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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
TruPlex HIV/HepB/Syphilis Rapid Test
DeviceA rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: TruPlex HIV/HepB/Syphilis Rapid Test PerformanceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Performance Evaluation
The study will assess the sensitivity and specificity of the TruPlex Test for detecting: * HIV-1 and HIV-2 antibodies * Syphilis antibodies * Hepatitis B surface antigen (HBsAg) Capillary blood, EDTA whole blood, EDTA-plasma and SST-serum samples will be tested using the TruPlex Test. Performance will be compared against approved, current on-market assays for the detection of HIV 1/2 antibodies, Syphilis antibodies, and HBsAg.
Time frame
6 monthsSecondary outcomes
1
Usability Evaluation
Usability will be determined via a questionnaire completed by trained personnel who used the device during testing. The usability questionnaire will use a scale of one (1) to 5 (1 - very difficult/very unlikely to 5 - very easy/very likely), with a rating of 3 being satisfactory.
Time frame
6 monthsSponsors and contacts
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bioLytical Laboratories
Lead sponsor
Saint Vincent's Hospital Melbourne
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: