An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada

Abstract Background Self testing for HIV is a targeted intervention with the potential to increase access, uptake and frequency of more effectively reach undiagnosed, especially in priority populations. The objectives this study were (1) evaluate INSTI self-test performance compared laboratory reference testing, (2) document if intended users can perform steps use device, (3) successfully interpret contrived positive, negative, invalid results. Study was be submitted Health Canada review regulatory approval purposes. Methods used cross-sectional design recruited consenting adults who representative self-testing from four community sites across Ontario, Québec, Manitoba between August 2019 March 2020. results observed Abbott Architect Ag/Ab Combo test. Usability outcomes critical (e.g., lancing finger, blood droplet into bottle, shaking bottle times) noncritical procedure also determined. Results Overall, 77% ( n = 522) participants 18 45 years age, 61% 410) male, 71% 480) had some college or education, 45% 307) employed; identity race ethnicity: Caucasian (44%; 296), African, Caribbean Black (17%; 113), Indigenous [First Nations, Métis Inuit] (14%; 95), Asian (16%; 106), Latin American (7%; 46). Primary analysis on 678 completed self-tests revealed positive percent agreement 100% (5/5, 95% CI: 43.6–97.0%) negative 99.5% (614/617, 98.6–99.8%) comparator method. overall interpretation participant observer 93.5% 633). For 708 took part usability study, average success rate determined “critical” successful completion test 92.4%. 97% 670) found instructions easy follow, 655) indicated that they would again. Of 404 interpreted strong weak results, ranged 90.6% (for 366) 99.3% 401). Conclusions addition regulatory-approved Canadian landscape could significantly rates. Having blood-based approved offer an accurate, acceptable, simple alternative facility-based particularly when impacted by Coronavirus pandemic restrictions.