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

To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples collected by trained operators at point-of-care settings. Additionally, to evaluate the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.

NCT Number	NCT07569913
Lead Sponsor	bioLytical Laboratories Collaborators: Saint Vincent's Hospital Melbourne
Conditions	HIV1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
Enrollment	500 participants
Start Date	2026-09-01
Primary Completion	2027-01-01 (estimated)
Study Completion	2027-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-06