Fyodor Urine Malaria Test (UMT)
Johns Hopkins University
Simple Urine based malaria test dipstick
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.
7.06 USD (Naira 2900) converted in June 2021
Blood based malaria tests
Goal 3: Good Health and well being
For both patients at home and healthcare professionals. Mainly for populations where malaria is an endemic disease most especially Suh-Saharan Africa.
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.
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.
Source: World Bank blog
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.
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
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 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.
In the packaging, there is a user manual with guidelines on how to use the dipstick
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.”
Yes. The manufacturer ensured that the product is up to standard and tested to meet the WHO requirements.
Summary of the results
- Sensitivity for the UMT was 83.75%
- specificity was 83.48%
- The positive predictive value was 77.91%
- The negative predictive value was 88.07%
Another multicenter evaluation was carried out by Wellington A. Oyibo
In context photographs (0)
You can use the form below to contribute a photo of this product.
In context files & documents (0)
Feedback from users, customers & distributors
Please let us know your experience in using this product through comments below.