Evaluation of two new immunochromatographic assays for diagnosis of malaria

Abstract

We assessed the performance of two new commercially available rapid diagnostic tests (RDTs) for malaria (SD Bioline Malaria Ag Pf test and Ag Pf/Pan test) in 200 patients with uncomplicated malaria between August and October 2007 in Madagascar. Results of the two RDTs were compared with those obtained by microscopy and real-time polymerase chain reaction. The sensitivity and specificity for detection of Plasmodium falciparum were 93% and 98.9%, respectively, for the SD Bioline Malaria Ag Pf test and 92.9% and 98.9% for the SD Bioline Malaria Ag Pf/Pan test. The sensitivity of the SD Bioline Malaria Ag Pf/Pan test was much lower for detection of other species (63.6%). The sensitivity of the two new assays decreased to 77.3% at parasitemia levels < 100 parasites/microL for detection of P. falciparum.