Guidance on evidence generation on new tuberculosis diagnostics

Overview

The Guidance on evidence generation (GEG) for new tuberculosis diagnostics advises researchers, developers, funders and other stakeholders on how evidence should be generated to inform WHO guideline development on new TB diagnostic tests, sample types and testing strategies. This document is the third in a series of WHO guidance on evidence generation documents, following the GEG for new regimens for tuberculosis treatment and on tuberculosis preventive treatment.

Evidence generated for new TB diagnostics has often been weak or incomplete: focused solely on test accuracy and provides little information on feasibility, acceptability, equity or cost; reported inconsistently; or excluding vulnerable populations. The guidance in the GEG helps address these gaps. It outlines 28 key messages covering diagnostic accuracy study design, participant selection, sample size and reporting, and how to generate evidence on people-important outcomes, values, cost–effectiveness, equity, acceptability and feasibility. It also presents a new analytical framework that maps the intended role of each new diagnostic and then supports users to utilize the map to ensure their study is appropriately tailored to produce results with potential to inform health policy.

Together with WHO’s target product profiles for tuberculosis diagnosis and detection of drug resistance, this new guidance provides a critical foundation for advancing diagnostic innovation and translating scientific evidence into effective policies and practice. By strengthening the quality, relevance and completeness of evidence generated, it will help inform robust WHO recommendations, support faster adoption of new diagnostic technologies and accelerate their uptake in countries.