Developing and evaluating a novel dry high throughput lamp assay for detection of low plasmodium falciparum infections.

Abstract

As the prevalence of malaria continues to decrease globally, optimism is growing as countries shift from bringing down the number of new malaria cases to aiming for malaria elimination. Supporting this bold goal is the World Health Organization (WHO) which has guidelines for how this goal may be attained as well as for certification of the elimination of malaria. Thus, it endorsed an ambitious goal of achieving global malaria elimination and eradication. Achieving this milestone requires identification and treatment of all parasite carriers, both symptomatic and asymptomatic. There is therefore need to develop improved high throughput diagnostics, with capacity to detect low parasitemia infections. This would enhance identification and treatment of all asymptomatic cases in the early stages of infection especially in non-endemic areas that play a major role in malaria transmission. The aim of this project was to develop and evaluate a dry high –throughput (HT) LAMP assay for detection of low intensity P. falciparum infections. The assay was modified to enhance throughput, optimized by assessment by inclusion of DMSO to increase sensitivity and specificity. The assay evaluated 134 samples which were validated against Nested PCR.HT-LAMP Sensitivity of 92.1%, Specificity 100 %, Positive predictive value of 100% and Negative predictive value of 97% was achieved. The two assays showed a strong agreement between them (k= 0.943). HT LAMP showed superior diagnostic capacity just like that of Nested PCR and thus it can be used in field evaluations in the quest to eliminate malaria. Further research should also be done to make a multiplex HT-LAMP assay that can detect other strains of Plasmodium and lyophilize the reagents for ease of filed application. Key Words: