HILYSENS

Highly sensitive and specific low-cost lab-on-a-chip system for Lyme disease diagnosis

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 Obiettivo del progetto (Objective)

'The aim of HILYSENS is to develop a novel lab-on-chip diagnostic tool to improve clinical diagnostic, disease monitoring and treatment of Lyme Disease by enabling specific and sensitive detection of the human serological response against its causative agent Borrelia burgdoferi infections. Lyme Disease is the most common tick-borne infection in Europe with around 85,000 new cases per year and its incidence is increasing due to climate change. Current laboratory diagnostic methods lack sensitivity and specificity to detect early cases as well as late manifestations of the disease such as chronic or autoimmune-related infections. For this reasons, disease incidence is underestimated as many cases go mis- or undiagnosed. Late, delayed, or inadequate treatment can lead to serious symptoms such as neuroborreliosis or arthritis, which can be disabling and difficult to treat. HILYSENS will develop a specific multi-antigen assay in a lab-on-a-chip device to detect Borrelia infections. HILYSENS will provide a compact and robust lab-on-chip system, designed to work with small volumes and without the need of expert operators. This tool together with a portable reader and user-friendly software will enable more precise, accurate and reproducible testing making it possible to become the standard tool for the disease diagnosis. A novel production approach for the lab-on-a-chip will be developed which will enable to target really low mass-production costs, overcoming one of the main issues of the lab-on-a-chip technology and opening great market opportunities for the participant SMEs. Sensitive and reliable patient diagnosis provided by HILYSENS device will optimise resources available to medical practitioners, heavily reducing the current costs of the disease, increasing profitability and most importantly, patients’ quality of life.'

Introduzione (Teaser)

Lyme disease (LD) is the most common tick-borne infection in Europe with over 85 000 new cases annually. Treatment is often delayed or inadequate due to misdiagnosis, resulting in painful and disabling symptoms.

Descrizione progetto (Article)

LD is caused by the bacterium Borrelia burgdorferi. Left untreated the disease can result in serious symptoms such as arthritis, cardiac muscle infection and neuroborreliosis, inflammation of the central nervous system.

The EU-backed 'Highly sensitive and specific low-cost lab-on-a-chip system for Lyme disease diagnosis' (HILYSENS) project was initiated to address diagnosis issues through the development of a portable, user-friendly, robust, Borrelia-specific multi-antigen assay in a microfluidic lab-on-a-chip (LOC) device. This should enable precise and reproducible detection of Borrelia antibodies in human blood serum for early diagnosis and monitoring of LD treatment progress.

HILYSENS members achieved considerable success in their endeavours. LOC prototypes were manufactured on a large scale using ultraviolet (UV) embossing with a nickel master. Capillary forces were used to transport a sample and reagents to the detection chamber inside the LOC. To optimise the detection system, several antigens specific for Borrelia infections were produced and tested on infected human samples.

Out of these, 16 were selected to detect different stages of Borrelia infection and results were validated using ELISA testing on human sera samples. The selected antigens were successfully immobilised on the chip surface. A fluorescence reader was built to enable detection through quantum dots coated with antibodies against human sera.

The LOC prototype was tested on 50 LD patient samples in order to correlate with clinical diagnostic results. Further development in a post-project phase is being engaged to improve functional features and optimize sensitivity, specificity and reproducibility parameters with regard to LD detection. Small and medium-sized enterprises (SMEs) effectively conducted knowledge transfer through an Exploitation Agreement between the participant SMEs.

Project outcomes have been disseminated through the http://hilysens.eu/ (project website) , posters, leaflets, slides and a public abstract to reach the scientific community, general public and industry.

Socioeconomic costs of LD amount to around EUR 660 million annually. Early and accurate detection of childhood and adult LD will not only considerably reduce health care costs but also improve patient outcomes and quality of life. These innovative LOCs will also increase EU competitiveness in the global medical biosensor devices sector by becoming the standard diagnostic tool for LD. Moreover, this LOC can also be adapted for other diseases and bacterial-sensing applications.