Analytical Performance of the Exacto Test HIV Self-Test: A Cross-Sectional Field Study in the Democratic Republic of the Congo.

The Democratic Republic of the Congo (DRC) has begun implementing HIV self-testing to boost the first "95" of the UNAIDS 95-95-95 targets by 2025. This study aims to assess the performance and usability of the Exacto Test HIV (Biosynex, Strasbourg, France) self-test in the lab and in the field. The Exacto Test HIV self-test demonstrated high virological performance (sensitivity, 99.6%; specificity, 100%) in the lab and in the field in the hand of untrained users (sensitivity, 100%; specificity, 98.9%). Taken together, the excellent performance and usability characteristics of the Exacto Test HIV (Biosynex) self-test make the kit a viable option for HIV self-testing in the DRC.