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.
This book provides a comprehensive overview of the recent trends in various Nanotechnology-based therapeutics and challenges associated with its development. Nanobiotechnology is an interdisciplinary research that has wide applications in the various fields of biomedical research. The book discusses the various facets of the application of Nanotechnology in drug delivery, clinical diagnostics, Nanomedicine and treatment of infectious and chronic diseases. The book also highlights the recent advancements on important devices and applications that are based on Nanotechnology in medicine and brief the regulatory and ethical issues related to nanomedical devices. It also reviews the toxicological profile of various nanomaterials and emphasizes the need for safe nanomaterials for clinical use. Finally, the book discusses the recent developments of potential commercial applications of Nanotechnology.
The political declaration of the first United Nations (UN) high-level meeting on tuberculosis (TB) calls countries to diagnose and treat 40 million people with TB globally between 2018 and 2022. Traditionally, in most countries, TB diagnosis has been performed using sputum-smear microscopy, a method developed more than 100 years ago, with suboptimal sensitivity. In recent years new technologies have emerged based on the detection of mycobacterial DNA or mycobacterial antigens. Over the past decade the World Health Organization (WHO) has published a number of guidelines developed by WHO-convened Guideline Development Groups (GDGs), using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to summarize the evidence and to formulate policy recommendations and accompanying remarks. The present document "WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection" consolidates five guidelines developed by WHO between 2016 and 2020. Earlier guidelines on diagnostics that were not developed according to the GRADE approach have not been included in this document. The WHO Consolidated Guidelines on Tuberculosis will group all TB recommendations in one document and will be complemented by matching modules of an operational handbook. The handbook will provide practical advice on how to put in place the recommendations at the scale needed to achieve national and global impact. A range of new diagnostic technologies have been endorsed by WHO during the past decade. These are listed below: - real-time polymerase chain reaction (PCR) assays - for example, Xpert MTB/RIF(r) (Ultra) (cartridge-based) and TruenatTM (chip-based);- line probe assays (LPAs) - for example, GenoType(r) MTBDRplus v1 and v2, GenoscholarTM NTM+MDRTB II and GenoType(r) MTBDRsl;- loop-mediated isothermal amplification (LAMP) - for example, TB-LAMP; and- antigen detection in a lateral flow format (biomarker-based detection) - for example, Alere DetermineTM TB LAM Ag. The present "WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection" provides background, justification and recommendations on these technologies. The document includes new recommendations on molecular assays intended as initial tests for the diagnosis of pulmonary and extrapulmonary TB and rifampicin resistance in adults and children.
This textbook covers the full spectrum of tuberculosis-related topics in a comprehensive yet easy-to-follow, readily accessible format. Filling a significant gap in tuberculosis literature, it addresses tuberculosis sensu latu, mirroring the content of the London Queen Mary University tuberculosis Diploma. Covering all aspects related to this condition, from prevention, diagnosis and treatment to public and global health, the book provides a broad overview of tuberculosis management. Further, it includes a wealth of case studies and exercises, making it an essential guide for all staff involved in tuberculosis management. Written by an international and interdisciplinary panel of experts, the book appeals to a broad readership including students, postdoctoral fellows, clinicians, researchers, and nurses, as well as public health officers working in tuberculosis control programs.
