Half of approved diagnostic tests for epidemic diseases in Africa unusable at primary care
Half of approved diagnostic tests for epidemic diseases in Africa unusable

Report reveals major diagnostic gap in African primary healthcare

A new report has found that approximately half of the approved diagnostic tests for six epidemic-prone diseases prioritised by the Africa Centres for Disease Control and Prevention (Africa CDC) cannot be used in most primary healthcare facilities across Africa because they require laboratory infrastructure that is often unavailable. The report, titled Diagnostics Deficit: Funding, Access, and Preparedness Gaps in African Health Systems, was launched by global health organisations PATH and Impact Global Health ahead of the African Union Extraordinary Health Summit in Accra, Ghana.

Half of diagnostics require lab infrastructure

The report found that 50 per cent of approved diagnostics for Mpox, dengue, cholera, bacterial meningitis, malaria and Ebola depend on laboratory facilities beyond the reach of many frontline health centres. For Ebola alone, 88 per cent of approved diagnostic tests require laboratory infrastructure. The findings come months after the 2026 Bundibugyo ebolavirus outbreak, during which health authorities initially failed to detect the virus because available diagnostic tests were designed to identify the Zaire strain of Ebola. The mismatch delayed confirmation of the outbreak by 10 days, highlighting the consequences of gaps in Africa's diagnostic preparedness.

Rapid diagnostic tests play a critical role in identifying outbreaks early, guiding treatment and helping health authorities contain the spread of infectious diseases. However, limited access to these tools, particularly in primary healthcare centres where many patients first seek treatment, continues to weaken disease surveillance and emergency response across the continent.

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Uneven progress in diagnostic innovation

The report examined six diseases selected from Africa CDC's priority list for their epidemic and outbreak potential: mpox, dengue, cholera, bacterial meningitis, malaria, and Ebola. Measles, although also on the priority list, was excluded because comparable G-FINDER funding data were unavailable. Researchers identified 577 approved diagnostic products across six diseases, with another 59 still under development. However, innovation remains heavily concentrated in just two diseases. Dengue and mpox account for 84 per cent of all approved and pipeline diagnostic products, while cholera and bacterial meningitis, both identified by Africa CDC as major outbreak and antimicrobial resistance threats, have only seven approved or pipeline products each.

Despite a growing number of diagnostic products, access remains a major challenge. Of the 577 approved diagnostics, 288 require clinical laboratory infrastructure, limiting their use in primary healthcare facilities. While 83 per cent of malaria diagnostics can be deployed at the primary healthcare level, most approved diagnostics for Ebola and mpox remain laboratory dependent, restricting their use in frontline health facilities.

Funding decline leaves Africa underprepared

Further review showed that investment in diagnostic research and development has continued to decline. Using G-FINDER data, the analysis found that annual funding for six diseases has fallen by nearly $4 million (approx. ₦6 billion depending on exchange rates) since 2015, dropping from almost $55 million to less than $26 million in 2024. It warned that funding typically rises during major outbreaks before falling sharply once emergencies subside, a cycle that leaves African countries inadequately prepared for future epidemics.

Commenting on the findings, Sabastine Wakdok, Director of Research at Impact Global Health, said a steady decline in funding reflects a diagnostic research system struggling to keep pace with Africa's growing outbreak risks. "Diagnostic R&D investment for six Africa CDC priority diseases has fallen nearly $4 million annually since 2015. More troubling, this decline persists despite rising disease incidence and outbreak risk," he said. He added that the continent was not receiving the sustained investment needed for epidemic-prone diseases, warning that outbreak-driven funding cycles leave Africa "perpetually underprepared."

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Experts call for sustained investment and access

Also commenting, PATH's Senior Director for the Centre for Advocacy and Policy, Bernard Aryeetey, said the challenge goes beyond developing new diagnostic technologies to ensuring they reach the people and health facilities that need them most. "It is not solely whether diagnostics exist, but also whether they can reach clinics and surveillance systems when they are most needed, especially during outbreaks," he said. He warned that unless barriers relating to access, affordability, deployment and manufacturing readiness are addressed, people will continue to die needlessly even when effective diagnostic tools are available.

Recommendations to close the diagnostic gap

To address identified gaps, the report called for sustained domestic and international investment in diagnostic research, arguing that emergency-driven funding alone cannot build resilient health systems. It urged African governments to increase national financing for diagnostics while encouraging global health donors to provide predictable, long-term support. Authors also recommended that Africa CDC make diagnostics a central pillar of the continent's health security strategy and called on researchers and manufacturers to prioritise developing diagnostic tools for use in primary healthcare facilities, rather than relying mainly on technologies that require sophisticated laboratory infrastructure.

To improve access across the continent, the report urged the African Medicines Agency to harmonise regulatory approval processes so that diagnostic tests approved in one African country can be recognised more easily in others. It also highlighted Africa's growing manufacturing capacity, noting that facilities across the continent can collectively produce more than 500 million diagnostic units annually. However, weak demand, fragmented regulation, financing constraints and limited ecosystem support continue to prevent manufacturers from operating at scale. The report concluded that although Africa has expanded its diagnostic pipeline in recent years, improving access, affordability, manufacturing capacity, and deployment will be critical to strengthening the continent's preparedness for future disease outbreaks.