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© American Society for Clinical Pathology
Maputo Conference / Scaling Up HiV, TB, and Malaria prograMS
Laboratory Challenges in the Scaling Up of HIV, TB,
and Malaria Programs
The Interaction of Health and Laboratory Systems, Clinical
Research, and Service Delivery
Deborah Birx, MD,1 Mark de Souza, PhD,2 and John N. Nkengasong, PhD1
Key Words: HIV; Tuberculosis; Malaria
A b s t r a c t
Strengthening national health laboratory systems
in resource-poor countries is critical to meeting the
United Nations Millennium Development Goals.
Despite strong commitment from the international
community to fight major infectious diseases, weak
laboratory infrastructure remains a huge rate-limiting
step. Some major challenges facing laboratory
systems in resource-poor settings include dilapidated
infrastructure; lack of human capacity, laboratory
policies, and strategic plans; and limited synergies
between clinical and research laboratories. Together,
these factors compromise the quality of test results
and impact patient management. With increased
funding, the target of laboratory strengthening efforts
in resource-poor countries should be the integrating of
laboratory services across major diseases to leverage
resources with respect to physical infrastructure; types
of assays; supply chain management of reagents and
equipment; and maintenance of equipment.
Reliable laboratory services in resource-poor set-
tings are critical for meeting the health-related Millennium
Development Goals of the United Nations.1 The development
and execution of functional laboratory services at each tier of
health care provision, from primary health centers to regional
and referral centers, are the very underpinnings to successful
care and treatment programs and will be critical in address-
ing future infectious diseases and long-term chronic disease
prevention and treatment.2,3
After decades of limited resources or resources primar-
ily focused on HIV, malaria, and tuberculosis (TB) research,
there has been an unprecedented increase in funding for ser-
vice delivery clinical programs to prevent, care for, and treat
HIV, TB, and malaria.4,5 For example, 5 years ago, it was
estimated that the combined budget for research and clinical
services addressing HIV, TB, and malaria in resource-poor
settings of the world was less than $1 billion. However, today,
the combined total budget is estimated at $10 billion per year
for HIV/AIDS alone, devoted primarily to service delivery.4,5
The increased funding places tremendous responsibilities on
clinicians, researchers, and policy makers in each country to
work closely with laboratory personnel to effectively and effi-
ciently strengthen laboratory capacity that is critical to fight
all 3 major diseases.
Because these diseases require similar types of laboratory
support, it is imperative that efforts to strengthen laboratory
systems transcend any single disease and address key labora-
tory needs at each care and treatment level in an integrated
manner. These integration efforts will require joint planning
for the required physical infrastructures, human capacity, and
policies needed to comprehensively address major infectious
diseases in a tiered network manner. Also key to addressing
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these issues is the need to bridge the gap between care and
treatment providers and the laboratories. Bridging the gap
requires a strong partnership among physicians, nurses, labo-
ratory technicians, and the community. This partnership will
help educate and influence the knowledge and interpretation
of key laboratory findings.
The concept of strengthening laboratories that integrate
multiple major diseases at each level of a health service will
also require that laboratory needs are matched carefully to the
level of clinical interventions.
Thus, each country will need to develop a national labo-
ratory strategy and policy and then work with partners and
donors to implement it at each level of the health system. Key
elements that need to be addressed in a laboratory strategic
plan include physical infrastructure, human capacity, policy
and advocacy, and roles of basic and clinical researchers.
Key points of discussion during the consideration of the
integrated laboratory strategy should consider the following:
(1) the physical infrastructure needed at each level for the
laboratory to provide a safe and efficient work environment
in which the physical space matches the equipment needed
for laboratory assays, (2) the assays to be performed and the
required throughput, (3) the supply chain of equipment and
reagents to prevent stock depletion, and (4) the provision
of routine equipment maintenance. Key to this opportunity
is defining the expected assay throughput and matching the
instrument specifications to the number of assays to be per-
formed. This aspect is often overlooked, with other issues
becoming the key areas of discussion.
Throughout resource-constrained areas, there are inad-
equately trained laboratory technologists and technicians,
and equally important, there are no clear service training
and long-term career pathways. The recently reauthorized
President’s Emergency Plan for AIDS Relief (PEPFAR)
program calls for the training of 140,000 health care work-
ers, including laboratory experts, to be trained in the next
5 years.6 This is a unique opportunity to address a wider
variety of laboratory training needs. Simply addressing the
absolute number of laboratory professionals without dealing
with career progression and continued education opportuni-
ties will not result in the development of a sustainable cadre
of key personnel. Moreover, ensuring that trained laboratory
staff have access to modern, well-functioning laboratory
equipment is crucial.
Policy and Advocacy
The large investment in HIV, TB, and malaria programs
has led to an expansion of creative services to remote popu-
lations; however, laboratory services have not always kept
pace with this expansion. To sustain these programs in the
next decade, we need to fully develop integrated laboratory
systems for all 3 diseases. To ensure this, key policy guid-
ance, standardized operating procedures for implementation,
and national quality management systems incorporating local
quality control and quality assurance programs will be critical.
Essential to the realization of the national laboratory plan is the
full engagement and support of the World Health Organization
and its regional offices, international donors, and implement-
ing partners to support a coordinated tiered laboratory system
that is sustainable with robust supply chains resulting in quality
laboratory results. In this issue of the Journal, Nkengasong and
colleagues7 review critical elements of a laboratory strategic
plan that needs to be addressed in a comprehensive manner.
They also highlight Ethiopia’s success in implementing its
laboratory plan. Policies governing standardization of labora-
tory commodities need to be established as part of the broader
strategic plan. Also in this issue of the Journal, Peter et al8
discuss opportunities and challenges in the standardization of
laboratory commodities, and Abimiku9 and Massambu and
Mwangi10 review country experiences in standardization in
Nigeria and Tanzania, respectively.
Role of Basic and Clinical Researchers
Finally, in each resource-constrained setting, there are
highly talented national scientists and international partners
with sophisticated and well-equipped research laboratories,
often with external accreditation. Although this expertise and
its allied infrastructure should not be distracted from their
focus on the research mission, these experts can provide an
excellent resource for the needed national discussion of the
laboratory system, participate in quality management systems,
and provide a forum for open discussions between service
delivery and research laboratories. In many countries, these
resources have provided intellectual and sometimes physical
support to the aggressive lifesaving service delivery programs.
This should be continued and applauded, but equally impor-
tant will be the long-term support and advocacy for integrated
tiered clinical laboratory systems and intellectual support to
develop national integrated national public health laboratory
and quality systems as outlined in the Maputo Declaration.11
Now is the time to build sustainable laboratory capacity in
resource-poor settings that can be used to manage existing epi-
demics, fight multiple emerging and reemerging diseases, and
provide local facilities for scientific investigators of all levels.
Am J Clin Pathol 2009;131:849-851 851
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© American Society for Clinical Pathology
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From the 1Global AIDS Program, National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention, US Centers for Disease
Control and Prevention, Atlanta, GA; and 2US Military HIV
Research Program, US Army Medical Component of the Armed
Forces Research Institute of the Medical Sciences (USAMC-
AFRIMS), Walter Reed Army Institute of Research, Bangkok,
Supported by the Global AIDS Program, National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, US Centers
for Disease Control and Prevention.
Address reprint requests to Dr Birx: Global AIDS Program,
National Center for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention, Centers for Disease Control and Prevention,
Corporate Square, Mail Stop E04 Atlanta, GA 30329.
The use of trade names is for identification only and does
not constitute endorsement by the US Department of Health and
Human Services, the Public Health Service, or the Centers for
Disease Control and Prevention. The findings and conclusions
in this article are those of the authors and do not necessarily
represent the views of the funding agency.
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3. Petti CA, Polage CR, Quinn TC, et al. Laboratory medicine
in Africa: a barrier to effective health care. Clin Infect Dis.
4. Roberts L, Jasny B. HIV/AIDS money matters. Science.
5. Cohen J. The great funding surge. Science. 2008;321:512-519.
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developing national strategic plans as a guide to strengthen
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standardization in laboratory networks. Am J Clin Pathol.
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11. World Health Organization. The Maputo Declaration on
strengthening of Laboratory systems. Maputo, Mozambique:
World Health Organization; January, 2008. http://www.who.
int/eportuguese/news/en/. Accessed January 24, 2008.