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Joint TDR/EC Expert Consultation on Biomarkers in Tuberculosis Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by UNICEF/UNDP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by UNICEF/UNDP/World Bank/WHO Joint TDR/EC expert consultation on biomarkers in tuberculosis Report of the joint TDR/EC expert consultation to evaluate the potential roles of biomarkers in the management of HIV-infected and HIV-uninfected patients with tuberculosis Geneva, Switzerland, 2–3 July 2008 Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by UNICEF/UNDP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by UNICEF/UNDP/World Bank/WHO Joint TDR/EC expert consultation on biomarkers in tuberculosis Report of the joint TDR/EC expert consultation to evaluate the potential roles of biomarkers in the management of HIV-infected and HIV-uninfected patients with tuberculosis Geneva, Switzerland, 2–3 July 2008 Authors: Professor Alimuddin Zumla, Dr Robert Wallis, Professor Mark Doherty, Professor Nigel Klein, Dr Shreemanta Parida, Dr Ole Olesen, Dr Hannu Lång, Dr Mahnaz Vahedi and Dr Philip Onyebujoh Final Biomarker report.indd 1 09.04.09 12:57 WHO Library Cataloguing-in-Publication Data Joint TDR/EC expert consultation on biomarkers in tuberculosis: report of the joint TDR/EC expert consultation to evaluate the potential roles of biomarkers in the management of HIV-infected and HIV-uninfected patients with tuberculosis, Geneva, Switzerland, 2–3 July 2008 / Alimuddin Zumla … [et al]. 1.Tuberculosis, Multidrug-resistant - drug therapy. 2.Extensively drug-resistant tuberculosis - drug therapy. 3.Biological markers - analysis. 4.Tuberculosis vaccines - immunology. 5.HIV infections - complications. I.Zumla, Alimuddin. II.Wallis, Robert. III.Klein, Nigel. IV.Olesen, Ole. V.Lång, Hannu. VI.Vahedi, Mahnaz. VII.Onyebujoh, Philip. VIII.UNICEF/UNDP/ World Bank/WHO Special Programme for Research and Training in Tropical Diseases. ISBN 978 92 4 159794 4 (NLM classification: WF 200) Copyright © World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2009 All rights reserved. The use of content from this health information product for all non-commercial education, training and information purposes is encouraged, including translation, quotation and reproduction, in any medium, but the content must not be changed and full acknowledgement of the source must be clearly stated. A copy of any resulting product with such content should be sent to TDR, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland. TDR is a World Health Organization (WHO) executed UNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases. This information product is not for sale. The use of any information or content whatsoever from it for publicity or advertising, or for any commercial or income-generating purpose, is strictly prohibited. No elements of this information product, in part or in whole, may be used to promote any specific individual, entity or product, in any manner whatsoever. The designations employed and the presentation of material in this health information product, including maps and other illustrative materials, do not imply the expression of any opinion whatsoever on the part of WHO, including TDR, the authors or any parties cooperating in the production, concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delineation of frontiers and borders. Mention or depiction of any specific product or commercial enterprise does not imply endorsement or recommendation by WHO, including TDR, the authors or any parties cooperating in the production, in preference to others of a similar nature not mentioned or depicted. The views expressed in this health information product are those of the authors and do not necessarily reflect those of WHO, including TDR. WHO, including TDR, and the authors of this health information product make no warranties or representations regarding the content, presentation, appearance, completeness or accuracy in any medium and shall not be held liable for any damages whatsoever as a result of its use or application. WHO, including TDR, reserves the right to make updates and changes without notice and accepts no liability for any errors or omissions in this regard. Any alteration to the original content brought about by display or access through different media is not the responsibility of WHO, including TDR, or the authors. WHO, including TDR, and the authors accept no responsibility whatsoever for any inaccurate advice or information that is provided by sources reached via linkages or references to this health information product. Graphic design: Lisa Schwarb Cover picture: WHO/TDR/Crump Printed by the WHO Document Production Services, Geneva, Switzerland Final Biomarker report.indd 2 09.04.09 12:57 CONTENTS Abbreviations ................................................................................................................................................................... 7 Executive summary ........................................................................................................................................................ 9 1. Introduction .........................................................................................................................................................10 • Not to be reproduced or quoted 2. Ideal characteristics of markers and surrogate end-points ......................................................................11 3. The TB and HIV pandemics: coinfection issues ...........................................................................................13 4. Clinical needs for markers ...............................................................................................................................13 4.1. Biomarkers of extent of disease ..................................................................................................................13 4.2. Biomarkers of treatment effect ...................................................................................................................14 4.3. Biomarkers of treatment outcome ...............................................................................................................14 4.4. Approaches to studying biomarkers ............................................................................................................15 5. Candidate microbiological markers ...............................................................................................................18 5.1. The basis and plausibility of bacteriological biomarkers ...........................................................................18 5.2. Mycobacterial load ......................................................................................................................................19 5.2.1. Quantitative sputum microbiological studies ....................................................................................21 5.3. Mycobacterial antigens: antigen 85 and antigen 85B ................................................................................21 5.4. Mycobacterial markers in urine ...................................................................................................................22 5.4.1. Trans-renal mycobacterial DNA .........................................................................................................21 5.4.2. Urine mycobacterial LAM ..................................................................................................................22 Joint TDR/EC expert consultation on biomarkers in tuberculosis 5.5. Volatile mycobacterial markers in breath ....................................................................................................22 3 6. Candidate host markers ....................................................................................................................................23 6.1. Interferon-gamma release assays (IGRAs) ..................................................................................................23 6.2. Antibodies to mycobacterial enzymes and 38 kDa antigen ........................................................................23 6.3. Host nonspecific immune parameters as biomarkers for treatment response ...........................................24 6.4. Soluble intercellular adhesion molecule type 1 (sICAM-1) .........................................................................24 6.5. Other nonspecific immune parameters as predictors of treatment outcome .............................................24 6.5.1. Neopterin ...........................................................................................................................................24 6.5.2. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) .................................................25 6.5.3. Soluble urokinase plasminogen activator receptor (suPAR) ..............................................................25 6.6. Host proteins ................................................................................................................................................25 6.7. IL-4/IL-4δ2 ratio ...........................................................................................................................................25 6.8. Whole blood
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