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

Syphilis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365606
• Other study ID #: CLS-015A
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: May 29, 2024

Study information

• Verified date: April 2024
• Source: bioLytical Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: May 29, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syphilis
• Syphilis Infection

Intervention

Device:
• iStatis Syphilis Ab Test
Capillary (fingerstick) blood, venous whole blood and plasma samples prospectively collected from the participants will be tested on the iStatis Syphilis Ab Test.

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 evaluate the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Antibody Test at Point-Of-Care (POC).	15 weeks