To support countries in their efforts to strengthen detection of TB disease and infection, the World Health Organization (WHO) has published an updated version of the WHO operational handbook on tuberculosis: module 3:diagnosis,to accompany the WHO consolidated guidelines on tuberculosis published earlier this year. The document provides laboratory personnel, clinicians and other clinical staff, as well as ministries of health and technical partners, with detailed guidance on implementing WHO evidence-based recommendations. Furthermore, it describes operational considerations for the use of WHO-recommended tests, providing an overview of all testing classes, presenting revised model algorithms, and outlining the steps and processes required to implement and scale up new tests and testing strategies.
The operational handbook presents several important updates (in comparison to the 2024 edition):
- combines the implementation guidance on diagnosis of TB infection, disease, and drug resistance into a single reference document;
- presents policy statements on the use of new interferon gamma release assays (IGRAs) for the detection of TB infection and updated targeted next generation sequencing solutions for the detection of drug-resistant TB;
- updates the pooled diagnostic accuracy estimates for the newly consolidated low-complexity automated and manual nucleic acid amplification tests;
- provides updates to the diagnostic algorithms and discordant result guidance in view of new recommendations on concurrent testing of respiratory and non-respiratory samples among adults and adolescents with HIV, children with HIV, and children without HIV or with unknown HIV status; and
- presents a new figure to guide use of drug susceptibility testing results for selection of appropriate TB and drug-resistant TB treatment regimens.
"The diagnostic options for people with TB infection and disease are increasing thanks to manufacturer engagement and research, generating new evidence. Ensuring equitable access to fast and accurate diagnosis for all who need it is essential, to strengthen prevention and drive us closer to the goal of ending TB" said Dr Tereza Kasaeva, Director of WHO's Department for HIV, TB, Hepatitis and STIs.
