Laboratory Testing for Celiac Disease
Helping Support Diagnosis Without Biopsies

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Celiac disease is a chronic and multiorgan autoimmune disease that affects the small bowel in genetically predisposed persons due to the ingestion of gluten.1 It can present a wide range of symptoms such as anemia, vague abdominal symptoms, esophagitis, neuropathy, ataxia, depression, short stature, osteomalacia, and multiple others.1 For the majority of patients, their celiac disease remains undiagnosed.1

 

Diagnostic guidelines for celiac disease recommend starting lab testing with anti-tissue transglutaminase IgA (tTG IgA) combined with the measurement of total serum IgA.1-3

For special conditions, the determination of IgA and IgG antibodies directed to deamidated gliadin peptides and anti-tissue transglutaminase IgG antibodies are recommended.1-3

 

Why choose Thermo Fisher Scientific as your partner in celiac disease testing?

Broadest portfolio for the in vitro diagnosis of wheat-related conditions. The EliA™ Celiac portfolio enables you to offer a best-in-class, workflow optimized testing algorithm to aid in the diagnosis of celiac disease:1-3

Best-in-class tissue transglutaminase IgA test

With a specificity of 98.5%, EliA Celikey IgA test is the most clinically relevant, fully automated, tissue transglutaminase IgA test—helping you help your customers to put their patients first by identifying more subjects suffering from celiac disease, correctly, the first time.4

Helping reduce endoscopies

The European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) 2019 guidelines for the diagnosis of celiac disease state that if an anti-tissue transglutaminase antibody test result is greater than 10 times the manufacturers upper limit of normal range (ULN), then endoscopy can be avoided in favor of confirmatory endomysial antibody (EMA) testing.2

To demonstrate the validity of the ESPGHAN guidelines to conditionally omit biopsies, a prospective multicenter study was performed.5 In this study, it was demonstrated that with a PPV of 99% at just 2 x ULN (20 EliA U/ml) and a PPV of 100% at just 5 x ULN (50 EliA U/ml), the EliA Celikey IgA test may help reduce endoscopies more than any other automated assay. 5

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References
  1. Al-Toma A, Volta U, Auricchio R, Castillejo G, Sanders DS, Cellier C, et al. European Society for the Study of Coeliac Disease (ESsCD) guideline for coeliac disease and other gluten-related disorders. United European Gastroenterol J. 2019;7(5):583-613.
  2. Husby S, Koletzko S, Korponay-Szabo I, Kurppa K, Mearin ML, Ribes-Koninckx C, et al. European Society Paediatric Gastroenterology, Hepatology and Nutrition Guidelines for Diagnosing Coeliac Disease 2020. J Pediatr Gastroenterol Nutr. 2020;70(1):141-56.
  3. Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA, American College of G. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol. 2013;108(5):656-76; quiz 77.
  4. Vermeersch P, Geboes K, Marien G, Hoffman I, Hiele M, Bossuyt X. Serological diagnosis of celiac disease: comparative analysis of different strategies. Clin Chim Acta. 2012;413(21-22):1761-7.
  5. Werkstetter KJ, Korponay-Szabo IR, Popp A, Villanacci V, Salemme M, Heilig G, et al. Accuracy in Diagnosis of Celiac Disease Without Biopsies in Clinical Practice. Gastroenterology. 2017;153(4):924-35.