Consolidated Guidelines
Acknowledgements
The recommendations and the text of the WHO consolidated guidelines on tuberculosis. Module 1: Prevention – tuberculosis preventive treatment, second edition are the result of collaboration among professionals in various specialties with extensive expertise and experience in public health policy, tuberculosis (TB) programme management and the clinical care of TB patients. The recommendations in these guidelines were developed by successive guideline development groups (GDGs) convened by WHO, the latest of which met in December 2023.
Executive summary
Tuberculosis infection (TBI) is defined as a state of persistent immune response to stimulation by M. tuberculosis antigens with no evidence of clinically manifest TB disease. It is estimated that about one fourth of the world’s population has been infected with TB. TB preventive treatment (TPT) is one of the key interventions recommended by WHO to achieve the End TB Strategy targets, as upheld by the United Nations High-level Meeting on TB in September 2023.
Abbreviations and acronyms
AlereLAM
Alere Determine™ TB LAM Ag
BD
Becton Dickinson
cfu
colony forming units
CI
confidence interval
CRS
References
- Resolution 73/3: Political declaration of the high-level meeting of the General Assembly on the fight against tuberculosis. New York: United Nations General Assembly; 2018 (https://www.who.int/publications/m/item/political-declaration-of-the-un-general-assembly-high-level-meeting-on-the-fight-against-tuberculosis).
- Resolution 78/L.4.
Truenat MTB, MTB Plus and MTB-RIF Dx assays
New molecular assays – the Truenat MTB, MTB Plus and MTB-RIF Dx assays (Molbio Diagnostics, Goa, India), hereafter referred to as Truenat – were developed in India, and may be used at the same health system level as Xpert MTB/RIF. Of the above-mentioned assays, MTB and MTB Plus are used as initial diagnostic tests for TB, whereas MTB-RIF Dx is used as a reflex test to detect rifampicin resistance for those with positive results on the initial Truenat tests.
Xpert MTB/RIF and Xpert MTB/RIF Ultra assays
The development of the Xpert MTB/RIF assay (Cepheid, Sunnyvale, United States of America [USA]) was a significant step forward for improving the diagnosis of TB and the detection of rifampicin resistance globally. However, Xpert MTB/RIF sensitivity is suboptimal, particularly in smear-negative and HIV-associated TB patients. The Xpert MTB/RIF Ultra (Cepheid, Sunnyvale, USA), hereafter referred to as Xpert Ultra, was developed by Cepheid as the next-generation assay to overcome these limitations. It uses the same GeneXpert® platform as the Xpert MTB/RIF.
1.1 Background
The political declaration at the first United Nations (UN) high-level meeting on tuberculosis (TB) held on 26 September 2018 included commitments by Member States to four new global targets (1), which were subsequently renewed at the second UN high-level meeting on TB on 22 September 2023 (2). One of these targets is that at least 90 per cent of the estimated number of people who develop TB are reached with quality-assured diagnosis and treatment in the 5-year period 2023–2027 (2).
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