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
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 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
1,000 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 diagnostic sensitivity and specificity between TruPlex Test and approved confirmatory assays for HIV, Syphilis and Hep B infection status will be determined. Performance evaluation will be conducted for all sites combined. Test invalid rate will be tabulated and reported.
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 months2
Contrived result interpretation evaluation
Trained operators will evaluate a panel of contrived (mock) TruPlexdevices. These devices are designed to represent a comprehensive range of test outcomes, including strong positives, weak positives, negatives and invalid results. Operators will interpret the results of the mock devices and record their interpretations which will be compared to the correct interpretation of the device.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
bioLytical Laboratories
Lead sponsor
Epicentre
Collaborator
Source ClinicalTrials.gov