Retrospective Study of iStatis Syphilis Ab Test (POC)

bioLytical Laboratories

Status: Completed

Conditions: Syphilis Infection; Syphilis

Treatments: Device: iStatis Syphilis Antibody Test

Study type: Observational

Funder types: Industry

Identifiers

NCT06367621

CLS-015C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,500 participants in 2 patient groups

iStatis Syphilis Antibody Test diagnostic device

Description:

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

Treatment:

Device: iStatis Syphilis Antibody Test

Reference test

Description:

Either serum or plasma samples were tested with Abbott Architect Syphilis Tp (EDA) and MD Macro-Vue Particle Agglutination (RPR)/Serodia Particle Agglutination (TPPA) where applicable