Retrospective Study of iStatis Syphilis Ab Test (POC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-15

Study Completion Date

2024-07-11

Brief Summary

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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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Detailed Description

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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

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Syphilis Syphilis Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

iStatis Syphilis Antibody Test

Intervention Type 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).

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

No interventions assigned to this group

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.