1. travel
2. tourist destinations
3. africa

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