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

Sponsor: bioLytical Laboratories • ClinicalTrials.gov ID: NCT07563309

Registry updated: 2026-10-02

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Description

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.

Interventions

TruPlex HIV/HepB/Syphilis Rapid Test (Device)
A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status

Eligibility criteria

Inclusion Criteria: * 18 years of age or older * Subject is able to provide and willing to sign and date the Informed Consent Form * Subject is able to complete the required testing on the allocated testing day. * Subject able to speak/read/write English or a translator is available * Subject is getting tested for HIV, and/or Syphilis, and/or Hepatitis B for one or more of the following reasons: * At risk for any one of the target diseases * Having signs or symptoms indicative of the target diseases * Routine testing * Note: Subjects who are pregnant and re-infected are eligible to participate * Unknown HIV or known HIV positive status with less than 12 months of Anti-Retroviral Treatment (ART). * Subject is willing to provide the fingerstick blood sample(s) and whole blood samples collected through venous blood draw (approximately 16 ml) required for the study. * Subject willing to participate in the study site's standard of care counselling and testing program and receive the study site's standard of care test results Exclusion Criteria: * Subject has a bleeding disorder * Subject is currently undergoing Syphilis treatment * Subject has received any experimental HIV vaccine * Subject received HBV vaccine within the last 7 days * Known HIV positive subjects and currently on ART for 12 months or longer * Any condition which, in the opinion of the Investigator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of study assessment, consent form and questionnaire etc. or bias the study outcome.

Conditions

HIV 1 Infection HIV 2 Infection Syphilis Infection Hepatitis B Infection

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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