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

NCT06365606 | Completed

• 1 other identifier: CLS-015A
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Conditions

Syphilis Infection; Syphilis

Keywords

syphilis rapid test; syphilis point of care tests; syphilis antibody test; iStatis Syphilis Ab Test; iStatis Syphilis Antibody Test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Performance onsite

EXPERIMENTAL

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

Performance in lab

EXPERIMENTAL

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

Interventions

iStatis Syphilis Ab Test DEVICE

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

Performance in lab; Performance onsite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• bioLytical Laboratories: lead

Study Sites (1)

Epicentre Health Research

Hillcrest, KwaZulu-Natal, 3650, South Africa

Location

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and the healthcare providers are not aware of the syphilis status.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: March 14, 2024
• Primary Completion: May 13, 2024
• Study Completion: July 11, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)