Evaluating Performance and Usability of the TruPlex HIVHepBSyphilis Rapid Test by Trained Users in Point-of-Care Settings

What this Trial Is About

Researchers are evaluating the clinical performance and usability of the TruPlex HIVHepBSyphilis Rapid Test in point-of-care settings. The study aims to assess the tests accuracy using various blood samples collected by trained operators, including capillary blood, EDTA whole blood, EDTA plasma, and SST serum. The study also evaluates how well trained healthcare professionals can interpret contrived test results and monitors the test systems reliability, including rates of invalid results. Trained healthcare professionals will collect non-invasive samples such as fingerstick capillary blood and venous blood to process into plasma and serum for testing on the TruPlex device. At least two lots of the TruPlex test will be used. Participants will complete usability questionnaires to assess their experience and success in understanding the test labels. They will also interpret a set of predefined contrived test results representing strong and weak positives, negatives, and invalid results to evaluate interpretation accuracy. Participants will provide fingerstick and venous blood samples and complete the studys testing on the allocated day. Blood samples will also be sent to a central laboratory for confirmatory testing of HIV, Syphilis, and Hepatitis B using approved assays. Remaining samples may be stored for further testing or future research. The study will measure the clinical performance of the TruPlex test over six months, along with usability and interpretation evaluations. Participants will be monitored throughout the study duration, which includes a six-month evaluation period.

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