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CLIA Transglutaminase IgA

Chemiluminiscence immunoassay for the detection of IgA antibodies to tissue transglutaminase (h-tTG) in human serum or plasma.

Catalog Number: CL-tTA100
Size: 100 tests
Regulatory status: CE IVD
Clinical topic: Immunology & Autoimmune Diseases
Diagnostic panel: Gastrointestinal Diseases
CLIA Transglutaminase IgA
  • Detection of IgA antibodies to tissue transgutaminase (tTG)
  • Evaluate celiac disease-suspected patients including patients with atypical symptoms
  • Evaluating individuals at (hereditary) increased risk of celiac disease
  • Monitoring of the gluten-free diet effects in celiac disease patients
  • Screening test for dermatitis herpetiformis, in conjunction with endomysial antibody test
  • Intended for human serum and plasma
  • Recombinant antigen (h-tTG) used

There are several serological tests that are sensitive in the evaluation of celiac disease. Celiac sprue (Celiac disease, gluten-sensitive enteropathy) is an immune-mediated inflammatory process following ingestion of wheat, rye, or barley proteins that occurs in genetically susceptible individuals. The main symptoms include inflammatory changes in the small intestine mucosa, diarrhea, anemia, weight loss, and general disorders in somatic and psychic development. Celiac disease cannot be confused with the (simple) gluten intolerance often connected with cow’s milk intolerance and intestinal mucosa changes but without activation of transglutaminase.

The most sensitive and specific serologic tests are tTG and deamidated gliadin antibodies. Positivity for tTG IgA and IgG antibodies indicate celiac disease and a small intestinal biopsy is recommended. Although the IgA isotype of these antibodies usually predominates in celiac disease, individuals may also produce IgG isotypes, particularly if the individual is IgA deficient.

The levels of anti-tTG tend to wane in the absence of gluten ingestion, therefore, these markers are useful to monitor adherence to a gluten-free diet.

Technical specifications

Technical data
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Technical data

Assay time30 min
Assay stability30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
Sample matrix Serum, Plasma
Sample volume10 µL
Sample stability7 days at 2-8 °C, 24 months at -20 °C
Measuring range5 - 200 U/ml
Assay/kit contentReagent Cartridge with specific reagents for the assay, magnetic particles, calibrators
Complementary productsWash buffer, Anchor® Tips, Stackable cuvettes, Trigger solutions

The kits are CE-IVD certified and intended for professional use.


References to CLIA Transglutaminase IgA

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  • Pelkowski TD, Viera AJ. Celiac disease: diagnosis and management. Am Fam Physician. 2014 Jan 15;89(2):99-105. PMID: 24444577.
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  • Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA; American College of Gastroenterology. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol. 2013 May;108(5):656-76; quiz 677. doi: 10.1038/ajg.2013.79. Epub 2013 Apr 23. PMID: 23609613; PMCID: PMC3706994.
    See more on PubMed
  • Hill ID, Fasano A, Guandalini S, Hoffenberg E, Levy J, Reilly N, Verma R. NASPGHAN Clinical Report on the Diagnosis and Treatment of Gluten-related Disorders. J Pediatr Gastroenterol Nutr. 2016 Jul;63(1):156-65. doi: 10.1097/MPG.0000000000001216. PMID: 27035374.
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  • Oxentenko AS, Rubio-Tapia A. Celiac Disease. Mayo Clin Proc. 2019 Dec;94(12):2556-2571. doi: 10.1016/j.mayocp.2019.02.019. PMID: 31806106.
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  • Bürgin-Wolff A, Dahlbom I, Hadziselimovic F, Petersson CJ. Antibodies against human tissue transglutaminase and endomysium in diagnosing and monitoring coeliac disease. Scand J Gastroenterol. 2002 Jun;37(6):685-91. doi: 10.1080/00365520212496. PMID: 12126247.
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  • Vitoria JC, Arrieta A, Arranz C, Ayesta A, Sojo A, Maruri N, García-Masdevall MD. Antibodies to gliadin, endomysium, and tissue transglutaminase for the diagnosis of celiac disease. J Pediatr Gastroenterol Nutr. 1999 Nov;29(5):571-4. doi: 10.1097/00005176-199911000-00018. PMID: 10554125.
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  • Di Sabatino A, Vanoli A, Giuffrida P, Luinetti O, Solcia E, Corazza GR. The function of tissue transglutaminase in celiac disease. Autoimmun Rev. 2012 Aug;11(10):746-53. doi: 10.1016/j.autrev.2012.01.007. Epub 2012 Feb 3. PMID: 22326684.
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