Actively Recruiting
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
Led by bioLytical Laboratories · Updated on 2026-05-04
1000
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
Sponsors
B
bioLytical Laboratories
Lead Sponsor
E
Epicentre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance and usability of the TruPlex HIV/HepB/Syphilis Rapid Test in point-of-care settings. The study aims to assess the test's accuracy using various blood samples collected by trained operators, including capillary blood, EDTA whole blood, EDTA plasma, and SST serum. The study also evaluates how well trained healthcare professionals can interpret contrived test results and monitors the test system's reliability, including rates of invalid results. Trained healthcare professionals will collect non-invasive samples such as fingerstick capillary blood and venous blood to process into plasma and serum for testing on the TruPlex device. At least two lots of the TruPlex test will be used. Participants will complete usability questionnaires to assess their experience and success in understanding the test labels. They will also interpret a set of predefined contrived test results representing strong and weak positives, negatives, and invalid results to evaluate interpretation accuracy. Participants will provide fingerstick and venous blood samples and complete the study's testing on the allocated day. Blood samples will also be sent to a central laboratory for confirmatory testing of HIV, Syphilis, and Hepatitis B using approved assays. Remaining samples may be stored for further testing or future research. The study will measure the clinical performance of the TruPlex test over six months, along with usability and interpretation evaluations. Participants will be monitored throughout the study duration, which includes a six-month evaluation period.
CONDITIONS
Brief 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 a translator available
- Getting tested for HIV, Syphilis, and/or Hepatitis B due to risk, symptoms, or routine testing
- Pregnant and re-infected individuals are eligible
- 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
- Willing to participate in standard of care counselling and testing program and receive standard care test results
You will not qualify if you...
- Has 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 making the participant unsuitable or unsafe for enrollment or interfering with study completion or outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo blood sample collection at point-of-care settings for testing with the TruPlex HIV/HepB/Syphilis Rapid Test and confirmatory laboratory tests. Usability and result interpretation evaluations are also conducted with trained healthcare professionals.
Testing and evaluations conducted during study visits over 6 months
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
P
Patrick Diaz
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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