A new blood test developed by ImmusanT in Boston and the Walter and Eliza Hall Institute can rapidly and accurately diagnose celiac disease without the need for prolonged gluten exposure, according to a preliminary result with 48 participants.

The new diagnostic test gave a result within 24 hours and the preliminary findings indicated it could accurately detect celiac disease. Larger studies will be needed to verify the results.

Celiac disease is caused by an abnormal immune (T cell) reaction to gluten in the diet, leading to damage to the small intestine. It can cause digestive symptoms such as nausea, vomiting, bloating, and diarrhea, as well as lethargy, anemia, headaches and weight loss. According to the authors, as many as one in 60 women and one in 80 men in Australia have celiac disease, but they say that four out of five remain undiagnosed.

Dr. Jason Tye-Din, Ms. Cathy Pizzey, Mr. Adam Girardin, and Dr. Melinda Hardy (left to right) from the Walter and Eliza Hall Institute. Credit: Walter and Eliza Hall Institute

"Current diagnosis of coeliac disease is limited by the need for intestinal biopsies and patients to be eating gluten," says Dr. Jason Tye-Din, gastroenterologist and head of celiac research at the Walter and Eliza Hall Institute in Melbourne. "For the many people who follow gluten-free diets without a formal diagnosis, reliable testing for coeliac disease requires them to consume gluten again, which is often unpleasant and difficult. Our findings reveal this novel blood test is accurate after only three days of gluten consumption, not the several weeks or months traditionally required to make a diagnosis using intestinal biopsies."

Tye-Din said that the blood test built on fundamental research discoveries the team had made about celiac disease. "This 'cytokine release' test measures the T cell response to gluten after three days of consumption, and a positive response is highly predictive of celiac disease.. With this test, we were able to detect a T cell response in the majority of study participants known to have celiac disease and importantly, the test was negative in all of the patients who did not have celiac disease, even though they followed a gluten-free diet and thought gluten was the cause of their symptoms."

Tye-Din said that many 'gluten sensitive' people found it distressing to reintroduce gluten into their diet in order to be tested properly for celiac disease. "People are fearful about experiencing unpleasant symptoms and end up stopping prematurely or avoiding testing altogether." 

"A test that simplifies diagnosis for patients is likely to significantly enhance disease detection. This new diagnostic approach is encouraging and we hope that larger studies can validate these findings and establish its role in the diagnosis of celiac disease, with the possibility of avoiding intestinal biopsies for diagnosis altogether."

Dr Bob Anderson, chief scientific officer at ImmusanT, said that the blood test could also assist in the monitoring of a therapeutic vaccine for celiac disease. "This is an important step toward a tool that could monitor changes in the small population of circulating T cells responsible for coeliac disease when using treatments intended to restore tolerance to gluten, such as Nexvax2®, the compound currently being developed by ImmusanT."

Citation: N. Ontiveros, J. A. Tye-Din, M. Y. Hardy and R. P. Anderson, 'Ex-vivo whole blood secretion of interferon (IFN)-γ and IFN-γ-inducible protein-10 measured by enzyme-linked immunosorbent assay are as sensitive as IFN-γ enzyme-linked immunospot for the detection of gluten-reactive T cells in human leucocyte antigen (HLA)-DQ2·5+-associated coeliac disease', Clinical&Experimental Immunology Volume 175, Issue 2, February 2014, Pages: 305–315. DOI: 10.1111/cei.12232. Source: Walter and Eliza Hall Institute