A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorbioLytical Laboratories
About this trial
The objectives of this study are as follows:
To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings
To evaluate the usability of the TruPlex test through:
Structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.
To assess user interpretation accuracy through a contrived result interpretation questionnaire, where intended users evaluate a set of pre-defined test results (e.g., strong/weak positives, negatives, invalids).
To monitor test system reliability, including invalid rates.
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 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
1,000 Participants
are divided into 1 treatment groupSponsors and collaborators
bioLytical Laboratories
Lead sponsor
Epicentre
Collaborator
Source ClinicalTrials.gov