Assessment of the Quality of Malaria Rapid Diagnostic Test, Adama District, East Shewa Zone, Ethiopia

Background: In Ethiopia, smear microscopy is the gold standard for malaria diagnosis however; it is not available in health post. Smear microscopy is time consuming, requires trained personnel and needs careful preparation and application of reagents to ensure quality results. Objective: This study was aimed at testing the diagnostic performance of SD BIOLINE malaria rapid diagnostic test (RDT) with reference to smear microscopy for the diagnosis of falciparum and vivax malaria in Ethiopia. Methods: Blood samples were collected from 402 patients suspected to have malaria in four health facilities in the late minor malaria transmission season from June18-30, 2014. The samples were examined immediately by smear microscopy and the RDT (SD BIOLINE Malaria HRP2/pLDH POCT Test kit). Statistical analysis was performed using Epi-info version 7 and the two-way contingency table analysis. Results: The overall parasite positivity using smear microscopy was 163 (45.6%): 136 (33.8%) for P. falciparum, 25 (6.2%) for P. vivax and two (0.5%) for mixed infections. Using the SD BIOLINE RDT, the overall parasite positivity was 176 (43.7%): 149 (37%) for P. falciparum, 26 (6.5%) for P. vivax and 1 (0.2%) for mixed infections. The overall sensitivity and specificity of SD BIOLINE RDT was found to be 98.2% (97.5–99.9%, 95% CI) and 95.2% (93.9–97.7%, 95% CI), respectively. The sensitivity and specificity of SD BIOLINE RDT was found to be 98.2% (94–99.1%, 95% CI) and 95.4% (93.9–97.1%, 95% CI), respectively. The positive predictive value (PPV) and the negative predictive value (NPV) were found to be 93.6% (88.5–96.1%, 95% CI) and 98.7% (95.3–99.8%, 95% CI), respectively. There was an excellent agreement between the smear microscopy and SD BIOLINE RDT with a Kappa value of 0.965 (0.896–0.988, 95% CI). Conclusion: The SD BIOLINE RDT test showed good sensitivity and specificity with an excellent agreement to the reference smear microscopy. The RDT could therefore be used in place of smear microscopy, at health post where the microscope not applicable.