Evaluation of Nxtektm Eliminate Malaria P.Fagagainest Qpcr to Detect Asymptomatic Plasmodium Falciparum Malaria among Schoolchildren in Jimma Zone; Gomma District, Ethiopia

Abstract

Background: Plasmodium falciparum (P. falciparum) histidine-rich protein2 (HRP2) and pan-Plasmodium lactate dehydrogenase (pLDH)-based rapid malaria diagnostic tests (RDTs) play a critical role in malaria control in endemic countries. NxTek TM Eliminate Malaria PfAgis newly developed HRP2-based highly sensitive malaria RDT. However, hardly any data on its field diagnostic performances are not available in the Jimma zone in south-western Ethiopia. Objective: To evaluate the diagnostic performance of the NxTek TM Eliminate Malaria PfAgagainst quantitative PCR (qPCR) for the detection of asymptomatic P. falciparum malaria infection amongschoolchildren from September –December2021. Methods:A school-based cross-sectional study was conducted from September to December 2021on 994 healthy school children (aged 5 to 15 years) using the multi-stage sampling technique. Finger-pricked blood samples were collected for microscopy, NxTek TM Eliminate Malaria PfAg, conventional RDT (Co-RDT), SD Bioline, and QuantStudio Multiplex PCR. Giemsa-stained blood smears were examined microscopically. Dry blood spots (DBS) were collected for qPCR assay. Results: The overall prevalence of asymptomatic malaria was 5%. The prevalence of P. falciparum was 4.5% by qPCR, 2.2% by NxTek TM Eliminate Malaria PfAg/Co-RDT, and 1.5% by microscope. Compared to qPCR, the sensitivity of NxTek TM Eliminate Malaria PfAgwas 44% and the specificity 100%. PPV and NPV were 100% and 97.43%, respectively. The accuracy of the test was 97.5%. The kappa value was reported as 0.62, indicating substantial agreement between the methods. Compared to the microscope, the sensitivity of the NxTek TM Eliminate Malaria PfAgwas 68.2% while the specificity was 100%. PPV and NPV were 100% and 99.5%, respectively. The accuracy of the test was 99.5%. The kappa value of 0.81 shows perfect agreement between the test methods. Conclusion: The results presented here suggest that NxTek TM Eliminate Malaria PfAghas a satisfactory agreement with qPCR and is a more sensitive tool than the microscope in asymptomatic children and could represent an alternative diagnostic tool for malariacontrol programs.