A-353 Lay User testing of Rapid Multiplexed HIV/TP test

Background Palladium Diagnostics had developed a rapid, multiplexed POC assay for Syphilis and HIV for fingerstick whole blood. To increase potential patient engagement and simplify sample collection it was decided to expand the sample type from fingerstick whole blood to saliva without changing the test time or performance. Additionally, the test was designed to have a lower carbon footprint by using a bioplastic (environmentally friendly foam) for structural components rather than injection molded parts as are commonly used in other assays. The assay was run both by professional users in a lab setting and lay users in the field. Methods A flow through rapid assay was produced and tested both by professional users in a lab setting using library sample and by lay users in a field setting using self collected samples. Results The results are shown in table 1, the assay performance was broadly similar for both whole blood and saliva, however the saliva dataset was much smaller for the professional use setting. The human factor analysis from the lay user field studies showed that they preferred the saliva collection procedure however for a small subset of subjects it proved difficult to collect sufficient sample for testing. For subjects who were able to collect adequate sample the results corresponded well between the device and lab-based ELISA. Conclusions The lay user experience validated test design and function and proved the usability in the field.