Performance Evaluation of Malaria Pf/Pv Combo Test Kit at Highly Malaria-Endemic Area, Southern Ethiopia: A Cross-Sectional Study

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.