Prospective observational study to evaluate the performance of the BioSure HIV Self-Test in the hands of lay users
Saunders et al.
Type of approach
Type of assistance
Key population: Men who have sex with men
UNAIDS HIV prevalence (2017)
Observational study to determine the ability of clinic attendees to follow the instructions, complete the test on themselves and correctly interpret the results. Participants interpreted three possibilities of contrived results, chosen at random from a sample of 12 devices, to ensure that a sufficient number of all possible test outcomes were included; participants were not given any further verbal instructions or assistance by the researcher. Study period: November 2014 to March 2016
Summary of findings
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. 3% of participants had difficulty using the finger-prick lancet (n=6/199) and 4% had difficulty expressing blood or collecting a sample (n=8/199), although not to a degree that meant that the test was unable to be performed.
Willingness to pay
Willingness to pay details
94.0% (95% CI 91.4 to 95.9) participants correctly interpreted the result of 551 contrived devices.
Linkage to prevention, care and treatment
A single participant had a reactive test result which was confirmed on a second point-of-care test, and a laboratory test.