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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07569913
Lead Sponsor bioLytical Laboratories
Collaborators: Saint Vincent's Hospital Melbourne
Conditions
(from sponsor)		 HIV1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
Related terms Hepatitis B
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov