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Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.
Sponsor: Abbott Rapid Dx
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
Conditions
Interventions
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