The WHO End TB Strategy calls for early diagnosis of TB for all individuals with presumptive TB and universal access to drug susceptibility testing (DST) for those diagnosed. Highly accurate, accessible, cost-effective and impactful diagnostic tests are essential for achieving these goals. To support advances in TB diagnostic testing, the WHO Global Programme on TB & Lung Health publishes target product profiles (TPPs) to inform development of new testing products, provides guidance on how to generate evidence on the effectiveness of developed technologies, and then assesses evidence on the use of new testing strategies, sample types and technologies that align with global priorities.
Evidence is now emerging on the effectiveness of (1) new near point-of-care (NPOC) molecular tests for the diagnosis of TB that differ from other WHO-recommended diagnostics in their level of complexity, robustness, and intended settings of use, (2) new easy-to-collect sample types (i.e., tongue swabs) with potential to expand access to testing services, and (3) a novel testing strategy (i.e., pooling of respiratory samples for low-complexity automated nucleic acid amplification testing) that could increase testing capacity without the need for additional tests, reduce program costs, and speed time to results by reducing testing volumes.
In response, WHO is issuing a public call for data, appealing to national TB programmes, implementers, industry, researchers, and other stakeholders to provide evidence that could address the following research questions:
· Can near point-of-care nucleic acid amplification technologies (NPOC-NAATs) be used on respiratory samples[1] for the initial diagnosis of TB?
· Can near point-of-care nucleic acid amplification technologies (NPOC-NAATs) be used on tongue swabs for the initial diagnosis of TB?
· Can low-complexity automated nucleic acid amplification tests (LC-aNAATs) be used on tongue swabs for the initial diagnosis of TB and rifampicin resistance?
· Can low-complexity automated nucleic acid amplification tests (LC-aNAATs) be used on pooled respiratory samples for the initial diagnosis of TB and rifampicin resistance?
Finally, quality data is requested on the use of design-locked and marketed diagnostic technologies with the specified sample types for the detection of pulmonary and extra-pulmonary TB. For more information on the defining characteristics of TB NPOC-NAATs see Annex 1. Data may address patient-important outcomes, diagnostic accuracy, feasibility, acceptability, and cost-effectiveness of the interventions outlined in the research questions above. To review research question Populations, Interventions, Comparisons, and Outcomes (PICOs) that may guide data suitability and preparation efforts see Annex 2. Further, for parameters on economic, acceptability, and feasibility data see Annex 3.
All data will be essential to facilitate the process of WHO policy updates scheduled for November 2025. Please send relevant data by 15th July 2025 to Alexei Korobitsyn at korobitsyna@who.int.
[1] For adults respiratory samples include sputum, bronchoalveolar lavage, and induced sputum. For children respiratory samples include sputum, bronchoalveolar lavage, induced sputum, nasopharyngeal aspirates, and gastric aspirates.