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

NCT06365606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2024-08-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • bioLytical Laboratories

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2024-05-13
Completion
2024-07-11

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06365606 on ClinicalTrials.gov