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A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
Sponsor: bioLytical Laboratories
Summary
The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings To evaluate the usability of the TruPlex test through: Structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings. To assess user interpretation accuracy through a contrived result interpretation questionnaire, where intended users evaluate a set of pre-defined test results (e.g., strong/weak positives, negatives, invalids). To monitor test system reliability, including invalid rates.
Official title: A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2025-12-18
Completion Date
2027-01-01
Last Updated
2026-10-02
Healthy Volunteers
Yes
Interventions
TruPlex HIV/HepB/Syphilis Rapid Test
A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status
Locations (3)
Epicentre Health Research (Johannesburg)
Johannesburg, Gauteng, South Africa
Epicentre Health Research
Durban, KwaZulu-Natal, South Africa
Epicentre Health Research (Cape Town)
Cape Town, Western Cape, South Africa