Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test
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 rifampici...
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| Published in | The Lancet infectious diseases Vol. 13; no. 4; pp. 349 - 361 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London
Elsevier Ltd
01.04.2013
Lancet Publishing Group Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
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| Abstract | 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. |
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| AbstractList | 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. 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.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. 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 ofMycobacterium 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. Summary 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. 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. |
| Author | Abubakar, Ibrahim McNerney, Ruth Kapata, Nathan Cuevas, Luis E Migliori, Giovanni Battista Marais, Ben J Zumla, Alimuddin Hoelscher, Michael Piatek, Amy Kim, Peter Lawn, Stephen D Memish, Ziad A Mwaba, Peter Schito, Marco Zijenah, Lynn Maeurer, Markus Bates, Matthew McHugh, Timothy D Alexander, Heather |
| Author_xml | – sequence: 1 givenname: Stephen D surname: Lawn fullname: Lawn, Stephen D organization: Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK – sequence: 2 givenname: Peter surname: Mwaba fullname: Mwaba, Peter organization: University of Zambia-University College London Medical School (UNZA-UCLMS) Research and Training Project, University Teaching Hospital, Lusaka, Zambia – sequence: 3 givenname: Matthew surname: Bates fullname: Bates, Matthew organization: University of Zambia-University College London Medical School (UNZA-UCLMS) Research and Training Project, University Teaching Hospital, Lusaka, Zambia – sequence: 4 givenname: Amy surname: Piatek fullname: Piatek, Amy organization: US Agency for International Development, Bureau of Global Health, Office of Health, Infectious Disease and Nutrition, Washington, DC, USA – sequence: 5 givenname: Heather surname: Alexander fullname: Alexander, Heather organization: Division of Global HIV/AIDS, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 6 givenname: Ben J surname: Marais fullname: Marais, Ben J organization: Sydney Emerging Infections and Biosecurity Institute, and The Children's Hospital at Westmead, Sydney Medical School, University of Sydney, Sydney, NSW, Australia – sequence: 7 givenname: Luis E surname: Cuevas fullname: Cuevas, Luis E organization: Department of Clinical Science, Liverpool School of Tropical Medicine, Liverpool, UK – sequence: 8 givenname: Timothy D surname: McHugh fullname: McHugh, Timothy D organization: Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, London, UK – sequence: 9 givenname: Lynn surname: Zijenah fullname: Zijenah, Lynn organization: University of Zimbabwe College of Health Sciences, Harare, Zimbabwe – sequence: 10 givenname: Nathan surname: Kapata fullname: Kapata, Nathan organization: University of Zambia-University College London Medical School (UNZA-UCLMS) Research and Training Project, University Teaching Hospital, Lusaka, Zambia – sequence: 11 givenname: Ibrahim surname: Abubakar fullname: Abubakar, Ibrahim organization: Centre for Infectious Disease Epidemiology, Department of Infection and Population Health, University College London, London, UK – sequence: 12 givenname: Ruth surname: McNerney fullname: McNerney, Ruth organization: Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK – sequence: 13 givenname: Michael surname: Hoelscher fullname: Hoelscher, Michael organization: Department for Infectious Diseases and Tropical Medicine, Klinikum of the University of Munich, Munich, Germany – sequence: 14 givenname: Ziad A surname: Memish fullname: Memish, Ziad A organization: Ministry of Health, Riyadh, Saudi Arabia – sequence: 15 givenname: Giovanni Battista surname: Migliori fullname: Migliori, Giovanni Battista organization: WHO Collaborating Centre for TB and Lung Diseases, Fondazione S Maugeri, Care and Research Institute, Tradate, Italy – sequence: 16 givenname: Peter surname: Kim fullname: Kim, Peter organization: Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA – sequence: 17 givenname: Markus surname: Maeurer fullname: Maeurer, Markus organization: Division of Therapeutic Immunology, LabMed, and Microbiology, Tumor and Cell Biology, Karolinska Institute and Center for Allogeneic Stem Cell Transplantation, Karolinska Hospital, Stockholm, Sweden – sequence: 18 givenname: Marco surname: Schito fullname: Schito, Marco organization: Henry M Jackson Foundation-Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA – sequence: 19 givenname: Alimuddin surname: Zumla fullname: Zumla, Alimuddin email: a.zumla@ucl.ac.uk organization: University of Zambia-University College London Medical School (UNZA-UCLMS) Research and Training Project, University Teaching Hospital, Lusaka, Zambia |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27239529$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/23531388$$D View this record in MEDLINE/PubMed http://kipublications.ki.se/Default.aspx?queryparsed=id:126689680$$DView record from Swedish Publication Index |
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| Snippet | Rapid progress has been made in the development of new diagnostic assays for tuberculosis in recent years. New technologies have been developed and assessed,... Summary Rapid progress has been made in the development of new diagnostic assays for tuberculosis in recent years. New technologies have been developed and... |
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| SubjectTerms | AIDS-Related Opportunistic Infections - diagnosis AIDS-Related Opportunistic Infections - microbiology Antibiotics, Antitubercular Bacterial diseases Biological and medical sciences Cost of Illness Cost-Benefit Analysis Drug Resistance, Bacterial Global Health Health Care Costs Human bacterial diseases Human immunodeficiency virus Humans Infectious Disease Infectious diseases Medical sciences Mycobacterium tuberculosis Mycobacterium tuberculosis - drug effects Mycobacterium tuberculosis - genetics Mycobacterium tuberculosis - isolation & purification Nucleic Acid Amplification Techniques Point-of-Care Systems - trends Predictive Value of Tests Rifampin Sputum - microbiology Tuberculosis Tuberculosis and atypical mycobacterial infections Tuberculosis, Multidrug-Resistant - diagnosis Tuberculosis, Multidrug-Resistant - drug therapy Tuberculosis, Multidrug-Resistant - epidemiology Tuberculosis, Multidrug-Resistant - mortality Tuberculosis, Pulmonary - diagnosis Tuberculosis, Pulmonary - epidemiology |
| Title | Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test |
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