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NCT06367621 Clinical Trial

Retrospective Study of iStatis Syphilis Ab Test (POC)

Syphilis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06367621
Other study ID # CLS-015C
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 15, 2023
Est. completion date April 15, 2024

Study information
Verified date April 2024
Source bioLytical Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1500
Est. completion date April 15, 2024
Est. primary completion date April 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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).

Locations
Country Name City State
South Africa Epicentre Health Research Hillcrest KwaZulu Natal

Sponsors (1)
Lead Sponsor Collaborator
bioLytical Laboratories

Country where clinical trial is conducted

South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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