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

Launched by ABBOTT RAPID DX · Sep 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the Determine™ Syphilis Advanced test, which is designed to detect syphilis infections. The goal is to see how accurately this test can identify people who have syphilis, as well as those who do not. The study will involve healthcare professionals and laboratory staff who will perform the test, and it will follow strict guidelines to ensure the results are reliable and safe.

To be eligible for this study, participants need to be at least 12 years old and either have a history of syphilis or not know their syphilis status. They must also agree to provide written consent and complete all parts of the study. Participants will have their blood tested and will play an important role in helping researchers understand how well this new test works. It's important to note that the study is not yet recruiting participants, so there will be more information available as it gets closer to starting.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).