Introduction

TMek2 is a rapid lab-on-chip diagnostic test, capable of separating and quantifying the biological components characterized by magnetic properties in a fluid. It is based on TMek, the chip patented in 2017 by Politecnico di Milano as a diagnostic test for malaria, with the “Social Patent” modality. TMek is the result of a research project funded by the Polisocial Awards program of Politecnico, Tid Mekii, which means “malaria” in the language of Cameroon, where one of the inventors worked for two years as a volunteer.

Technical features

Malaria is a very serious and extremely widespread disease: according to the World Health Organization, in 2016 it is estimated that 216 million new cases and 445,000 deaths occurred, mostly in Africa. In less than 5 minutes TMek provides an accurate diagnosis of the presence of any type of plasmodium, the parasite that causes malaria in the patient blood. The tests currently available for this diagnosis are: observation of the blood drop under the microscope, PCR and Rapid Diagnostic Tests (RDT), all characterized by long execution times and the need for expert operators, not always available in the countries where the malaria is endemic. TMek2 can also identify other parasites with magnetic properties (e.g. Schistosoma mansoni). The TMek2 patent application protects an apparatus composed of a silicon chip (for details see Tmek sheet), a microfluidic system for the preparation and isolation of the blood sample to be analyzed by the chip and the positioning control system of the chip in the electronic reader. The microfluidic system takes the patient’s blood drop, treats it appropriately to optimize the reading of the chip and automatically inserts it into the reader, avoiding contamination and risks for healthcare professionals.

Possible Applications

• Quantification of biological components, cellular and non-cellular, dispersed in a biological fluid sample (blood, urine, saliva, sweat etc.) or in a sample of fluids extracted from biological solids (e.g. faeces);
• Pan-plasmodic analysis, able to identify any type of malarial plasmodium;
• Diagnosis of schistosoma mansoni infection.

Advantages

• Increased sensitivity level (100 parasites / µl);
• Qunatitative Method;
• No risk of contamination of the operator handling the sample;
• absence of false positives;
• compatibility with use in tropical areas without specialized personnel;
• speed of execution <5 min;
• low cost (<10 € per test).