Local packaging of WHO-approved HIV tests, a shift in Africa’s diagnostic capacity

For decades, Africa’s public health systems have depended heavily on imported diagnostics to support disease detection, surveillance, and treatment programmes. While these products often meet global quality standards, the model has left countries exposed to supply disruptions, long lead times, and limited control over availability, weaknesses that became particularly visible during recent global crises.

Against this backdrop, Nigeria’s approval to locally package a WHO-prequalified HIV rapid diagnostic test (RDT) may appear technical or procedural. In reality, it represents a deeper shift in how African countries can strengthen health security while still meeting the highest international quality benchmarks.

The test, already prequalified by the WHO, can now be packaged at Colexa Biosensor, an IVD facility in Lagos, following approval under the WHO Pre-Qualification Change Notification process. This makes the site the only one on the continent currently authorised to package a WHO-prequalified HIV RDT. While the distinction may sound narrow, it carries significant implications for procurement, program delivery, and the broader push toward local manufacturing of essential health commodities.

WHO pre-qualification is the gold standard used by governments, donors, and international agencies to assess the safety, quality, and performance of diagnostics used in public health programmes. Any modification to a pre-qualified product, including changes to manufacturing or packaging location, requires rigorous review to ensure that standards are maintained. Approval, therefore, is not symbolic; it reflects the ability of the local facility to consistently demonstrate compliance through documented processes, traceability, and quality assurance systems.

For Nigeria’s HIV response, the practical impact is clear. The locally packaged Standard Q HIV RDT has been evaluated by the Federal Ministry of Health and the National AIDS and STI Control Programme (NASCP) and is listed on the National HIV Testing Algorithm. This listing allows federal and state governments, as well as donor-funded programs, to procure the test for use across public health settings.

In a country where millions of tests are required annually to support prevention, treatment initiation, and surveillance, the reliability of supply is not a luxury; it is a necessity. Local packaging reduces dependence on fully imported finished products, helping to shorten lead times, improve responsiveness to demand fluctuations, and lower the risk of stock-outs caused by global logistics disruptions.

These advantages are not unique to Nigeria. Across Africa, health systems have struggled with delayed shipments, rising freight costs, and competition for limited global supplies. Localising parts of the value chain, even at the packaging stage, can improve resilience without compromising quality, provided global standards are rigorously enforced.

Critically, local packaging does not mean lower standards. On the contrary, WHO approval requires proof that processes are standardised, repeatable, and auditable. Facilities must demonstrate batch control, full documentation, and traceability comparable to that of original manufacturing sites. In this sense, local packaging shifts the narrative from “import substitution” to standards replication, the ability to meet the same requirements locally that are applied anywhere in the world.

The broader implications extend beyond HIV diagnostics. The same Lagos facility also produces blood glucose meters and test strips, addressing the growing burden of non-communicable diseases such as diabetes. This dual focus reflects a reality facing many African countries: health systems must now manage infectious diseases alongside rising chronic conditions, often with limited resources.

From a development perspective, this convergence matters. Diagnostics are foundational to effective healthcare delivery, yet they are often overlooked in discussions about industrialisation and health security. Medicines attract more attention, but without reliable testing, treatment decisions become delayed or inaccurate, undermining outcomes and increasing costs.

Local involvement in diagnostic production and packaging can also generate spillover benefits, skills development in quality management, stronger regulatory capacity, and improved alignment between health policy and industrial policy. These benefits, however, are not automatic. They depend on sustained investment, competent oversight, and clear regulatory pathways.

Another often overlooked dimension of localising diagnostics is its effect on regulatory maturity. When products are fully imported, national regulators primarily play a gatekeeping role. Local packaging, however, requires regulators to move further upstream, strengthening inspection capacity, documentation review, post-market surveillance, and ongoing quality monitoring. This shift contributes to more robust regulatory ecosystems, which are essential not only for diagnostics but for medicines, vaccines, and medical devices more broadly.

There are also implications for regional integration. As Africa advances the objectives of the African Continental Free Trade Area (AfCFTA), the ability of countries to produce or package quality-assured health commodities locally could support more efficient cross-border supply within the continent. If harmonised regulatory pathways are pursued, WHO-approved locally packaged diagnostics could, over time, serve multiple markets, reducing duplication of effort and improving access across neighbouring countries.

However, realising these benefits will require deliberate coordination. Local capacity must be matched by predictable procurement volumes, transparent tender processes, and continued technical oversight. Without this, facilities that meet global standards may struggle to operate sustainably.

Ultimately, the value of localising WHO-approved diagnostics lies not only in national self-reliance but in the opportunity it creates to reposition Africa as a credible contributor to global health supply chains, capable of meeting international standards while responding to local and regional health needs.

It is also important to recognise the limits of local packaging. On its own, it does not eliminate dependence on imported raw materials or global manufacturers. Nor does it solve challenges related to financing, distribution, or last-mile delivery. Without coordinated procurement planning and predictable demand, even locally packaged products can face sustainability challenges.

This is where policy coherence becomes essential. Governments, donors, and development partners must move beyond one-off approvals to support integrated strategies that link local manufacturing, regulatory strengthening, and health programme needs. Donor procurement policies, in particular, can play a decisive role by recognising and prioritising quality-assured locally packaged products where available.

Nigeria’s experience offers a practical example of what is possible when regulatory rigour, technical partnerships, and policy alignment converge. It challenges the assumption that global standards must always be met outside Africa and shows that compliance is not a function of geography but of systems, skills, and accountability.

For the continent, the question is no longer whether African facilities can meet WHO standards; they clearly can. The more pressing question is whether enough investment is being made to scale such models responsibly and replicate them across countries and product categories

As Africa grapples with ongoing HIV challenges, emerging disease threats, and a rising burden of non-communicable diseases, resilient diagnostic supply chains will be central to health security. Local packaging of WHO-approved diagnostics is not a silver bullet, but it is a meaningful step toward reducing vulnerability and increasing agency.