Fyodor Urine Malaria Test (UMT)
Johns Hopkins University
Africa, South-East Asia, South America. Source: Fyodor website
Blood based malaria tests
Untrained individual and trained individuals.
This product can be purchased directly from websites
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.
This product is for one-time use. Its shelf life is unknown.
According to Fyodor, 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.
A 2014 study in which the disease prevalence was 41.2% found that the detection sensitivity for the UMT was 83.75%. In addition, the UMT had a sensitivity of 120 parasites/μl but the sensitivity at parasite density less than ≤200 parasites/μl was 50% and 89.71% at density ≥201 parasites/μl with specificity of 83.48%. The positive and negative predictive values were 77.91% and 88.07%, respectively. Ultimately, the study concluded that the UMT showed moderate level of sensitivity compared with blood smear microscopy. The test kit requires further improvement on its sensitivity in order to be deployable for field use in malaria endemic regions.
An additional clinical trial was conducted in 2014, however, the results of the clinical performance were not published.
Fyodor, Johns Hopkins University, University of Lagos (Nigeria), Federal Ministry of Health (Nigeria), Duke University
Malaria is a leading cause of death worldwide. Accurate diagnostics help lead to proper treatments. Expert advisors also suggest that for a correct diagnostic through urine there needs to be a normalization to a well known marker such as creatinine, given that for urine (or oral fluid) diagnostics the state of hydration contributes to the quality of the sample, too much fluid will dilute the sample and dehydration will concentrate the sample.
Oguonu, T., et al. The performance evaluation of a urine malaria test (UMT) kit for the diagnosis of malaria in individuals with fever in south-east Nigeria: cross-sectional analytical study. Malaria Journal. 2014; 13:403. DOI: 10.1186/1475-2875-13-403
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