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EliA Assays for Celiac Disease (CeD)
After symptom onset, it takes about 11 to 13 years before a patient is correctly diagnosed with celiac disease.1
Help your laboratory expediate the diagnosis of celiac disease with the aid of the EliATM celiac disease portfolio.
What assays are a part of the EliA celiac disease portfolio?
A collection of vital CeD markers
The EliA celiac disease portfolio is made up of four assays: EliA Celikey IgA and EliA Celikey IgG as well as EliA GliadinDP IgA and EliA GliadinDP IgG, which deliver reliable, high-specificity results that aid in the clinical diagnosis of celiac disease.2-9
EliA Celikey IgA
EliA Celikey IgA (tTG-IgA* assay) has a higher specificity compared to competitors as well as a positive predictive value of up to 100%, which can aid in an accurate celiac disease diagnosis without invasive intestinal biopsies.2-3, 5, 10-11
EliA GliadinDP IgA
Deamidated gliadin peptide IgA assays, like EliA GliadinDP IgA , add diagnostic sensitivity, with the potential to identify non-IgA-deficient, anti-tTG-IgA seronegative patients. 12
EliA GliadinDP IgG
Deamidated gliadin peptide IgG assays, like EliA GliadinDP IgG, help in identifying celiac disease in patients that have total IgA and low/negative levels of tissue transglutaminase IgA (tTG-IgA) (a common symptom found in patients with CeD).13-14
EliA Celikey IgG
tTG-IgG† assays, like EliA Celikey IgG, can be used as a reliable second step to help confirm the diagnosis of CeD in patients with initial low total IgA level or selective IgA-deficiency.13-15
*Tissue transglutaminase Immunoglobulin A
†Tissue transglutaminase Immunoglobulin G
Why use EliA assays to aid in diagnosing celiac disease?
The power of a robust menu
By offering EliA Celikey and EliA GliadinDP assays in laboratory testing, you ensure that patients who may have low levels of total IgA don’t get misdiagnosed as well as help to potentially prevent invasive intestinal biopsies in pediatric patients.2-3, 10
Faster differentiation
Celiac disease can be associated with a variety of symptoms which may overlap with over diseases.16-20 Because EliA autoimmunity assays are quick and convenient blood tests, laboratories that offer this testing can help healthcare providers in expediting the differentiation of celiac disease from other disease states.19,21
Long term cost effectiveness for patients
EliA autoimmunity testing helps prevent delays in the diagnosis of celiac disease which can lead to further health issues and hospitalizations that decrease a patient’s quality of life.1, 22-26
After patients are diagnosed with celiac disease, they spend less money on medical visits and miss fewer days of work and school.23-25, 27-28
Valuable information no matter the outcome
While true positive results from the EliA celiac disease portfolio aid in the diagnosis of celiac disease, true negative results can also help narrow differential diagnoses as well as guide decisions in impactful care.2-3,19
EliA celiac disease portfolio laboratory testing algorithm
Applying a standardized testing profile with EliA celiac disease assays allows for convenient and efficient testing for primary care and specialists alike.
For additional info on EliA tests, autoimmune diseases, and/or educational tools and resources, contact our experts.
Resources
Whether you’re a healthcare provider or laboratorian, Thermo Fisher Scientific offers valuable resources geared to your specific needs.
These products may not be cleared for use in your country. Please contact your sales representative for information about specific product availability.
References
1. Norström, F., Lindholm, L., Sandström, O. et al. Delay to celiac disease diagnosis and its implications for health-related quality of life. BMC Gastroenterol 11, 118 (2011). https://doi.org/10.1186/1471-230X-11-118 Gray A M, et al. BMC Health Serv Res 2010;10:105
2. Penny, H.A., Raju, S.A., Lau, M.S. et al. (27 more authors) (2021) Accuracy of a no-biopsy approach for the diagnosis of coeliac disease across different adult cohorts. Gut, 70 (5). pp. 876-883. ISSN 0017-5749
3. Werkstetter, Katharina Julia et al. “Accuracy in Diagnosis of Celiac Disease Without Biopsies in Clinical Practice.” Gastroenterology vol. 153,4 (2017): 924-935. doi:10.1053/j.gastro.2017.06.002
4. Vermeersch, P., et al. "Serological diagnosis of celiac disease: comparative analysis of different strategies." Clin Chim Acta 413(21-22): 1761-1767. (2012).
5. Vermeersch, Pieter et al. “Diagnostic performance of IgG anti-deamidated gliadin peptide antibody assays is comparable to IgA anti-tTG in celiac disease.” Clinica chimica acta; international journal of clinical chemistry vol. 411,13-14 (2010): 931-5. doi:10.1016/j.cca.2010.02.060
6. EliA Celikey IgA Directions for Use 2020 for the Phadia 250 Laboratory System.
7. EliA GliadinDP IgA Directions for Use 2020 for the Phadia 250 Laboratory System.
8. EliA GliadinDP IgG Directions for Use 2020 for the Phadia 250 Laboratory System.
9. EliA Celikey IgG Directions for Use 2020 for the Phadia 250 Laboratory System.
10. Ho, Shaun Sc et al. “Role of serological tests in the diagnosis of coeliac disease in children in New Zealand.” Journal of paediatrics and child health vol. 56,12 (2020): 1906-1911. doi:10.1111/jpc.15076
11. Mubarak, Amani, et al. "Tissue transglutaminase levels above 100 U/mL and celiac disease: a prospective study." World Journal of Gastroenterology: WJG 18.32 (2012): 4399.
12. Sugai E, Hwang HJ, Vázquez H, Smecuol E, Niveloni S, Mazure R, Mauriño E, Aeschlimann P, Binder W, Aeschlimann D, Bai JC. New serology assays can detect gluten sensitivity among enteropathy patients seronegative for anti-tissue transglutaminase. Clin Chem. 2010 Apr;56(4):661-5.
13. Husby, Steffen et al. “European Society Paediatric Gastroenterology, Hepatology and Nutrition Guidelines for Diagnosing Coeliac Disease 2020.” Journal of pediatric gastroenterology and nutrition vol. 70,1 (2020): 141-156. doi:10.1097/MPG.0000000000002497
14. Rubio-Tapia, Alberto et al. “American College of Gastroenterology Guidelines Update: Diagnosis and Management of Celiac Disease.” The American journal of gastroenterology vol. 118,1 (2023): 59-76. doi:10.14309/ajg.0000000000002075
15. Villalta D, Alessio MG, Tampoia M, et al. Testing for IgG class antibodies in celiac disease patients with selective IgA deficiency. Clin Chim Acta. 2007;382(1-2):95-99. doi:10.1016/j.cca.2007.03.028.
16. Haggård, Linnea et al. “High prevalence of celiac disease in autoimmune hepatitis: Systematic review and meta-analysis.” Liver international : official journal of the International Association for the Study of the Liver vol. 41,11 (2021): 2693-2702. doi:10.1111/liv.15000
17. Caio, Giacomo et al. “Celiac disease: a comprehensive current review.” BMC medicine vol. 17,1 142. 23 Jul. 2019, doi:10.1186/s12916-019-1380-z
18. Sun, X., et al. (2016). "Increased Incidence of Thyroid Disease in Patients with Celiac Disease: A Systematic Review and Meta-Analysis." PLoS One 11(12): e0168708.
19. Wolf J, Petroff D, Richter T, Auth MKH, Uhlig HH, Laass MW, Lauenstein P, Krahl A, Händel N, de Laffolie J, Hauer AC, Kehler T, Flemming G, Schmidt F, Rodrigues A, Hasenclever D, Mothes T. Validation of Antibody-Based Strategies for Diagnosis of Pediatric Celiac Disease Without Biopsy. Gastroenterology. 2017 Aug;153(2):410-419.e17. doi: 10.1053/j.gastro.2017.04.023. Epub 2017 Apr 28. PMID: 28461188.
20. Lebwohl, Benjamin et al. “Celiac disease and non-celiac gluten sensitivity.” BMJ (Clinical research ed.) vol. 351 h4347. 5 Oct. 2015, doi:10.1136/bmj.h4347
21. Lacy, Brian E et al. “ACG Clinical Guideline: Management of Irritable Bowel Syndrome.” The American journal of gastroenterology vol. 116,1 (2021): 17-44. doi:10.14309/ajg.0000000000001036
22. van der Windt, Daniëlle A W M et al. “Diagnostic testing for celiac disease among patients with abdominal symptoms: a systematic review.” JAMA vol. 303,17 (2010): 1738-46. doi:10.1001/jama.2010.549
23. Mearns, Elizabeth S et al. “Systematic Literature Review of the Economic Burden of Celiac Disease.” PharmacoEconomics vol. 37,1 (2019): 45-61. doi:10.1007/s40273-018-0707-5
24. Cappell, K., et al. (2020). "Healthcare Resource Utilization and Costs in Celiac Disease: A US Claims Analysis." Am J Gastroenterol 115(11): 1821-1829.
25. Violato, M., et al. (2012). "Resource use and costs associated with coeliac disease before and after diagnosis in 3,646 cases: results of a UK primary care database analysis." PLoS One 7(7): e41308.
26. Dahiya, D. S., et al. (2022). "Celiac disease hospitalizations: an emerging challenge in the United States." Ann Gastroenterol 35(4): 383-392.
27. Gray, A. M. and I. N. Papanicolas (2010). "Impact of symptoms on quality of life before and after diagnosis of coeliac disease: results from a UK population survey." BMC Health Serv Res 10: 105.
28. Long, K. H., et al. (2010). "The economics of coeliac disease: a population-based study." Aliment Pharmacol Ther 32(2): 261-269.
