Retrospective Study of iStatis Syphilis Ab Test (POC)

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.

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Epicentre Health Research

Hillcrest, KwaZulu-Natal, 3650, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Treatment and study plan

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).

Primary outcomes

Sensitivity and specificity of the iStatis Syphilis Ab Test

Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

bioLytical Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Apr 16, 2024
Registry last updated: Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed