Retrospective Study of iStatis Syphilis Ab Test (POC)

Completed

• Conditions: Syphilis; Syphilis Infection
• Interventions: Device: iStatis Syphilis Antibody Test

• Registration Number: NCT06367621
• Lead Sponsor: bioLytical Laboratories

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 Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-12
• Primary Completion: 2024-04-15
• Study First Posted: 2024-04-16
• Study Completion: 2024-07-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Anti-Tp negative samples:

   -Stored at ≤ -80°C.

2. Anti-Tp negative samples - pregnant women:

   • Samples from pregnant women, 1st and multipara
   • Samples found negative or false reactive for anti-Tp assay with the reference method.
   • Stored at ≤ -80°C.

3. Anti-Tp positive samples:

   • Samples screened with Abbott Architect Syphilis Tp and confirmed positive with BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA).
   • Stored at ≤ -80°C.

4. Anti-Tp positive samples - pregnant women:

   • Samples from pregnant women
   • Samples screened with Abbott Architect Syphilis Tp and confirmed positive with BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA).
   • Stored at ≤ -80°C.

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
iStatis Syphilis Antibody Test diagnostic device	iStatis Syphilis Antibody Test	Bio-banked plasma and serum samples available to Epicentre Health Research will be used for testing on iStatis Syphilis Antibody Test device.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the iStatis Syphilis Ab Test	8 weeks	To estimate the diagnostic specificity and diagnostic sensitivity of the iStatis Syphilis Antibody Test in detecting anti-Tp in plasma and serum

Trial Locations

Locations (1)

Epicentre Health Research; 🇿🇦 Hillcrest, KwaZulu Natal, South Africa