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.

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