Clinical standards for the diagnosis, treatment and prevention of TB infection

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Abstract

BACKGROUND:

Tuberculosis (TB) preventive therapy (TPT) decreases the risk of developing TB disease and its associated morbidity and mortality. The aim of these clinical standards is to guide the assessment, management of TB infection (TBI) and implementation of TPT.

METHODS:

A panel of global experts in the field of TB care was identified; 41 participated in a Delphi process. A 5-point Likert scale was used to score the initial standards. After rounds of revision, the document was approved with 100% agreement.

RESULTS:

Eight clinical standards were defined: Standard 1, all individuals belonging to at-risk groups for TB should undergo testing for TBI; Standard 2, all individual candidates for TPT (including caregivers of children) should undergo a counselling/health education session; Standard 3, testing for TBI: timing and test of choice should be optimised; Standard 4, TB disease should be excluded prior to initiation of TPT; Standard 5, all candidates for TPT should undergo a set of baseline examinations; Standard 6, all individuals initiating TPT should receive one of the recommended regimens; Standard 7, all individuals who have started TPT should be monitored; Standard 8, a TBI screening and testing register should be kept to inform the cascade of care.

CONCLUSION:

This is the first consensus-based set of Clinical Standards for TBI. This document guides clinicians, programme managers and public health officers in planning and implementing adequate measures to assess and manage TBI.

Translated abstract

CONTEXTE :

L’objectif de ces normes cliniques est d’orienter l’évaluation et la prise en charge de l’infection tuberculeuse (TBI), ainsi que la mise en place du traitement préventif antituberculeux (TPT). Le TPT réduit le risque de TB active et de morbidité et mortalité associées.

MÉTHODES :

Un panel d’experts internationaux en matière de soins antituberculeux a été identifié ; 41 experts ont participé à un processus Delphi. Une échelle de Likert à 5 points a été utilisée pour noter les normes initiales. Après plusieurs révisions, le document a été approuvé par tous les experts (100%).

RÉSULTATS :

Huit normes cliniques ont été définies : Norme 1, tous les individus des groupes à risque de TB doivent subir un test de dépistage de la TBI ; Norme 2, tous les candidats au TPT doivent prendre part à une consultation de santé informative/éducative (y compris les aidants d’enfants) ; Norme 3, test de dépistage de la TBI : le moment et le test de référence choisi doivent être optimisés; Norme 4, une TB active doit être écartée avant d’instaurer un TPT ; Norme 5, tous les candidats au TPT doivent subir différents examens initiaux ; Norme 6, tous les individus démarrant un TPT doivent recevoir l’un des protocoles recommandés ; Norme 7, tous les individus ayant démarré un TPT doivent subir des examens de contrôle ; Norme 8, un dépistage de la TBI doit être réalisé et un registre des tests doit être tenu pour orienter la cascade de soins.

CONCLUSION :

Il s’agit du premier ensemble de normes cliniques pour la TBI fondées sur un consensus. Notre objectif est d’améliorer les soins et la qualité de vie des patients en orientant les cliniciens, responsables de programme et agents de santé publique en matière de planification et de mise en place de mesures adéquates d’évaluation et de prise en charge de la TBI.

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Most cited references 79

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A prospective blood RNA signature for tuberculosis disease risk

Daniel E. Zak, Adam Penn-Nicholson, Thomas Scriba … (2016)

Background Identification of blood biomarkers that prospectively predict progression of Mycobacterium tuberculosis infection to tuberculosis disease may lead to interventions that impact the epidemic. Methods Healthy, M. tuberculosis infected South African adolescents were followed for 2 years; blood was collected every 6 months. A prospective signature of risk was derived from whole blood RNA-Sequencing data by comparing participants who ultimately developed active tuberculosis disease (progressors) with those who remained healthy (matched controls). After adaptation to multiplex qRT-PCR, the signature was used to predict tuberculosis disease in untouched adolescent samples and in samples from independent cohorts of South African and Gambian adult progressors and controls. The latter participants were household contacts of adults with active pulmonary tuberculosis disease. Findings Of 6,363 adolescents screened, 46 progressors and 107 matched controls were identified. A 16 gene signature of risk was identified. The signature predicted tuberculosis progression with a sensitivity of 66·1% (95% confidence interval, 63·2–68·9) and a specificity of 80·6% (79·2–82·0) in the 12 months preceding tuberculosis diagnosis. The risk signature was validated in an untouched group of adolescents (p=0·018 for RNA-Seq and p=0·0095 for qRT-PCR) and in the independent South African and Gambian cohorts (p values <0·0001 by qRT-PCR) with a sensitivity of 53·7% (42·6–64·3) and a specificity of 82·8% (76·7–86) in 12 months preceding tuberculosis. Interpretation The whole blood tuberculosis risk signature prospectively identified persons at risk of developing active tuberculosis, opening the possibility for targeted intervention to prevent the disease. Funding Bill and Melinda Gates Foundation, the National Institutes of Health, Aeras, the European Union and the South African Medical Research Council (detail at end of text).

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The cascade of care in diagnosis and treatment of latent tuberculosis infection: a systematic review and meta-analysis.

Hannah Alsdurf, Philip C Hill, Alberto Matteelli … (2016)

WHO estimates that a third of the world's population has latent tuberculosis infection and that less than 5% of those infected are diagnosed and treated to prevent tuberculosis. We aimed to systematically review studies that report the steps from initial tuberculosis screening through to treatment for latent tuberculosis infection, which we call the latent tuberculosis cascade of care. We specifically aimed to assess the number of people lost at each stage of the cascade.

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The global prevalence of latent tuberculosis: a systematic review and meta-analysis

Adam Cohen, Victor Dahl Mathiasen, Thomas Schön … (2019)

In 1999, the WHO estimated that one-third of the world's population had latent tuberculosis infection (LTBI) which was recently updated to one-fourth. However, this is still based on controversial assumptions in combination with tuberculin skin test (TST) surveys. Interferon-gamma release assays (IGRAs) with a higher specificity than TST have since been widely implemented, but never used to estimate the global LTBI prevalence. We conducted a systematic review and meta-analysis of LTBI estimates based on both IGRA and TST results published between 2005 and 2018. Regional and global estimates of LTBI prevalence were calculated. Stratification was performed for low, intermediate and high TB incidence countries and a pooled estimate for each area was calculated using a random effects model. Among 3280 studies screened, we included 88 studies from 36 countries with 41 IGRA (n=67 167) and 67 TST estimates (n=284 644). The global prevalence of LTBI was 24.8% (95% CI: 19.7–30.0%) and 21.2% (95% CI: 17.9–24.4%) based on IGRA and a 10 mm TST cut-off respectively. The prevalence estimates correlated well to WHO incidence rates (Rs=0.70, p<0.001). In the first study of the global prevalence of LTBI derived from both IGRA and TST surveys, we found that one-fourth of the world's population is infected. This is of relevance as both tests, although imperfect, are used to identify individuals eligible for preventive therapy. Enhanced efforts are needed targeting the large pool of latently infected as these individuals continuously constitutes an enormous source of potential active TB.

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Author and article information

Journal

Journal ID (nlm-ta): Int J Tuberc Lung Dis

Journal ID (iso-abbrev): Int J Tuberc Lung Dis

Journal ID (publisher-id): jtld

Title: The International Journal of Tuberculosis and Lung Disease

Publisher: International Union Against Tuberculosis and Lung Disease

ISSN (Print): 1027-3719

ISSN (Electronic): 1815-7920

Publication date (Print): March 2022

Publication date (Electronic): 1 March 2022

Volume: 26

Issue: 3

Pages: 190-205

Affiliations

[1 ]Respiratory Diseases Clinical Epidemiology Unit, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy

[2 ]Division of Infectious Diseases, Department of Medicine, National University Hospital, National University Health System, Singapore City

[3 ]Division of Infectious and Tropical Diseases, Spedali Civili University Hospital, Brescia, Italy

[4 ]WHO Collaborating Centre for TB/HIV Collaborative Activities and for TB Elimination Strategy, University of Brescia, Brescia, Italy

[5 ]Centre for Global Public Health, Institute for Population Health Sciences, Queen Mary University, London, UK

[6 ]Translational Research Unit, National Institute for Infectious Diseases “Lazzaro Spallanzani”, IRCCS, Rome, Italy

[7 ]USAID, Bureau for Global Health, TB Division, Washington, DC, USA

[8 ]Directorate General for Disease Surveillance and Control, Ministry of Health, Muscat, Oman

[9 ]Infectious Disease Translational Research Programme, Department of Medicine, National University of Singapore, Yong Loo Lin School of Medicine, Singapore City

[10 ]Department of Infectious Diseases, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile

[11 ]Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique

[12 ]ISGlobal, Barcelona Centre for International Health Research, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain

[13 ]IAME UMR1137, INSERM, University of Paris, F-75018 Paris; AP-HP-Bichat Hospital, Associate laboratory of National Reference Center for Mycobacteria and Antimycobacterial Resistance, Paris, France

[14 ]Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA

[15 ]Tuberculosis Control Unit, Tan Tock Seng Hospital, Singapore, Singapore

[16 ]Helio Fraga Reference Center, Oswaldo Cruz Foundation Ministry of Health, Rio de Janeiro, Brazil

[17 ]Victorian Tuberculosis Program, Melbourne Health, Melbourne, VIC, Australia

[18 ]Department of Infectious Diseases, Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Australia

[19 ]KNCV Tuberculosis Foundation, The Hague, The Netherlands

[20 ]Paediatric Clinic, Pietro Barilla Children’s Hospital, University of Parma, Parma, Italy

[21 ]Mycobacteriology Research Center (MRC), National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran

[22 ]Institute for Infection and Immunity, St George’s, University of London, London, UK

[23 ]Department of Paediatrics, Center for International Child Health, University of Melbourne, Melbourne, VIC, Australia

[24 ]Murdoch Children’s Research Institute, Royal Children’s Hospital, Melbourne, Australia

[25 ]Institute for Global Health, University College London, London, UK

[26 ]International Union Against Tuberculosis and Lung Disease, Paris, France

[27 ]Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK

[28 ]The Global Tuberculosis Program, Texas Children’s Hospital, Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA

[29 ]Academic Tuberculosis Program Center, Faculty of Medicine, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil

[30 ]Operational Center, Medecins Sans Frontieres (MSF), Paris, France

[31 ]Department of Infectious Diseases and Microbiology, The Children’s Hospital at Westmead, Westmead, NSW, Australia

[32 ]The University of Sydney Institute for Infectious Diseases, Sydney, NSW, Australia

[33 ]Montréal Chest Institute, Montréal, QC, Canada

[34 ]Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, Research Institute of McGill University Health Centre, Montréal, QC, Canada

[35 ]McGill International Tuberculosis Centre, Montréal, QC, Canada

[36 ]Infectious Diseases, National Centre for Infectious Diseases, Singapore

[37 ]Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias CIPTIR, University Hospital of Monterrey UANL (Universidad Autonoma de Nuevo Leon), Monterrey, Mexico

[38 ]Faculdade de Medicina, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil

[39 ]Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa

[40 ]Republican Research and Practical Center for Pulmonology and Tuberculosis, Minsk, Belarus

[41 ]Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy

[42 ]Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam

[43 ]Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK

[44 ]Department of Infection, Royal London Hospital, Barts Health NHS Trust, London, UK

[45 ]Blizard Institute, Queen Mary University of London, London, UK

[46 ]National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia

[47 ]TB Competence Center, Swiss Lung Association, Berne, Switzerland

[48 ]Public Health Consulting Group, Lugano, Switzerland

[49 ]National University of Singapore Institute for Health Innovation & Technology (iHealthtech), Singapore, Singapore

Author notes

^* GBM, SJW, AM, DZ, DG, LDA, RC and CWMO contributed equally to this Clinical Standard.

Correspondence to: Catherine W. M. Ong, 10th floor, Tower Block, 1E Kent Ridge Road, Singapore 119228. E-mail: catherine_wm_ong@ 123456nuhs.edu.sg

Article

DOI: 10.5588/ijtld.21.0753

PMC ID: 8886963

PubMed ID: 35197159

SO-VID: 6093e223-0493-4602-8b1f-52d469efa456

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution Licence ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.

History

Date received : 16 December 2021

Date accepted : 17 December 2021

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Pages: 17

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Clinical standards for the diagnosis, treatment and prevention of TB infection

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Abstract

BACKGROUND:

METHODS:

RESULTS:

CONCLUSION:

Translated abstract

Related collections

UCL: UN SDG 03 Good Health and Well-Being

Most cited references 79

A prospective blood RNA signature for tuberculosis disease risk

The cascade of care in diagnosis and treatment of latent tuberculosis infection: a systematic review and meta-analysis.

The global prevalence of latent tuberculosis: a systematic review and meta-analysis

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Cited by 28

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