Field performance evaluation of the GenBody ConfiSign HIV self-test for blood-based HIV screening in Uganda

HIV self-testing (HIVST) is a crucial strategy to reach the UNAIDS 95-95-95 targets by increasing testing coverage in high-burden areas like Uganda. The ConfiSign HIV Self-Test, a blood-based, direct-sampling, vertical flow, single-use rapid test, demonstrated perfect sensitivity and specificity during laboratory validation. This study assessed its performance and operational characteristics in the field compared to the Wondfo HIV Self-Test, which served as the standard of care. A cross-sectional mixed-methods study was conducted from 09 April 2025 to 30 May 2025 at 15 health facilities in Uganda. Participants (n = 2,434, aged ≥14 years) performed self-testing with ConfiSign and Wondfo (standard of care) under observation. Diagnostic accuracy was calculated against Wondfo. Usability, acceptability, and feasibility were evaluated via questionnaires (n = 798 for usability/acceptability; n = 90 for feasibility). Discordant results were resolved using ELISA and PCR. Participants were predominantly female (61.7%) and aged 18-29 (51.8%). ConfiSign positivity was 6.2% versus 6.0% for Wondfo. Sensitivity was 100%, specificity 99.8% (95% CI: 99.53-99.93). Three discordant results were resolved as negative via PCR and ELISA. Usability was high, with 94.7% of users finding components easy to handle and 83.3% collecting samples without difficulty. Acceptability was strong, as 98.0% would reuse the test and 99.0% would recommend it. Feasibility assessments across operational, usability, performance, economic, and acceptability domains yielded positive scores, supporting integration into Uganda's HIV testing framework. These findings confirm the kit's diagnostic accuracy and ease of use in field settings, supporting its adoption for HIVST in Uganda. We suggest improvements such as instructions in the local language and the inclusion of additional gauze for better acceptance.