Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
Study NCT ID:
NCT05227404
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2022-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Point-of-Care (EPOC) for COVID-19
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
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:
(EPOC)
Brief Summary:
EPOC is designed to examine the feasibility of conducting two point-of-care (POC) tests the LumiraDx SARS-CoV-2 Antibody Test and the RightSign COVID-19 IgG/IgM Rapid Test for SARS-CoV-2 antibodies and compare the reproducibility of these tests to tests run at a central laboratory on specimens obtained from the same study participants at the same time.
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?:
False
Is an FDA AA801 Violation?: