This is the first prototype for diagnosing gluten intolerance which does not require an intestinal biopsy. The new device identifies the disease by analysing a drop of blood in less than 20 minutes. The device is the result of a European project led by Rovira i Virgili University in Tarragona.
Rovira i Virgili University in Tarragona presented the first prototype for a non-invasive low-cost device to detect celiac disease without the need for an intestinal biopsy. The project was led by Dr O'Sullivan, an ICREA researcher linked to the URV’s Department of Chemical Engineering.
The prototype is the product of 54 months of research by 20 partners from 10 different European countries under the aegis of the European CD-MEDICS project (Celiac Disease- Management, Monitoring and Diagnosis using Biosensors and an Integrated Chip System).
The CD-MEDICS consortium has developed an inexpensive diagnostic tool which identifies genetic and serological markers associated with celiac disease (HLA DQ2/DQ8) in less than 20 minutes using a drop of blood from a finger prick.
If these genes are detected in the patient, the device also looks for antibodies that indicate whether the disease has developed and if the patient’s diet so far has included gluten. The tests are performed in small disposable microfluidic cartridges, containing trials, reagents, sensors and fluid control mechanisms. These are inserted into an instrument about the size of a laptop which analyzes the sensor data and provides the results of the analysis for the doctor.
The device is also equipped with an electronic interface that connects directly to hospital information systems, enabling physicians to access patient records quickly and easily.
The development of this intelligent device means that patients will no longer require a biopsy to determine whether they have celiac disease. Diagnosis will be done in primary care centres, hospitals or by doctors much faster and at a lower cost. Celiac disease, or gluten intolerance, is a disorder that affects 1% of the European population. It is an autoimmune disease triggered by eating gluten, a protein found in wheat, barley, rye and oats.
Gluten intolerance causes severe injury to the mucosa of the small intestine leading to inadequate absorption of nutrients from food. Symptoms can include anaemia, hair loss, joint pain, behavioural problems, severe fatigue and gastrointestinal problems. Sometimes the apparent innocuousness of the symptoms can make diagnosis extremely difficult.
For every individual who is properly diagnosed with the disease, there are seven people who are not diagnosed at all. Because diagnosis can be so difficult, the average time it takes to identify the disease in adults is 11.7 years. Diagnostic methods used to date require a blood test to identify the antibodies associated with celiac disease in addition to a biopsy to determine the existence or extent of the intestinal damage typical of the disease. In 2012, the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition changed diagnostic criteria to include a combination test for TTG antibodies, total IgA and HLA-typing.
Failure to treat celiac disease may lead to infertility, osteoporosis and intestinal cancer, as well as the possibility of developing other diseases like diabetes mellitus, autoimmune thyroiditis and many others.
CD-MEDICS (CELIAC Disease-Management, Monitoring and Diagnosis using Biosensors and an Integrated Chip System) is the name of the European project for the diagnosis, monitoring and management of celiac disease using biosensors and integrated systems on a chip. Twenty institutions from ten EU countries (Germany, Belgium, Slovenia, Spain, Finland, Greece, Ireland, Italy, Sweden, and the United Kingdom) are taking part n the project.
The project is headed by Dr. Ciara O’Sullivan of Rovira i Virgili University who launched the project in February 2008; it is slated to run for a period of 54 months, until 31 July 2012. The project team includes experts in the fields of bio-, micro- and nanotechnologies.
The European Commission funded the project with 9.5 million euros (at a total cost of over 12 million euros) as part of the Seventh Framework Programme, which aims to strengthen European leadership in science and technology.