Status:
NOT_YET_RECRUITING
Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.
Lead Sponsor:
Abbott Rapid Dx
Conditions:
Syphilis Infection
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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 per...
Detailed Description
Syphilis is a sexually transmitted infection (STI) caused by the spirochete Treponema pallidum subspecies. Globally, there were an estimated 7.1 million adults between 15 and 49 years of age who acqui...
Eligibility Criteria
Inclusion
- 12 years of age or older.
- The participant has confirmed previous / current syphilis according to their medical history, or the participant has unknown or negative syphilis infection status.
- The participant agrees to provide written informed consent.
- The participant agrees to complete all aspects of the study.
- Additional inclusion criteria for frozen samples:
- The ethics committee-required written informed consent for study testing, or required documentation for sample use from a commercial vendor, is available.
- Sufficient volume for testing is available and the sample quality is adequate (for example no significant sample hemolysis)
- The sample must have been collected in EDTA vacutainers or serum tubes, processed to plasma and the plasma frozen within 36 hours of blood collection.
Exclusion
- Participant has already participated in this study on a previous occasion.
- Participant is deemed vulnerable and / or unfit for participation in the study by the Investigator.
- Participant is unwilling or unable to provide informed consent.
- Participant is currently enrolled in a study to evaluate an investigational new drug or vaccine.
- Additional exclusion criteria for frozen samples
- The sample has undergone more than one freeze thaw cycle
- The sample has been kept at -20 °C (± 5 °C) longer than 12 months. If the sample has been kept longer than 12 months, the storage temperature must have been colder than -20 °C (± 5 °C).
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06584214
Start Date
September 1 2024
End Date
December 1 2024
Last Update
September 4 2024
Active Locations (1)
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1
Uganda Virus Research Institute
Entebbe, Uganda