Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
Sponsor: bioLytical Laboratories
Summary
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.
Official title: A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2026-09-01
Completion Date
2027-06-01
Last Updated
2026-05-06
Healthy Volunteers
Yes
Interventions
TruPlex HIV/HepB/Syphilis Rapid Test
A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status.
Locations (1)
St Vincent's Hospital (Melbourne), Dept. of Gastroenterology
Melbourne, Victoria, Australia