The Technical Advisory Group (TAG) on diagnostics and laboratory strengthening reviewed evidence for the comparability of results of the assays Xpert MTB/RIF and Xpert MTB/RIF Ultra performed on the GeneXpert 6-colour system compared to the 10-colour instrument. The evidence showed that the two systems are comparable in detecting Mycobacterium tuberculosis complex as well as detecting resistance to rifampicin. Based on the conclusion drawn by the TAG, WHO/GTB issues this policy statement in order to guide countries regarding running the two tests on the two systems.

The “WHO operational handbook on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection, third edition” is the latest edition replacing the one issued in 2021. A new class of technologies for drug susceptibility testing is endorsed by WHO and included in this edition: targeted next generation sequencing. The operational handbook aims at facilitating the implementation of the WHO recommendations by the Member States, technical partners, and others involved in managing patients with TB and DR-TB. It provides practical information on existing and new tests recommended by WHO, step-by-step advice on implementing and scale-up testing to achieve local and national impact and lastly, model diagnostic algorithms, which are updated to incorporate the latest recommendations. An overview of budgetary considerations and information sheets on each of the newly recommended tests is provided. The class of targeted next generation sequencing is recommended for the detection of resistance to a number of first- and second-line anti-TB drugs, rather than culture-based phenotypic drug susceptibility testing. The recommendations will open for faster detection of resistance to a range of anti-TB drugs directly from sputum samples.

The “WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection, third edition” is the latest document replacing the one issued in 2021. This latest edition includes new recommendations on the use of a new class of diagnostic technologies: targeted next-generation sequencing (NGS) tests for the diagnosis of drug-resistant tuberculosis (TB). The recommendations provide a novel approach for the rapid detection of drug resistance to new anti-TB drugs using the latest technologies. The consolidated guideline provides background, justification and recommendations on these and earlier endorsed TB diagnostic technologies. This document is accompanied by the “WHO operational handbook on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection, third edition”, which aims at facilitating the implementation of the WHO recommendations by the Member States, technical partners, and others involved in managing patients with TB and DR-TB.

Tuberculosis (TB) strains with drug resistance (DR-TB) are more difficult to treat than drug-susceptible ones, and threaten global progress towards the targets set by the End TB Strategy of the World Health Organization (WHO). There is thus a critical need for evidence-based policy recommendations on the treatment and care of patients with DR-TB, based on the most recent and comprehensive evidence available. In this regard, the WHO consolidated guidelines on drug-resistant tuberculosis treatment fulfil the mandate of WHO to inform health professionals in Member States on how to improve treatment and care for patients with DR-TB. Between 2011 and 2018, WHO has developed and issued evidence-based policy recommendations on the treatment and care of patients with DR-TB. These policy recommendations have been presented in several WHO documents and their associated annexes, including the WHO treatment guidelines for multidrug- and rifampicin-resistant tuberculosis, 2018 update, issued by WHO in December 2018. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups (GDGs), using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. The present Consolidated guidelines include a comprehensive set of WHO recommendations for the treatment and care of DR-TB, derived from these WHO guidelines documents. The consolidated guidelines include policy recommendations on treatment regimens for isoniazid-resistant TB (Hr-TB) and MDR/RR-TB, including longer and shorter regimens, culture monitoring of patients on treatment, the timing of antiretroviral therapy (ART) in MDR/RR-TB patients infected with the human immunodeficiency virus (HIV), use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care.

Between 2011 and 2019, WHO has developed and issued evidence-based policy recommendations on the treatment and care of patients with DR-TB. These policy recommendations have been presented in several WHO documents and their associated annexes, including the WHO Consolidated Guidelines on Drug Resistant Tuberculosis Treatment, issued by WHO in March 2019. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups, using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. The present WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment includes a comprehensive set of WHO recommendations for the treatment and care of DR-TB. The document includes two new recommendations, one on the composition of shorter regimens and one on the use of the BPaL regimen (i.e. bedaquiline, pretomanid and linezolid). In addition, the consolidated guidelines include existing recommendations on treatment regimens for isoniazid-resistant TB and MDR/RR-TB, including longer regimens, culture monitoring of patients on treatment, the timing of antiretroviral therapy (ART) in MDR/RR-TB patients infected with the human immunodeficiency virus (HIV), the use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care. The guidelines are to be used primarily in national TB programmes, or their equivalents in Ministries of Health, and for other policy-makers and technical organizations working on TB and infectious diseases in public and private sectors and in the community.