TABLE OF CONTENT
1.1 Statement of the Problem
1.2 Significance of the Study
1.3 Research Questions
1.4 Research Hypothesis
2.1 Taxonomy of Malarial parasite:
2.2 Morphological forms of
Epidemiology of Malaria
2.4.1 Malaria in Nigeria
2.4.2 Factors That Contributes to High Malaria Risk
2.5 Clinical features of Malaria
2.5.1 Laboratory Diagnosis of
of Malaria in Nigeria
2.6.1 Progress of
2.6.2 Problems of Malaria Control
2.6.3 Prospects for Control
Presentation and Analysis
4.2 Testing of Hypothesis
Discussion, Conclusion and
of the study
Malaria is a life-threatening illness, that has
continued to pose public health challenges. It affects millions of people all
around the globe especially, in Africa, Asia and South America. Malaria is
currently endemic in over 100 countries with 3 billion people at risk of
infection and around 225 million cases in 2009, leading to approximately
781,000 deaths (WHO, 2010). Malaria
has remained a major public health problem in Nigeria, and is responsible for 30% childhood and 11% maternal mortality (FMoH, 2005).
It accounts for 300,000 deaths each year and about 60% of outpatient visits (President’s
Malaria Iniative, 2011). Together
Nigeria, and the Democratic Republic of Congo account for over 40% the
estimated total malaria burden and deaths globally (WHO, 2012). It
is caused by the asexual form of the parasitic protozoan know as Plasmodium. The species incriminated are Plasmodium
falciparum, Plasmodium vivax, Plasmodium malariae, and
Plasmodium ovale which is found
humans and Plasmodium knowlesi which found in non-humans. Among
these parasites, Plasmodium falciparum and Plasmodium vivax are
the most widespread and common causes of mixed-species malaria, which is
defined as co-infection with more than one species or genotype of Plasmodium
(Mayxay et al., 2004).
Most cases of malaria are uncomplicated, commonly
presenting with fever and sometimes with other non-specific symptoms including
headache, and aches and pains elsewhere in the body (Gilles, 1991; WHO, 2003). Mtoni
and Senosi (2007) noted that early diagnosis and treatment are key to
addressing morbidity and mortality due to malaria. Proper management of malaria cases
within the first 24 hours of onset is considered to be the best way to reduce
its morbidity and mortality (Singh et
al., 2013). This would be adequately achieved if most of the patients have
access to laboratory facilities (Kamugisha et al., 2008). Most victims of malaria still
die, because the disease is not diagnosed in time by health workers (Uzochukwu et al., 2009). Microscopy is the gold standard for laboratory diagnosis
of malaria in many developing countries, though expertise may be lacking in
both endemic and non-endemic settings (Moody, 2002), especially in Nigeria. However,
in situations lacking reliable microscopic
diagnostic tests (RDTs) may offer a useful alternative to microscopy (Nour et al., 2009).
In general, RDTs are fast, easy to perform and
relatively cheap (Lubell et al.,
lot of research and development has been going on to develop alternative
methods for laboratory diagnosis of malaria. Rapid diagnostic tests have been developed,
validated and field tested. It was introduced in
the nineties, but has now undergone many improvements (Martha et al., 2010). Malaria rapid diagnostic
test plays a key role in malaria control and
programmes in order to avoid unnecessary anti-malarial therapy, to prevent drug
resistance and to enhance case finding (Eibach et al., 2013). The RDTs are based
principle of immunochromatography, which require finger prick blood and detect
malaria specific antigen. There are three different RDTs that
are available commercially; one of them is specific for detecting P. falcipraum antigens, while the other
two detects one or more of the three human malaria species. The RDTs
provide quick results, are reliable, and require less skilled persons as compared to
microscopic diagnosis. They do not require electricity or any equipment. It
promotes patient’s confidence as well as health services.
More than 60 RDT brands
and over 200 different products have been developed. Of these, the WHO and
Foundation for Innovative New Diagnostics (FIND) evaluated 70 from 26
manufacturers (WHO, 2008; 2009). Of these products, 39 are three-band tests
that detect and differentiate P. falciparum from non falciparum species
(Martha et al., 2010). The CareStart™
Malaria HRP-2/ pLDH (Pf/pan) Combo Test and the SD Bioline Ag pf/pan, HRP-2 and
pan-pLDH are both a three-band RDT detecting HRP-2 and pan-pLDH. This present study is focused on evaluating the
efficacy of two of the many RDTs; SD Bioline and CareStart™ Malaria kits using
it microscopy test as the gold standard for the diagnosis of malaria.
SD Bioline (Ag
pf/pan, Cassette, RDT, kit) is a one
step differential diagnosis by detecting HRP-II antigen from Plasmodium falciparum and pLDH antigen from other species (P. vivax, P. malariae, P. ovale) in
human whole blood. The CareStart (Combo, dev., RDT) is
a test designed for the differential diagnosis between Plasmodium falciparum and
other Plasmodium species such as Plasmodium vivax, Plasmodium ovale and Plasmodium
malariae. Though, the gold standard for malaria testing remains
microscopy, but the limitations associated with this technique could affect the
speed of delivery of quality services to the patients (Ameh et al., 2012).
1.1 Statement of the Problem
Microscopy has been in use for over 100 years and is
inexpensive, rapid and relatively sensitive when used appropriately (Laveran,
1891). Microscopy is regarded as the ‘gold standard’ for malaria diagnosis
(WHO, 1999). However, the lack of skilled scientists in medical facilities in
affected areas often leads to poor interpretation of data. In addition,
microscopy is time consuming, labour intensive, and cannot detect sequestered P. falciparum parasites (Leke et al., 1999). It is less reliable at
low-density parasitaemia that is, 50 parasites (ml blood) (Kilian et al., 2000; Bell et al., 2005). Even though microscopy
is cheap, reliable and available on an instant base, it has limitations. For
instance, in resource-limited centres, there are problems of equipment,
training manpower, and workload, whereas in non-endemic countries, laboratory
staff may lack sufficient exposure to malaria positive samples resulting in low
expertise (Moody, 2002; Hanscheid,
Nigeria, RDTs are still new to the people, and they are unsure of the efficacy,
accuracy and authenticity. It has been 7 years since the launching of malaria
RDTs in Nigeria but the populace know little or nothing about Malaria RDTs due
to poor promoting from the part of manufacturers. In addition, the implementation
of RDTs also faces many difficulties such as logistics; transport and
continuous supply, limited shelf life and the need of
proper storage rooms. RDTs are quickly affected by humidity and extreme
temperatures (Wongsrichanalai et al., 2007). They are not able to
quantify parasitaemia and may give false positive
to the persistence of antigens that can remain in the circulation of a patient
after treatment (Wongsrichanalai et al., 2007).
of the Study
essence of continuous research and development is to find a way to improve the
lives of people around the globe. Thus,
finding an alternatively cheap, fast, convenient and effective way to diagnosis
malaria is a key to control malaria.
This study is therefore significant in many ways:
finding of this study will be useful and helpful to the Federal and State Government
with regard to malaria eradication in making
decisions on implementation of RDTs for routine diagnosis in the Nigeria,
especially in rural areas.
findings of this study will provide an alternative, effective and reliable
diagnosis of malaria patients in both those that are asymptomatic and
are fast, easy to perform and relatively cheap and can easily be used by both
the trained and untrained.
1.3 Research Questions
of SD Bioline and Carestart when compared to microscopy?
Can RDTs such as SD Bioline and Carestart
be alternative for the gold standard (microscopy) in the diagnosis of malaria.
HA: RDTs are more efficient
in the detecting of malaria cases than microscopy
Microscopy is more
efficient in defecting malaria than RDTs
and Objectives of the Study
The aims and objectives
of this study were to:
Evaluate the efficacy of the Carestart
Malaria HRP2 and pLDH/HRP2 Combo compared to microscopy in the diagnosis of
Determine the sensitivity, specificity,
positive and negative predictive values of the malaria RDTs to microscopy.
Determine the relationship between malaria
parasite density and results of malaria RDTs.
Correlate results of negative malaria
detection rate by microscopy to results of malaria RDTs.
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