HIV testing is an essential health service and is the critical gateway to both prevention and treatment. With several countries facing significant financial uncertainty, it is urgent for countries to adopt pragmatic cost-saving measures. By prioritizing low-cost and effective differentiated HIV testing solutions, countries can ensure continuity of services for people living with HIV on life-saving treatment and protect hard-won public health gains.
To adapt to this new environment, WHO encourages countries to adopt low-cost WHO pre-qualified HIV rapid tests as the first test in their testing strategy and update their national algorithms accordingly. This also applies to the HIV syphilis dual tests in antenatal care. Adopting a high quality and low-cost first test in a national HIV testing algorithm will result in an immediate and substantial reduction in testing costs for countries. Countries can refer to WHO's Toolkit to optimize HIV testing algorithms to select a listed low-cost product and to be able to rapidly transition their testing programmes.
WHO recommends flexible algorithms and supports verification studies during or after the algorithm transition, using multiple WHO prequalified products as the first test.
For additional savings, WHO urges countries to adopt low-cost and quality-assured HIV self-tests (blood or oral). Programmes with limited health workers and testing capacity may also consider using HIV self-tests as an alternative first test, especially in contexts where gaps in maintaining service delivery remain. Further guidance on using HIV self-tests can be found in the 2024 WHO Consolidated guidelines on differentiated HIV testing service . This includes a recommendation on facility-based self-testing. It also aims to help countries sustain and expand HIV testing coverage amid constrained budgets.
"The global HIV response and epidemic control is at risk," said Dr Meg Doherty, Director of WHO Global HIV, Hepatitis and STI Programmes. "We must continue to do everything we can to support countries in delivering life-saving HIV services. Providing countries flexibility and shifting to low-cost, quality-assured HIV rapid tests , dual HIV/syphilis and self-tests will ensure impact, quality and allow more resources to reach people living with HIV and prevent new infections."
WHO can support countries to expedite product availability in countries, such as through waivers to expedite regulatory approvals, which are needed to make this rapid transition. Existing national regulatory pathways can also help fast-track the introduction and registration of new products.
There is a wide selection of low-cost, WHO-prequalified HIV tests available . Countries can use the WHO diagnostic catalogue and product selection tool to review these options and optimize their national testing strategies. "This guidance is only possible thanks to WHO's Prequalification (PQ) Programme, which ensures that quality-assured diagnostics are accessible and affordable for all low- and middle-income countries," said Dr Rogerio Gaspar, Director of WHO Department of Regulation and Prequalification.
The WHO PQ Programme evaluates HIV in vitro diagnostics against international standards of quality, safety and performance. It plays a crucial role in ensuring that countries can provide high-quality diagnosis, effective prevention, and access to treatment for those who need it.
Engagement with procurers and those hosting pooled procurement mechanisms is critical as well.
"The Global Fund welcomes this important guidance from the World Health Organization, which will help countries sustain life-saving HIV services," said Marijke Wijnroks, the Global Fund's Head of Strategic Investment and Impact. "We look forward to working with countries to support adoption and implementation of this guidance to both minimize the costs of HIV tests and ensure sustained provision and access to HIV testing services."
With support from global partners, WHO continues to work to secure access to HIV diagnostics in all countries and across all settings to ensure life-saving services continue and no one is left behind.
