EVALUATION OF THE EFFICACY OF THE CARESTART MALARIA HRP2 AND PLDH/HRP2 COMBO COMPARED TO MICROSCOPY IN THE DIAGNOSIS OF MALARIA.


EVALUATION OF THE EFFICACY OF THE CARE START MALARIA HRP2 AND PLDH/HRP2 COMBO COMPARED TO MICROSCOPY IN THE DIAGNOSIS OF MALARIA.  

Table of content

Title page………………..i

Certification………….…ii

Dedication………………iii

Acknowledgement……….iv

Table of content……...…v

Chapter one

1.0    introduction

1.1    statement of the problem

1.2    significance of the study

1.3    research questions

1.4    research hypothesis   

1.    Aims and objectives of the study

Chapter two

Literature review

2.1    taxonomy of malarial parasite:

2.2 morphological forms of malaria parasites

Morphology of trophozoites

Morphology of gametocytes

Morphology of schizonts

Morphology of trophozoites

Morphology of gametocytes

Morphology of schizonts

Morphology of trophozoites

Morphology of gametocytes

Morphology of schizonts

Morphology of trophozoites

Morphology of schizonts

2.3    generalized lifecycle for plasmodium species

2.4    the 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 malaria

Type of rdts

Principle

The use of rdt in nigeria

Efficacy of rdts

Advantage of rdts

Disadvantage rdts

2.6    control of malaria in nigeria

2.6.1    progress of malaria control

2.6.2    problems of malaria control in nigeria

2.6.3    prospects for control

Chapter three

Materials and methods

3.1    study area

3.2    ethical consideration

3.3     research design

3.4    study population

3.5    questionnaires

3.6    administration of questionnaires

3.7    collection of specimen

3.8    data analysis

Chapter four

Result analysis

4.1    data presentation and analysis

4.2    testing of hypothesis

Chapter five

Discussion, conclusion and recommendations

5.1    discussion

5.2    conclusion

5.3    recommendations

5.4    limitations of the study

References

Appendix

Questionnaire

CHAPTER ONE

1.0     INTRODUCTION:  EVALUATION OF THE EFFICACY OF THE CARESTART MALARIA HRP2 AND PLDH/HRP2 COMBO COMPARED TO MICROSCOPY IN THE DIAGNOSIS OF MALARIA.

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 diagnosis, rapid 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., 2007). A 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 elimination 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 on the 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, 2003).

In 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 results owing to the persistence of antigens that can remain in the circulation of a patient after treatment (Wongsrichanalai et al., 2007). 

1.2     Significance of the Study: 

          The 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:

The 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. The findings of this study will provide an alternative, effective and reliable diagnosis of malaria patients in both those that are asymptomatic and symptomatic. RDTs are fast, easy to perform and relatively cheap and can easily be used by both the trained and untrained.

1.3     Research Questions

What is the efficacy 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.

1.4     Research Hypothesis    

HA:  RDTs are more efficient in the detecting of malaria cases than microscopy

HO:   Microscopy is more efficient in defecting malaria than RDTs

1.                 Aims 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 malaria. 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.

                5.2    Conclusion

This study showed that the efficacy and performance of CareStart Ag-Pf/pan and SD Bioline malaria Ag-Pf/pan. RDTs are rapid and simple to perform and the results can be interpreted by anyone or healthcare workers. CareStart Ag-Pf/pan and SD Bioline malaria Ag-Pf/pan is a useful test which has shown desirable results to alleviate the diagnostic challenges by many people who cannot access microscopic services for malaria diagnosis in Nigeria. The results of this study also indication that RDTs should be evaluated in each new setting before they are deployed, in view of possible variations in performance in different populations.

Overall, while 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 especially in endemic areas. RDTs will indisputably help to target malaria treatment in areas where microscopy is poor; on-going evaluations of field use accuracy and further studies on potential factors affecting the sensitivity and specificity of RDTs are proposed. Hence, the RDT can become a good screening test for the diagnosis of malaria in the laboratory. However, the cost of RDT analysis can be a burden to patients in a setting like ours, but this can be averted by interventions from the government and non-profit organizations considering its contribution to patient’s care.

5.3    Recommendations

Based on the findings, discussion, and conclusion of this study, it is imperative to highlight the relevance of malaria RDTs in diagnosing malaria, especially in endemic areas like Nigeria. The study therefore makes the following recommendations to improve on the use, understanding of RDTS in Nigeria, especially in tackling this dreadful disease called malaria.

1.    It is important to adopt a standard malaria testing algorithm for RDTs in the laboratory. Also that negatives malaria RDTs tests must be confirmed by microscopy before communication to the clinician, while positive results by RDTs can be reported without confirmation by microscopy.

2.    Malaria RDTs can be used for the diagnosis of malaria. As malaria is a multisystem disorder which pose major health threat and could mimic many diseases. Clinicians, especially those in endemic areas, should be aware of the varied manifestations and maintain a high index of suspicion for the disease so that the diagnosis and treatment are timely and morbidity and mortality minimized.

3.    Malaria RDTs could be used as alternative where microscopy services are not operational (for instance as a result of power failure, or in the evenings, weekends, and during public holidays) or as a primary diagnostic tool for rural and remote areas without microscopy services, but should not be regarded as a first-line diagnostic test.   5.4    Limitations of the study

This study has several limitations. The data were collected as part of routine programmatic activities and were unlinked to patient records. Thus, it was impossible to collect clinical information, such as recent intake of antimalarials or the presence of other factors, which may have influenced the results. Another limitations is that the + system has been used to grade parasitaemia instead of a parasite count. This less accurate estimation may have influenced the results on sensitivity especially in the stratified analysis of parasitaemia levels. It is important to note that the described data were obtained in true field conditions, that is conditions that were suboptimal in terms of RDTs storage and handling and staff expertise, and non-standardized specimens may have been present. It is known that such factors influence RDTs performance, but it is difficult to optimize all these variables under difficult real-life conditions.

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EVALUATION OF THE EFFICACY OF THE CARESTART MALARIA HRP2 AND PLDH/HRP2 COMBO COMPARED TO MICROSCOPY IN THE DIAGNOSIS OF MALARIA.



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