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Guideline Development Group (GDG) meeting to review the evidence of accuracy of Loop-mediated Isothermal Amplification (TB-LAMP) as a replacement test for sputum smear microscopy The diagnostic method under consideration involves Loop-mediated Isothermal Amplification (TB- LAMP), a unique temperature-independent way of DNA amplification, and is facilitated by a visual optic readout in an instrument that is robust and can be used at the peripheral health centre level. LAMP was chosen because it only requires a heating block and no sophisticated temperature control device, and because it has an endpoint that is detectable by naked eye. The method has been developed by the manufacturer Eiken Chemical Co., Ltd, in partnership with the Foundation for Innovative and New Diagnostics (FIND). The TB-LAMP technology was initially evaluated by WHO in May 2013. The assay has potential as a rapid TB diagnostic tool, but the body of evidence presented on the TB-LAMP assay was insufficient during that evaluation to make a recommendation either in favour of, or against the use of TB-LAMP as a replacement test for sputum smear microscopy. Objectives 1. To assess the available data on the accuracy (sensitivity and specificity) of TB-LAMP for diagnosis of active TB adults and children, as a replacement or add-on test; 2. To assess the available data on the accuracy (sensitivity and specificity) of TB-LAMP for screening (triage test) for active TB adults and children; 3. To determine the positioning of the LAMP assay in TB screening and diagnostic algorithms; 4. To conduct an economic analysis of the affordability, cost, and cost-effectiveness of TB-LAMP implementation for TB diagnosis or screening compared with sputum microscopy or Xpert MTB/RIF; 5. To outline potential issues to be addressed in WHO policy recommendations on the use of the TB-LAMP assay. List of Participants The Steering Group 1. Dr Chris Gilpin, Scientist, GTB/LDR 2. Dr Alexei Korobitsyn, Technical Officer, GTB/LDR 3. Dr Karin Weyer, Coordinator, GTB/LDR 4. Dr Fuad Mirzaev, Medical Officer, GTB/LDR 5. Mr Wayne van Gemert, Technical Officer, GTB/LDR The Guidelines Development Group (GDG) 1. Dr Jan Brozek, Faculty of Health Sciences, McMaster University, Health Sciences Centre, Canada (speciality: guideline methodologist)

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Page 1: Guideline Development Group (GDG) meeting to review the ... · replacement test for sputum smear microscopy The diagnostic method under consideration involves Loop-mediated Isothermal

Guideline Development Group (GDG) meeting to review the evidence of accuracy of Loop-mediated Isothermal Amplification (TB-LAMP) as a

replacement test for sputum smear microscopy

The diagnostic method under consideration involves Loop-mediated Isothermal Amplification (TB-

LAMP), a unique temperature-independent way of DNA amplification, and is facilitated by a visual

optic readout in an instrument that is robust and can be used at the peripheral health centre level.

LAMP was chosen because it only requires a heating block and no sophisticated temperature control

device, and because it has an endpoint that is detectable by naked eye. The method has been

developed by the manufacturer Eiken Chemical Co., Ltd, in partnership with the Foundation for

Innovative and New Diagnostics (FIND). The TB-LAMP technology was initially evaluated by WHO in May 2013. The assay has potential as a rapid TB diagnostic tool, but the body of evidence presented on the TB-LAMP assay was insufficient during that evaluation to make a recommendation either in favour of, or against the use of TB-LAMP as a replacement test for sputum smear microscopy.

Objectives 1. To assess the available data on the accuracy (sensitivity and specificity) of TB-LAMP

for diagnosis of active TB adults and children, as a replacement or add-on test; 2. To assess the available data on the accuracy (sensitivity and specificity) of TB-LAMP

for screening (triage test) for active TB adults and children; 3. To determine the positioning of the LAMP assay in TB screening and diagnostic

algorithms; 4. To conduct an economic analysis of the affordability, cost, and cost-effectiveness of

TB-LAMP implementation for TB diagnosis or screening compared with sputum microscopy or Xpert MTB/RIF;

5. To outline potential issues to be addressed in WHO policy recommendations on the use of the TB-LAMP assay.

List of Participants

The Steering Group

1. Dr Chris Gilpin, Scientist, GTB/LDR 2. Dr Alexei Korobitsyn, Technical Officer, GTB/LDR 3. Dr Karin Weyer, Coordinator, GTB/LDR 4. Dr Fuad Mirzaev, Medical Officer, GTB/LDR 5. Mr Wayne van Gemert, Technical Officer, GTB/LDR

The Guidelines Development Group (GDG)

1. Dr Jan Brozek, Faculty of Health Sciences, McMaster University, Health Sciences Centre, Canada (speciality: guideline methodologist)

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2. Dr Jeremiah Muhwa Chakaya, Kenya, Kenya Medical Research Institute (speciality: former TB programme manager and former chair of the WHO Strategic and Technical Advisory Group for TB)

3. Dr Gavin Churchyard, Chief Executive Officer, Aurum Institute for Health Research, South Africa (speciality: TB/HIV specialist)

4. Dr Daniela Cirillo, Italy, San Raffaele Scientific Institute (SRL) (speciality: TB laboratory specialist)

5. Prof Francis Drobniewski, Director, Health Protection Agency, HPA Mycobacterium Reference Unit, Clinical TB and HIV Group, Centre for Infectious Disease, Barts and The London School of Medicine and Dentistry (speciality: TB laboratory specialist)

6. Prof Moses Joloba, National TB Reference Laboratory, Kampala, Uganda (speciality: TB laboratory specialist)

7. Prof Satoshi Mitarai, Deputy Head of the Department and Bacteriology Division Chief, Center director of Mycobacterium Collection Library, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association (speciality: TB laboratory specialist)

8. Dr Beatrice Mutayoba, National TB Programme, (speciality: National TB Programme Manager) Tanzania

9. Dr Thomas Shinnick, Associate Director for Global Laboratory Activities, Mycobacteriology Laboratory Branch, Division of Tuberculosis Elimination, Centers for Disease Control and Prevention (speciality: TB laboratory specialist)

10. Dr Wendy Stevens, South Africa, National Health Laboratory Service (NHLS) (speciality: TB/HIV specialist)

11. Dr Francis Varraine, Médecins sans Frontières, Paris, France (speciality: TB clinician) 12. Dr Anna Vassall, London School of Hygiene and Tropical Medicine (speciality: health

economist) 13. Ms Ingrid Oxley Oxland, HIV & AIDS Research Unit, South Africa (speciality: patient

representative) 14. Dr Thato Mosidi, South Africa (speciality: patient representative) 15. Dr Paul Klatser, KIT Biomedical Research, Amsterdam, Netherlands (speciality: TB

laboratory specialist) 16. Dr Karen Steingart, Cochrane Infectious Diseases Group, Liverpool School of Tropical

Medicine, Liverpool, UK (speciality: systematic reviewer) 17. Dr Yasuhiro Yasutomi, Director, Tsukuba Primate Research Centre, National Institute

of Biomedical Innovation, Japan (speciality: Molecular and cellular immunologist) 18. Dr Arata Kochi, Former Director WHO Tuberculosis Programme (speciality: Public

Health)

The Systematic Review Team

1. Dr Voahangy Rasolofo Razanamparany PhD Institute Pasteur de Madagaskar Antananarivo, Madagaskar (speciality: systematic reviewer)

2. Dr Hojoon Sohn, McGill University, Montreal, Canada (speciality: economic analysis reviewer)

3. Dr Pamela Nabeta, FIND (speciality: coordinator of demonstrational studies)

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Biosketches

The Guidelines Development Group (GDG)

1. Jan L. Brozek, M.D., Ph.D.

Affiliation McMaster University

Address 1200 Main St West, L8S 4K1

Hamilton, Onario, Canada

Mail: [email protected]

Dr. Brożek is a faculty in the Department of Clinical Epidemiology and Biostatistics and in the Division

of Clinical Immunology and Allergy, Department of Medicine at McMaster University in Hamilton,

Ontario, Canada. Jan is an active member of the GRADE working group the aim of which is to create

a sensible, systematic, and transparent approach to the development of clinical practice guidelines

and grading quality of evidence and strength of recommendations. He is a member of the Cochrane

Collaboration’s Applicability and Recommendations Methods Group. He is a methodologist for the

American Thoracic Society where he has been involved in the development of multiple clinical

practice guidelines. He has also developed guidelines with World Allergy Organisation, Saudi

Ministry of Health, and has advised various other organizations on guideline development. His

current academic interests focus on systematic reviews of therapeutic and diagnostic interventions

particularly in allergy, improving presentation of evidence syntheses to patients, clinicians and

health care decision makers, and the development and adaptation of clinical practice guidelines.

2. Dr Jeremiah Muhwa Chakaya

Affiliation Centre for Respiratory Diseases Research, Kenya Medical Research Institute

Address P.O. Box 19692-00202, Nairobi, Kenia

Tel : +390226437947

Fax: +390226435183

Mail: [email protected]

Dr Muhwa Chakaya is Chief Research Officer and Consultant Chest Physician at Kenya Medical

Research Institute.

3. Dr Gavin Churchyard MBBCH, FCP (SA), MMED (Int Med), PhD

Affiliation Aurum Institute

Address Aurum House, The Ridge, 29 Queens Road,

Parktown, Johannesburg, 2193

Tel : +27 (0) 10 590 1306

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Fax: +27 (0) 86 613 3718

Mail: [email protected]

Prof Churchyard is a specialist physician and the founder and Chief Executive Officer of The Aurum

Institute NPC, an independent, not for profit, proudly South African, public benefit organization that

focuses on TB and HIV service delivery, technical assistance and research. Prof Churchyard is the

Vice-Chair of the NIH funded AIDS Clinical Trials Group Transformative Science Group for TB, Chair of

the ACTG Host Directed Therapy for TB working group, and an Ex-officio member of the TB

biomarkers working group, Prof Churchyard is the Chair the WHO Task Force for the Development of

New Policies for the Treatment of TB, Chaired the 2013 WHO Post 2015 Research Pillar meeting. Prof

Churchyard was also the Chair of the WHO/TDR Disease Reference Group for TB, Leprosy and Buruli

Ulcer (2009-2013), and was a member of the WHO Strategic Technical Advisory Group for TB (2010-

2014), and was a member of the WHO Working Groups for TB screening and TB/HIV, and a member

of the WHO Stop TB Partnership Research Movement that identified global research priorities for TB.

Prof Churchyard is a co-author of the WHO guidelines for Xpert MTB/Rif, intensified TB case finding

and isoniazid preventive therapy. Prof Churchyard has published research on TB diagnostics,

including MGIT, Capilia, Hain, Xpert MTB/RIF and urine LAM.

4. Dr Daniela Maria Cirillo MD PhD

Affiliation Fondazione Centro San Raffaele

Address Via Olgettina, 60, Milan, Italy

Tel : +390226437947

Fax: +390226435183

Mail: [email protected]

Daniela Maria Cirillo MD, PhD, is a board certified clinical microbiologist, Head of the Emerging

Bacterial Pathogens Unit at the San Raffaele Scientific Institute (HSR) in Milan, Italy since 2002. The

main activities carried out by the Unit are research on new diagnostic for MDR/XDR-TB,

M.tuberculosis pathogenesis, virulence markers and as WHO Tuberculosis SupraNational Reference

Laboratory, providing technical assistance for implementation of new tools for tuberculosis diagnosis,

Quality Assurance Programmes, molecular typing of and first and second line M tuberculosis drug

sensitivity testing. Her laboratory is also a WHO collaborating Centre for Laboratory Strenthening

and tthe Italian reference center for molecular typing of Mycobacteria.

Dr. Cirillo’s particular areas of expertise include clinical bacteriology and infection control, new

diagnostic tools evaluation, molecular typing of Multidrug resistant Organisms, TB Laboratory

strengthening, DRS and operational research protocols development, training packages

development, research on new diagnostics for active and latent TB Infections, nosocomial infection.

She and her collaborators provide technical support to the following Countries: Mozambique,

Burkina Faso, Kosovo, Albania, Bulgaria, Turkey, Nigeria, Ivory Cost, Zanzibar,Turkey, Gibuti and

Macedonia. International appointments: Co-Chair of the New Diagnostic Working Group of the

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StopTB partnership, Core Group elected member of the Global Drug Resistance Initiative (GDI) of the

Stop Tb partnership-WHO, member of Global Laboratory Initiative. Member of the Scientific and

Technical Advisory Board (STAG) 2011-2014 . Member of the Core Group of the ERLN-TB. She was

the coordinator of two FP7 projects approved by the EU aimed at development of new diagnostic

tools and at the development of an European network for study and clinical management of TB drug

resistance. She serves as a peer reviewer for the International Journal of Tuberculosis and Lung

Disease, European Respiratory Journal, Journal of Clinical Microbiology, Emerging Infectious Disease,

Clinical Infectious Diseases.

5. Prof Francis Drobniewski

Affiliation Imperial College London

Address South Kensington Campus, London SW7 2AZ

Tel : +44 (0)20 7589 5111

Mail: [email protected]

Professor Drobniewski is Professor of Global Health and Tuberculosis at Imperial College London. He is also the Director of the WHO Supranational Reference Laboratory.

His clinical work includes roles as a Consultant Medical Microbiologist and Director at the UK Public Health England National Mycobacterium Reference Laboratory and a Consultant Physician in Clinical Tuberculosis

Key research activities have been targeted at understanding the genetic and biochemical

mechanisms of drug resistance, in order to be developed into practical diagnostic tests, evaluated in

multicenter trials and implemented into NHS and clinical practice. These have involved utilising

multiple approaches including social and behavioural to address clinical problems and achieve

desired goals.

6. Prof Moses Joloba

Affiliation National TB Reference Laboratory

Address Kampala, Uganda

Mail: [email protected]

Prof. Moses Joloba is the current Chair of the Department of Medical Microbiology, Makerere

University College of Health Sciences. Dr Joloba completed his MbChB at Makerere University

Medical School, Kampala, Uganda, in 1994, did his Master of Science in Microbiology in 1996

and PhD in Molecular Microbiology 2003 at Case Western Reserve University, Cleveland,Ohio,

USA, In 2001, he joined Makerere University College of Health Sciences as a faculty member,

and in 2003 he established the Molecular Biology laboratory in the Department of Medical

Microbiology. He is the current Head of CTRL in Kampala, which is designated as WHO SRL.

7. Prof Satoshi Mitarai

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Affiliation Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association (JATA)

Address 3-1-24 Matsuyama, Kiyose, Tokyo 204-8533, Japan

Tel: +81-42-493-5762

Fax: +81-42-492-4600

Mail: [email protected]

Prof. Satoshi Mitarai is the head of microbiology laboratory in the Research Institute of Tuberculosis,

which is working as the national reference laboratory of Japan and the Supra-national Reference

Laboratory in the WHO Western Pacific Region. He has provided many technical supports to the

countries over ten years. He has over twenty years of research experiences in the development and

evaluation of new diagnostics in Japan, Asian and African countries. He is currently working as the

professor of mycobacteriology in the graduate school of biomedical science in Nagasaki University.

8. Dr Beatrice Mutayoba MD, MPhil

Affiliation National Tuberculosis and Leprosy Program, Ministry of Health and Social Welfare

Address 6 Samora Machel Avenue, 11478, Dar es Salaam, TanzaniaGeneva,

Tel : +255 22 21..500

Fax: +255 22 21..500

Mail: [email protected]

Dr. Beatrice Mutayoba has over ten years experience as a Public Health Specialist and Research

Scientist leading operational research and clinical trials in the area of Tuberculosis in Tanzania.

Beatrice completed studies in Norway for his Master of Philosophy in Epidemiology of tuberculosis

and was formerly Head of the TB Epidemiology Unit at the National Institute for Medical Research,

Muhimbili Medical Research Centre. She is now the Program Manager for the Tuberculosis and

Leprosy program in Tanzania. Beatrice is currently leading the development of Xpert/Rif roll out plan

in Tanzania with support from FIND and other partners. She was recently appointed to be a member

of the World Health Organization Strategic and Technical Advisory Group for Tuberculosis (WHO

STAG - TB).

9. Thomas M. Shinnick, PhD

Affiliation U.S. Centers for Disease Control and Prevention

Address 1600 Clifton Road, Atlanta GA USA

Tel : +14046391474

Fax: +14046391287

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Mail: [email protected]

I have been working on the laboratory aspects of the diagnosis, treatment, and control of TB for

more than 25 years. My career has included directing research in academic and public health

settings (author/co-author of more than 175 publications) and managing the Mycobacteriology

Laboratory Branch of CDC which included the TB Reference Laboratory, research activities, support

for clinical and epidemiologic studies, and setting of public health policy for TB laboratories. Most

recently, as the Associate Director of DTBE for Global Laboratory Activities, I have been responsible

for leading the Division’s efforts in improving TB laboratory capacities and for directing laboratory

research in international settings. Also, I serve in leadership roles on international committees that

address laboratory needs for TB control in resource-limited settings including the Global Laboratory

Initiative (GLI) of the Stop TB Partnership (chair); Bacteriology and Immunology sub-section of the

International Union Against TB and Lung Diseases (The Union); Advisory Board for the TB CARE

Program; Board of Directors of the African Society for Laboratory Medicine; and Project Steering

Committee of the UNITAID-funded EXPAND-TB Program.

With respect to the laboratory detection of TB, I served on numerous WHO Expert Groups that

evaluated diagnostics and helped develop recommendations for their use; co-led efforts to provide

guidance to USG-supported programs for the programmatic implementation of the Xpert MTB/RIF

assay; developed and implemented national strategic plans to implement the Xpert MTB/RIF test

MDR TB; and conducted operational research to evaluate the impact of the test on laboratory

performance and on MDR TB detection, treatment, and control.

10. Dr Professor Wendy Stevens MBBcH (MD); FCPath (Haem); MMed(Haem)

Affiliation Head: Department of Molecular Medicine and Haematology, University of the

Witwatersrand, Priority Programs for the National Health Laboratory Service (NHLS)

Address Wits Medical School, Faculty of Health Sciences, 7 York Road, Parktown

Tel: +2711 489-8505

Fax: +2711 484-5812

Mail: [email protected]

Professor Stevens is currently Professor and Head of the Department of Molecular Medicine and

Haematology at the University of the Witwatersrand and the National Health laboratory Service

(NHLS) the largest haematology department in South Africa. Her research efforts have been largely

focussed in HIV for the past 15 years and this can be supported by over 200 peer reviewed

publications and as many conference presentations. She has contributed significantly to the

development of capacity for affordable, accessible HIV diagnosis and monitoring in South Africa and

over 60 centres in sub-Saharan Africa. Research activities have included the expansion of early infant

diagnosis of HIV, affordable viral load, CD4 and investigation of HIV drug resistance.In 2006, she

received an award from the National department of Science and Technology for her contribution to

the development of laboratory capacity in Southern Africa. In 2013, She won the NHLS awards for

innovation, service excellence and the Best NHLS laboratory. She has been an advisor to and

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investigator for the following HIV research networks: the International AIDS Vaccine Initiative (IAVI)

(New York), the HIV VaccineTrials Network (HVTN)(NIH funded, Seattle), the AIDS Clinical Trials

Group (ACTG)(NIH funded), the Microbicide Development Program (UK based funding), amongst

others.

Other funders of her research include: Netherlands AIDs fund, Bill and Melinda Gates Foundation

(BMGF), Grand Challenges Canada, the Center for Disease Control (CDC) and USAID. She has also

served as a consultant for the World Health Organization (Geneva), CDC (Atlanta) and NIH

(Bethesda, USA) on a number of different working groups. Since November 2010, she has been

appointed head of National Priority Programs at the National Health Laboratory Service focusing on

laboratory efforts related to HIV, TB and other opportunistic infections. Recently her time has been

spent planning and ensuring the implememtation of the National GeneXpert Program, including all

quality assurance and connectivity solutions. The verification and EQA panels using dried culture

spots has resulted in several national innovation awards and in May 2015, the African Prize for

innovation for the greatest social impact. She has recently worked on expanding these programs to

incorporate vulnerable populations such as the Correctional Services, peri-mining communities and

children. She is also involved in developing the National HIV drug resistance strategy, the National

POCT policy, the National TB thinktank and the anti-microbial resistance strategy working group.

11. Dr Francis Varraine

Affiliation Médecins sans Frontières

Address 8 rue St Sabin, Paris, France

Mail: [email protected]

Current position - International Medical Coordinator, at Médecins sans Frontières.

12. Dr Anna Vassall

Affiliation London school of hygiene and tropical medicine

Address London, UK

Mail: [email protected]

Anna Vassall is a health economist with around twenty years’ experience in economic analysis. Her

first degree is in economics. She then worked in the NHS supporting funding/contracting. She then

took an MSc in Health Planning and Financing at the LSHTM, thereafter working for DFID as a health

economist in the UK and Pakistan. This was followed by a period at Royal Tropical Institute (KIT)

Amsterdam working on health planning and financing, aid effectiveness and the cost-effectiveness of

tuberculosis and reproductive health in a wide range of low and middle income countries. Thereafter

she directed and provided economic support to European Community and World Bank funded

health sector reform and development projects in Yemen, East Timor, Syria and Sudan. Her PhD is in

the economic evaluation of tuberculosis control. She has worked as an academic since 2010 (at

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LSHTM) specialising in research into the economics of HIV and TB, with a particular focus on health

services and systems. She has published over 50 papers; and is a member of the TB modelling and

analysis consortium (TB-MAC).

13. Ms Ingrid Oxley Oxland

Affiliation HIV and AIDS research Unit

Address South Africa

Mail: [email protected]

While working as a dietitian in public hospitals, Ingrid contracted pulmonary tuberculosis in 2011 and finished nine months of treatment. Then in 2012, she was diagnosed with pre- XDR-TB and finished two years of treatment. Ingrid currently works part- time at the Nelson Mandela Metropolitan University as a research assistant and is busy with further studies.

14. Dr Thato Mosidi

Affiliation Patient representative

Address South Africa

Mail: [email protected]

Thato Mosidi is a young South African doctor who was diagnosed with occupational Extensively Drug Resistant Tuberculosis (XDR-TB) in 2013. The long term (60 months) treatment success rate of XDR-TB in South Africa is 11%. After contracting XDR-TB through her work in the public sector, Dr Mosidi enrolled in a clinical access programme allowing some patients to access a new drug, bedaquiline

15. Prof. Paul R. Klatser, PhD

Affiliation: Royal Tropical Institute (KIT)

Address: KIT Biomedical Research, Meibergdreef 39, 1105 AZ Amsterdam, The Netherlands

Tel: +31-205665440

Fax: +31-20-6971841

Mail: [email protected]

Prof. dr. Paul R. Klatser is heading the The Royal Tropical Institute’s (KIT) department KIT Biomedical

Research in Amsterdam, The Netherlands with more than 40 professionals. He has full-devolved

responsibility for the strategy and management of the department including instituting and

overseeing appropriate mechanisms to ensure research excellence, teaching quality, financial

viability, health and safety, and effective staff management. He is member of the Management

Team of KIT. Acquisition is a major task, as 60% of the turn-over of the department comes from

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external grants. He performs consultancy work as an advisor to various international institutes, such

as WHO, and to the EU in various fields of biomedical research development (infectious diseases,

rapid diagnostics). He is on the board of different institutes/foundations. He has experience in

dissemination of knowledge through trainings and workshops. His department distributes a wide

variety of diagnostic materials and services developed by the department to the health care

community including those as WHO/OIE/FAO Leptospirosis. Reference Laboratory. The latter is

accredited according the ISO15189 quality standard.

Paul Klatser has a background in biochemistry/immunology and is currently actively involved in

tuberculosis research and diagnostic product development also together with private companies; he

supervises several PhD students. He blends active research with consultancy, management and

developing business for KIT BR and its clients. He regularly advises multi-lateral organisations such as

WHO on diagnostic issues related to infectious diseases and he is board member of various editorial

committees and organisations, both national and international. He has published over 125 papers in

international peer-reviewed journals and several book chapters. He is Professor in Development and

Evaluation of Diagnostic Tests in Developing Countries at the University of Amsterdam and Professor

Extraordinary in Biomedical Research for Development at the Free University of Amsterdam.

16. Dr Karen Steingart, MD MPH

Affiliation Cochrane Infectious Diseases Group, Liverpool School of Tropical Medicine

Address Pembroke Place, Liverpool, Merseyside L3 5QA, United Kingdom

Tel: +1 646-243-9043

Fax: + 1 775-254-3124

Email: [email protected]

Dr Karen Steingart is an Editor with the Cochrane infectious Diseases Group. She is a public health

physician and methodologist. She is the lead author of two Cochrane diagnostic test accuracy

reviews on the Xpert® MTB/RIF assay (original and update) and co-author of a recently published

Cochrane diagnostic test accuracy review on MTBDRsl. In addition, she has published several non-

Cochrane systematic reviews on the diagnostic accuracy of tuberculosis tests, including fluorescence

microscopy and commercial serological tests. Karen is also an Editor with the Cochrane Diagnostic

Test Accuracy Working Group. She is trained in the Grading of Recommendations Assessment,

Development and Evaluation (GRADE) approach to grading the quality of evidence and strength of

recommendations. She has contributed to several recent World Health Organization policies on

tuberculosis. She serves as Coordinator for the Evidence Synthesis and Policy Subgroup of the Stop

TB Partnership's New Diagnostics Working Group. Karen lives in Portland, Oregon, USA

17. Professor Yasuhiro Yasutomi DVM, PhD

Affiliation National Institutes of Biomedical Innovation, Health and Nutrition JAPAN

Address 1-1 Hachimandai,Tsukuba, Ibaraki 305-0843, JAPAN

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Tel: +81-29-837-2053

Email: [email protected]

Dr. Yasuhiro Yasutomi has over twenty years experience as an Infectious Immunology Scientist

in Japan and US. He was a Research fellow at Harvard Medical School from 1990-1991 and then

Instructor 1992-1996. He was associate professor in Mie University Graduate School of

Medicine from1996-2007. He is Director at Tsukuba Primate Research Center in National

Institute of Biomedical Innovation, Health and Nutrition, and Professor in Mie University

Graduate School of Medicine in July 2007 to present. The Tsukuba Primate Research Center in

Japan plays a significant role in the development of pharmaceutical products and medical

technologies. The center is the facility of forefront in Japan for animal experiment. The center

also evaluates state-of-the-art medical technology, the efficacy of new drugs and safety

assessments using not only monkeys but also other experimental animals. He is rewarded with

grant from Global Health Innovative Technology Fund (GHIT) about development of TB vaccine.

18. Dr Arata Kochi

Affiliation Public Health expert

Address Route de Chermoran 14, Randognue 3975, VS, Switzerland

Email: [email protected]

TB clinician and public health expert, who is the former director of the World Health Organization's

tuberculosis program.

The Systematic Review Team

1. Dr Voahangy Rasolofo Razanamparany PhD

Affiliation Institut Pasteur de Madagascar

Address BP 1274. Ambatofotsikely, 101- Antananarivo, Madagascar

Tel : +261202241272

Fax: +261202241534

Mail: [email protected]

Dr Voahangy Rasolofo has over twenty-five years experience as a Biology Scientist. Voahangy

completed studies in Bordeaux (France) for her doctorate in molecular biology. She is a former

graduate student of the Institut Pasteur in Paris (Mycobacteriology; General Immunology; Human

genetics and Infectious diseases). After post-doctoral studies at Sanofi Elf Biorecherches (Labège,

France), she joined the Institut Pasteur de Madagascar (IPM) and has been involved in the research

programme on mycobacteria at IPM in Antananarivo, Madagascar. Voahangy is currently the Head

of the Mycobacteria Unit (IPM) and is in charge of the tuberculosis research programme, which

includes operational researches and drug resistance surveys in collaboration with the National

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Tuberculosis Control Programme (NTCP) of the Ministry of Health, evaluation of new diagnostic tools

for tuberculosis, studies on multidrug-resistant (MDR) strains, and research on Mycobacterium

tuberculosis genetic diversity and human immune response.

2. Mr. Hojoon Sohn, MPH, Ph(c)

Affiliation McGill University

Address 3650, Rue Saint-Urbain, bureau K3.09, Montreal, QC, H3H 2A1, Canada

Tel : +514-980-0325

Mail: [email protected]

Mr. Hojoon Sohn is a health economist and an epidemiologist by training, and has actively been

involved in nearly all of the TB diagnostic test evaluation, demonstration, cost-effectiveness studies

at FIND since 2007 as a consulting health economist. Hojoon has also worked as a consultant to the

U.S. CDC in Thailand and the Ministry of Public Health of Thailand for the evaluation and

implementation of MGIT (2007) and interned at the WHO in the Laboratory strengthening team of

the department of Communicable Disease and Surveillance (CSR) in Lyon, France (2004). Hojoon

received AB honors in Biochemistry (minor Economics) from Bowdoin College (2004) and MPH in

health policy and management from the University of Michigan at Ann Arbor (2006) and is currently

completing his doctorate in epidemiology at McGill University (expected 2015).

3. Dr Pamela Nabeta

Affiliation FIND

Address Campus Biotech, Building B2, Level 0, 9, Chemin des Mines, 1202 Geneva,

Switzerland

Tel : +41 22 749 29 31

Mail: [email protected]

Dr. Pamela Nabeta joined FIND in February 2008. She is working closely with the Chief Scientific Officer, Mark Perkins, and Senior Medical Officer, Catharina Boehme, to assist in the planning and coordination of evaluation and specimen collection studies for new diagnostic tools for tuberculosis detection.

Before joining FIND, Dr. Nabeta earned her Medical Degree from Universidad Peruana Cayetano Heredia, Lima-Peru. In May 2004, she worked as a Research Associate at the Instituto de Medicina Tropical "Alexander von Humboldt" and in 2006 she was the General Coordinator for tuberculosis projects at the Institute.

Dr. Nabeta has been participating as a co-investigator for the FIND trial site in Peru and collaborating closely with FIND for the evaluation of several new diagnostic tools in the development pipeline.