

• Conditions: Covid19
• Interventions: Device: Theram COVID-19 Rapid Antigen Test

• Registration Number: NCT04878068
• Lead Sponsor: Cannabis Research Associates

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-05-06
• Last Update Submitted: 2021-05-06
• Study First Posted: 2021-05-07
• Last Update Posted: 2021-05-07
• Study Start: 2021-05-15
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rapid Antigen Saliva Test	Theram COVID-19 Rapid Antigen 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

Primary Outcome Measures

Name	Time	Method
Establish Performance of Therma COVID-19 Rapid Antigen Test	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Participant Feedback	1 day	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)
User Feedback	1 day	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)