The Relevance of Positive Control Wells in Monitoring the Performance of Malaria Rapid Diagnostic Test in the Field for Effective Case Management of Malaria

International Journal of Research and Scientific Innovation (IJRSI) | Volume VII, Issue X, October 2020 | ISSN 2321–2705

The Relevance of Positive Control Wells in Monitoring the Performance of Malaria Rapid Diagnostic Test in the Field for Effective Case Management of Malaria

Okangba, C. C¹, Oyibo W.A.², Thompson, E. T.³, Ejime E.⁴, Ajani, T.A.⁵, Elikwu, C.J.⁶, Okangba, K. K^7
1,4,5,6,7 Department of Medical Microbiology and Parasitology Benjamin Carson (SNR) School of Medicine, Babcock
University, Illisan –Remo, Ogun State, Nigeria
²ANDI Center of Excellence for Malaria Diagnosis/WHO-FIND Malaria Specimen Collection Site, Department of Medical and
Parasitology College of Medicine, University of Lagos, Lagos, Nigeria
³Department of Medical Microbiology and Parasitology, Jos University Teaching Hospitals, Nigeria

ABSTRACT
Background: Malaria rapid diagnostic tests (MRDTs) are potential breakthrough in the provision of accurate diagnosis in remote areas, but widescale use is hampered by uncertainty over accuracy under field conditions. Rapid diagnostic tests (RDTs) are central to fulfilling the WHO’s recommendation for parasitologic confirmation of all suspected cases of malaria. RDT performance may be compromised when exposed to the high temperature conditions typical of most malaria endemic regions. However, a systematic method to monitor RDT
quality and performance in endemic countries is lacking at the present time. Current methods to monitor RDT
performance in the field include comparing results from RDTs to diagnoses made by light microscopy and
observing health workers perform tests. These methods are not substitutes for direct quality control. Positive Control Wells (PCWs), which contain recombinant malaria parasite antigen, are a novel method for addressing this need for quality assurance. In this study, the suitability of PCWs as quality control kit for malaria RDTs quality assurance testing was evaluated.
Objective: Assess the performance of malaria RDTs using Positive Control Wells and compared with highly characterized Quality Control samples in the case management of malaria.
Method: A total of thirty-five malaria RDTs compromising of twenty-four Histidine rich protein II, five Plasmodium lactate dehydrogenase and three Plasmodium falciparum/ Plasmodium vivax Malaria Rapid Diagnostic Tests were monitored for their performance in the field using Positive Control Wells (PCWs) The CTK Positivia Malaria Ag Rapid Test Assay Control kit with Catalog Number C0010 PCWs (Produced by CTK Biotech, Inc. 10110 Mesa Rim road, San-Diego, CA 92121 USA), and then compared with highly characterized Quality Control (QC)samples. Thermal stability was also assessed after one month of storage at elevated temperatures of 35, 40 and 45oC in the incubator and humidity. The QC samples were diluted to different parasitaemia dilutions (2000, 1000, 200, 150, 100 and 50parasites/microliter of blood {µL}) and then tested with the same MRDTs used to evaluate the performance of the PCWs and to determine the antigen concentration of the PCWs. The wells were reconstituted with buffer for both the positive and negative control wells.

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