Methods
In 2025, WHO commissioned a series of systematic reviews of published and final, publication-ready unpublished data on the near point-of-care nucleic acid amplification tests (NPOC-NAATs) used on sputum and tongue-swabs, low complexity automated NAATs (LC-aNAATs) used on tongue-swabs, as well as LC-aNAATs used on pooled sputum. The systematic reviews included data on diagnostic accuracy (i.e., sensitivity and specificity), impact on patient important outcomes, economic and implementation considerations, and qualitative evidence on feasibility, acceptability, equity, end-user values and preferences. Synthesized evidence was assessed following the GRADE method and risk of bias and concerns about applicability were assessed using the QUADAS-2 tool.
WHO convened a Guideline Development Group (GDG) on 10-14 November 2025 to discuss the findings of the systematic reviews and make recommendations. During the discussion, the GDG members formulated successive drafts of the recommendations based on their assessment of the evidence. Several factors determined the direction and strength of the recommendations (e.g., strong or conditional), including the certainty in the estimates of effect (“quality of the evidence”), values and preferences, how substantial the anticipated desirable and undesirable effects were, certainty on the balance of the benefits and harms, resource implications, health equity, acceptability, and feasibility. The GDG made recommendations about which populations required a particular diagnostic approach, outlining considerations for implementation, monitoring and evaluation and future research. All GDG decisions were reached by discussion and consensus on the recommendations, including their strength and, where appropriate, the conditions to be attached to them.
This update aims to inform national TB programmes, clinicians and other stakeholders about the key findings and considerations on the use of near point-of-care molecular tests, tongue swabs, and pooled sputa for the initial diagnosis of TB. An overview of the evidence, recommendations, remarks and brief considerations for each intervention are presented below. Implementation of these recommendations will result in earlier and more timely diagnosis of TB for a greater range of individuals at lower costs for disease control programs. In settings with incomplete access to testing services and constrained resources, rapid review of local barriers to testing and adoption of these advances as possible solutions for gap closure is critical.