REVIEW 10.1111/j.1469-0691.2010.03279.

Point-of-care tests for diagnosing infections in the developing world

R. W. Peeling and D. Mabey

London School of Hygiene and Tropical Medicine, London, UK

Abstract

Infectious diseases continue to cause an enormous burden of death and disability in developing countries. Increasing access to appropri-
ate treatment for infectious diseases could have a major impact on disease burden. Some common infections can be managed syndromi-
cally without the need for diagnostic tests, but this is not appropriate for many infectious diseases, in which a positive diagnostic test is
needed before treatment can be given. Since many people in developing countries do not have access to laboratory services, diagnosis
depends on the availability of point of care (POC) tests. Historically there has been little investment in POC tests for diseases that are
common in developing countries, but that is now changing. Lack of regulation of diagnostic tests in many countries has resulted in the
widespread use of sub-standard POC tests, especially for malaria, making it difficult for manufacturers of reliable POC tests to compete.
In recent years increased investment, technological advances, and greater awareness about the importance of reliable diagnostic tests
has resulted in rapid progress. Rapid, reliable and affordable POC tests, requiring no equipment and minimal training, are now available
for HIV infection, syphilis and malaria, but POC tests for other infections are urgently needed. Many countries do not have established
criteria for licensing and introducing new diagnostic tests, and many clinicians in developing countries have become disillusioned with
diagnostic tests and prefer to rely on clinical judgment. Continuing advocacy and training in the use of POC tests are needed, and sys-
tems for quality control of POC tests need to be developed if they are to achieve their maximum potential.

Keywords: Developing world, infections, point-of-care tests, review

Clin Microbiol Infect 2010; 16: 1062–1069

Corresponding author and reprint requests: R. W. Peeling,

Diagnostic Research, London School of Hygiene and Tropical
Medicine, Keppel Street, London WC1E 7HT, UK
E-mail: rosanna.peeling@lshtm.ac.uk

presenting to health facilities continues to be of paramount

Introduction
Infectious diseases continue to cause millions of deaths every
year, the vast majority of them in developing countries, and
a huge burden of disability. Because many of the deaths
caused by infection are in young children, the burden of dis-
ease attributable to infectious diseases, in terms of healthy
life-years lost, is high [1]. Strategies for reducing the burden
of disease caused by infectious diseases include: vaccination
programmes, which are now being expanded to cover Strep-
tocccus pneumoniae and Haemophilus influenzae type b infec-
tions, in addition to the traditional vaccine-preventable
childhood diseases; health education, to promote breast-
feeding, hand-washing, and safe sex; the use of insecticide-
impregnated bed-nets in malaria-endemic communities;
improved provision of clean water and sanitation; and mass
drug administration for certain neglected tropical diseases.
However, appropriate clinical management of sick patients
importance, and represents a tremendous challenge in global
health.
Most patients in developing countries are treated at health
facilities that do not have access to laboratory tests. Patients
in rural areas may have to walk for hours to reach a clinic
where laboratory services are available. If they are asked to
come back for their results the following day or week, many
will fail to do so. The 2004 World Development Report
cites lack of accessibility as one of the major reasons why
health services fail [2].
In many cases, patients can be effectively treated by fol-
lowing WHO guidelines for syndromic management. For
example, children with fever, cough and rapid breathing are
treated for bacterial pneumonia according to guidelines for
the Integrated Management of Childhood Illness (IMCI), using
an antibiotic that covers the common causes; and patients
presenting with symptoms of sexually transmitted infection
(STI), such as urethral discharge or genital ulcer, are treated

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CMI Peeling and Mabey Point-of-care tests for diagnosing infections 1063

for the common causes of those syndromes [3,4]. Syndromic
management can be highly effective, but inevitably results in
overtreatment, resulting in wasted resources and, potentially,
increased antimicrobial resistance. In other cases, e.g. where
asymptomatic infection is common, clinical features are non-
specific, or treatment is potentially toxic and/or difficult to
administer, diagnostic tests are needed. Ideally, the diagnosis
should be made at the point of care, so that treatment can
be started without delay, and should not depend on the
availability of a laboratory or of highly trained staff. This
review will focus on point-of-care (POC) tests for infectious
diseases that could be used to improve clinical management
in resource-limited settings.
Unmet Needs for POC Tests in the
Developing World
Although POC tests are commercially available for several
infectious diseases of public health importance in the devel-
oping world, a large unmet need remains [5] (Table 1).
Fever in children
Until 2009, the WHO recommended that all children pre-
senting to health facilities with fever in malaria-endemic areas
should be treated presumptively for malaria [6]. Since 2009,
as a result of the increased cost of artemisinin combination
treatment and the availability of POC tests with acceptable
performance, the WHO has recommended that malaria
treatment should only be given to children in whom malaria
parasites are detected in the blood [7]. However, with the
increasing use of malaria POC tests, it has become clear that
the majority of children presenting to health services with
fever in malaria-endemic areas do not have malaria [8–10].
Moreover, mortality is higher in the group without malaria,
many of whom are suffering from other infections that are
not adequately treated [11]. Hospital-based studies in Africa
have found that a high proportion of children admitted with
fever are suffering from serious bacterial infections [12,13].
In many cases, because of the spread of antimicrobial resis-
tance, the treatment recommended in the IMCI guidelines
may not be effective [11,14–17]. A POC test for the com-
mon causes of fever, which will be different in different geo-
graphical areas, could have a major impact on the
management of life-threatening infections. It is also important
to know the local antimicrobial susceptibility of the major
bacterial pathogens, which may change rapidly, although
POC tests are not necessarily needed to determine this.
Acute lower respiratory infections
Acute lower respiratory infections are estimated to cause
1 million deaths annually in children aged <5 years [1]. The
WHO IMCI guidelines suggest simple criteria for the clinical
diagnosis of pneumonia and of severe pneumonia in children
presenting to health facilities with fever and cough. Those with
pneumonia should be treated with antibiotics, and those with
severe pneumonia should be referred to hospital [3]. Studies
in Asia and Africa have shown that these guidelines are c. 90%
sensitive and 70% specific [18]. In Africa, many children with
pneumonia do not have access to a trained health worker,
and thus do not receive antibiotics. In Asia and South Amer-
ica, many children receive antibiotics unnecessarily. A simple
POC test to identify children who need antibiotic treatment
that is at least 95% sensitive and 85% specific, and can be used
by a community health worker or pharmacist, could save
more than 150 000 lives annually in Africa, and greatly reduce
overtreatment in Asia and South America [18].
Screening tests for STIs, including human immunodeficiency
virus (HIV) infection
For infectious diseases that cause few or no symptoms but
may result in serious sequelae, such as HIV infection and

TABLE 1. Unmet needs for point-of-care (POC) tests in the developing world

Current diagnosis Unmet need for POC test

Syndromes/conditions
Acute lower respiratory infections
Febrile illness in children
Sexually transmitted infections,
including HIV
Antenatal care
Diseases
Malaria
Tuberculosis
Human African trypanosomiasis
Visceral leishmaniasis
Syndromic management using Integrated Management
of Childhood Illness algorithms
Presumptively treat for malaria in areas of high endemicity
Syndromic management for patients presenting with symptoms;
POC tests to screen for HIV and syphilis
POC test for HIV; haemoglobin POC test for anaemia
Rapid antigen detection tests
None
None that works well
POC serological test works well in India but not in Africa
Test/biomarker to distinguish between bacterial and viral pneumonia
Multiplex POC test for common causes of fever
POC test for genital chlamydial and gonococcal infections;
POC test for paediatric diagnosis of HIV; POC test for
CD4 and viral load
Multiplex POC test for screening HIV, malaria, syphilis, and anaemia
Test for active tuberculosis and antimicrobial susceptibility
POC test for staging disease; POC test of cure
POC test of cure

HIV, human immunodeficiency virus.

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1064 Clinical Microbiology and Infection, Volume 16 Number 8, August 2010
TABLE 2. The ideal rapid test: ASSURED criteria
A = Affordable
S = Sensitive
S = Specific
U = User-friendly (simple to perform in a few steps with minimal training)
R = Robust and rapid (can be stored at room temperature and results available
in <30 min)
E = Equipment-free or minimal equipment that can be solar-powered
D = Deliverable to those who need them
many STIs, diagnostic tests are needed for screening. Early
diagnosis and treatment can reduce the risk of development
of long-term complications and prevent further transmission,
including transmission from mother to child. High-quality
POC tests are available for the serological diagnosis of HIV
infection and syphilis, but POC tests for other STIs, espe-
cially gonorrhoea and chlamydial infection, are urgently
needed [19,20].
POC tests to detect antibodies to HIV-1 and HIV-2 have
revolutionized the diagnosis of HIV infection in developing
countries, greatly increasing access to screening [21,22]. A
POC test for CD4 count could help clinicians in resource-
limited settings to decide when to start antiretroviral treat-
ment, and a POC test for viral load would be of great value
in identifying treatment failure and the need for second-line
treatment. A POC test that would also detect viral antigen
or nucleic acid, and hence identify those with acute infection
and a high viral load, could be of great public health value
[23,24]. A POC test for early paediatric diagnosis would be
useful, as maternal antibodies can be detected in sera of
infants for up to 18 months [25]. Increased funding in this
area has led to the development of several promising POC
technologies for measuring CD4 and viral load. Their perfor-
mance needs to be evaluated before widespread adoption.
Prenatal care
POC tests are urgently needed to provide better care for
pregnant women, as they have difficulty in walking or travel-
ling long distances to seek antenatal services that can screen
them for HIV infection, syphilis, malaria and anaemia. A mul-
tiplex POC test that can be used with whole blood from a
finger prick would be ideal.
Tuberculosis (TB)
In 2007, an estimated 13.7 million people were living with
active TB, 9.3 million developed TB, and 1.8 million died
from TB [26]. Because it requires treatment with several
drugs for a minimum of 6 months, TB cannot be treated pre-
sumptively; a definitive diagnosis must be made before treat-
ment initiation. Resistance to first-line treatment is an
increasing problem, especially in developing countries [27].
The mainstay of diagnosis remains sputum microscopy. It is,
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CMI
at best, 70% sensitive, and less so in HIV-positive patients.
Moreover, it is laborious and time-consuming, and requires
electricity, a functioning microscope, and a well-trained tech-
nician. Culture is more sensitive, but takes up to 6 weeks on
conventional media. Rapid liquid culture systems can give a
result within 10 days, and can also provide data on antimi-
crobial susceptibility. Nucleic acid amplification methods are
now commercially available, but are prohibitively expensive.
A simple, affordable POC test for TB that could also identify
drug-resistant strains would be of enormous public health
benefit [28–30].
Neglected tropical diseases
Human African trypanosomiasis (HAT) and visceral leishman-
iasis (VL) are parasitic infections that are almost invariably
fatal unless treated. Because they affect mainly poor rural
communities, progress in developing new treatments has
been slow, and both require courses of parenteral treatment
that are potentially toxic. A POC agglutination test for anti-
body has been developed for HAT, but its performance is
suboptimal, and it is only useful for diagnosing the West Afri-
can form of the disease [31]. As treatment of HAT depends
on whether or not the central nervous system is involved, it
cannot be started until a lumbar puncture has been per-
formed, with a cell count on cerebrospinal fluid. A simple
POC test for HAT, which would identify those with central
nervous system involvement, would be of great value. A sim-
ple lateral-flow POC test, which detects antibody, has been
developed for VL. It is highly specific, and has good sensitiv-
ity in Asia, but is less sensitive in African populations [32,33].
For both VL and HAT, a POC test of cure would also be of
great value.
Challenges in Providing POC Tests in the
Developing World
Lack of access to good-quality diagnostic tests for infec-
tious diseases is a major contributor to the enormous
burden of infectious diseases in the developing world. The
challenges are gradually being overcome, but progress has
been slow.
Lack of investment in diagnostic research and development
and in diagnostic services
Diagnostics and diagnostics research are often undervalued.
The Lewin report on the value of diagnostics noted that
although diagnostics comprise <5% of hospital costs and
about 1.6% of all USA Medicare costs, their findings influence
60–70% of healthcare decisions [34]. In the developing
CMI Peeling and Mabey Point-of-care tests for diagnosing infections
world, expenditure on diagnostics is often a negligible pro-
portion of healthcare spending. A WHO report showed that
only 6% of health expenditure at a district hospital in Malawi
is on diagnosis [35].
The development of a diagnostic test is estimated to take
5–10 years, with an investment ranging from $2 million to
$10 million [36]. For products with a viable commercial mar-
ket, this is driven, funded and managed largely by the private
sector, drawing on appropriate expertise as needed. In the
developing world, there has been little private sector interest
in investing in diagnostic product development, because of a
perceived lack of return for investment.
Lack of regulatory standards for the approval of diagnostics
National and international regulatory processes for drugs
provide safeguards for their safety and efficacy. Most coun-
tries have a process for reviewing research evidence from
drug trials to determine whether a new drug should be
introduced and how it should be used. Unfortunately, apart
from tests used for blood banking, regulatory standards are
often lacking for diagnostic tests, especially tests for diseases
that are uncommon in industrialized countries [37,38]. As a
result, diagnostic tests are often sold and used in the devel-
oping world without any evidence of effectiveness.
Variable quality of laboratory services
Laboratory diagnosis improves patient care most efficiently
within well-managed healthcare systems. This requires the
following: technical competence, access to good-quality
reagents, and an understanding of quality control; healthcare
providers who value and are able to interpret laboratory
results to guide clinical management; and a system for timely
communication between the laboratory and the healthcare
provider. Even when laboratory services are available, there
are often problems with the quality of the services, owing to
lack of resources, supplies, and trained personnel [39]. These
problems lead to physicians not trusting laboratory results,
which in turn leads to further neglect of laboratory services.
The Way Forward
The year 2008 marked the 30th anniversary of the declara-
tion of Alma-Ata at the International Conference of Primary
Health Care, at which United Nations member states com-
mitted to strengthen primary healthcare for the attainment
of health to permit people to lead socially and economically
productive lives [40]. The use of appropriate technology that
is affordable, relevant to the needs of the population and sci-
entifically sound was emphasized. In terms of diagnostics,
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1065
what are technologies that can be used in primary-healthcare
settings to improve global health?
The ideal POC test
The acronym ASSURED was coined at a 2003 WHO Special
Programme for Research and Training in Tropical Diseases
(WHO/TDR), for the ideal characteristics of a test that can
be used at all levels of the healthcare system [36] (Table 2).
Few existing tests fulfil all of these criteria. In 2004, the
Bill & Melinda Gates Foundation convened a Global Health
Diagnostics Forum to determine the attributable benefits of
improved diagnostics for global health [41]. The conclusion
was that investment in increasing access to diagnostics
will have a greater impact than improvements in test
performance.
Advocacy for appropriate diagnostics
Major efforts are needed to draw attention to the impor-
tance of improved diagnostics for global health. Advocacy
should be aimed at donors, at policy-makers in developing
countries, and at the private sector, including both the diag-
nostics and the pharmaceutical industries, as better diagnos-
tics can decrease the cost of clinical trials and facilitate
evidence-based use of drugs in the developing world.
In the last decade, donors and funders, notably the Bill &
Melinda Gates Foundation, the US National Institutes of
Health, the Wellcome Trust, the UK Department of Interna-
tional Development, and the European Commission, have
increasingly invested in the development of improved diag-
nostics for the developing world. It is hoped that this
increase in funding will result in a robust pipeline of candi-
dates and products along the diagnostic developmental path-
way. But advocacy for diagnostic leadership in developing
countries to create or strengthen the health infrastructure
for better utilization of existing and improved diagnostics is
still needed.
Technological advances
The human genome and genomes of major infectious disease
pathogens have been sequenced, making it possible to iden-
tify novel microbial diagnostic targets and biomarkers as ‘sig-
natures’ of infection. Rapid progress in microbial genetics
and proteomics, together with breakthroughs with innovative
technologies, are currently creating opportunities for the
field to move rapidly forwards if funding is made available.
New technologies have the potential to improve specimen
processing, to enrich diagnostic targets, and to amplify signals
for rapid detection [6,42].
Promising technologies that are being marketed or in the
late stages of development include the following: the use of
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1066 Clinical Microbiology and Infection, Volume 16 Number 8, August 2010
magnetic beads to concentrate nucleic acid or antigens in
clinical samples without the need for centrifugation [43]; a
variety of isothermal nucleic acid amplification techniques,
which can provide the sensitivity of current nucleic acid
amplification techniques without the need for thermal
cycling—some of these, such as recombinase polymerase
amplification technology, can provide a result in 15 min with
the use of a battery-powered instrument [44]; nanobiosen-
sors, which can detect low levels of microbes in a biological
sample in seconds [45]; hand-held microfluidic devices, which
are gradually being commercialized for multiplex detection of
infectious diseases [46–48]; and cost-efficient and robust
optical instrumentation for reading fluorescent signals, which
are being developed to further increase the sensitivity of
POC tests [49].
Enormous investments have been made by governments
in the development of rapid detection technologies for
agents of bioterrorism. The convergence of these detection
technologies with those for diagnostic target concentration
and amplification has led to the development of promising
POC tests on integrated platforms that will require little
user input other than loading the specimen. The result will
be displayed in hand-held devices or, if necessary, built-in
communications modules will allow data transmission for
surveillance purposes.
Product development partnerships
In recent years, partnerships such as the Foundation for
Innovative New Diagnostics, the Program for Appropriate
Technology in Health, the Infectious Diseases Research Insti-
tute and the US National Institutes of Health consortia for
Point of Care Diagnostics have been working with diagnostic
companies to develop POC tests for TB, malaria, STIs, and
neglected tropical diseases. These partnerships create oppor-
tunities for researchers in both the public and private sec-
tors with disease expertise and knowledge of diagnostic
targets to work with those in science and engineering. Test
development grants should include funding for scientists to
spend time in developing country settings where the test
would be deployed before the target product profile can be
finalized and the development plan made [50]. Recently, the
Canadian government announced a 5-year programme,
Grand Challenges Canada, whose first call is for proposals
for POC test development.
Drive for innovation in the developing world
The product pipeline of diagnostics for infectious diseases of
public health importance in the developing world is weak, as
large diagnostics companies have shown little interest, and
companies in the developing world generally do not have suf-
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CMI
ficient research funding or expertise. The WHO/TDR has
recently initiated an African Network for Drugs and Diag-
nostics Innovation, aimed at promoting and building research
and development capacity for target discovery and product
development [51]. This initiative is supported by the WHO/
TDR, the African Development Bank, the European Union,
pharmaceutical companies, and governments in the region.
Discovery research and innovation in public health have
often been hampered by issues with intellectual property. The
Inter-governmental Working Group on Innovation, Intellectual
Property and Public Health, convened by the WHO, has devel-
oped a Global Strategy and Plan of Action to lower the barri-
ers for innovation in public health by exploring different
options for dealing with intellectual property and patent fees.
Development of harmonized regulatory standards
The lack of regulatory standards in developing countries has
resulted in POC tests of low quality being sold and used in
many developing countries [37]. Companies with high-quality
tests cannot compete in markets flooded with cheap, low-
quality tests. There is an urgent need for countries to adopt
quality standards in the approval of diagnostic tests. As most
companies do not have funds to conduct trials in every
country, securing agreements among countries to reduce
regulatory bureaucracy by adopting harmonized regulatory
standards with an international or regional platform would
reduce the cost for companies seeking to register their
products in multiple countries. Those savings can be passed
onto the customers, while ensuring purchasing options and
competition to maximize the choice of proven diagnostic
technologies.
Although there are diagnostic manufacturers’ associations
in Europe, the USA, Japan, China, and India, the establish-
ment of an international federation of diagnostic manufactur-
ers’ associations would give the diagnostics industry a single
voice and an enhanced ability to negotiate with governments
and international agencies. Like the International Federation
of Pharmaceutical Manufacturers’ Association, this federation
should set quality standards and develop a Code of Conduct
for its members, so that the industry has credibility. Like the
pharmaceutical industry, this federation would need to work
with governments to deal with counterfeit products entering
the health system. Creative solutions are also needed to reg-
ulate Internet services that promote and sell unproven diag-
nostic tests.
Bridging the gap between research and policy
Even when diagnostic products are available, many govern-
ments do not have clearly defined processes to select tests
and develop policy and guidelines for their appropriate use.
CMI Peeling and Mabey Point-of-care tests for diagnosing infections
The criteria for selection and procurement should be based
on test performance, reproducibility, heat stability, cost, the
indications for use, and the settings in which the tests will be
used. However, the evaluation of test performance and
other operational characteristics often suffers from a lack of
rigour, such as insufficient sample size or inappropriate study
population. To address the lack of quality standards in diag-
nostics evaluations, the WHO/TDR has assembled a Diag-
nostics Evaluation Expert Panel to provide advice on the
design and conduct of diagnostic evaluations. In collaboration
with the Nature Publishing Group, supplements (http://
www.who.int/tdr) on Evaluating Diagnostics have been pub-
lished for malaria, STIs, and VL.
Capacity building for uptake and delivery of POC tests
Technological advancement is only one side of the coin [52].
Even when a test with acceptable performance is available,
there are considerable challenges and difficulties in introduc-
ing new tests in developing countries. Test introduction and
sustainable adoption depend on a robust healthcare system
and many other factors, including supply chain management,
to avoid frequent stockouts of diagnostics and/or drugs.
Screening of pregnant women for syphilis is recommended
policy in most countries, yet it is estimated that 500 000
babies die each year of congenital syphilis in sub-Saharan
Africa, because of lack of access to antenatal screening [53].
Although several rapid syphilis tests have been found to have
acceptable performance characteristics and to be cost-effec-
tive, and a rapid chlamydial test has been shown to lead to
more cases being treated than PCR, few countries have
taken advantage of these new tools [19,54–56]. The Bill &
Melinda Gates Foundation is funding a multi-country project
on the feasibility and cost-effectiveness of using rapid syphilis
tests for screening prenatal women and high-risk populations.
It is hoped that these implementation projects will identify
barriers, build capacity for stock management and procure-
ment, and encourage the uptake of POC tests.
Global health initiatives, such as the Global Fund for AIDS,
TB, and malaria, the President’s Emergency Program for AIDS
Relief, and the President’s Malaria Initiative, in addition to fund-
ing improved care and treatment, have made significant pro-
gress in terms of improving the capacity of developing
countries to offer healthcare, including quality diagnostic ser-
vices. Other non-governmental organizations and universities
have also increased their efforts at building capacity for diag-
nostic testing and quality management of laboratories [57–59].
Quality assurance
Quality assurance is often considered to be a luxury in
developing countries and, perhaps as a result of this, many
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1067
doctors have little confidence in the results of diagnostic
tests. Once POC tests have been introduced, it will be
important to make proficiency panels widely available to
ensure that they are correctly used [56,57].
Educating healthcare providers
Health providers need to be educated on how to use and
interpret POC tests correctly. This should be included in
medical and nursing school curricula, and continuing medical
education should be provided to doctors, with updates on
diagnostics, similar to those for drugs provided by the phar-
maceutical industry.
Conclusion
Many high-quality diagnostic tests for infectious diseases are
commercially available, but they are neither accessible nor
affordable to most patients in the developing world, where
laboratory services are often limited to major urban centres.
By increasing access to appropriate diagnosis and treatment,
POC tests for infectious diseases could save many lives in
developing countries. Reliable and affordable POC tests are
available for HIV infection, malaria, syphilis, and some
neglected tropical diseases, and it is likely that POC tests for
other diseases will become available in the near future. POC
tests can be used to improve global health, but only if they
are rigorously evaluated, correctly used, and effectively
regulated.
Transparency Declaration
Prof. Peeling has received grants for diagnostics research
from the Bill and Melinda Gates Foundation. Prof. Mabey has
received grants for diagnostics research from the Wellcome
Trust and from the International Trachoma Initiative, which
is funded by Pfizer Inc. Neither author has a commerical
relationship with the diagnostics industry, and neither has
any conflict of interest related to the submitted manuscript.
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