Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2
NCT ID: NCT04878068
Last Updated: 2021-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2021-05-15
2021-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
12 Years
ALL
No
Sponsors
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Cannabis Research Associates
OTHER
Responsible Party
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Principal Investigators
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Ira Price, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Central Contacts
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Other Identifiers
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TB20
Identifier Type: -
Identifier Source: org_study_id
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