Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367621
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
Retrospective Study of iStatis Syphilis Ab Test POC
Sponsor:
bioLytical Laboratories
Organization:
bioLytical Laboratories
Study Overview
Official Title:
Retrospective Evaluation of Diagnostic Specificity and Sensitivity for iStatis Syphilis Ab Test at the Point-Of-Care Sites
Status:
COMPLETED
Status Verified Date:
2024-08
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:
None
Brief Summary:
The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest The data will be used to demonstrate the product is safe and effective for its intended use The data obtained will be used in the application for CE certification under In Vitro Diagnostic Medical Device Regulation IVDR and World Health Organization WHO prequalification
Detailed Description:
The objectives of this study are to establish the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Ab Test Left-over samples stored at -80ᵒC from the previous trials conducted by Epicentre will be used for this study The samples are tested in a routine testing environment Serum samples were tested for evidence of syphilis infection using a non-treponemal Rapid Plasma Reagin RPR assay All reactive samples were further tested quantitatively
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