Project
Development of modern infection diagnostics based on electrochemical sensor arrays as detection elements of portable, low-cost POC devices dedicated to rapid and reliable genetic analyses
Abstract
The main goal of the project is to develop a genetic diagnostic procedure, along with the necessary tools for its implementation, that can be directly used in target devices for modern electrochemical molecular diagnostics, fully meeting the requirements of analyses conducted in the POC mode.
Description
The aim of the project is to develop a genetic diagnostic procedure, along with the necessary tools for its implementation, which can be directly utilized in target devices for modern electrochemical molecular diagnostics that fully meet the requirements of analyses conducted in POC (Point-of-Care) mode.
The main assumptions of the project include complete mobility of conducted analyses without any technological barriers, miniaturization, low costs — both per analysis and for the device necessary to perform it — simplicity of performing the assay by non-qualified personnel, short analysis time, and high reliability of the obtained results.
The project plans to develop both the detection elements of such a device and compatible reaction mixtures, along with the optimization of conditions for the amplification of genetic markers. The model system implemented in the project will involve identifying the presence of a selected microorganism species responsible for a specific infection and determining its antibiotic resistance profile based on the detection of DNA sequences in the analyzed sample. Importantly, the work in this project will focus on analyzing unpurified samples, both for nucleic acid amplification and amplicon detection. This will allow, in the final POC tool, the elimination of one of the stages of the assay process, thereby significantly simplifying the device design, achieving an unprecedented level of miniaturization, and reducing production costs — all of which could contribute to the widespread availability of various types of genetic analyses.
The aforementioned goals will be achieved through the development and application of new constructional and biological solutions in the diagnostic procedure. These will include biological electrochemical sensors developed using printed electronics technology, based on self-assembled monolayers serving as biorecognition elements.
Such an approach enables printing multiple electrodes in a small area, which, once properly modified, will function as detection elements for identifying amplified amplicons. This will ensure high throughput for conducted analyses and clearly contrast with current routine solutions, which rely on changes in optical parameters of solutions during amplification reactions (e.g., RT-PCR and fluorescence detection, as well as all commercially available automatic platforms) or, in traditional methods, amplification reactions followed by product separation on agarose or polyacrylamide gels.
The molecular recognition proposed by the project authors, conducted directly on the surface of electrodes, will represent a significant innovation in genetic analysis.
This is particularly important as it enables genetic analysis of unpurified samples and direct acquisition of an electrical (current) signal.
From the biological side, the project will involve:
- i) a reaction mixture dedicated to the amplification of several gene fragments from an unpurified sample, optimized in composition for analyses using the developed multi-electrode sensor;
- ii) proprietary fusion polymerases, allowing efficient amplification of nucleic acids from unpurified samples at approximately 35°C (single-temperature DNA amplification without the need for precise thermal control).
Ultimately, these solutions will enable the development of a diagnostic tool the size of a smartphone, with a simple design, low unit cost, and full mobility for conducting genetic analyses.
Funding
Medical Research Agency in the frame of National Recovery Plan, Component D Effectiveness, accessibility and quality of the health system, Investment D3.1.1 Comprehensive Development of Research in the Field of Medical Sciences and Health Sciences
Contractor
Warsaw University of Technology
Project No
2024/ABM/03/KPO/ KPOD.07.07-IW.07-0081/24-00
Project value
3 773 380,00 zł
CEZAMAT: 301 805 zł
Contract signing date: 11.03.2025
Project value
1 822 070 PLN