Syphilis, Syphilis Infection
Conditions
Keywords
diagnostic kit, diagnostic devices, lateral flow device test, syphilis rapid test, syphilis point of care tests, iStatis Syphilis Antibody Test
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.
Interventions
DEVICEiStatis 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).
Sponsors
bioLytical Laboratories
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Africa
Outcome results
None listed