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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Syphilis
• Syphilis Infection

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