Retrospective Study of iStatis Syphilis Ab Test (POC)

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06367621
Study type	Observational
Source	bioLytical Laboratories
Contact
Status	Active, not recruiting
Phase
Start date	November 15, 2023
Completion date	April 15, 2024

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