NCT07563309Recruiting
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- 18 Dec 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- bioLytical Laboratories
- Diseases
- Hepatitis B, HIV
- NCT number
- NCT07563309
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 18 Dec 2025 to the primary completion date, 1 Dec 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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
Other illness
- Subject has a bleeding disorder
- 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.
Other
- Subject is currently undergoing Syphilis treatment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Epicentre Health Research (Cape Town) Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| Epicentre Health Research Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
| Epicentre Health Research (Johannesburg) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.