Abstract
Background Malaria rapid diagnostic tests (RDTs) are alternative diagnostic methods that have enabled reliable biological diagnostic testing in all situations where previously only clinical diagnosis was available. Varying diagnostic accuracy of malaria RDTs makes policymakers confused while choosing malaria test kits for their country. Objective The aim of this study was to evaluate the diagnostic performance of currently being used malaria RDT in Southern Ethiopia. Methods A cross-sectional study design was conducted from October 1 to December 15, 2016. A total of 160 patients were included in the study. Finger-prick blood sample was obtained from study subjects for the RDT test and microscopic examination. Collected data were entered and analyzed using SPSS version 20.0. Result The test kit evaluated had an overall sensitivity, specificity, PPV, and NPV of 97.44%, 93.67%, 93.83%, and 97.37%, respectively, to detect the presence or absence of malaria. Sensitivity and specificity of the kit for P. falciparum detection were 63.27% and 94.3% and for P. vivax detection were 86.96% and 95.62%, respectively. The agreement between microscopy and RDT for specific identification of malaria species was moderate with a kappa value of 0.568. Conclusion The overall performance of the kit was below the WHO standard. Further study on a large sample size is recommended to be carried out in the study area to use the test kit instead of microscopy for malaria diagnosis. Providing training on quality malaria laboratory diagnosis and availing necessary supplies for malaria diagnosis shall also be considered.
Highlights
In Ethiopia, malaria is the leading cause of morbidity and mortality
rapid diagnostic tests (RDTs) are alternate diagnostic methods which enabled reliable biological diagnostic testing in situations where previously only clinical diagnoses were available, it has varying diagnostic accuracy across different geographical regions [6, 7]. eir adoption needs to be guided by local sensitivity tests, to detect functional problems due to exposure to heat, humidity, and manufacturing faults [8, 9]
TM In this study, Care Start Combo test showed an overall sensitivity, specificity, positive predictive values (PPVs), and NPV of 97.44%, 93.67%, 93.83%, and 97.37%, respectively. It showed a better performance when compared with the study conducted in Butajira area, south-central Ethiopia, with overall sensitivity and specificity for the diagnosis of malaria of 90.8% and 82.7%, respectively [15]. e variation in the result may be due to the difference in the method used, with a greater sample size, as they
Summary
In Ethiopia, malaria is the leading cause of morbidity and mortality. Almost 75% of the country is malarious, and an estimated 51 million people (68% of the population) live in areas at risk of malaria [1]. RDTs are alternate diagnostic methods which enabled reliable biological diagnostic testing in situations where previously only clinical diagnoses were available, it has varying diagnostic accuracy across different geographical regions [6, 7]. Malaria rapid diagnostic tests (RDTs) are alternative diagnostic methods that have enabled reliable biological diagnostic testing in all situations where previously only clinical diagnosis was available. E aim of this study was to evaluate the diagnostic performance of currently being used malaria RDT in Southern Ethiopia. E test kit evaluated had an overall sensitivity, specificity, PPV, and NPV of 97.44%, 93.67%, 93.83%, and 97.37%, respectively, to detect the presence or absence of malaria. Further study on a large sample size is recommended to be carried out in the study area to use the test kit instead of microscopy for malaria diagnosis. Providing training on quality malaria laboratory diagnosis and availing necessary supplies for malaria diagnosis shall be considered
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