A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorbioLytical Laboratories
About this trial
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.
Eligibility criteria
Qualifiers
18 years of age or older
Subject is able to provide and willing to sign and date the Informed Consent Form
Subject is able to complete the required testing on the allocated testing day.
Subject is able to speak/read/write English or a translator is available
Disqualifiers
Subject has a bleeding disorder
Subject is currently undergoing Syphilis treatment
Subject has received any experimental HIV vaccine
Subject received HBV vaccine within the last 7 days
Trial design
Treatments tested in this trial
- TruPlex HIV/HepB/Syphilis Rapid Test
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
bioLytical Laboratories
Lead sponsor
Saint Vincent's Hospital Melbourne
Collaborator
Source ClinicalTrials.gov