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Study identifier: NCT07563309 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test

Condition: HIV 1 Infection · HIV 2 Infection · Syphilis Infection  ·  Sponsor: bioLytical Laboratories

PhaseNA
Planned participants1000
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Ana Subramanian  ·  16042046784  ·  asubramanian@biolytical.com

Patrick Diaz  ·  16042046784  ·  pdiaz@biolytical.com

Always discuss trial participation with your own doctor first.

Locations (3)

Epicentre Health Research (Johannesburg)Johannesburg, Gauteng, South AfricaRecruiting
Epicentre Health ResearchDurban, KwaZulu-Natal, South AfricaRecruiting
Epicentre Health Research (Cape Town)Cape Town, Western Cape, South AfricaRecruiting

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Source record: clinicaltrials.gov/study/NCT07563309