Fyodor Urine Malaria Test (UMT)

Target SDGs

Market Suggested Retail Price

$7.00

Target Users (Target Impact Group)

Household, Community, Small and Medium-sized Enterprises, Public Sector Agencies, NGOs

Distributors / Implementing Organizations

m-medix (Online Pharmacy and drug store)  

Competitive Landscape

Direct competitors include DDG Rapid Assessment of Infectious Diseases (RAID) Device.

Regions

South America, Southeast Asia, Sub-Saharan Africa

Manufacturing/Building Method

Fyodor Urine Malaria Test kit is mass-produced in Baltimore, Maryland United States by the Fyodor Biotechnologies Inc and is supplied around the world mainly in the Sub-Saharan region and the Tropics.

Intellectural Property Type

Patent

User Provision Model

User can acquire the test strips from the developers, online pharmacies like m-medix and other local pharmacies mostly in Nigeria 

Distributions to Date Status

Unknown

Design Specifications

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%.

Product Schematics

Technical Support

In the packaging, the developer includes the guide notice for users.

Third-party organizations like m-medx also published these user guides.

Replacement Components

No components are needed since each pack comes with a dipstick fully packed and sealed for single use.

Lifecycle

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/uL but the sensitivity at parasite density less than 200 parasites/uL was 50% and 89.71% at density ?201 parasites/uL 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.

Safety

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

Compliance with regulations

Yes. The manufacturer ensured that the product is up to standard and tested to meet the WHO requirements.

Evaluation methods

An observational cross-sectional diagnostic test study as well as case-control, prospective clinical trial was conducted. Detailed methods can be found on each link.

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

Other Information

In news, the World Bank article published as a blog in 2016 acknowledges Fyodor Biotechnologies as a company disrupting Malaria testing.

Another article by the Swiss Re Foundation publishes the UMT as the first non-blood malaria test technique.