Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-16 @ 6:06 PM
Study NCT ID:
NCT04878068
Status:
UNKNOWN
Last Update Posted:
2021-05-07
First Post:
2021-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2
Sponsor:
Cannabis Research Associates
Organization:
Study Overview
Official Title:
POC Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2 Virus in Human Saliva
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: