Protocol No: ECCT/18/07/03 Date of Protocol: 16-07-2018

Study Title:

Development of innovative integrated system to reduce malaria transmission towards elimination
 in the Lake Victoria basin, Kenya

Study Objectives:
Laymans Summary:
Abstract of Study:

Microscopy is considered a gold standard in malaria testing. Microscopy requires reporting of both the presence (or absence) of malaria parasite as well as the proportion of malaria-infected red blood cells (%), which is deduced by comparing white blood cell counts with red blood cell counts. This labor-intensive method requires many resources including: well trained laboratory technicians, high quality consumables such as liquid stain and glass slides, and quality assurance programs to perform the microscopic examination with excellent precision. Currently marketed Rapid Diagnostic Tests (hereinafter RDTs) can analyze one sample in fifteen to thirty minutes. Since these RDTs are capable of determining the presence or absence of malaria infection by simply observing the presence of positive bands after applying blood to the test kit, they represent useful alternative methods in malaria-epidemic regions where microscopy is not implementable. RDTs, however, do not completely exclude the necessity of microscopy. Microscopy is still required when the number of plasmodia found in blood of patients with malaria is low, or in order to detect less common species such as Plasmodium ovale and Plasmodium malariae. Moreover, RDTs are qualitative testing, and therefore, therapeutic efficiency cannot be confirmed through monitoring. For this reason, the emergence of drugresistant strains brought about by discontinuation of antimalarial drugs in the middle of treatment has been a concern.

 This study will verify the sensitivity performance of XN-30 in determining the percentage of red cells infected with P. falciparum.It will also evaluate the possible utilization of XN-30 autoanalyser in surveillance of malaria in endemic areas. Study participants will be febrile and afebrile patients visiting Homa Bay County Hospital in Kenya.

The XN-30 is capable of partially lysing red blood cells and the plasma membrane of plasmodia by using a newly developed reagent (Lysercell M). This is accomplished after diluting aspirated samples using diluted solution (CELLPACK DCL) at a certain dilution ratio. This lysis allows plasmodia to remain in the erythrocytes. Subsequently, the XN-30 stains the nucleic acids of plasmodia remaining in red blood cells by means of staining solution (Fluorocell M) added along with the reagent (Lysercell M).

It is believed that findings from this study will contribute to malaria control measures and can be useful in large scale medical examinations, such as mass screenings and therapeutic monitoring