WHO Guidance Sets Evidence Standards for the Next Generation of TB Diagnostic Tests

WHO’s guidance covers diagnostic tests, sample types and testing strategies, with recommendations for study design and reporting that can help turn research findings into policy.

The World Health Organization has published its first guidance on how to build strong evidence for new tuberculosis (TB) diagnostic tests. Released on 20 October, the document is intended for researchers, developers, funders and others whose work can shape future WHO recommendations.

New tests can only improve care when the evidence shows how they perform in real settings and what they mean for people who need them. WHO's guidance covers diagnostic tests, sample types and testing strategies, with recommendations for study design and reporting that can help turn research findings into policy. The publication is the third in WHO's evidence generation guidance series.

From test accuracy to evidence that matters to people

The guidance sets out methods for studying diagnostic accuracy, selecting participants, calculating sample sizes and reporting results. It also calls for evidence on outcomes that matter to patients and health systems, including cost-effectiveness, equity, acceptability and feasibility.

WHO's Tereza Kasaeva, Director of the Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections, said the guidance gives researchers, developers and funders a "clear road map" for producing evidence on new tests, sample types and testing strategies.

A framework to connect tests with care

A new analytical framework maps the role a diagnostic is meant to play along the clinical pathway, then links that role to decisions about study design, populations, methods and reporting. This gives researchers a way to plan studies around how a test could be used and to present findings in a form that can inform policy.

The guidance responds to recurring evidence gaps. Studies have sometimes focused only on test accuracy, left out vulnerable groups who could benefit from new diagnostics, or reported little about cost, equity, acceptability and feasibility. Inconsistent reporting has also made results harder to compare and synthesize.

Building a stronger route from research to practice

The new publication follows WHO's guidance on evidence generation for new TB treatment regimens and preventive treatment. It also complements WHO's target product profiles for TB diagnosis and drug-resistance detection.

With more complete and relevant evidence, WHO can make stronger recommendations, and countries can assess new diagnostic technologies with greater confidence. The guidance is designed to help speed the adoption of useful tests and support their uptake in health systems.