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NOT YET RECRUITING
NCT06584214
NA

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

Sponsor: Abbott Rapid Dx

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multi-centre Study to Evaluate the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2024-09

Completion Date

2024-12

Last Updated

2024-09-04

Healthy Volunteers

Yes

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.

Locations (1)

Uganda Virus Research Institute

Entebbe, Uganda