1. Recognition and assessment of coeliac disease Implementing NICE guidance 2009 NICE clinical guideline 86

2. What this presentation covers Background Scope Recommendations Costs and savings Discussion Find out more

3. Background Coeliac disease is a state of heightened immune response to ingested gluten in genetically susceptible people It is believed to be present in up to 1 in 100 of the population It often goes unrecognised and is consequently under-diagnosed. Only 10–15% of people with the condition are thought to be clinically diagnosed and some people have no symptoms There is some uncertainty about which serological tests are most suitable for use in the diagnostic process

4. Scope The guideline covers recognition, assessment and investigation of people who present with gastrointestinal or non-gastrointestinal symptoms or signs that are suggestive of coeliac disease The target population is adults and children with symptoms and/or signs that suggest coeliac disease

5. Recommendations The key areas for recommendations are: When to offer testing Dietary considerations before testing Other information before serological testing Serological tests After serological tests

6. Offer serological testing to people with any of the symptoms, signs and conditions associated with coeliac disease Consider offering serological testing to people with conditions that are sometimes associated with coeliac disease When to offer testing

7. Inform people that: testing is accurate only if they follow a gluten-containing diet when following a gluten-containing diet they should eat some gluten in more than one meal every day for at least 6 weeks before testing they should not start a gluten-free diet until diagnosis is confirmed by intestinal biopsy Dietary considerations before testing

8. Inform people that any result from self-testing needs to be discussed with a healthcare professional and confirmed by laboratory results Explain what coeliac disease is, the purpose of serological tests and what the results mean, and the implications of a positive or negative test Inform people that a delayed diagnosis can result in continuing ill health and long-term complications, and in children can result in growth problems Other information before serological testing

9. Tests should be undertaken in laboratories with clinical pathology accreditation Do not use immunoglobulin G (IgG) and immunoglobulin A (IgA) anti-gliadin antibody (AGA) tests Do not use self-tests and/or point-of-care tests for coeliac disease as a substitute for laboratory-based testing Do not use human leukocyte antigen (HLA) DQ2/DQ8 testing in the initial diagnosis of coeliac disease Serological tests: 1

10. Laboratories should use tests in the following order: IgA tissue transglutaminase (tTGA) as the first choice If tTGA test is equivocal, use IgA endomysial antibodies (EMA) test If serology is negative, check for IgA deficiency If IgA deficiency is confirmed, use IgG tTGA and/or IgG EMA serological tests Values and interpretation of results, and recommended actions should be communicated clearly Serological tests: 2

11. Offer referral to a gastrointestinal specialist for intestinal biopsy, to confirm or exclude coeliac disease, to people with: positive serological results negative serological results but with continuing clinical suspicion After serological tests

12. Costs per 100,000 population Recommendations with significant incremental costs Incremental costs (£ per year) Gastrointestinal specialists6,812 Obtaining samples for serological testing17,573 Intestinal biopsies16,833 Serological testing4,504 Estimated incremental cost of implementation45,722

13. Discussion How do we improve recognition of coeliac disease in people presenting with the signs, symptoms and conditions associated with coeliac disease? What serological tests and testing strategies do we use in the diagnostic process for coeliac disease and are these the ones recommended in this guideline? How do we ensure that patients are given all the necessary information on: dietary considerations before testing for coeliac disease the diagnostic process?

14. Find out more Visit www.nice.org.uk/CG86 for:www.nice.org.uk/CG86 the guideline the quick reference guide Understanding NICE guidance costing report and template audit support commissioning factsheet guide to resources