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RECRUITING
NCT07563309
NA

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

Sponsor: bioLytical Laboratories

View on ClinicalTrials.gov

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

DEVICE

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