Abstract
Background: Early and accurate diagnosis of malaria followed by prompt treatment is crucial to reduce morbidity and mortality in endemic regions. Presumptive treatment of malaria is widely practiced where microscopy or rapid diagnostic tests are not readily available. Introduction of rapid diagnostic tests (RDTs) for the treatment of malaria needs prior evaluation of their performance relative to reference methods. Hence, this study evaluated the diagnostic capacity of GENEDIA® Malaria Pf/pan Ag Rapid Test relative to blood smear for P. falciparum and P. vivax malaria in Ethiopia. Methods: This was a cross-sectional study conducted from November to December 2014 on malaria blood samples collected from symptomatic patients who visited malaria control center in Adama, Oromia Region, Ethiopia. Thick and thin malaria blood films stained by 10% Giemsa working solution were examined microscopically under 100x magnifications for Plasmodium detection, species identification and determination of parasitaemia. The RDT was performed as per the manufacturer’s instruction. Results: A total of 417 febrile malaria suspected outpatients were diagnosed in the study center. Of which, 149(35.7%) by light microscopy (Pf =47; Pv =93; mixed Pf/Pv =9), and 151 (36.2%) by Genedia® RDT (Pf=20; Pv=87; Pf/pan=44) were positive for malaria. RDT detected 0.6% (n=27) mixed Pf/pv cases on samples that were P. falciparum conformed by microscopy. The general sensitivity, specificity, positive and negative predictive value of GENEDIA® test relative to microscopy were respectively 95.3%, 96.6%, 94.0% and 97.4%. Conclusion: The GENEDIA® Malaria Pf/pan Ag test showed good sensitivity and specificity to diagnose malaria in Ethiopia, with respect to the blood film microscopy.
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