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Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.

NCT06584214 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-09-04

No results posted yet for this study

Summary

This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test. The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff. The study will also have a retrospective study arm. The Determine™ Syphilis Advanced validation will be conducted in accordance with the World Health Organization\'s TSS-6 guidance on Syphilis rapid diagnostic tests, ISO 20916 (In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice), the study protocol, Good Clinical Practice and the respective local medical device laws.

Conditions

  • Syphilis Infection

Interventions

DIAGNOSTIC_TEST

Diagnostic test: Determine™ Syphilis Advanced test

The Determine™ Syphilis Advanced test is intended as an aid in detecting antibodies to Treponema pallidum in individuals with current or past infection.

Sponsors & Collaborators

  • Abbott Rapid Dx

    lead INDUSTRY

Principal Investigators

  • Pontiano Kaleebu, Professor, MD PhD · MRC/UVRI and LSHTM Uganda Research Unit

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Uganda

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 NCT06584214 on ClinicalTrials.gov