First-ever certified reference material to improve diagnosis of coeliac disease

The JRC has developed, ERM-DA487/IFCC, a new certified reference material with universal characteristics to boost accuracy in coeliac disease testing, leading to better diagnosis and treatment for patients.

The challenge of diagnosis 
Coeliac disease diagnosis relies on the accurate measurement of biomarkers, such as specific antibodies (called anti-tTG antibodies) found in blood.  Despite available medical laboratory tests, diagnosing and treating this disease remains challenging, due to a lack of harmonisation in test results, both for diagnosis and treatment evaluation.   
If the measurements are not comparable between laboratories, it may indeed lead to incorrect diagnoses, misdiagnoses, or delayed diagnoses and/or inadequate patient care.
  
A new standard for diagnosis 
To address this issue, the JRC has released a new Certified Reference Material (CRM) to improve the comparability of medical tests for coeliac disease. It’s a reference material used as a standard to calibrate and validate laboratory tests. There was a strong need to establish an international standard for the medical laboratory tests for coeliac disease. 
The JRC collaborated with the Medicines and Healthcare products Regulatory Agency in the UK, a World Health Organization (WHO) collaborating centre. One large batch of material was produced and one part of this batch is recognised as the first WHO international standard for anti-tTG antibodies, while the other part was certified and will be distributed by the JRC as a CRM. 
The new material has universal properties that make it widely applicable, regardless of the specific test method, laboratory or location. It is a common reference point across different testing methods, laboratories and countries, which is essential for ensuring accuracy and consistency in coeliac disease diagnosis. 

What is coeliac disease? 
Coeliac disease is an autoimmune disorder occurring in genetically susceptible individuals when they eat food containing gluten. It triggers an immune response that mainly attacks the cells in the small intestine. This leads to impaired absorption of nutrients, causing a range of health problems.  
It affects approximately 1% of the EU population, or around 4.5 million people. The prevalence of this condition is substantial, with many patients remaining undiagnosed or experiencing delayed diagnosis. 

The new CRM is available for purchase through the JRC’s online reference materials catalogue.