NCT06367621

Retrospective Study of iStatis Syphilis Ab Test (POC)

Retrospective Evaluation of Diagnostic Specificity and Sensitivity for iStatis Syphilis Ab Test at the Point-Of-Care Sites

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (actual)
• Sponsor: bioLytical Laboratories · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Syphilis
• Syphilis Infection

Interventions

Type	Name	Description
DEVICE	iStatis Syphilis Antibody Test	1500 stored samples (plasma/serum) will be tested in a routine testing environment using the iStatis Syphilis Antibody Test diagnostic device. Results of tests will not be used for patient management decisions (observaltional).

Timeline

• Start date: 2023-11-15
• Primary completion: 2024-04-15
• Completion: 2024-07-11
• First posted: 2024-04-16
• Last updated: 2024-08-12

Locations

1 site across 1 country: South Africa