Fyodor’s Urine Malaria Test (UMT) is a novel commercial dipstick technology for rapid point-of-need diagnosis of clinical malaria from urine instead of blood.
Market Suggested Retail Price
Distributors / Implementing Organizations
Intellectural Property Type
User Provision Model
Distributions to Date Status
Indispensable equipment for function (Y/N)
Maintenance or calibration required by user at time of use? (Y/N)
Yes, Clean container
Number of Tests Performed
Power supply type: Continuous, Recharging only (V, time required, battery life), Other
Time required for procedure (minutes)
Most generally, the Fyodor Urine Malaria strip is based on Lateral flow techniques. At the Immunological level, clinical malaria commonly results in elevated levels of Histidine Rich Protein-2 and or its protein fragments in the patient’s urine. Against this background, cognate recombinant monoclonal antibody reagents were developed by Fyodor. This qualitative assay consists of a nitrocellulose membrane strip containing relevant antibody reagents and controls immobilized at the specific individual site on the membrane. Dipping the immunochromatographic dipstick in urine, specific malaria parasite protein present in the urine migrates and interacts with immobilized cognate monoclonal antibody resulting in dark-colored strips on the dipstick. UMT strips are packaged in a sealed Mylar foil pouch with a desiccant and stored at room temperature. The UMT is a sensitive and specific immunochromatographic lateral flow assay that 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. Results Positive (+) for malaria is indicated by two red lines on the test strips; Negative (-) for malaria is shown by one red line on the test strip; Invalid result is shown when there is no line on the test strip, in this case, you have to repeat the test. Sensitivity: Adults: 85% | Children ?5: 93%, Specificity: Adults: 84% | Children ?5: 83%.
In the packaging, the developer includes the guide notice for users. Third-party organizations like m-medx also published these user guides.
No components are needed since each pack comes with a dipstick fully packed and sealed for single use.
This product is for one-time use.
Manufacturer Specified Performance Parameters
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. Among the performance targets set were:
- Sensitivity of above 80%
- Specificity of above 80%
- Giving results in under 25 minutes
- Using urine as a sample other than blood
Vetted Performance Status
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/?l but the sensitivity at parasite density less than ?200 parasites/?l was 50% and 89.71% at density ?201 parasites/?l with a 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 a moderate level of sensitivity compared with blood smear microscopy. The test kit requires further improvement on its sensitivity to be deployable for field use in malaria-endemic regions. An additional clinical trial was conducted in 2014.
The Fyodor Urine Malaria strip is a class device under the category of measuring devices. Although not obliged to meet stringent conformity protocols the developers ensure that they comply with the requirements through clinical trials and their protocol. This means that, although the device does not get into contact and affect the human body part, it can provide dependable results for a prescription.
Complementary Technical Systems
In the packaging, there is a user manual with guidelines on how to use the dipstick
Academic Research and References
Oyibo, W. A., Ezeigwe, N., Ntadom, G., Oladosu, O. O., Rainwater-Loveth, K., O’Meara, W., … & Brieger, W., 2017, “Multicenter pivotal clinical trial of urine malaria test for rapid diagnosis of Plasmodium falciparum malaria,” Journal of clinical microbiology, 55(1), pp. 253-263.
Oguonu, T., Shu, E., Ezeonwu, B. U., Lige, B., Derrick, A., Umeh, R. E., & Agbo, E., 2014, “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, 13(1), pp. 1-6.
Okete, J. A., Oden, E. M., & Adofikwu, C. E., 2018, “Reliability of Urine Malaria Test (UMT) for Malaria Diagnosis,” Asian Journal of Research in Medical and Pharmaceutical Sciences, pp.1-9.
Nuru, J., 2017, “MALARIA DIAGNOSIS: CAN THE FUTURE BEAT THE STATUS QUO?.”
Godwin, A. A., Sulieman, M. M., & Panda, S. M., 2017, “Efficiency of Urine Malaria Test Kit for the Diagnosis of Malaria of Febrile Patients in Gombe, Nigeria.”
Compliance with regulations
Yes. The manufacturer ensured that the product is up to standard and tested to meet the WHO requirements.