DIAGNOSTIC PERFORMANCE EVALUATION OF THE SD BIOLINE MALARIA ANTIGEN AG PF/PAN TEST (05FK60) IN A MALARIA ENDEMIC AREA OF SOUTHERN ETHIOPIA

Rapid diagnostic tests (RDTs) capable of detecting and differentiating Plasmodium species are needed in areas in which microscopy is unsuitable. This study was conducted to assess the diagnostic performance of the rapid test kit - SD BIOLINE Malaria Ag Pf/Pan((r)) (05FK60) in an endemic area. Microscopy of Giemsa-stained blood films were performed to detect and estimate the Plasmodium density in malaria suspected patients. The performance of the SD BIOLINE Malaria Ag Pf/Pan test was evaluated using 272 Plasmodium-positive and 102 negative blood samples. The overall sensitivity of the SD BIOLINE Malaria Ag Pf/Pan test was 99.5% for P. falciparum and 92.6% for non-P. falciparum malaria infections. The respective specificity, PPV, and NPV of the test were 98.0, 98.4, and 99.0% for the diagnosis of P. falciparum, and 100.0 %, 100.0%, and 94.4% for non-P. falciparum species. The SD BIOLINE Malaria Ag Pf/Pan test showed an excellent performance in diagnosing Plasmodium infections in an endemic setting. Therefore, this point-of-care test could be used as an alternative to microscopy in places where P. falciparum is endemic and microscopy is unsuitable.