Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586905
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
A Cross-sectional Investigational Study to Evaluate the Sensitivity Specificity and Utility of the MedMira Inc Multiplo Complete Syphilis TPnTP Antibody Test POCT to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa Ontario
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Cross-sectional Investigational Study to Evaluate the Sensitivity Specificity and Utility of the MedMira Inc Multiplo Complete Syphilis TPnTP Antibody Test POCT to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa Ontario the MedMira Inc Multiplo Complete Syphilis TPnTP Antibody Test is Authorized for Investigational Use
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Due to the recent resurgence of infectious syphilis in Canada and the changing epidemiology of the disease to involve heterosexuals and females of child bearing age leading to a record number of congenital syphilis cases and stillbirths the demand of a rapid test such as POCT that can be used at the place and time that front-line public health workers meet the at risk population is getting louder Indeed during a number of federal provincial and territorial meetings on the control of syphilis outbreaks in Canada requests for POCT to detect syphilis infections have repeatedly come up However before a POCT can be widely used research to find out if it is accurate and reliable is necessary This study is designed to test the performance of the MedMira Inc Multiplo Complete Syphilis TPnTP Antibody Test POCT MedMira Inc Halifax Nova Scotia in an urban clinic Sexual Health Clinic in Ottawa Ontario Canada and compare its performance in parallel with the usual testing method the gold standard ie conventional syphilis serology testing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None