Blood-based HIV self-test shows strong accuracy in Uganda field trial

A large field study in Uganda has found that the ConfiSign HIV Self-Test, a blood-based rapid screening kit, performed with very high accuracy when used by members of the public under observation, matching the performance it showed in earlier laboratory validation.

Researchers conducted a cross-sectional mixed-methods study from 9 April 2025 to 30 May 2025 at 15 health facilities across Uganda. A total of 2,434 participants aged 14 years or older carried out self-testing with the ConfiSign device alongside the Wondfo HIV Self-Test, which served as the standard of care. Most participants were female (61.7%) and aged between 18 and 29 (51.8%).

The ConfiSign test is a single-use, direct-sampling, vertical flow rapid test that uses a small blood sample. In the field evaluation, 6.2% of ConfiSign results were positive compared with 6.0% for the Wondfo test. Measured against the Wondfo result, ConfiSign showed a sensitivity of 100% and a specificity of 99.8% (95% confidence interval: 99.53–99.93).

Three results were discordant between the two tests. These were resolved as negative when checked with laboratory-based ELISA and PCR testing, indicating that the ConfiSign device had produced false-positive rather than false-negative readings in those cases.

Beyond diagnostic accuracy, the study assessed how easy and acceptable the kit was to use. Usability questionnaires completed by 798 participants showed that 94.7% found the components easy to handle and 83.3% collected their samples without difficulty. Acceptability was also strong: 98.0% of users said they would use the test again and 99.0% said they would recommend it.

A separate feasibility assessment involving 90 participants scored the kit across operational, usability, performance, economic and acceptability domains, and returned positive results in each. The authors say these findings support integrating the ConfiSign test into Uganda’s HIV testing framework.

HIV self-testing is considered an important tool for reaching the UNAIDS 95-95-95 targets by expanding testing coverage in high-burden settings such as Uganda. The study team noted that the field results confirm the kit’s diagnostic accuracy and ease of use outside the laboratory.

The researchers also identified practical improvements that could increase acceptance of the kit, including providing instructions in the local language and including additional gauze in the test pack. The study was observational and compared ConfiSign against the Wondfo self-test rather than a laboratory reference for every sample, with discordant results alone resolved by ELISA and PCR, so the reported accuracy figures reflect that comparison.

Subject of Research: Field performance of a blood-based HIV self-test in Uganda

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

Article References: Kyokushaba, J., Mujuni, D., Kasone, V., Namakula, A., Makoha, C., Mugalula, F., Okiira, C., Nyegenye, W., Katusiime, C., Mutumba, R., & Nabadda, S. (2026). Field performance evaluation of the GenBody ConfiSign HIV self-test for blood-based HIV screening in Uganda. PLOS One, 21(10), e0361282. https://doi.org/10.1371/journal.pone.0361282

Image Credits: AI Generated

DOI: 10.1371/journal.pone.0361282

Keywords: HIV self-testing, Uganda, rapid diagnostic test, ConfiSign, diagnostic accuracy, sensitivity, specificity, public health, field evaluation, HIV screening, Field, performance