TB diagnosis to become more accessible and cost-effective through innovative approaches

• Evidence from Unitaid-funded studies informed the new World Health Organization (WHO) policy guidance that recommends innovative diagnostic approaches with the potential to reduce costs, expand access and bring TB testing closer to communities.

The World Health Organization (WHO) has issued new recommendations to make tuberculosis (TB) diagnosis more affordable and to bring it closer to where people seek care. For the first time, WHO recommends pooled testing to diagnose TB – an approach that combines multiple samples into a single test, significantly reducing costs and allowing more people to get tested with similar resources. The guidelines also recommend tongue swabs for people who are unable to produce sputum, and near point-of-care technologies that bring advanced testing to primary healthcare and community settings and deliver results in minutes rather than days.

These recommendations draw on growing evidence, including from multi-country studies supported by Unitaid and partners, and reflect a broader shift toward decentralized TB testing approaches that address long-standing access barriers.

“As resources for TB become increasingly scarce, the need to adapt is clear,” said Dr. Philippe Duneton, Executive Director at Unitaid. “These innovations reduce costs and bring diagnosis closer to communities – bringing us one step closer to making TB care accessible for all. Unitaid is committed to going further and supporting countries as they adopt these interventions to reach more people.”

Despite being preventable and curable when diagnosed early, TB remains the world’s leading infectious disease killer. Each year, an estimated three million people with TB go undiagnosed and untreated. For many, the right diagnostic tool is too far away or simply not designed for their needs. People living far from health facilities with laboratories face long travel times, delayed results, high out-of-pocket costs and missed opportunities to start treatment earlier. As health systems struggle with increasingly tight budgets, they are often forced to make difficult choices about who gets tested. These innovative technologies and approaches can help countries save costs while expanding access to TB diagnosis.

Since 2022, Unitaid has invested US$ 44 million to advance TB diagnostics, supporting multi-country efforts with partners including the Liverpool School of Tropical Medicine (LSTM) and FIND.

Through the “Start Taking Action for TB Diagnosis – Start4All” consortium, LSTM and partners in seven countries have generated some of the first global evidence showing that pooled testing can substantially expand access to molecular TB diagnosis without compromising accuracy. A study involving nearly 15,000 participants demonstrated that pooled testing maintains high diagnostic performance, while significantly reducing cartridge use and laboratory workload. Analysis conducted by the National TB Program in Cameroon demonstrated that this approach could cut testing costs by up to 65% in some settings. For national TB programs, reinvestment of such savings could increase access to TB testing and contribute to reaching the ‘missed millions’ worldwide.

Cameroon was one of the project sites and an early adopter of pooled testing to improve access to TB diagnostics.

“Pooled testing has allowed us to more than double the number of people receiving rapid molecular tests for TB,” said Cyrille Mbuli from the Center for Health Promotion and Research. “This approach uses existing lab personnel, equipment, and reagents, and can scale with almost no additional investment. Pooling has dramatically expanded our capacity to provide TB services and could be applied to other disease areas as we move toward greater integration.”

Unitaid-funded work with FIND also generated critical evidence on the acceptability of tongue swabs and near point-of-care technologies. Findings from this research show that tongue swabs are well accepted by both people being tested and the health workers administering them, and may help reduce discomfort and hesitation around TB testing.

Building on these results, Unitaid is now taking its investments further to generate evidence that optimizes innovative TB diagnostic approaches for children, who face the greatest challenges in early detection. While previous research has focused on adults and adolescents, these efforts aim to ensure that the youngest, most vulnerable patients can also benefit from new technologies and approaches. At the same time, Unitaid is looking at approaches across the screening and testing continuum to ensure innovative and low-cost tools, including near point-of-care technologies, are available where they are most needed. Together, these initiatives complement Unitaid’s broader commitment to ending TB – from prevention to diagnosis to treatment – including efforts to tackle drug-resistance.