Prospective observational study to evaluate the performance of the BioSure HIV Self-Test in the hands of lay users

Objectives In order to assess whether the BioSure HIV Self-Test could be reliably performed by users at home and to determine whether they were able to perform and correctly interpret the test, we carried out an evaluation study among attendees at a sexual health service. Methods A prospective observational study of clinic attendees to determine their ability to follow the instructions, complete the test on themselves and correctly interpret the results. The evaluation included interpretation of three dummy (contrived) devices, chosen at random from a sample of 12 devices, to ensure that a sufficient number of all possible test outcomes were included. Results Two hundred participants were recruited. 97.0% (95% CI 93.5 to 98.9) conducted the test so as to achieve a valid result. 99.5% correctly identified the test result. Participants correctly interpreted the result of 94.0% (95% CI 91.4 to 95.9) of 586 contrived devices. Conclusions The majority of participants were able to follow the instructions and perform the test in order to get a valid result. Interpretation of the test results was good and the majority of participants were able to correctly read the result of their own and contrived tests. The availability of HIV self-tests will provide another option to increase access to testing particularly for those who may not wish or are unable to access clinical services.