Actively Recruiting
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
Led by bioLytical Laboratories · Updated on 2026-05-04
1000
Participants Needed
3
Research Sites
54 weeks
Total Duration
On this page
Sponsors
B
bioLytical Laboratories
Lead Sponsor
E
Epicentre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Able and willing to sign and date the Informed Consent Form
- Able to complete the required testing on the allocated testing day
- Able to speak, read, and write English or have access to a translator
- Being tested for HIV, Syphilis, or Hepatitis B because of risk, symptoms, routine testing, or pregnancy with re-infection
- Unknown HIV status or known HIV positive with less than 12 months of Anti-Retroviral Treatment (ART)
- Willing to provide fingerstick and venous blood samples (approximately 16 ml)
- Willing to participate in the site's standard counseling and testing program and receive test results
You will not qualify if you...
- Having a bleeding disorder
- Currently undergoing Syphilis treatment
- Received any experimental HIV vaccine
- Received Hepatitis B vaccine within the last 7 days
- Known HIV positive and on ART for 12 months or longer
- Any condition that makes participation unsuitable, unsafe, or may interfere with study assessments or bias outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Epicentre Health Research (Johannesburg)
Johannesburg, Gauteng, South Africa, 2193
Actively Recruiting
2
Epicentre Health Research
Durban, KwaZulu-Natal, South Africa, 3650
Actively Recruiting
3
Epicentre Health Research (Cape Town)
Cape Town, Western Cape, South Africa, 7925
Actively Recruiting
Research Team
A
Ana Subramanian
CONTACT
P
Patrick Diaz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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