HIV self-testing and the global diagnostic gap: Addressing a decade of missed opportunity.

In 2015, a survey-based analysis across 16 sub-Saharan African countries estimated that nearly half of people living with HIV were undiagnosed, implying ~11 million people in the region were outside the treatment cascade. However, HIV self-testing (HIVST), a technology effectively positioned to close this gap, was deployed at negligible scale for a decade following WHO recommendation in 2016. The gap has narrowed, but through conventional testing rather than HIVST, and 2.6 million people in sub-Saharan Africa and 4.9 million globally still did not know their HIV status in 2025. The decade of delay carries a likely avoidable burden of millions of illnesses, deaths and onward transmissions, though this has not been formally modelled.The need for HIVST in low- and middle-income countries was estimated at 177 million self-tests in 2020, rising to 192 million by 2025. Confirmed procurement over the same period reached only 21 million kits in total, an average of 5.3 million per year, or 3% of estimated annual need.Four interlocking structural failures explain this missed opportunity: 1) research capture through demonstration projects that substituted for population-scale deployment; 2) the early supervised self-testing paradox in which provider-assisted delivery reconstituted the clinic barriers HIVST was designed to bypass; 3) procurement conservatism that suppressed market development; and 4) an accountability failure with no publicly accessible Africa-level volume series, making the scale of the missed opportunity impossible to measure from published data.Four actions could improve access: 1) mandatory public reporting of HIVST commodity volumes; 2) a dedicated Africa-specific distribution target of at least 50 million kits per year within the UNAIDS 95-95-95 framework; 3) community-based distribution as the default model for the general population; and 4) explicit HIVST volume commitments in the GHSD's 2026-2030 memoranda of understanding and work plans.