Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites

Not Applicable

Completed

• Conditions: Syphilis Infection; Syphilis

• Registration Number: NCT06365606
• Lead Sponsor: bioLytical Laboratories

Brief Summary

This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at

Detailed Description

A trained healthcare provide will collect 50μL of capillary whole blood and 11mL of EDTA venous whole blood (VWB) to be tested with the iStatis Syphilis Ab Test on site according to the 'Test Procedure' described in the Instructions for Use (IFU) supplied with the reagents. Same procedure must be followed using the extracted plasma sample to test 30μL of the plasma sample extracted and obtained through processing of the VWB on the iStatis Syphilis Ab Test. An aliquot of the plasma sample will be transferred to the central laboratory to establish the reference test result using an enzyme immunoassay (EIA) (Abbott Architect Syphilis Tp EDA). In case of positive results in the EIA reference test of (Abbott Architect Syphilis Tp EDA), the sample will be sent for BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA) testing.

Study Timeline

• Study Start: 2024-03-14
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-15
• Primary Completion: 2024-05-13
• Study Completion: 2024-07-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Participants/subjects (males, females, and pregnant women) getting tested for syphilis for one or more of the following reasons:

  o at risk for syphilis ohaving signs and symptoms indicative for syphilis oRoutine testing

• Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.

Exclusion Criteria

• Participant younger than 18 years old
• Participants unable to provide written informed consent
• Participants currently undergoing treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the iStatis Syphilis Ab Test	15 weeks	To evaluate the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Antibody Test at Point-Of-Care (POC).

Trial Locations

Locations (1)

Epicentre Health Research; 🇿🇦 Hillcrest, KwaZulu Natal, South Africa

Epicentre Health Research

🇿🇦Hillcrest, KwaZulu Natal, South Africa