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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 1, 2026 → Dec 1, 2026
See other at-risk trials from bioLytical Laboratories

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 1, 2026 to Dec 1, 2026
    • Interventions: TruPlex HIV/HepB/Syphilis Rapid Test (Device) to TruPlex HIV/HepB/Syphilis Rapid Test (Device)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07563309
Lead Sponsor bioLytical Laboratories
Collaborators: Epicentre
Conditions
(from sponsor)		 HIV 1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
Related terms Hepatitis B
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov