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- - TB DIAGNOSTICS

Wednesday, 10th of April 2013

• TB DIAGNOSTICS

 

The Lancet Infectious Diseases, Volume 13, Issue 4, Pages 349 - 361, April 2013

 

Published Online: 24 March 2013

Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test

Stephen D Lawn FRCP a b, Peter Mwaba FRCP c d, Matthew Bates PhD c e, Amy Piatek MS g, Heather Alexander PhD h, Prof Ben J Marais FCPaed i, Prof Luis E Cuevas MD j, Prof Timothy D McHugh PhD e, ProfLynn Zijenah PhD k, Nathan Kapata MMed c d, Prof Ibrahim Abubakar FRCP f l, Ruth McNerney PhD a, ProfMichael Hoelscher FRCP m, Prof Ziad A Memish FRCP n o, Prof Giovanni Battista Migliori FRCP p, Peter KimMD q, Prof Markus Maeurer FRCP r, Marco Schito PhD s, Prof Alimuddin Zumla FRCP c e

Summary below; full text is at

http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2813%2970008-2/fulltext

Rapid progress has been made in the development of new diagnostic assays for tuberculosis in recent years. New technologies have been developed and assessed, and are now being implemented. The Xpert MTB/RIF assay, which enables simultaneous detection of Mycobacterium tuberculosis (MTB) and rifampicin (RIF) resistance, was endorsed by WHO in December, 2010. This assay was specifically recommended for use as the initial diagnostic test for suspected drug-resistant or HIV-associated pulmonary tuberculosis. By June, 2012, two-thirds of countries with a high tuberculosis burden and half of countries with a high multidrug-resistant tuberculosis burden had incorporated the assay into their national tuberculosis programme guidelines. Although the development of the Xpert MTB/RIF assay is undoubtedly a landmark event, clinical and programmatic effects and cost-effectiveness remain to be defined. We review the rapidly growing body of scientific literature and discuss the advantages and challenges of using the Xpert MTB/RIF assay in areas where tuberculosis is endemic. We also review other prospects within the developmental pipeline. A rapid, accurate point-of-care diagnostic test that is affordable and can be readily implemented is urgently needed. Investment in the tuberculosis diagnostics pipeline should remain a major priority for funders and researchers.

a Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK

b Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa

c University of Zambia-University College London Medical School (UNZA-UCLMS) Research and Training Project, University Teaching Hospital, Lusaka, Zambia

d Ministry of Health, Lusaka, Zambia

e Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, London, UK

f Centre for Infectious Disease Epidemiology, Department of Infection and Population Health, University College London, London, UK

g US Agency for International Development, Bureau of Global Health, Office of Health, Infectious Disease and Nutrition, Washington, DC, USA

h Division of Global HIV/AIDS, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA

i Sydney Emerging Infections and Biosecurity Institute, and The Children's Hospital at Westmead, Sydney Medical School, University of Sydney, Sydney, NSW, Australia

j Department of Clinical Science, Liverpool School of Tropical Medicine, Liverpool, UK

k University of Zimbabwe College of Health Sciences, Harare, Zimbabwe

l Health Protection Agency, London, UK

m Department for Infectious Diseases and Tropical Medicine, Klinikum of the University of Munich, Munich, Germany

n Ministry of Health, Riyadh, Saudi Arabia

o College of Medicine, Alfaisal University, Riyadh, Saudi Arabia

p WHO Collaborating Centre for TB and Lung Diseases, Fondazione S Maugeri, Care and Research Institute, Tradate, Italy

q Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA

r Division of Therapeutic Immunology, LabMed, and Microbiology, Tumor and Cell Biology, Karolinska Institute and Center for Allogeneic Stem Cell Transplantation, Karolinska Hospital, Stockholm, Sweden

s Henry M Jackson Foundation-Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA

Correspondence to: Prof Alimuddin Zumla, Centre for Clinical Microbiology, Division of Infection and Immunity, University College London Royal Free Campus, Royal Free Hospital, London NW3 2PF, UK