‘Game-changer' new blood test to detect prevalent autoimmune disease without nightmare side effects
People with coeliac disease may soon be able to avoid consuming large quantities of gluten – the substance that triggers their symptoms – to get a diagnosis.
New clinical research published in the journal Gastroenterology has shown a 'game-changer' blood test for gluten-specific T cells that can detect coeliac disease – even when no gluten has been consumed.
Currently, people with suspected coeliac are required to eat large amounts of gluten for weeks to get an accurate diagnosis.
However, researchers said the new blood test could boost rates of diagnosis, identify patients at risk of severe reactions to gluten and detect silent coeliac disease in asymptomatic people.
Coeliac disease is an autoimmune condition where the body attacks its own tissues when gluten is eaten, which prevents normal digestion and absorption of food, with the risk of developing serious health complications. It is driven by eating gluten, a protein found in wheat, barley and rye.
An estimated 1 in 100 people have it in the UK. However, only 36 per cent with the condition are clinically diagnosed, according to Coeliac UK.
Undiagnosed or untreated coeliac disease can result in complications such as osteoporosis, unexplained infertility, neurological dysfunction and, in rare instances, small bowel cancer, Coeliac UK says.
Currently, all coeliac testing methods require regular gluten consumption to be effective, the researchers said.
Many people are deterred from seeking a definite diagnosis because they do not want to consume gluten and be sick, the Australia-based scientists added.
Associate Professor Jason Tye-Din, Head of WEHI's Coeliac Research Laboratory and a gastroenterologist at the Royal Melbourne Hospital, said: 'There are likely millions of people around the world living with undiagnosed coeliac disease simply because the path to diagnosis is difficult, and at times, debilitating.'
'By eliminating the need for a gluten challenge, we're addressing one of the biggest deterrents in current diagnostic practices,' she added.
'This test could be a game-changer, sparing thousands of people the emotional and physical toll of returning to gluten. It's a major step towards faster, safer diagnosis.'
The study evaluated the potential of a blood test to measure an immune marker interleukin 2 (IL-2).
In 2019, researchers found this immune marker spiked in the bloodstream of people with coeliac disease shortly after they ate gluten.
The scientists used blood samples from 181 volunteers, including 75 people with treated coeliac disease, 13 with active, untreated coeliac disease, 32 people with non-coeliac gluten sensitivity and 61 healthy people.
Participant blood samples were then mixed with gluten in a test tube for a day to see if the IL-2 signal appeared.
The team was 'thrilled' to find the test could detect the condition with up to 90 per cent sensitivity and 97 per cent specificity – even in patients following a strict gluten-free diet, PhD researcher Olivia Moscatelli, who was diagnosed with coeliac disease at 18, said.
The IL-2 signal only increased in the volunteers with coeliac disease, showing the immune response to gluten can be detected in a tube, without the need to consume gluten, researchers said.
Ms Moscatelli said the test also performed exceptionally well in people with coeliac disease who had other autoimmune conditions, such as type 1 diabetes or Hashimoto's thyroiditis.
The Walter and Eliza Hall Institute team are now collaborating with Novoviah Pharmaceuticals to confirm the test's accuracy across diverse populations and find real-world data.
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