Local Packaging of WHO-Approved HIV Tests, a Shift in Africa’s Diagnostic Capacity

 

By Chidinma Onwumere

Nigeria’s public health system has taken a further step toward strengthening diagnostic self-reliance with the local packaging of a WHO pre-qualified HIV Rapid Diagnostic Test (RDT) at a facility in Lagos. The development highlights a broader shift in how essential health commodities are produced, supplied, and regulated across the continent.

The HIV test in question, the Standard Q HIV 1 & 2 RDT was previously manufactured and distributed as a fully imported finished product. Through regulatory approval granted under the WHO Pre-Qualification Change Notification, local packaging is now authorised at Colexa Biosensor, a Nigerian facility, making it the only site in Africa currently approved to package a WHO-prequalified HIV RDT.

While the technical designation may appear procedural, its implications are significant. WHO pre-qualification is a globally recognised quality benchmark used by national governments and international donors to guide procurement decisions for public health programs. Any change to a pre-qualified product, including where it is packaged, requires rigorous assessment to ensure that quality, safety, and performance remain unchanged.

For Nigeria, the approval represents more than a regulatory milestone. It addresses a longstanding vulnerability in health systems across Africa: dependence on imported diagnostics and the fragility of global supply chains. During recent global disruptions, including the COVID-19 pandemic, many countries experienced delays in access to essential medical commodities, exposing the risks of over-reliance on distant manufacturing hubs.

By enabling local packaging of a WHO-approved HIV test, Nigeria improves its ability to respond more quickly to demand fluctuations, reduce lead times, and maintain continuity of supply for national HIV programs. The test has been evaluated and approved by the Federal Ministry of Health and the National AIDS and STI Control Programme and is listed on the National HIV Testing Algorithm, making it eligible for procurement by government agencies and international partners supporting HIV services in the country.

From a programme perspective, inclusion on the national algorithm is critical. It ensures that test kits used in public health settings meet required performance standards and align with national testing strategies. It also allows donor-funded programs, such as those supported by multilateral agencies and global health initiatives, to procure the product locally while maintaining compliance with international quality requirements.

The shift toward local packaging also brings economic and institutional benefits. Shorter supply chains can lower logistics costs, improve predictability, and create opportunities for skills transfer in quality management, regulatory compliance, and manufacturing operations. Importantly, local involvement does not replace global standards; rather, it requires demonstrable adherence to them. WHO-approved local packaging is contingent on standardised processes, full traceability, and the ability to consistently prove compliance through documentation and audits.

Health policy experts note that such approvals challenge persistent assumptions that high-quality diagnostic manufacturing must occur outside Africa. Instead, they suggest a growing recognition that African facilities, when supported by strong regulatory oversight and technical partnerships, can meet the same benchmarks applied globally.

Beyond HIV diagnostics, the Lagos facility also produces blood glucose meters and test strips, reflecting a parallel focus on non-communicable diseases such as diabetes, which are rising rapidly across Nigeria and the continent. This dual focus on communicable and non-communicable diseases aligns with evolving health priorities, as African countries face a growing burden of chronic illness alongside infectious diseases.

The broader significance of this development lies in its potential scalability. While the immediate impact is national, the regulatory pathway demonstrated in Nigeria could inform similar initiatives elsewhere in Africa. Regional health bodies and policymakers have long advocated for greater local production of essential medical products as part of health security and economic development strategies. However, progress has often been constrained by regulatory complexity, quality assurance requirements, and limited technical capacity.

By meeting WHO pre-qualification standards for local packaging, Nigeria offers a practical example of how these barriers can be addressed. It also underscores the importance of collaboration between global manufacturers, local operators, regulators, and international agencies, in building sustainable diagnostic capacity.

As demand for HIV testing remains high, particularly among key populations and in underserved areas, reliable access to quality-assured diagnostics remains central to prevention, treatment, and surveillance efforts. Local packaging does not eliminate the need for global supply chains, but it can make them more resilient, responsive, and context appropriate.

More broadly, the development contributes to an ongoing debate about how African countries can move beyond consumption toward greater participation in the value chain of global health products. In this sense, the local packaging of a WHO-approved HIV test is less about a single facility or product and more about what it represents: a gradual but meaningful shift toward health system self-reliance grounded in global standards

As African governments and development partners continue to prioritize pandemic preparedness, universal health coverage, and supply chain resilience, such models may play an increasingly important role in shaping the future of healthcare delivery on the continent.