Researchers Develop Accurate, Inexpensive Gluten Intolerance Test

TARRAGONA, SpainA pioneering new test to detect celiac disease has been developed by researchers in Spain and could be available in hospitals within a few years, offering an accurate, quick, cost-effective diagnosis and monitoring solution. Current procedures for celiac disease testing rely on a doctor performing a costly, invasive biopsy that is then sent to an external specialized lab for analysis.

Celiac disease causes gluten intolerance, which triggers inflammation of the small intestine after a person consumes food containing gluten, such as bread, pasta, some drinks and processed meat products. Currently, the only effective treatment is a gluten-free diet.

Part of the problem is a lack of awareness about the disease among medical professionals and the general public. In some countries awareness is high, whereas in others many doctors have never heard of it," said Ciara O'Sullivan, a research professor in the Nanobiotechnology & Bioanalysis Group at Universitat Rovira i Virgili. On the other hand, current testing procedures are costly, invasive and complicated, and in some European countries, particularly in Eastern Europe, and in developing countries there simply aren't the facilities to test for it."

Developed in the CD-Medics* project by a consortium of 20 partners with the support of 9.5 million in funding from the European Commission, the system is the result of a convergence of innovative technologies from several scientific disciplines including microfluidics, nanotechnology and genetic testing.

Our goal was to develop a quick, low-cost and highly accurate test for celiac disease that can be carried out at point-of-care, in the doctor's clinic or even perhaps in the patient's home," said O'Sullivan. Before CD-Medics there was nothing like this available and while our focus was on celiac disease, the technology we developed can also be used to diagnose and monitor a wide variety of other diseasesessentially any disorder that can be detected by looking for DNA or protein markers."

The CD-Medics approach requires only one drop of blood placed into a so-called lab-on-a-chip device, which looks like a credit card but incorporates several innovative components: a micro-structured fluidic network allowing for a precisely controlled flow of reagents, a specially adapted surface for capturing the biological components being looked for, and an electrically driven sensor system to enable integrated and extremely fast detection. The disposable lab-on-a-chip is placed into a biomedical interface instrument and analysis of the blood sample is carried out in a matter of minutes. Results can then be immediately output to the hospital information system and added to the patient's electronic health record (EHR).

For the first time, we have two microsystems of completely different functionalitiesone for DNA typing and the other for the detection of antibodies - and we have designed these microsystems to have a common interface with the instrument so that only one instrument with one slot is required for both microsystems," O'Sullivan said. For diagnosing celiac patients two tests are necessary as DNA testingspecifically for variants of the HLA gene associated with the diseaseor testing for gluten antibodies alone can return false positives. Testing for both means the results are much more accurate."

Follow-up tests to monitor the patient's response to treatment can be carried out in the same way using only the microsystem to detect gluten antibodies. The project partners have patented the technology along with several other important microsystems innovations that went into the CD-Medics devices with a view to developing a commercial product in the near future. The team next will conduct trials with 200 to 300 patients at University Medical Centre Maribor in Slovenia, comparing the results of celiac tests using their system with analyzed tissue samples from biopsies.