Fyodor Urine Malaria Test (UMT)

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.

This product is for one-time use.

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.