First International Conference :: Program Book December 1–3, 2012: Satellite Sessions

Transcript

FIRST INTERNATIONAL CONFERENCE :: PROGRAM BOOK CAPE TOWN INTERNATIONAL CONVENTION CENTRE, CAPE TOWN, SOUTH AFRICA DECEMBER 1–3, 2012: SATELLITE SESSIONS DECEMBER 4–7, 2012: MAIN CONFERENCE ASLM-book-layout9.indd 1 11/20/12 11:06 PM ROUNDTABLE DISCUSSION SCHEDULES WEDNESDAY, DECEMBER 5 TIME ROUNDTABLE DISCUSSIONS ROOM NUMBER 5:30PM–7:00PM 1. M  inisterial and Expert Panel Discussion: ASLM Vision 2020 Moderator: Hon. Aaron Motsoaledi, Minister of Health of South Africa Please find session detail in conference book supplement. Room 1.4 2. R  ole of Laboratory Accreditation in Patient Management: Clinical Pathology Co-conveners: Tim Tucker, Strategic Evaluation Advisory and Development, South Africa and Emmanuel Idigbe, Nigeria Institute Medical Research, Nigeria Auditorium 2 3. A  t the interface of research and surveillance Co-conveners: Oyewale Tomori, Redeemer’s University, Nigeria and Amadou A Sall, Institut Pasteur de Dakar, Senegal Auditorium 1 4. L  aboratory support for control of STIs Co-conveners: David Lewis, National Institute for Communicable Diseases, South Africa and Ron Ballard, Centers for Disease Control and Prevention, USA Room 1.6 5. C  ryptococcossis: Preventing Fungal Disease Co-conveners: Tom Chiller, Centers for Disease Control and Prevention, USA and Nelesh Govender, National Institute for Communicable Diseases, South Africa Room 2.6 THURSDAY, DECEMBER 6 TIME ROUNDTABLE DISCUSSIONS ROOM NUMBER 5:30PM–7:00PM 6. A  pproaches to public-private partnerships Moderator: Maurine Murtagh, The Murtagh Group, USA Please find session detail in conference book supplement. Auditorium 1 7. L  aboratory needs for international health regulations Convener: Arunmozhi Balajee, Centers for Disease Control and Prevention, USA Auditorium 2 8. F  lu Laboratory Network Co-conveners: Jean-Michel Heraud, Institut Pasteur, Madagascar and Julius J. Lutwama, Uganda Virus Research Institute, Uganda Room 1.4 9. E  valuation and regulatory aspects of POC diagnostics Co-conveners: Alex Opio, Ministry of Health, Uganda and Jane Carter, African Medical and Research Foundation, Kenya Room 1.6 10. International collaboration with ASLM to strengthen lab medicine Co-conveners: Tsehaynesh Messele, African Society for Laboratory Medicine, Ethiopia and Vanessa Steenkamp, University of Pretoria, South Africa Room 2.6 108 ASLM-book-layout9.indd 108 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:06 PM ROUNDTABLE DISCUSSION 2 ROLE OF LABORATORY ACCREDITATION IN PATIENT MANAGEMENT: CLINICAL PATHOLOGY At conclusion of this session, the participant will be able to: Date: Wednesday, December 5 Time: 5:30PM–7:00PM Location: Auditorium 2 Co-Conveners: Tim Tucker, Strategic Evaluation, Advising and Development Consulting, South Africa, and Emmanuel Oni Idigbe, Nigerian Institute of Medical Research, Nigeria » Recognize the need for continuous improvement in laboratory testing » Understand the importance of quality laboratory testing for patient care and management Laboratory accreditation programs as a framework for implementation of quality management systems in resource limited settings: Experience from Ghana Speaker 1. Beatrice van der Puije, Samuel Duh, Patrick Njukeng: Prompt and accurate diagnosis is key to patient management, with 60-80% of all diagnostic decisions being based on laboratory results. The consequences of poor laboratory systems to patient care includes increased morbidity and mortality, unreliable surveillance data for public health programs and wastage of resources from over investigation and over treatment of patients. Accreditation of laboratories is to improve laboratory standards that ensure the accuracy and reliability of results. However many accreditation programs are too cost and resource intensive for resource-limited settings. A step-wise approach such as the World Health Organizations (WHO) Afro Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) is a more cost effective and sustainable approach to the implementation of quality management systems. In 2010, the Global Health Systems Solutions (GHSS, along with Ghana Health Services (GHS), started implementing SLIPTA in public hospital laboratories. Programme implementation followed the recommended guidelines of baseline assessments, workshops based on the training tool Strengthening Laboratory Management Towards Accreditation (SLMTA) and improvement projects. Progress of the first cohort of laboratories has been encouraging with an average of score by of 58 % compared to the average at baseline of 41%.The buy in and commitment from upper management of the hospitals, laboratory staff, clinicians and patients played major roles in the success of programme implementation. Mentorship has also been crucial to successful implementation. Improvement in the quality of laboratory services will lead to improved patient management in these hospitals. Human Capacity Development For Laboratory Accreditation In Nigeria Speaker 2. Emmanuel Oni Idigbe: Many laboratories in sub-Saharan Africa including Nigeria, lack the relevant resources and human capacity to implement and sustain quality management systems (QMS), as such, only 348 laboratories were accredited in the sub region in 2010. Consequently, the quality of tests results from most laboratories in these countries remains questionable. In Nigeria, only 2(≈0.04%) laboratories out of 5340 have any form of ISO Certification. Also 23 PEPFAR supported laboratories are currently being strengthened towards accreditation but only 2(8.7%) have achieved the 5-star ranking based on the WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist. As a result, the quality of services of most laboratories in the country is still very poor. This has frequently resulted in significant levels of misdiagnosis and mismanagement of clinical conditions often A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 109 109 11/20/12 11:06 PM ROUNDTABLE DISCUSSION 2 with grave consequences. This called for an urgent need to drastically improve the quality management systems of laboratories in Nigeria. To address this situation, Nigeria embraced the WHO-AFRO Strengthening Laboratory Management Towards Accreditation (SLMTA) program to prepare laboratories to achieve ISO15189 standard. However, successful implementation of the accreditation scheme requires trained personnel who will roll out SLMTA workshops, mentor and monitor laboratory progress towards QMS. Inadequate number of trained personnel to take ownership and sustain the implementation of the SLMTA programme posed a serious challenge. As at July 2012, there were only 7 trained personnel that could conduct SLMTA workshops for laboratorians in the country. Also human capacity for in-country Master trainers was not available. To improve this situation, the Nigerian Institute of Medical Research (NIMR) through a grant support from IANPHI/CDC conducted a SLMTA TOT in August and trained 24 additional personnel and 3 master trainers. This has significantly enhanced available human capacity for SLMTA programmes in Nigeria. Recently, 6 additional non-PEPFAR laboratories have enrolled in the SLMTA programme. Role of Laboratory Accreditation in Patient Management: The Kisumu, Kenya experience Speaker 3. Clement Zeh: Laboratory evidence is the cornerstone of medical treatment and prevention, influencing up to 80% of hospital health care decisions and costs between 3–5% of total health care costs. The quality and level of utilization of laboratory services in many developing countries remain deplorable; however, significant strides have been made towards quality strengthening in these regions. KEMRI/CDC HIV-Research laboratory was the first medical research laboratory in Kenya to achieve ISO 15189 accreditation (2008). With continuous improvement of the quality systems, this laboratory was re-accredited in March 2012. Through the accreditation, this laboratory has witnessed huge reduction in costs and cutting off wastages, easy streamlined management and process control, high quality service delivery and client satisfaction, as well as staff competence and ownership. The accreditation has served as a magnet for collaborations for research and programmatic activities. Collaboration strategies have produced huge cost-saving synergies that have helped the laboratory leverage on its traditional funding sources to sustain its operations, including the accreditation itself. The accreditation has had spill-over effects, the laboratory currently plays vital roles in the country with regards to HIV patient management including supporting the country on drug resistance (DR) testing to inform first and second line failures as well as WHO DR surveys, validation of DBS for viral load testing that is currently being adopted in the rest of the country, providing national and regional inter-laboratory mentorship programs. The laboratory also serves as KMLTTB and ASLM collaborating centre as a training site for capacity building for Laboratory QMS, accreditation and validation of new devices and reagents. 110 ASLM-book-layout9.indd 110 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:06 PM WEDNESDAY, DECEMBER 5 How Quality Improvement was transitioned from the Buea Regional Hospital (BRH) laboratory into the rest of the hospital Speaker 4. Mbome Njie Victor: While need and importance of delivering quality hospital service is easy to discern and agree on in order to meet the Millennium Development Goals for health, doing so presents some challenging management issues. How hospitals in Africa effectively implement continuous quality improvement services is critical. Here with our experience at the Buea Regional Hospital (BRH) in Cameroon. Methods: The BRH with a capacity of 120 beds, sees averagely 30, 000 patients annually. Between May 2010 and June 2012, with technical support from the Centers for Disease Control and Prevention (CDC) and the Global Health Systems Solutions, we successfully implemented SLMTA - Strengthening Laboratory Management Towards Accreditation. SLMTA impact improved the quality of laboratory services, and the establishment of the BRH Quality Improvement Task Force (QUITAF) which organized QI workshops to set the pace for a QI culture. We used a “6S” approach for QUITAF: Specification, Staff, Space, System, Support, Style. We administered 1,000 patient survey questionnaires and laid emphases on “the individual’s responsibility to QI” and the implementation of No-Cost QI projects with clear indicators, from the different units of the hospital. Results: After 3 months of implementing QUITAF, there was improvement in the overall cleanliness of the hospital environment, a faster turnaround time, consistency in laboratory results and better patient management. Patient safety was recognized as an important concern in improving the quality of health care services. Conclusion: The successful implementation of SLMTA in the BRH laboratory led to the implementation of a QI culture to the rest of the hospital through QUITAF. The process is iterative, with more detail needed in some areas. Tim Tucker, Strategic Evaluation Advisory and Development, South Africa Co-Convener: Tim Tucker is a medical doctor, a registered specialist Clinical Virologist, with a PhD in molecular virology. After qualifying as a medical doctor, Tim practiced for some years in general medicine and subsequently at the University of Cape Town specialist liver disease research unit, where he conducted multiple clinical research studies. He then completed a PhD in molecular virology at the University of Cape Town, where he led a laboratory and clinical research team in various aspects of HIV and hepatitis viruses. He is an honorary member of staff in the Clinical Virology Department of the University of Cape Town. Tim was the head of the South African AIDS Vaccine Initiative (SAAVI), a large product development-based consortium. The product development aspects and significant clinical trial capacity created by SAAVI resulted in the consortium becoming a well-respected, global HIV vaccine developer. During this time, Tim acquired many regulatory and product development skills relating to the SA regulatory environment as well as that of the USA and Europe. Tim is also the past deputy chair of the African AIDS Vaccine Program, and has sat on boards and international committees relating to HIV and product development. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 111 111 11/20/12 11:06 PM ROUNDTABLE DISCUSSION 2 Beatrice van der Puije, Global Health Systems Solutions, Ghana Speaker 1: Beatrice van der Puije received her MSc Medical immunology at Kings College, University of London in 2004. She is a laboratory professional with over 8 years experience as a research and clinical laboratory scientist with the National Health Service (NHS) in the UK. Beatrice was born in Accra, Ghana, but has lived and worked for most of her life in the United Kingdom. She gained a BSc in Biomedical Sciences from London Metropolitan University in 2000 and an MSc in Medical Immunology from Kings College University of London in 2004. She worked as a Clinical Scientist specializing in Immunology from 2000- 2006 at Kings College NHS Trust and during this time was involved in research into Autoimmune Hepatitis (AIH) Type 2. In 2006 she moved to Hammersmith and Fulham NHS trust where she worked as a Senior Biomedical scientist from 2006 – 2009. It was during this period, she moved into Laboratory Quality assurance and Health and Safety as a member of the hospitals quality assurance team, responsible for ensuring maintenance of standards for Clinical Pathology Accreditation (CPA). Beatrice moved to Ghana in 2009 and started work as Quality Manager for Medlab Ghana Limited, the then only accredited laboratory in the Country. She joined Global Health Systems Solutions (GHSS) in 2010 as Quality Manager and currently is the Programs Manager overseeing the implementation of accreditation in public sector laboratories in Ghana. Beatrice is also a part-time lecturer at the University of Ghana, Legon on Laboratory organization and management. Emmanuel Oni Idigbe, Nigeria Institute Medical Research, Nigeria Speaker 2/ Co-Convener: Emmanuel Oni Idigbe who is a medical microbiologist by training, joined the Nigerian Institute of Medical Research in 1979 as a Research fellow II after his Ph.D programme at the University of Glasgow. He has had 33 years service at the Nigeria Institute Medical Research during which he rose through the various research appointments and became the Director-General of the Institute in 2000; a position he held until 2008. In the past 37 years of his research and academic career, he served as a lecturer in Medical Microbiology in the University of Glasgow and University of Lagos and was appointed Adjunct Professor at the Northwestern University in Chicago in May 2010. His research interests are in the areas of Tuberculosis, HIV/AIDS, TB/HIV. He has contributed significantly to development of human and infrastructural capacities for health research in Nigeria. Professor Idigbe established the National Reference Laboratory for HIV/AIDs which was ISO certified in 2007. He also established the National Reference Laboratory for Tuberculosis in Nigeria. In the 1990s, he developed and established a database for HIV/AIDS in Nigeria. He further carried out a comparative study on the evaluation of the efficacy of branded versus generic antiretroviral drugs in the clinical management of HIV/AIDS. He is currently the Chairman of the National Committee for Multi-Drug Resistant TB in Nigeria and has established structures for routine surveillance of MDR-TB in the country. Over the years he has supervised several students on their M.Sc and Ph.D programmes. Professor Idigbe currently serves on the Executive Boards of several National and International health based organizations Professor Idigbe has been a recipient of over 20 national and international grants including the IANPHI Grant for laboratory accreditation in Nigeria. He has also received several fellowship grants and awards of excellence. He presently has 112 scientific publications in peer-reviewed journals. 112 ASLM-book-layout9.indd 112 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:06 PM WEDNESDAY, DECEMBER 5 Clement Zeh, Centers for Disease Control and Prevention, Kenya Speaker 3: Clement Zeh is the current Director of the KEMRI/ CDC’s HIVResearch Laboratory in Kisumu, Kenya. Dr. Zeh received his Ph.D. degree from the University of Amsterdam, the Netherlands focusing on the genetic diversity of HIV: implications for diagnosis, therapy and prevention of mother-to-child transmission.. Dr Zeh serves in many key national and international bodies including membership of the World Health Organization (WHO) working group for HIV drug resistance, WHO working group on the development of algorithms for HIV incidence estimation and member of Steering Committee for Africa AIDS Vaccine Partnership among others. Dr. Zeh has authored over 20 articles published in peer-reviewed journals and serves as a guest reviewer for numerous journals including the African Journal of Laboratory Medicine. Dr. Zeh has been instrumental in evaluation of HIV testing strategies, diagnostic and incidence tests. He has more than 12 years of experience in HIV/AIDS and STI research and has been an investigator in several clinical trials and method validations studies Mbome Njie Victor, Regional Delegation of Health, Buea, Cameroon Speaker 4: Victor Mbome is the Regional Delegate of Health in the South West region of Cameroon, vice chair of the Cameroon Baptist Convention Health Board, and a lecturer in the Faculty of Health Sciences of the University of Buea. Previously he served as hospital director in two regional hospitals and an Inspector of services at the central level of Cameroon’s Ministry of Public Health. Dr. Mbome studied Dental Surgery (B.D.S degree) at the College of Medical Sciences in the University of Benin, Benin City Nigeria, Public Health (M.P.H degree) at the University of Leeds in England and Health Systems Management (Diploma) at the Galilee College in Israel Additionally, Dr. Mbome has taken certificate courses in Public Oral Health from the W.H.O Collaborating Centre in Radboud University Holland and Improving the Quality of Health Care from the Harvard School of Public Health. His present passion is for quality improvement in health care service delivery, which is the platform on which he draws inspiration to execute his many leadership responsibilities. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 113 113 11/20/12 11:06 PM ROUNDTABLE DISCUSSION 3 AT THE INTERFACE OF RESEARCH AND SURVEILLANCE Date: Wednesday, December 5 Time: 5:30PM–7:00PM Location: Auditorium 1 At conclusion of this session, the participant will be able to: » Explore how to successfully manage surveillance and research using cost effective diagnostic strategies Co-Conveners: Oyewale Tomori, Redeemer’s University, Nigeria, and Amadou A Sall, Institut Pasteur, Senegal CE Credits: 1.5 CMLE Contact Hours » Discuss viral disease transmission in Central Africa » Recognize the importance of laboratory data on public health control and decision making Strengthening microbiological surveillance and PCR diagnosis of bacterial meningitis in six African countries Speaker 1. Jean-Marc Collard: This capacity building programme aimed to strengthen the epidemiological and microbiological surveillance of bacterial meningitis in six countries among the most affected ones in the African Meningitis Belt. To cope with the recent changes in the epidemiological patterns of meningococcal outbreaks, the implementation of a PCR assay for diagnosis and surveillance of bacterial meningitis was an important milestone for the achievement of effective national prevention and control programmes in Africa. The polymerase chain reaction (PCR) method for the diagnosis of acute bacterial meningitis (diagnosis of Neisseria meningitidis (Nm), Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae) and serogroup prediction for Nm has been transferred from the Institut Pasteur (Paris, France) into six laboratories from sub-Saharan countries. The starting Workshop and training sessions in 2007 had gathered 19 scientists (biologists and epidemiologists). Since then, a second training session was organised at the Pasteur Institute in Paris in December 2010 to consolidate the knowledge of consortium members. Each laboratory had upgraded their protocols to international standards and acquired adequate equipment (thermocyclers) for PCR applications. Two rounds of standardization of protocols and quality assurance were also conducted among laboratories in these six countries with satisfactory results. The six laboratories continued their focus to enhance capacity building in the strengthening of human resources and infrastructure/equipment for meningitis surveillance and molecular epidemiology of circulating strains. Training to develop existing skills and expertise, standardization but also developing and achieving research programmes in the field of meningitis have been the mainstays of this programme. Hepatitis C Virus Infection in Cameroon: How a Medical Laboratory can generate Research Data for Public Health Purposes. Speaker 2. Richard Njouom: Hepatitis C virus (HCV) infection is endemic in Cameroon, particularly among elderly people (> 50 years). The distribution of seroprevalence is heterogeneous according to population studied. An iatrogenic diffusion of HCV in Cameroon around year 1940 has been demonstrated. A very low contribution mother-to-child, sexual and intrafamilial transmissions in the diffusion of HCV have been observed. High genetic diversity of HCV with the circulation of three different genotypes (1, 2, and 4) and more than 10 subtypes have also 114 ASLM-book-layout9.indd 114 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:06 PM WEDNESDAY, DECEMBER 5 been documented. The epidemic history of HCV infection in Cameroon indicated a three-phase model of population growth : 1) a long initial period of relatively constant population size (from MRCA to 1900) suggesting the endemic nature of HCV in Cameroon, with long time presence of types 1 and 4, and more recent introduction of type 2; 2) a short period of exponential growth (from 1920-1940 to 1960) suggesting the existence of an extremely efficient route of transmission at this time in Cameroon; and 3) a slowdown in the rate of spread (from 1960 to 2000) which may reflect a lower transmission rate and confirms the cohort effect of HCV transmission in Cameroon. All these data, which are very useful for public health authorities, were generated by serological and molecular techniques at the laboratory of virology of the Pasteur Centre of Cameroon using samples and epidemiological information collected on the field. This is a good example of how public health laboratory can generate useful data for decision makers. The Importance of Laboratory in Research and Surveillance of Acute Respiratory Infections in Madagascar Speaker 3. Norosoa Razanajatova: The National Influenza Centre (NIC) in Madagascar is involved in the influenza surveillance since 1972. Its main objectives are to (i) monitor the circulation of influenza viruses in Madagascar, (ii) share viruses with WHO, (iii) build capacities to implement acute respiratory infections surveillance and (iv) estimate burden of disease. During recent pandemic, the NIC Madagascar was able to early detect and monitor the outbreak through its laboratory capacities and sentinel surveillance network. As part of the preparedness of the country for the next pandemic flu and other respiratory viruses, NIC developed molecular tools that enable the detection of 14 respiratory viruses (including influenza). We also implemented ILI and SARI surveillance in the country allowing us to better characterize and estimate prevalence of viral etiological agents among ILI and SARI cases and identify factors linked to severity as well as estimate burden of disease. At the international level, multicentre research project was established to study circulation of influenza strains isolated in some Sub-Saharan African countries and in Madagascar. In conclusion, the NIC laboratory plays a critical role in research and surveillance of influenza viruses and other viral respiratory infections. Driving these two activities together is feasible in developing countries and is necessary to accumulate data that will increase our understanding on the epidemiology of influenza in our region. It is therefore helpful for the Ministry of Health and stakeholders that want to develop new cost-effective strategies aimed at reducing morbidity and mortality due to influenza and other respiratory viruses. Dynamics of canine rabies in Bangui, Central African Republic between 2005 and 2012. Speaker 4. Emmanuel Nakouné Yandoko, Vianney Tricou, Xavier Konamna, Benjamin Selekon and Mirdad Kazanji: Although it represents an important public health threat, canine rabies is still a neglected tropical enzootic disease in Africa. Tens of thousands of people die of rabies each year in this continent despite available vaccines for both humans and animals. In Central African Republic (CAR), animal vaccination is not commonly done. Between 2006 and 2012, the only serious attempt to control the disease was a mass euthanasia of stray dogs in Bangui, the capital of CAR, in 2010. To explore the dynamics of rabies virus amongst dogs in Bangui and investigate the impact of the mass dogs euthanasia on the genetic diversity of the virus, post-mortem samplings of brains collected by the A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 115 115 11/20/12 11:06 PM ROUNDTABLE DISCUSSION 3 veterinary services from dogs with suspicious behaviours were analysed. The initial diagnostic was done by direct immuno-fluorescence and PCR. A portion of the N gene was also amplified and sequenced to determine the molecular epidemiology of the circulating strains. In 2005, none canine rabies case was recorded in Bangui. Between 2006 and 2010, 110 (of 123 suspicious cases i.e. 89% of positivity) were notified. Again, in 2011, none case was recorded in the city. But in 2012, Bangui has experienced a recrudescence of canine rabies with 31 positive samples (of 37 suspicious samples i.e. 84%) recorded from the beginning of the year. Even though controversial, the mass euthanasia of stray dogs had temporally lowered the number of canine rabies cases but did not stop the circulation of the virus. Preliminary phylogenetic analysis indicates that strains from both Africa I and Africa II clades have circulated in Bangui during the study period. This study provides insight into factors associated with the current epidemic in Bangui and is relevant to determining an effective policy for controlling the virus. Amadou Sall, Institut Pasteur, Dakar, Senegal Co-convener: Amadou Sall is currently the head of the Arboviruses and viral hemorrhagic fever unit, director of the WHO collaborating center and member of the governing board at Institut Pasteur de Dakar. He is also the director and founder of the international course on “arboviruses and viral hemorrhagic fever diagnosis, prevention, control and outbreak management” organized by Institut Pasteur Dakar in partnership AMP, Ministry of health of Senegal and University Cheikh Anta Diop Dakar. Dr. Sall is a virologist and has a PhD in Public health. He received his scientific education at Universities Paul Sabatier at Toulouse, Paris Orsay and Pierre et Marie Curie in France. Dr Sall’s research focused primarily on ecology and evolution of arboviruses and viral hemorrhagic fever and diagnostics of the latter viruses is a priority in his laboratory. He has published more than 60 papers and book chapters and give more than 80 scientific communications in international meeting. Oyewale Tomori, Redeemer’s University, Nigeria Co-convener: Oyewale Tomori is currently Professor of Virology at the Redeemer’s University, Nigeria, where he also served as Vice-Chancellor (2004-2011). He became the Head of the Department of Virology at the University of Ibadan in 1984, leading research efforts that investigated viral infections, including Ebola Hemorrhagic Fever, Lassa Fever, Yellow Fever, and Marburg in various African countries. In 1994, he became the WHO Africa Region Virologist. During the ten year tenure, he set up the African Regional Polio Laboratory Network, comprising of 16 laboratories, providing diagnostic support to the global polio eradication initiative. Professor Tomori serves on several national and international advisory bodies including the WHO Africa Regional Polio Certification Committee, WHO Eastern Mediterranean Regional Polio Certification Committee, and WHO Advisory Committees on Variola Virus Research, Polio Research, and Yellow Fever Disease. He is a member of the WHO Strategic Advisory Group. 116 ASLM-book-layout9.indd 116 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM WEDNESDAY, DECEMBER 5 Jean-Marc Collard, Centre de Recherche Médicale et Sanitaire, Niger Speaker 1: Jean-Marc Collard is currently the Head of the Biology Unit at the ‘Centre de Recherche Médicale et Sanitaire’ (CERMES) in Niger. He is also the PI in Niger for MenAfriCar (African Meningococcal Carriage Consortium) and PAGe (Pneumococcal African Genomics Consortium). Previously, Dr. Collard worked at the Scientific Institute of Public Health (IPH) in Brussels (Belgium), first as an expert in biosafety and recombinant DNA, and after the ‘anthrax crisis’ as the Head of the Bacteriology division to manage the bacteriological activities of the IPH and build a BSL3 facility for emerging diseases. He also acted as Head ad interim of the Microbiology department of the IPH (2006-2007) and as General Director ad interim of CERMES (October 2011 – April 2012). Dr. Collard started his career as post-graduate from the University of Liège (Belgium) in 1989 with a PhD in Biological Sciences. Richard Njouom, Centre Pasteur, Cameroon Speaker 2: Richard Njouom, PhD, is a senior scientist with experience in virology, molecular biology and public health. He is now the Head of the Virology Unit at the Centre Pasteur of Cameroon and his activities are focused on viral hepatitis and respiratory viruses. His main topic of research is Molecular epidemiology of hepatitis B, C and D viruses on human and non human primates in Central Africa and their impact on diagnosis, treatment and clinical evolution of the disease. Additionally he is the head of the NIC of Cameroun. He is the leading author of more than 30 international publications. Norosoa Razanajatova, Institut Pasteur, Madagascar Speaker 3: Norosoa Razanajatova, is a PhD student at the National Influenza Centre, Virology Unit, Institut Pasteur de Madagascar, Antananarivo, Madagascar since 2008. Her main research interests are: study etiology of ARI; identify an eventual seasonality of common respiratory viruses; develop diagnostic tools to predict, prevent and watch for the emergence of a viral outbreak; and study genetic aspects of important respiratory viruses to contribute the elaboration of vaccine. Dr. Razanajotova has previously participated in many trainings and workshops on serological and molecular diagnosis, and genome sequencing of emerging viruses which were organized by WHO and CDC. She was also an oral and poster presenter during international meetings as the Africa Influenza Scientific Symposium, African Network for Influenza Surveillance and Epidemiology (ANISE), and Options for the Control of Influenza VII. Emmanuel Nakoune-Yandoko, Institut Pasteur, Bangui Speaker 4: Emmanuel Nakoune-Yandoko is currently a research fellow at the laboratory of Arboviruses, Hemorrhagic Fever, Flu Virus and Rabies at the Institut Pasteur, in Bangui, Cote D’Ivoire. Dr. Nakoune-Yandoko received his PhD in molecular biology in 2007 in Nancy France. He has authored and co-authored several publications in peer reviewed journals. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 117 117 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 4 LABORATORY SUPPORT FOR CONTROL OF STIs Date: Wednesday, December 5 Time: 5:30PM–7:00PM Location: Room 1.6 At conclusion of this session, the participant will be able to: » Describe recent advances in the laboratory diagnosis of sexually transmitted infections (STIs) Co-Conveners: David Lewis, NICD, South Africa and Ron Ballard, CDC-Atlanta CE Credits: 1.5 CMLE Contact Hours » Understand the role of the laboratory in STI control programs in resource constrained settings, including the complementary functions of point of care and reference testing for disease surveillance and management. The Role of the Laboratory in support of Syndromic Management Speaker 1. Ron Ballard: The syndromic approach to STI case management is based on the identification of relatively constant combinations of symptoms and signs (syndromes) and on knowledge of the most common causative organisms of these syndromes and their antimicrobial susceptibilities. Clinical algorithms (flow charts) are then developed using locally determined etiologies of the syndromes and the antimicrobial susceptibilities of the organisms to guide health-care workers to manage patients who present with a particular syndrome. The exact treatment is chosen typically to cover the major causative pathogens responsible for the syndrome in the specific geographic setting. Laboratory services will continue to be important at the public health level where they contribute to the development and validation of these national STI case management guidelines and assist in the necessary epidemiological and microbiological monitoring. The laboratory will also continue to play an essential role in screening of patients for asymptomatic infections, medico-legal cases and for the diagnosis of problem cases. The laboratory will also provide support for quality assurance of point-of-care (POC) diagnostic services at peripheral clinical sites, for example, the detection of maternal syphilis among women attending antenatal care. In the future, it is anticipated that inexpensive, POC diagnostic tests for chlamydial, gonococcal and trichomonal infections will be used as an adjunct to syndromic algorithms in order to reduce the amount of overtreatment inherent in the approach when applied to women with vaginal discharge. How Should the Laboratory Respond to the Public Health Challenge of Limiting the Spread of Multidrug resistant Gonorrhoea? Speaker 2. David Lewis: Laboratory-based surveillance of gonococcal antimicrobial resistance is critical in terms of providing key intelligence data to health departments. It ensures that appropriate antimicrobial therapy is included in flow charts for those syndromes for which Neisseria gonorrhoeae may be a causative organism. Effective gonorrhoea control may reduce the risk of HIV transmission from co-infected patients to HIV sero-discordant sexual partners. The emergence and spread of multi-drug resistant gonorrhoea within the African continent is the most important threat to the on-going success of syndromic management in Africa. Whilst the syndromic management approach has empowered nurses to make same-day syndromic diagnoses without the need for additional laboratory tests, it has weakened the ability of laboratories to successfully culture N. gonorrhoeae and undertake antimicrobial susceptibility testing for this fastidious pathogen. Antimicrobial 118 ASLM-book-layout9.indd 118 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM WEDNESDAY, DECEMBER 5 resistance surveys for N. gonorrhoeae is a specialised activity that is best led through a country’s national STI reference laboratory. This presentation will review the diagnostic methods available to ensure successful N. gonorrhoeae culture and also the pros and cons of the various antimicrobial susceptibility testing methodologies. As part of good laboratory practice, all laboratories should ensure that quality systems are in place. It is clear that Africa will only be able to respond to the public health challenges of limiting the spread of multi-drug resistant gonorrhoea if there is a substantial input in terms of resources, staff training and capacity building at the level of the peripheral laboratories. The role of the Laboratory in the Control of Syphilis Speaker 3. Yaw Adu Sarkodie: Increasingly, syphilis continues to be a major sexually transmitted infection in many parts of Africa, though the epidemiology of genital ulcer disease seems to be changing in favour of viral genital ulceration. Apart from facilitating the transmission of HIV, the adverse birth outcomes resulting from mother to child transmission of syphilis could be phenomenal. In the recent past, the WHO and other agencies have supported the introduction of point of care tests for syphilis which among other things enables same day testing and treatment for syphilis. Deployed pragmatically In the antenatal setting this could lead to a drastic reduction of mother to child transmission of syphilis. There are on-going efforts towards a global elimination of congenital syphilis following on from these exciting developments. This presentation looks at the changing role of the laboratory in the support of global syphilis elimination efforts. These roles include among others training and use of syphilis point of care tests outside the traditional laboratory setting, quality assurance and importantly the use of the tests in many countries in Africa where treponematoses other that syphilis are endemic The role of laboratory tests for Human Papillomavirus in cervical screening and vaccination programmes in Africa. Speaker 4. Anna-Lise Williamson: Specific types of human papillomavirus (HPV) are the cause of cervical cancer, one of the most important female cancers in Africa. The time from infection with HPV to the development of cervical cancer is long enough to allow the detection and treatment of pre-cancerous lesions. Many deaths from cervical cancer could be prevented if better prevention, screening and treatment programmes were in place. In particular countries need to consider both cervical screening programmes and vaccination. There are now HPV vaccines available that would prevent at least 60% of the cervical cancers in Africa. These vaccines need to target young girls before their sexual debut. However, since vaccination will not prevent all cervical cancers, the cervical screening programmes need to continue for both vaccinated women and those women who were too old to be vaccinated. Conventionally cervical cytology has been used for screening for cervical disease. However, there are now HPV tests that can be used to identify women at risk of cervical disease. In low resource settings one HPV test followed by treatment can have a significant impact on cervical disease. HPV tests can also be combined with cytology to further improve the detection of women at risk of developing cervical cancer in better resourced communities. The prevalence of HPV and cervical disease is significantly increased in women co-infected with HIV. HPV infection has also been demonstrated to increase the risk of acquisition of HIV. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 119 119 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 4 Ron Ballard, Centers for Disease Control and Prevention, Atlanta Speaker 1 and Co-Convener: Ron Ballard serves as the Associate Director for Laboratory Science, Center for Global Health , U. S. Centers for Disease Control and Prevention in Atlanta, U.S.A. He previously served as Branch Chief, Laboratory Reference and Research Branch within the Division of Sexually Transmitted Disease Prevention at CDC from 2001 to 2010. Dr. Ballard obtained his primary degree (M.I.Biol. Biochemistry) in 1973 from the University of the South Bank, London, U.K. and his PhD from the University of the Witwatersrand, Johannesburg, South Africa. Prior to CDC, Dr. Ballard served as scientific staff of the Medical Research Council Trachoma Research Unit at Lister Institute for Preventive Medicine in Chelsea, London and later as Director of the National Reference Centre for STDs at the South African Institute for Medical Research in Johannesburg and Associate Professor in the Department of Microbiology and Infectious Diseases at the University of the Witwatersrand. His most recent research interests include development and application of diagnostic and typing tests for STDs, tropical STDs and STD/HIV interactions. David Lewis, National Institute for Communicable Diseases, South Africa Speaker 2 and Co-Convener: David Lewis is Head of the Centre for HIV and Sexually Transmitted Infections at the National Institute for Communicable Diseases, a division of the National Health Laboratory Service in Johannesburg, South Africa. He holds honorary professorial appointments at the Universities of the Witwatersrand and Cape Town. He has worked in the field of STIs since 1989, both as a consultant physician and a microbiologist. His current work involves both HIV/STI research and surveillance in Southern Africa with special interests in gonococcal antimicrobial resistance and genital ulcer disease. Professor Lewis recently played a leading role in STI guideline revisions in South Africa, Madagascar, and Namibia and for the Southern African Development Community. Professor Lewis frequently works with the World Health Organization (WHO) as a temporary technical advisor and has assisted with revision of the recent WHO global STI guidelines and WHO manual for the laboratory diagnosis of STIs. Yaw Adu Sarkodie, Kwame Nkrumah University of Science and Technology, Ghana Speaker 3: Yaw Adu-Sarkodie is the Professor of Clinical Microbiology at the School of Medical Sciences, Kwame Nkrumah University of Science and Technology, Ghana. He is also consultant Clinical Microbiologist and Genitourinary Physician at the Komfo Anokye Teaching Hospital, Kumasi, Ghana. He works closely with the National AIDS/STD Control Programme in Ghana and is a member of many of its Technical Working Groups. His research interests are in STI clinical Management, evaluation of diagnostics related to STI and antimicrobial resistance. 120 ASLM-book-layout9.indd 120 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM WEDNESDAY, DECEMBER 5 Anna-Lise Williamson, University of Capetown, South Africa Speaker 4: Anna-Lise Williamson is a virologist at the Institute of Infectious Disease and Molecular Medicine, University of Cape Town and is on the staff of the Division of Medical Virology, Dept Clinical Laboratory Sciences, University of Cape Town (UCT) and the National Health Laboratory Service.Professor Williamson spent most of her childhood in Zambia and did her undergraduate and post-graduate training at the University of Witwatersrand where she obtained a PhD in 1985. In 1987 she moved from the Veterinary Research Institute (Onderstepoort) to work at UCT where she was promoted Ad hominem to Professor in 2004 and awarded a Chair in Vaccinology in 2008. She is head of the World Health Organisation (WHO) HPV Labnet laboratory for the Africa Region (NHLS). She has headed the South Africa AIDS Vaccine Initiative funded vaccine development team since 2000. She is internationally recognized for HIV vaccine and Human Papillomavirus (HPV) expertise. Her research interest is the impact of HIV co-infection on the natural history of HPV. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 121 121 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 5 CRYPTOCOCCOSIS: PREVENTING FUNGAL DISEASE Date: Wednesday, December 5 Time: 5:30PM–7:00PM Location: Room 2.6 At conclusion of this session, the participant will be able to: » Describe recent advances in the laboratory diagnosis of sexually transmitted infections (STIs) Co-Conveners: Tom Chiller, CDC-Atlanta and Nelesh Govender, NICD, South Africa CE Credits: 1.5 CMLE Contact Hours » Understand the role of the laboratory in STI control programs in resource constrained settings, including the complementary functions of point of care and reference testing for disease surveillance and management Cryptococcal Disease Management in South Africa: SA HIV Clinician’s Society Guidelines and new WHO Cryptococcal Disease Guidelines. Speaker 1. Graeme Meintjes: This talk will review current South African cryptococcal disease guidelines and highlights of the WHO guidelines. The review of cryptococcal disease management will focus on laboratorybased diagnosis challenges and treatment. WHO and collaborators have been working to develop a comprehensive set of recommendations on the diagnosis, prevention, and management of cryptococcal disease in adults, adolescents, and children. Guidelines in the form of Rapid Advice were released in December 2011, and the full guidelines will become available in 2012.These recommendations are aimed at a variety of audiences, including policy makers, national treatment advisory boards, HIV program managers, healthcare providers, and partnering organizations who provide support for the implementation of HIV care and treatment services. The recommendations are based on several guiding principles: (1) Early diagnosis is key to improving mortality due to cryptococcal diseases. (2) Early ART initiation is the most important and cost-effective preventive strategy to reduce the incidence and high mortality associated with CM. (3) The use of optimal antifungal treatment regimens will improve survival, clinical and neurological outcomes, and promote rapid fungal clearance, while minimizing drug-related toxicities. (4) Prompt referral for HIV testing and care should be undertaken as soon as appropriate following diagnosis of cryptococcal disease, to facilitate early HIV diagnosis, uptake of ART, and retention in care. Phased-in Implementation of a National Cryptococcal Screening Program Speaker 2. Samuel Oladoyinbo and Thapelo Maotoe: In 2012, the South African government included cryptococcal screening in their national strategic plan. Cryptococcal meningitis has both a high morbidity and high mortality and bears a high cost to the health care system. The later the diagnosis is made the more severe the disease and the more costly the treatment. The ability to detect cryptococcal antigen (CrAg) in blood early in asymptomatic infection allows for early diagnosis and early treatment. Screening at risk patients (CD4<100) can identify persons who may benefit from fluconazole therapy, thereby reducing deaths. Screening is based on using serum (or plasma) to detect circulating antigen using a simple, commercially available assay. A novel, point-of-care “dipstick” assay is now available. This preventive strategy is also very cost-effective. This will save lives and reduce cost of treatment as these patients can be treated with oral fluconazole. South Africa began phased in implementation of a screen and treat program in September and continues to expand sites where testing 122 ASLM-book-layout9.indd 122 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM WEDNESDAY, DECEMBER 5 will be performed. This is a reflex lab testing strategy performed on sample of blood that are collected for CD4 testing when the CD4 cell count is found to be less than 100. A standard treatment algorithm for screen and treat was developed as well as standard training materials for clinic staff and laboratories. A monitoring and evaluation program has also been developed to track the outcomes. Cryptococcal Screening: Laboratory perspectives and considerations in South Africa and sub-Saharan Africa Speaker 3. Nelesh Govender: Cryptoccocal infection can be diagnosed by India Ink staining, culture, and by detecting Cryptococcal antigen (CrAg). Sensitivity for both India Ink and culture are around 50%, whereas CrAg testing has a sensitivity of greater than 90%. There are several different CrAg tests currently available which include EIA, latex agglutination (LA), and lateral flow assay (LFA). The newest of these, the LFA, provides a rapid and simple test that is highly sensitive and stable at room temperature and can be done as a point of care test with minimal laboratory infrastructure. CrAg can be detected in the sera of patients with cryptococcal infection weeks to months before symptoms of meningitis develop. The LFA allows for a simple way to screen sera of at risk patients (CD4<100) using either a reflex laboratory setting, where blood from CD4 testing done in the lab is used to reflex into CrAg testing if the CD4 < 100, or using a point of care strategy in the clinic setting. The reflex strategy will be applied to the current program in South Africa, where CD4 labs will conduct crypto screening on patients with CD4<100. In 2012, the South African government included cryptococcal screening in their national strategic plan. In collaboration with National Health Laboratory Service (NHLS), the ministry of health is conducting a phased-in implementation of cryptococcal screening in South Africa using a laboratorybased reflex strategy. Demonstration of the new rapid dipstick antigen test (LFA) (audience to participate in hands-on demonstration) Speaker 4. Sean Bauman (demonstration): The lateral flow assay (LFA), developed and manufactured by Immunomycologics (IMMY), is a new, rapid dipstick test that can be used for both cryptococcal diagnosis and screening. Dr. Bauman will briefly review the steps required to perform the LFA test and will conduct a hands-on workshop during the session. Implementation of Cryptococcal Screening: Cost Effectiveness and Perspectives from Uganda Speaker 5. David Meya: In a cohort of 295 HIV-infected, ART-naïve Ugandans, with a CD4 count <100 cells/μL, 8.8% were CRAG-positive. Of these, 21 were treated with fluconazole (200-400mg) for 2-4 weeks, per physician discretion. CM developed in 3 of the patients who received fluconazole, and 30-month survival was 71%. In the 5 CRAG-positive patients with a CD4<100 cells/μL who were not treated with fluconazole, all died within 2 months of initiating ART. Based on a CRAG latex agglutination cost of $16.75, the estimated number needed to treat (NNT) to detect one person with asymptomatic antigenemia was 11.3, at a cost of $190 in a population with a CD4 count <100 cells/μL. The number needed to prevent one death was 15.9 at a cost of $266. Thus, CRAG screening in a population with a CD4 count <100 cells/μL was concluded to be cost-effective at $21 per quality-adjusted life year (QALY) saved. The CRAG LFA costs $2 per test (from the manufacturer for resource-limited areas), thus the cost per death averted is ~$32 at a cost-effectiveness of $2.50 per QALY. Determining that this CRAG testing and preemptive treatment strategy is cost effective will be useful to HIV/AIDS programs in areas where cryptococcal disease is prevalent and will provide evidence as to which interventions reduce the overall burden of HIV/AIDS-associated opportunistic infections to health systems. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 123 123 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 5 Tom Chiller, Centers for Disease Control and Prevention, Atlanta Co-convener: Tom Chiller has spent the last decade trying to advance public health strategies to fight fungal diseases. He is an infectious disease physician and has been working with partners around the world to develop a screen and treat strategy for cryptococcal infection. Graeme Meintjes, University of Capetown, South Africa Speaker 1: Graeme Meintjes is an infectious diseases physician based at the University of Cape Town and GF Jooste Hospital in Cape Town. His research interests include TB-IRIS, cryptococcal meningitis and complications of antiretroviral therapy. He is a leading expert on the management of cryptococcal disease and co-authored the South African Guidelines for the Prevention, Diagnosis, and Management of Cryptococcal Meningitis and Disseminated Cryptococcosis in HIV-Infected Patients. Samuel Oladoyinbo, Centers for Disease Control and Prevention, South Africa Co-Speaker 2: Drs. Oladoyinbo and Maotoe provide technical, monitoring and evaluation, and research support for HIV/AIDS care and treatment activities in their respective agencies. They provide cross-cutting support for PEPFAR partners in South Africa and participate in interagency activities related to HIV/AIDS care and treatment. Thapelo Maotoe, US Agency for Internation Development, South Africa Co-Speaker 2: Drs. Oladoyinbo and Maotoe provide technical, monitoring and evaluation, and research support for HIV/AIDS care and treatment activities in their respective agencies. They provide cross-cutting support for PEPFAR partners in South Africa and participate in interagency activities related to HIV/AIDS care and treatment. 124 ASLM-book-layout9.indd 124 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM WEDNESDAY, DECEMBER 5 Nelesh Govender, National Institute for Communicable Diseases, South Africa Co-convener/Speaker 3: National Institute for Communicable Diseases (NICD), Johannesburg, South Africa. Dr. Govender is the head of the Mycology Reference Unit and co-director of the Centre for Opportunistic, Tropical & Hospital Infections at NICD, South Africa’s national public health institute. His work focuses on laboratory-based surveillance for candidemia and cryptococcal meningitis. Sean Bauman, Immuno-Mycologics, Inc., USA Speaker 4: Sean Bauman is the president and chief executive officer of IMMY, an organization dedicated to manufacturing high-quality fungal diagnostics and improving diagnostic capacity in resource-limited settings. David Meya, Makerere University Speaker 5: Lecturer at Makerere University, College of Health Sciences, Uganda, and adjunct assistant professor at University of Minnesota Dr. Meya is an infectious diseases physician and a leading expert on costeffectiveness analyses of cryptococcal screening in Africa A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 125 125 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 7 LABORATORY NEEDS FOR INTERNATIONAL HEALTH REGULATIONS Date: Thursday, December 6 Time: 5:30PM–7:00PM Location: Auditorium 2 Convener: Arunmozhi Balajee, CDC-Atlanta CE Credits: 1.5 CMLE Contact Hours At conclusion of this session, the participant will be able to: » Understand the 8 core capacities within the World Health Organization’s revised International Health Regulations (IHR 2005) and their relationship to the lab. » Analyze gaps in identifying, reporting, and responding to public health emergencies in order to develop and maintain response capacity. Laboratory Capacity for the International Health Regulations: South African Perspective Speaker 1. Lucille Blumberg: Laboratory capacity is a critical component of the International Health Regulations (2005). In South Africa an extensive national laboratory network operated by the National Health Laboratory Service (NHLS) would meet the needs for laboratory testing for priority health conditions together with the National Institute for Communicable Diseases (NICD), a public health institute and division of the NHLS. The reference units for new and emerging pathogens including those where special bio security conditions are critical are housed within the NICD. These include a BSL-4 facility and a number of BSL-3 facilities where molecular testing and characterization and cultures can be performed where indicated for diseases such as polio, the viral haemorrhagic fevers, influenza, plague and anthrax amongst others. The NICD is also responsible for laboratory –based surveillance programmes for a number of these diseases. The laboratories are accredited by a national body and are required to comply with national and international safety standards. The laboratory network has contributed and been involved in a number of outbreaks including the newly described Arena virus, the Lujo, virus which resulted in the death of four of the five persons infected in South Africa and Zambia in 2008, cholera, influenza A (H1N1) pdm 09 and influenza AH5N2, polio (Namibia 2005), and Ebola and Marburg in Africa, demonstrating a capacity to identify new and emerging pathogens. Surveillance systems for the clinical detection of the priority diseases do exist but there are gaps in recognition, reporting of disease and submission of specimens and a need for these to be strengthened. Financial constraints are challenging and affect critical infrastructure maintenance to ensure bio safety and bio security and also ensure adequate training and retention of staff. Addressing the laboratory capacity strengths and gaps towards IHR 2005 implementation: a case study from Tanzania Speaker 2. Janneth Mghamba: Implementation of International Health Regulations (IHR 2005), require strengthening laboratory capacity services for communicable diseases, Food Safety, Chemical, Radiological and nuclear Events. The recent 2010 IHR 2005 core capacity assessment for the country laboratory core capacity in facilitation of the implementation of IHR 2005 in Tanzania have given a clear roadmap of what needs to be done, which is similar for most resource poor countries. The presentation aims to share the country’s current situation of the laboratory capacity strengths, challenges, and the on going activities which are geared to strengthen the laboratory capacity. The recent Ebola threat in Tanzania in 2012, from neighbouring country Uganda will be taken as an example 126 ASLM-book-layout9.indd 126 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM THURSDAY, DECEMBER 6 Laboratory capacities for IHR2005 implementation in poor resource setting; opportunities and challenges in Uganda. Speaker 3. Atek Kagirita: The International Health Regulations (IHR[2005]) are a set of legally binding regulations for all World Health Organization (WHO) Member States. The purpose and scope of the IHR are “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.” IHR2005 shifted from disease based approach to public health risks irrespective of their origin or source and this requires holistic multi-sectoral approaches to their response. The IHR require States to strengthen core surveillance and response capacities at all levels and core capacity 8 calls for strengthening of national laboratory capacities for early detection and confirmation of public health risks. This binding instrument of international law entered into force on 15 June 2007 In Uganda the coordination of emergencies is a mandate of the Office of the Prime Minister and executed by a multi-sectoral Disaster Preparedness and Management committee. Recently the OPM is coordinating a long standing Nodding disease epidemic that has ravaged children in northern part of the country. The national health laboratory network is scattered in different sectors and under various institutional management. However, for health sector, there is a national health laboratory policy of 2009 and a fiveyear strategic plan that highlight the strengthening of laboratory services delivery, and efforts have been made to address areas of laboratory networking, Biosafety, Quality assurance, disease outbreak response and proper specimen management among others The implementation of IHR-2005 is done through the framework of the integrated disease surveillance and response (IDSR) strategy, and Uganda has applied for extension of 2 years to achieve full implementation. The objective is to improve national lab capacity for detection and confirmation of all public health hazards, strengthen specialized laboratory networking for improved resource utilization and to increase laboratory workforce awareness of IDSR/ IHR 2005 implementation. Biosafety & Biosecurity: the way and the barrier to the IHR Commitments Speaker 4. Alina Munkawa: The fast growing global village has vastly contributed to the complexity of the biorisk and subsequently challenged the local response to borderless this threat. As a result, biosafety and biosecurity are rapidly dominating the world policy dialogues. The World Health Organisation, to which most if not all African Countries are Member States, has as an enforcement effort to recognition of biosafety and biosecurity provided a common framework for all member states around the globe through the International Health Regulations. The countries, specifically in Africa, face not only the human and financial capacity challenges but also the infrastructure that promote the harmonised and biorisk-aware cross border interactions. IHR 2005 (Article 44) requires Member State collaboration to provide technical cooperation as well as financial and logistical support particularly in the development, strengthening and maintenance of public health capacity. Of the eight core capacities that the state parties are encouraged to develop in order to be compliant to IHR includes laboratory capacity and biosafety and biosecurity. This session aims to highlight the key elements of the requirements of the Laboratory capacity and will discuss gaps, needs and plans to develop this capacity. This presentation will highlight the efforts engaged and challenge encountered by most African countries and development partners in implementation of the IHR particularly the laboratory biosafety and biosecurity. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 127 127 11/20/12 11:07 PM Arunmozhi Balajee, Centers for Disease Control and Prevention, Atlanta Convener: Arunmozhi Balajee is a graduate of the University of Madras (India) and completed her postdoctoral training in laboratory at the Fred Hutchinson Cancer Research Center, Seattle, US. Currently she acts as the Associate Director for Laboratory Programs in the Division of the Global Diseases Detection and Emergency Response, Center for Global Health. In this role she coordinates laboratory capacity building efforts internationally for implementing the surveillance and response activities of WHO IHR 2005. Additionally, Dr. Balajee also provides technical assistance or laboratory capacity building in Haiti Lucille Blumberg, National Institute for Communicable Diseases, South Africa Speaker 1: Lucille Blumberg is a deputy director at the National Institute for Communicable Diseases ( NICD), a branch of the National Health Laboratory Service, and is based in Johannesburg, South Africa. She heads the Division for Public Health Surveillance and Response which includes the National Outbreak and Travel Health Units and is the medical consultant to the Centre for Emerging and Zoonotic Infections. She is an Associate Professor at the University of the Stellenbosch, Western Cape Province and is an Infectious Diseases specialist, clinical microbiologist and travel medicine specialist. Her special interests are tropical and travel-related diseases, zoonosis, drug-resistant TB and management of severe malaria. Prof Blumberg is a member of the IHR working group in South Africa. She led the laboratory programme for the 2012 Soccer World Cup in South Africa. She is a member of a number of South African and international expert groups and has been involved in a number of outbreaks in South Africa including cholera, rabies, Rift Valley fever, Lujo virus and influenza A H1N1 and H5N2. Janneth Mghamba, Field Epidemiology and Laboratory Management Project, Tanzania Speaker 2: Janneth Mghamba is a medical doctor who later received masters of science in both Epidemiology & Biostatistics and in Applied Epidemiology. She is currently the national focal person for the International Health Regulations (2005) for Tanzania. Dr. Mghamba is also a part time lecturer for MSc in International Health at the University of Copenhagen and a field coordinator overseeing field component for the residents in the Tanzania Field Epidemiology and Laboratory Management Program. Previously, she served as Project medical doctor for multiple projects supported by CDC, USAID and the Tanzanian Ministry of Health. Dr. Mghamba has co-authored and published multiple publications in peer-reviewed journals and has developed a number of widely used policy and technical guidelines and reports. 128 ASLM-book-layout9.indd 128 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM Atek Kagirita, Central Public Health Laboratories, Ministry of Health, Uganda Speaker 3: Atek Kagirita holds a Master of Science in Molecular Biology and Biotechnology (MUK), Postgraduate Diploma in Management (UMI), Bachelor Degree in Biomedical Laboratory Technology, and Diploma in Medical Microbiology from MUK. He has vast experience in epidemic disease surveillance and outbreak response, is a National trainer for Biorisk management, IDSR/ IHR 2005 technical implementation, Microbiology strengthening training and other Laboratory areas, a member of National task force on epidemics and rapid response team, an investigator for Walter Reed/MoH antibiotic surveillance project, National Laboratory coordinator for Africhol cholera surveillance and Secretary of the National Health Laboratory Biorisk committee. Alina Munkawa, Namibia Institute of Pathology, Namibia Speaker 4: Alina Munkawa is currently responsible for Occupational Health, Safety and Biosafety at Namibia Institute of Pathology. She is also serving as a Council Member of the African Biological Safety Association (AfBSA) representing the Southern Africa Region, since 2010. She holds a Post Graduate Diploma in Occupational and Environmental Health & Safety Management. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 129 129 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 8 FLU LABORATORY NETWORK Date: Thursday, December 6 Time: 5:30PM–7:00PM At conclusion of this session, the participant will be able to: Location: Room 1.4 » Discuss the challenges of flu surveillance in resource constrained Co-conveners: Jean-Michel Heraud, Institut Pasteur, Madagascar, and Julius J. Lutwama, Uganda Virus Research Institute, Uganda countries » Discuss cost effective approaches for improving influenza surveillance CE Credits: 1.5 CMLE Contact Hours and response to improve public health » Discuss the “one health” approach for influenza laboratories Evidence of extensive and long term circulation of pandemic Influenza virus (H1N1) 2009 in pigs in Reunion Island (Indian Ocean): the need for a one health approach Speaker 1. Eric Cardinale: The pandemic influenza A/H1N1 virus (H1N1pdm09) struck Reunion Island during austral winter 2009 (JulySeptember 2009) and according to serologic data, has infected almost 45% of the island human population. We report here that the local swine herds, previously free of any influenza virus, were massively contaminated by the H1N1pdm09 virus. Serological and virological investigations indicated continuous virus circulation among pigs in 2010 and more than 40% of pig herds remained infected in 2011, after disappearance of the virus in humans. Swine infection was mainly asymptomatic, except in July-August 2010 when several farms reported flu-like symptoms on animals that were related to H1N1pdm09. The long term persistence of the pandemic virus in pigs rises concern about the role of swine as a reservoir and as an intermediate host for the emergence, through reassortments or mutations, of novel zoonotic viruses. This study highlights the need for the one health approach. The “One Health” approach is a collaborative and all-encompassing way to address, when relevant, animal and public health globally. Today, more than 60% of emerging diseases in humans are zoonotic; the interface between humans and animals is widely recognized as a critical juncture where zoonotic diseases emerge and re-emerge. This interface is continuously affected by several factors as increased globalization; the growth and movement of human and livestock populations; closer interactions between livestock and wildlife. We take into account that new paradigm in a common surveillance network (SEGA) to improve early detection, prevention and control, and reduce the public and animal health risks from these emerging zoonotic diseases. Molecular Evolutionary Analysis of pH1N1 2009 Influenza Virus and Intense Co-Circulation of NonInfluenza Respiratory Viruses during the First Wave of Pandemic Influenza in Reunion Island: A Cohort Study Speaker 2. Hervé Pascalis: In March 2009, a new variant Influenza A virus, pH1N1, emerged from Mexico and the United States. In response, the CRVOI and CIC-EC of Reunion Island launched a collaborative, prospective study that would encompass a large cross section of the island’s population. The goal being: to catalogue and describe the evolution of pH1N1 virus as it spread through the general population in terms of virology and epidemiology. Serology data revealed widespread transmission of pH1N1 throughout Reunion’s population: infected individuals displayed either mild or no clinical symptoms, but seroconversion was detected in ~ 63% of individuals under 20 years of age, ~ 40% in the 20-59 and ~ 17% in the elderly. 130 ASLM-book-layout9.indd 130 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM THURSDAY, DECEMBER 6 pH1N1 was detected in nasal swabs from a total of 71 individuals via classical virology-based techniques. Parallel screening for other respiratory viruses provided evidence for co-circulation of different viral strains before, during and after the pH1N1 epidemic wave. Phylogenetic analysis of 28 sequenced viral isolates showed Reunion pH1N1 has come from clade 7 of globally circulating Influenza A variants. Reunion isolates formed a distinct sub-cluster of clade 7 with sequence divergence suggesting 2 successive viral introductions. Date estimates from molecular phylogenies predicted clade emergence some time before the first detection of pH1N1 by the epidemiological surveillance system. Besides, phylogenetic relatedness was observed between Reunion pH1N1 viruses and those from other countries in South-western Indian Ocean area. WHO – Strengthening of the Global Influenza Surveillance and Response System (GISRS) in Africa – past, present and future. Speaker 3. Terry G. Besselaar, Dhamari Naidoo and Wenqing Zhang: Global influenza surveillance has been conducted through WHO’s Global Influenza Surveillance and Response System (GISRS) for over half a century. WHO GISRS monitors the evolution of influenza viruses and provides recommendations in areas including laboratory diagnostics, vaccines, antiviral susceptibility and risk assessment. It also serves as a global alert mechanism for the emergence of influenza viruses with pandemic potential. Efforts to strengthen GISRS have resulted in the expansion of this global laboratory network from the 1950s to currently include 140 National Influenza Centres (NICs) in 110 countries, areas or territories. Six WHO Collaborating Influenza Centres (CCs) for Reference and Research, 4 Essential Regulatory Laboratories and 12 H5 Reference Laboratories also form essential components of the network. Laboratory capacity strengthening has led to the designation of a total of 18 WHO NICs in Africa by 2012 compared to only a few NICS in past years. This has been achieved by support for training activities, participation in the WHO External Quality Assessment Project for detection of influenza viruses by PCR, the Virus Shipment Fund project for sharing clinical specimens/virus isolates with the WHO CCs for further characterization and various other collaborations. The challenge facing the continent lies in improving and sustaining influenza surveillance activities, thus allowing Africa to contribute to global surveillance and response and thereby fulfilling its shared responsibility in global health security. New opportunities: bringing molecular testing to point-of-care. Speaker 4. Ruth McNerney: Molecular tests have largely remained research tools in Africa because they are neither robust nor affordable. However, a new generation of tests are emerging that may prove more accessible. New technology being developed includes nucleic acid amplification and detection platforms intended for use at point of care. Isothermal alternatives to PCR are faster and reduce the need for instrumentation. Portable battery run platforms are now available. Integrated sample preparation and signal detection reduces technical input making devices easy to use. Multiplexing is being explored where tests for several targets are combined in a single reaction, saving time and cutting costs. Wireless and mobile phone technology has the potential to deliver surveillance data in real time. This new generation of RNA based tests might assist influenza control in Africa through improved surveillance and rapid detection of outbreaks. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 131 131 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 8 Jean-Michel Heraud, Institut Pasteur, Madagascar Co-convener: Jean-Michel Heraud’s major research interests are (1) study etiology of ARI, (2) identify an eventual seasonality of common respiratory viruses, and (3) develop diagnostic tools to predict, prevent and watch for the emergence of a viral outbreak. He has acquired a broad experience in infectious disease and public health, obtained through years of work at the Institut Pasteur from French Guiana, education in France and his intensive research at the National Institutes of Health (NIH). He joined the Institut Pasteur from Madagascar (IPM) in 2007 as Director of the National Influenza Center to actively participate to developing Influenza Surveillance in partnership with Ministry of Health. In 2010, he was appointed Chief of the Virology unit at the IPM and now leads several public health and research programs covering a broad variety of topics (Influenza and other respiratory viruses, Arboviruses, Hepatitis, Zoonotic pathogens…) Julius Julian Lutwama, Uganda Virus Research Institute, Uganda Co-convener: Dr. Julius Julian Lutwama is a Senior Principal Research Officer with the Ministry of Health at the Uganda Virus Research Institute, Entebbe. Dr. Lutwama originally trained as an Entomologist but received further specialized training in molecular virology and entomology at the Centers for Diseases Control, Fort Collins, Colorado, USA. He is the head of the Department of Arbovirology, Emerging and Re-Emerging Viral Infectious Diseases at the Uganda Virus Research Institute (UVRI). He also heads the WHO Collaborating National Influenza Center and the Highly Infectious Diseases Diagnostic Laboratory at UVRI. Over the 27 years of research work at UVRI, he has worked on many virus diseases including Influenza, Ebola, Marburg, O’nyongnyong, Bwamba, Pongola, Yellow Fever, Rift Valley Fever, Dengue, Zika, West Nile, etc. He has published widely in local and international peer reviewed journals on a number of virus diseases. He has participated in numerous virus diseases outbreak investigations, response and control. He is a member of several local and international health sciences committees and associations. He heads and coordinates a number of collaborating programs at UVRI. Eric Cardinale, CIRAD, France Speaker 1: Eric Cardinale has been working for 19 years in tropical countries mainly in Africa (Cameroon, Chad, Ivory Coast, Senegal, and Zambia) and in Asia (China, Vietnam). He is a veterinarian and PhD in epidemiology and microbiology, working for CIRAD, a French research centre working with developing countries to tackle international agricultural and development issues. He has always been working at the interface between human and animal health and between epidemiology and microbiology: Avian influenza (included H5N1) in Vietnam and Africa, Brucellosis and Tuberculosis in Cameroon, Salmonellosis and Campylobacteriosis in Senegal and Indian Ocean, West Nile fever in Madagascar, Rift Valley Fever in Comoros, Madagascar and Mayotte... His primary research interests remain bacterial and viral zoonoses. He is currently in charge of animal and veterinary public health at CRVOI (Center for research and intelligence on emerging diseases in the Indian Ocean) based in Reunion Island. He is coordinating a surveillance network on animal diseases in the Indian Ocean entitled “AnimalRisk-OI” and building the integrated human-animal health network “SEGA” for the Indian Ocean Commission. 132 ASLM-book-layout9.indd 132 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM THURSDAY, DECEMBER 6 Hervé Pascalis, Pasteur Institute, Guiana Speaker 2: Hervé Pascalis has been working for 18 years in virology and in molecular biology, including phylogenetic aspects, virus discovery. In French Guiana, at the Pasteur Institute, he has carried out cloning research and secondary data analysis on an emerging virus, Mayaro virus an alphavirus. At the University of Antilles-Guiana, he carried out the setting up of the first two years teaching for the Master degree which didn’t exist at the time. When he came back to Reunion Island, he has been working at the CRVOI since it was first established, from 2008 up to now. He has implemented the Biosafety Lab level 3 and is in charge of it. As PI or co-Investigator on several ongoing research programs, European- or French government-Funded, targeting the investigation of pathogens in human health, in Wild Fauna (micromammals and bats), and domestic fauna, with special interest on zoonotic pathogens as well as entomological studies. Terry Gail Besselaar, World Health Organization, Switzerland Speaker 3: Terry Gail Besselaar is currently employed by the World Health Organization, Geneva, where she is in the Global Influenza Surveillance and Response System (GISRS), Influenza Virus and Vaccine Support team. Her main contributions are towards strengthening the Global Influenza Surveillance and Response System in terms of pandemic preparedness by providing influenza laboratory and virological expertise and played a key role in the global response to the 2009 influenza A(H1N1) pandemic. Dr Besselaar has been in the virology field as a scientist for 29 years and has specialized in influenza for the past 19 years. Prior to joining WHO in 2008, she was the Head of the Respiratory Virus Unit at the National Institute for Communicable Diseases in Sandringham, South Africa and the Director of the WHO National Influenza Centre there. She contributed to the South African national pandemic preparedness plan and was a member of the WHO Global Influenza Pandemic Task Force from 2006 -2008. Ruth McNerney, London School of Hygiene & Tropical Medicine, UK Speaker 4: Ruth McNerney is a Senior Lecturer in Pathogen Biology and Diagnostics at the London School of Hygiene & Tropical. She is currently engaged on the Affordable Access Project to streamline and harmonize regulatory approval of diagnostics in developing countries and on a project to facilitate tech transfer and local production for improved access to in vitro diagnostics, with a focus on Africa. She has worked on various aspects of diagnostics and drug resistance, including tests for tuberculosis and has recently co-ordinated a project to sequence the genomes of a global collection of TB strains. She is a scientific advisor to the UK All Party Parliamentary Advisory Group on Tuberculosis and a core member of the New Diagnostics Working Group of the STOP TB Partnership. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 133 133 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 9 EVALUATION AND REGULATORY ASPECTS OF POC DIAGNOSTICS Date: Thursday, December 6 Time: 5:30PM–7:00PM Location: Room 1.6 At conclusion of this session, the participant will be able to: » Identify various Point of Care tests used in diverse health care settings and discuss their Co-conveners: Alex Opio, Ministry of Health, Uganda, and Jane Carter, AMREF, Kenya CE Credits: 1.5 CMLE Contact Hours public health benefits » Understand the unique challenges to providing high quality diagnostics in non-laboratory environments » Recognize the need for careful planning when implementing a point of care testing program The FDA Perspective on the Approval of Infectious Disease Diagnostics Speaker 1. Elliot P. Cowan: The U.S. Food and Drug Administration regulates in vitro diagnostics (IVDs) to meet requirements set forth in laws and regulations. For IVDs for infectious agents that present the greatest risk to public health, such as HIV, this includes evaluation of the design of the device to meet its intended use, a determination that the manufacturing process is under strict control (including an inspection of the manufacturing facilities), and assessing the results of analytical and clinical studies to determine expected performance, among other factors. The goal is to ensure that quality is built into the product and maintained through its lifetime of clinical use. When considering tests to implement, countries may consider products that have been approved by stringent regulatory authorities, such as the FDA. This approach can be useful in providing some assurance that the product meets certain quality standards that can be applied in many settings. These can thought of as “constants” and include such factors as product design and manufacturing (assuming the manufacturing site is the one that was approved for the product by the stringent regulatory authority), analytical studies, and the quality management system. However, there are a number of factors that may not necessarily carry over to all settings and require additional validation. These can be thought of as “variables,” and there are a number to consider. These variables should be taken into account when considering adopting a test approved by a stringent regulatory authority, to assure maximum public health benefit in specific settings. Role of Laboratory Accreditation in Patient Management Speaker 2. Rosanna Peeling: Laboratory accreditation is the process in which the quality management of the laboratory and the competency of its personnel are documented and certified against an official standard. It is the best mechanism to ensure that results produced by a laboratory are accurate and provide the best evidence to guide patient management. An accredited laboratory subscribes to the principles and practices of quality management and continuous quality improvement, supported by internal and external education and training. At a minimum, all laboratory procedures should be defined by standard operating procedures and all equipment should be calibrated and monitored for safety and effectiveness. The competency of the laboratory personnel in performing their tasks can be monitored or assured by subscription to a proficiency or external quality assurance programme, such as those offered by the College of American Pathologists (CAP) Proficiency Programs or the United Kingdom National External 134 ASLM-book-layout9.indd 134 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM THURSDAY, DECEMBER 6 Quality Assurance (UK NEQAS) programme. Subscribing to these programmes ensure that clinical laboratory test results are accurate, reliable and comparable, regardless of where the laboratories are. Accreditation can be achieved regardless of the size of the laboratory and the complexity of its procedures as long as it subscribes to quality principles and practices. Investment into laboratory quality should be an essential component of a laboratory and not considered a luxury because the combination of quality management and proficiency is what instills public confidence in clinical laboratory results used for patient management. Regulatory Aspect Of Point Of Care Diagnostics; The Nigeria Scenario Speaker 3. Chinyere Charity Ilonze: In recent times, there has been an upsurge in the demand and need to use point of care diagnostics for efficient health care delivery. This has in turn exposed the regulatory gaps and the need for National Regulatory Authorities (NRA) to take charge of the regulatory aspect of POC to avoid chaotic distribution of substandard or fake POC’s within their jurisdiction. NRAs’ in developing countries have been considered non stringent and requires further strengthening in various aspects of their regulatory functions (Milstien and Belgharbi, 2004). POC’s therefore as an emerging area in healthcare and a majority with advanced technology poses a regulatory challenge to most developing countries in Africa. The entire process between discovery of products and the accessibility (Plotkin, 2005) takes a long duration of time. Increased regulatory activities of various National Regulatory Authorities (NRA) have further elongated the time. These activities, though place hurdles for manufacturers ( Milstien and Belgharbi, 2004) have led to ensuring to a large extent that only quality, safe and efficacious products are permitted for use within their jurisdiction. This however implies that POC’s developed and targeted for diseases in developing countries may encounter difficulties with regulatory approval process resulting in delayed delivery and use for the intended population. Efficient harmonized regulatory approval process which can produce timely delivery of quality POC to the African populace is therefore urgently needed. The Nigeria NRA, National Agency for Food and Drug Administration and Control (NAFDAC) was established by decree 1993 (as amended) to control and regulate medicines, food, medical devices and other regulated products. The agency therefore has an established regulatory framework for POC’S which continually improves in line with global best practices. This paper outlines the regulatory approval processes of POC’s and medical devices generally in Nigeria to elicit comparison with other NRA’s procedures and further action. ASLM role in regulating POC Diagnostics Speaker 4. Giorgio Roscigno: In the last ten years we have witnessed a great advancement in diagnostics technology which has led to the further development of POC technologies, which complement the rapid diagnostics tests and are currently being introduced in/control programs all over Africa. However, the uptake of these potentially game-changing technologies has been slow due to the complicated regulatory landscape, the challenges of ensuring test quality as testing is decentralized to more remote settings, and the limited guidance to countries on how to effectively implement these new technologies Currently, few countries in Africa have stringent national regulatory authorities, leading to registration requirements that are unclear and inconsistent. The product registration process is costly and timeconsuming, making manufacturers hesitant to register their products in certain countries, and resulting A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 135 135 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 9 in the cost of registration being passed onto the end customer. Manufacturers often lack understanding of how to submit a high quality dossier, and so the process takes longer than it should with several rounds of submission.There are harmonization efforts underway for several other product categories, including drugs and vaccines, and these could be leveraged for diagnostics. ASLM can play a critical role to improve the regulatory landscape for diagnostics in Africa, including: » Helping countries to standardize regulatory procedures and requirements; » Harmonizing in-country validations to avoid duplication of effort; » Establishing centers of excellence to accelerate product evaluations; » Providing standard protocols and disseminating evaluation results; and » Connecting manufacturers, MOHs, and national laboratories to streamline the process. In the area of Regulatory improvements, ASLM has identified several deliverables to accelerate the expansion of POC testing in Africa which will be discussed and an update will be presented Alex Opio, Ministry of Health, Uganda Co-Convener: Alex Opio is a Ugandan Medical Doctor specialized in Epidemiology. He has a long national level experience in the provision of health services. He received his medical training from Makerere University, Uganda qualifying as a Medical Doctor in 1980. From 1981 to 1985, he worked at Entebbe Grade “A” Hospital as a medical officer. In 1985, he proceeded for postgraduate training at the University of London where he obtained a Master of Science degree in Maternal and Child Health. In 1987, he became the Assistant Manager of the Uganda National Expanded Programme on Immunization. Later, in 1989, he proceeded again for further studies enrolling for a Ph.D. course at Case Western Reserve University, Cleveland, Ohio, USA to study Epidemiology and Biostatistics. After obtaining his Ph.D. in 1994, he returned to Uganda to continue with work at the Ministry of Health. Since then, Alex has grown through the ranks to his current position of Assistant Commissioner of Health Services in the Department of National Disease Control. Jane Carter, African Medical and Research Foundation, Kenya Co-Convener: Jane Carter has worked for 27 years at the African Medical and Research Foundation (AMREF), the largest non-governmental health organization based in Africa. A medical doctor specializing in internal medicine and hematology, she is currently the technical director for AMREF’s regional clinical and diagnostics program, based in Nairobi, Kenya. She has extensive experience in training clinicians and laboratory staff in improved diagnostic practices. She has participated actively in national laboratory policy development in Africa and the Asia Pacific Region and in developing appropriate strategies for improving quality diagnostic services and the application of diagnostic accuracy to the rational use of drugs. Dr. Carter is a member of the World Health Organization’s expert advisory panel on health laboratory services. She has published a number of papers on laboratory development in resource-limited countries. 136 ASLM-book-layout9.indd 136 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM THURSDAY, DECEMBER 6 Elliot P. Cowan, U.S. Food and Drug Administration, Silver Spring, MD, USA Speaker 1: Elliot Cowan has been serving as chief of the product review branch in the division of emerging and transfusion transmitted diseases, office of blood research and review at the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research since 2005. He is also a member of the laboratory technical working group in the Office of the Global AIDS Coordinator for the President’s Emergency Plan for AIDS Relief (PEPFAR), serving as chair of the HIV diagnostics subcommittee and providing technical assistance for laboratory quality assurance issues in PEPFAR countries. Dr. Cowan received his Bachelor’s degree from Williams College and his PhD in biology and biomedical sciences from Washington University in St. Louis. Rosanna Peeling, London School of Hygiene and Tropical Medicine, UK Speaker 2: Rosanna Peeling is Professor and Chair of Diagnostics Research at the London School of Hygiene and Tropical Medicine (LSHTM). Trained as a medical microbiologist, she previously served as the research coordinator and head of diagnostics research at the UNICEF/UNDP/World Bank/WHO Special Programme on Research and Training in Tropical Diseases (WHO/TDR) in Geneva, Switzerland, and the Chief of the Canadian National Laboratory for Sexually Transmitted Diseases. She is a member of many international advisory panels and editorial boards, and is the recipient of many awards, including the YM-YWCA Women of Distinction Award. Her research was featured in a Discovery Channel documentary on chlamydia infection and infertility. Chinyere Charity Ilonze, National Agency for Food and Drug Administration and Control Speaker 3: Chinyere Ilonze is a Regulatory officer of over 10years experience. She joined the National Agency for Food and Drug Administration and Control (NAFDAC) Nigeria in 2002 and is currently the Head of Medical devices, Vaccines and Biological Registration Unit. She is deeply involved with all processes in the licensing of medical devices including Point Of Care Diagnostics. Dr Ilonze holds a master’s degree in Public health and has attended several courses on regulatory processes. She has also participated actively in various International Regulatory fora. Chinyere resides in Lagos Nigeria, with her husband and three lovely children, her hobbies include family outing, gospel music, preaching and humanitarian community services. Giorgio Roscigno Speaker 4: Giorgio Roscigno served as the African Society for Laboratory Medicine as Chief Operating Officer from 10/2011–9/2012, and continues to serve ASLM to date. Previously, he worked as first Chief Executive Officer at Foundation for Innovative New Diagnostics (FIND) in Geneva for eight years where he oversaw the development of five new WHO-approved diagnostic tools for tuberculosis, the distribution and implementation of these tools in 27 high-burden countries and the establishment of ambitious programs in malaria and sleeping sickness. Before joining FIND, Roscigno was among the founding members of the Global Alliance for TB Drug Development (New York / Brussels), a non-profit public-private partnership dedicated to the discovery of new tuberculosis drugs. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 137 137 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 10 INTERNATIONAL COLLABORATION WITH ASLM TO STRENGTHEN LABORATORY MEDICINE At conclusion of this session, the participant will be able to: Date: Thursday, December 6 Time: 5:30PM–7:00PM Location: Room 2.6 Co-conveners: Tsehaynesh Messele, ASLM Vanessa Steenkamp, Univ of Pretoria, SA CE Credits: 1.5 CMLE Contact Hours » Appreciate the synergistic outcomes of effective global laboratory partnerships » Understand the vital role of international collaboration to strengthen laboratory medicine Laboratory Collaboration with ASLM and Speaker 1. El-Hadj Belabbes: Each country in African public health other laboratory Societies: The experience laboratory operates within the parameters of its mission and the of North Africa societies will be great boundaries of its jurisdiction. Most public health laboratories are not distinct entities, but exist within the organizational hierarchy of the country’s public health ministry. The role, structure and even funding of public health laboratories is so variable. Despite the differences among them, all public health laboratories share certain roles and responsibilities: emergency response, reference testing, surveillance, laboratory data, and training. ASLM offers a unique opportunity for countries in Africa to network and foster south-south collaboration. Countries in North Africa have established laboratories societies and this creates a unique opportunity for partnership and collaboration with other African countries in a whole host of areas including training, quality management systems, operational research, continuous medical laboratory education, and inservice training. This talk will highlight these key areas. Egyptian Society of Clinical Chemistry Speaker 2. Mohamed Shaarawy: Egyptian Society of Clinical Chemistry (ESCC) was established in 1970 as a non-profit organization to lead the advancement of professional laboratory medicine practice in Egypt. ESCC works in collaboration with governmental institutions, WHO-EMRO, IFCC-Lab Medicine, Industry, Academic Centers and Universities to support efforts in laboratory diagnostics used for prediction, diagnosis, monitoring of therapy and prognosis to enhance quality care for patients. It is also to noted that ESCC has an important role in preventive medicine which is well appreciated by the Egyptian Ministry of Health. ESCC publishes Arab Journal of Laboratory Medicine since 1970 till now (30 volume x 3 issues). ESCC organized 57 congresses (International, Regional, National) which were accompanied by Industrial exhibitions in addition to several workshops. Pharmacognenomics is the application of the systemic screening of the human genome for the search of genetic markers sensitive to the, action of the drugs. The importance of pharmcogenetic testing in routine medical practice is very valuable for better and safe treatment. Pharmacogenetic research has made tremendous progress in recent years, with the identification of numerous inherited variants that influence drugs response. As a result many drug labels have been updated with information about relevance of pharmagentic biomarkers. 138 ASLM-book-layout9.indd 138 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM THURSDAY, DECEMBER 6 Examples of phamsogentic tests used to predict ADRs (thiopurine drugs) or response to treatment in clinical practice involves: CYP2C9 and clopidogrel; CYP2C9, VDORCI and warfarin; CYP2D6 and tamoxifen; Molecular predictors used with anti-cancer drugs; Phamagenomic of antidepasents, Example of personalized medicine service in the Center of Genomic Medicine, Faculty of Medicine, Cairo University are shown. Translational Medicine in the 21st Century: Role of the Biomedical Laboratory Profession Speaker 3. Vincent S. Gallicchio: The field of laboratory science is engaged in a revolution characterized by discoveries focused in the sciences described as “omics” that are rapidly changing biomedical laboratory medicine. As this revolution unfolds those engaged in the practice of biomedical laboratory medicine have discovered there is a significant void to understand how this new knowledge within “omics” will advance biomedical laboratory practice. How does the increase in this new knowledge being created impact the practice of biomedical laboratory medicine? The old paradigm “from bench to bedside” now has been replaced with the terminology of “translational medicine”. Enormous investments of time, labor and money in biomedical research by the public and private sector are pressured to demonstrate benefits, specifically to patients. Do these investments actually provide benefits to patients? There is a need to demonstrate these advances made as the result of the tremendous investments in research actually improve clinical outcomes for patients. This need has created evidence base medicine. Incorporated in this effort are advances in both diagnostics and therapeutics through the use of well-designed clinical trials eventually to become incorporated into daily medical practice. For the biomedical laboratory the challenge is improving cooperation with basic researchers, clinicians, laboratory professionals, and manufacturers. Recent developments such as “biomarkers” are an example of the current revolution in improving the diagnosis of and treatment of diseases. For educators one challenge is to determine the impact of this revolution in how we educate future biomedical laboratory scientists globally. This presentation will attempt to address these issues. Strengthening the performance of laboratories Speaker 4. Jean Sakandé: The goal of the laboratory network is to strengthen the performance of laboratories. Usually, laboratory network contribute for strengthening laboratories through 5 mechanisms: quality assurance programs, provision of training for laboratory personnel, provision of supplies and equipment, linking of laboratory data and activities to surveillance and promotion of national self-sufficiency and sustainability of laboratory services. Laboratory network can be specialized (Specific disease: TB Laboratory Network) or integrated (all laboratory activities: National Public Health Network). For improvement of regional epidemiological surveillance, National Laboratory Networks are organized into Regional Laboratory Networks (Middle East Consortium on Infectious Disease Surveillance, MECIDS, WHO/AFRO Public Health Laboratory Network , West African Laboratory Network: RESAOLAB). In this talk, I share with participants: the Seven Steps to Building a Statewide Laboratory Network (GUIDE TO DEVELOPING LABORATORY NETWORKS, Carol Kirk, Pete Shult, Ph.D.) and my experiences in laboratory networking through the National Laboratory Network of my country (Burkina Faso) and through the success story of RESAOLAB Project in Burkina Faso, Mali and Senegal funded by Fondation Mérieux and French Development Agency. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 139 139 11/20/12 11:07 PM ROUNDTABLE DISCUSSION 10 Tsehaynesh Messele, African Society for Laboratory Medicine, Ethiopia Co-Convener: The broad public health career of Dr. Tsehaynesh Messele has involved research, laboratory system development and management, emergency management, and high level leadership in the public sector. Messele currently serves as Chief Executive Officer of the African Society for Laboratory Medicine, a newly launched pan-African professional society dedicated to improving laboratory medicine throughout Africa. She previously served as Director General of the Ethiopian Health and Nutrition Research Institute (EHNRI) from 2004-2011 and as a senior technical advisor for the Federal HIV/AIDS Prevention and Control Office of Ethiopia. Messele initiated and led the development of the first National Laboratory Strategic Plan in Ethiopia, as well as its revision into a future integrated system plan. She has published and co-authored more than 60 publications in peerreviewed journals and book chapters. In 2002, the Ethiopian Public Health Association recognized her work through the prestigious “Young Public Health Researcher Award” for outstanding performance in public health research. Messele earned her PhD in 2001 from University of Amsterdam. Vanessa Steenkamp, University of Pretoria, South Africa Co-Convener: Vanessa Steenkamp heads the Phytomedicine Unit in the Department of Pharmacology, University of Pretoria, South Africa. She holds a PhD in Clinical Chemistry with emphasis on the toxicology of traditional herbal remedies. She is actively involved in scientific organizations both locally and abroad: president of the African Federation of Clinical Chemistry; vice-president of the Toxicology Society of South Africa and secretary-general of the South African Association of Basic and Clinical Pharmacology. She also serves on the executive committee of the International Federation of Clinical Chemistry, and is past president of the South African Association of Clinical Biochemistry. She recently completed her term as director of education on the board of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. Dr. Steenkamp is the author and co-author of more than 60 scientific papers. serves as reviewer for 18 international peer-reviewed journals, and is part of the editorial board of four journals. She has received numerous national and international awards. El-Hadj Belabbes, ASLM Ambassador, Algeria Speaker 1: Prof. Belabbes, is a Medical Doctor, Professor of Medical Microbiology, and long-time advocate for laboratory medicine in Africa, accepted the position in March. Prof. Belabbes has been working to promote and strengthen African laboratory medicine since 2001, when he became a member of the World Health Organization, African Regional Office (WHO/AFRO) network of public health laboratories. He then served as WHO/AFRO Laboratory Officer from 2006-2012. Through his work with WHO/AFRO, Belabbes was able to participate in the majority of activities that led to the creation of ASLM, of which he is one of the founding members. Over the past 30 years, Prof. Belabbes has worked in laboratory medicine in both public health and research capacities. For 16 years he occupied the position of Department Head, first at the Laboratory of Medical Biology at the University Hospital of East Algiers/Rouiba, then at the Department of Human Virology at the Institut Pasteur in Algeria. He also provided direction for Algeria’s National Reference Laboratory of HIV/AIDS and the National Reference Laboratory of Influenza. 140 ASLM-book-layout9.indd 140 CAPE TOWN, SOUTH AFRICA : DECEMBER 1-7, 2012 11/20/12 11:07 PM THURSDAY, DECEMBER 6 Mohamed Shaarawy, Cairo University, Egypt Speaker 2: Mohamed Shaarawy currently serves as a Professor in Clinical Biochemistry and as Scientific Director of Genomic Medicine Center at Cairo University, Egypt. He is a member of 10 international medical societies and has authored and published several chapters in books and 214 scientific publications in international and Egyptian medical journals. Dr. Shaarawy has also served as the Editor in Chief of the Arab Journal of Laboratory Medicine since 1980. Furthermore, he is the President of the Egyptian Society for Clinical Chemistry and the Honorary President of the Arab Federation of Clinical Biology. Vincent S. Gallicchio, Clemson University, South Carolina Speaker: 3 Vincent S. Gallicchio has more than 40 years of experience as a biomedical laboratory science administrator, educator and researcher. He serves as Professor of biological sciences and public health at Clemson University in South Carolina, U.S., where he also directs the UNESCO Education and Research Satellite Center Program. He holds a Ph.D. in hematology, a Master’s degree in vertebrate physiology and a Bachelor’s in biology. He also holds a post-graduate degree in medical technology and has completed post-doctoral fellowships in vertebrate physiology and experimental hematology. He also holds an honorary diploma in internal medicine and oncology. He has published more than 150 peerreviewed papers in scientific journals, six books, 40 book chapters, and holds 11 U.S. patents and one international patent. Additionally, Dr. Gallicchio has served as President of the International Society of Lithium Research (ISLR), the International Federation of Biomedical Laboratory Science (IFBLS) and Alpha Eta, the national academic honor society for health science professionals in the U.S. Jean Sakandé, University Hospital of Ouagadougou, Burkina Faso Speaker: 4 Jean Sakande currently serves as a Professor of Biochemisty and Clinical Biologist at the University Hospital of Ouagadougou, Burkina Faso. He is also the Director of Health Laboratories and the coordinator of National Laboratories Network of Burkina Faso. Dr. Sakande, an expert in quality management, is an active member of many national and international societies working towards improving health care including the Medical Society of Burkina Faso and the International Aids Society. Dr. Sakande has authored and published numerous publications on biology, quality management, drug discovery areas. A S L M 2 0 1 2 F I R S T I N T E R N AT I O N A L C O N F E R E N C E : P R O G R A M B O O K ASLM-book-layout9.indd 141 141 11/20/12 11:07 PM