An observational study in Covid19, sponsored by Cannabis Research Associates. Status unknown. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-05-07.
Sponsored by Cannabis Research Associates · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 300 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Cannabis Research Associates is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Time frame: 1 day
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)
Time frame: 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)
Time frame: 1 day
No study locations are listed for this record.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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