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
1 other identifier
observational
300
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedStudy Start
First participant enrolled
May 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedMay 7, 2021
April 1, 2021
2 months
April 27, 2021
May 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Participant Feedback
1 day
User Feedback
1 day
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Participant is willing to sign verbal informed consent form
- Age 12 or older and parents or legal guardians must consent for children as required by law.
- Participant is attending COVID-19 testing centre for a nasopharyngeal swab sample
- Participant is willing to provide a self-collected saliva sample
You may not qualify if:
- \. Participant has previously tested positive for COVID-19 within the past 90 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ira Price, MD
McMaster University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2021
First Posted
May 7, 2021
Study Start
May 15, 2021
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
May 7, 2021
Record last verified: 2021-04