The World Health Organization (WHO) has released its first guidance on generating evidence for new tuberculosis (TB) diagnostic tests, aiming to improve research quality and support the faster adoption of effective diagnostic technologies worldwide.
The document provides researchers, test developers, funders and other stakeholders with recommendations for producing evidence that can inform WHO guidelines on new diagnostic tests, sample types and testing strategies.
The guidance outlines key research considerations, including diagnostic accuracy study design, participant selection, sample size and reporting standards. It also emphasises the importance of evaluating patient outcomes, cost-effectiveness, equity, acceptability and feasibility alongside test accuracy.
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A new analytical framework maps the role of diagnostic tests across the clinical pathway, linking each stage to appropriate study designs, populations, methods and reporting requirements.
“Robust evidence is the foundation of strong WHO recommendations. This guidance gives researchers, developers and funders a clear road map for generating the evidence WHO needs on innovative tuberculosis tests, sample types and testing strategies, so that better diagnostics reach more people who need them, faster,” said Tereza Kasaeva, Director, Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections.
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The new guidance complements WHO’s existing target product profiles for TB diagnosis and drug-resistance detection. By improving the quality and relevance of research evidence, WHO aims to strengthen policy recommendations and accelerate access to effective TB diagnostic technologies across countries.
