Fyodor Biotechnologies, Inc.

The purpose of this study is to evaluate the clinical performance of the one-step Fyodor Urine Malaria Test (UMT), to determine its accuracy (sensitivity and specificity) for the diagnosis of Plasmodium falciparum malaria in febrile patients. A total of 1500 properly consented children and adults presenting with fever (axillary temperature ≥37.5°C) or history of fever in the last 48 hours (Group 1), 250 apparently "healthy" individuals (Control, Group 2), and 50 patients with Schistosoma hematobium and Rheumatoid arthritis (Group 3), will be recruited. Matched urine and fingerprick (capillary) blood samples will be collected and tested using the UMT and, Binax NOW® malaria rapid diagnostic test (blood test) and thick smear microscopy, respectively. The overall agreement of the UMT results to the Binax NOW analysis and thick smear microscopy will be used to establish UMT sensitivity and specificity.