Retrospective Study of iStatis Syphilis Ab Test (POC)

NCT06367621 | Completed

• 1 other identifier: CLS-015C
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Syphilis; Syphilis Infection

Keywords

diagnostic kit; diagnostic devices; lateral flow device test; syphilis rapid test; syphilis point of care tests; iStatis Syphilis Antibody Test

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the iStatis Syphilis Ab Test

  To estimate the diagnostic specificity and diagnostic sensitivity of the iStatis Syphilis Antibody Test in detecting anti-Tp in plasma and serum

  8 weeks

Study Arms (2)

iStatis Syphilis Antibody Test diagnostic device

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

Device: iStatis Syphilis Antibody Test

Reference test

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

Interventions

iStatis Syphilis Antibody Test DEVICE

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).

iStatis Syphilis Antibody Test diagnostic device

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Retrospective cross-sectional study on left-over samples stored at -80°C from previous trials conducted by Epicentre Heath Research.

You may qualify if:

• Anti-Tp negative samples:
• Stored at ≤ -80°C.
• 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.
• 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.
• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• bioLytical Laboratories: lead

Study Sites (1)

Epicentre Health Research

Hillcrest, KwaZulu-Natal, 3650, South Africa

Location

Biospecimen

Retention: SAMPLES WITH DNA

Retrospective samples are used for testing with the investigational device as well as reference testing. All remaining samples are retained per site policy and procedures.

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: November 15, 2023
• Primary Completion: April 15, 2024
• Study Completion: July 11, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)