Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877002
Status:
TERMINATED
Last Update Posted:
2023-03-24
First Post:
2021-05-03
Brief Title:
Performance Study of SONA Saliva C-19 Rapid Test
Sponsor:
Sona Nanotech Inc
Organization:
Sona Nanotech Inc
Study Overview
Official Title:
Novel Salivary Rapid Testing of SARS_CoV_2
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Limited participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Sona Saliva C-19 Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus Performance of the Sona Saliva C-19 Rapid Test assay will be assessed by comparison to a RT-PCR reference method
Detailed Description:
The clinical performance of the Sona Saliva C-19 Rapid Test will be evaluated in a prospective clinical study conducted at a single 1 investigational site in Toronto Cananda
Consenting patients of ages 18 any gender or raceethnicity who presents at the test site with COVID-19 like symptoms during the 2021 COVID-19 season will be asked to take part in the study will be sequentially enrolled and tested
Trained operators with laboratory experience who have received training on the use of the Sona Saliva C-19 Rapid Test will conduct the testing and represent the intended users
A subjects participation in this study will consist of a single visit Following the completion of the informed consent process study questionnaire and a review of InclusionExclusion criteria to determine eligibility each subject will receive a unique study identification number be asked to provide a sample for testing
Consenting patients of ages 18 any gender or raceethnicity who presents at the test site with COVID-19 like symptoms during the 2021 COVID-19 season will be asked to take part in the study will be sequentially enrolled and tested
Trained operators with laboratory experience who have received training on the use of the Sona Saliva C-19 Rapid Test will conduct the testing and represent the intended users
A subjects participation in this study will consist of a single visit Following the completion of the informed consent process study questionnaire and a review of InclusionExclusion criteria to determine eligibility each subject will receive a unique study identification number be asked to provide a sample for testing
Study Oversight
Has Oversight DMC:
None
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?:
None