Fyodor’s Urine Malaria Test (UMT), currently in clinical validation, is indicated for use in individuals who present with fever suspected of being malaria. The UMT (licensed with exclusive global rights from Johns Hopkins University, Baltimore, Maryland) incorporates a novel dipstick technology that is ideal for rapid point-of-need diagnosis of clinical malaria from urine instead of blood, and offers significant advantages over microscopy and other malaria diagnostics, which require the use of blood. The UMT dipstick detects novel Plasmodium proteins shed in the urine of febrile malaria patients and can be performed and read by persons with little or no training. These novel proteins or fragments are not cleaved by any known proteases, are highly immunogenic and elicit early immune response, and thus present as early markers of clinical malaria.
The UMT is a sensitive and specific immunochromatographic lateral flow assay which can be easily performed by an untrained individual using a urine sample. To perform, the test strip is dropped into a clean container with as little as 100 µl (5 drops) of urine, allowed to wick up the strip for 1-2 minutes, and incubated at room temperature for 20 minutes. If two visible lines appear on the strip, the test is positive; if one line appears, the test is negative.
The UMT demonstrates equivalent performance compared to commercially available blood-based rapid tests for the diagnosis of clinical malaria, with a limit of detection of 125 parasites/µl, well within the 100-200 parasites/µl analytical performance range recommended for malaria RDT’s by the World Health Organization.