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

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

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

Study Overview

• Status: Completed
• Conditions: Syphilis; Syphilis Infection
• Intervention / Treatment: Device: iStatis Syphilis Ab Test

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 Type: Interventional
• Enrollment (Actual): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • KwaZulu Natal
    • Hillcrest, KwaZulu Natal, South Africa, 3650
      • Epicentre Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Performance onsite; Capillary (fingerstick) blood samples collected from the participants will be tested with the iStatis Syphilis Ab Test in the hands of trained healthcare professionals at the point-of-care setting.	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.
Experimental: Performance in lab; Venous whole blood and plasma samples collected from the participants will be tested with the iStatis Syphilis Ab Test in the hands of trained healthcare professionals at the point-of-care setting. The results are compared with Abbott Architect Syphilis Tp (EDA) referent test, and in cases of positive results, further confirmatory testing (BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA)) will be conducted.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: bioLytical Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Actual): May 13, 2024
• Study Completion (Actual): July 11, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: syphilis rapid test; syphilis point of care tests; syphilis antibody test; iStatis Syphilis Ab Test; iStatis Syphilis Antibody Test
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Treponemal Infections; Urogenital Diseases; Genital Diseases; Syphilis
• Other Study ID Numbers: CLS-015A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No