CLIA Transglutaminase IgA

Description

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 data

• Assay time: 30 min
• Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
• Sample matrix: Serum, Plasma
• Sample volume: 10 μL
• Sample stability: 7 days at 2-8 °C, 24 months at -20 °C
• Measuring range: 5 – 200 U/ml
• Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
• Note: The kits are CE-IVD certified and intended for professional use.

Specifications

• Catalog Number: CL-tTA100
• Size: 100 tests
• Regulatory status: CE IVD
• Clinical topic: Immunology & Autoimmune Diseases
• Diagnostic panel: Gastrointestinal Diseases
• Producer: TestLine Clinical Diagnostics s.r.o.

References

• 9212111,9834256,10934583,14600421,15472035,16436335,18803427,20042872,22266486
• Green PH, Cellier C. Celiac disease. N Engl J Med. 2007 Oct 25;357(17):1731-43. doi: 10.1056/NEJMra071600. PMID: 17960014.
• Harrison MS, Wehbi M, Obideen K. Celiac disease: more common than you think. Cleve Clin J Med. 2007 Mar;74(3):209-15. doi: 10.3949/ccjm.74.3.209. PMID: 17375801.
• Pelkowski TD, Viera AJ. Celiac disease: diagnosis and management. Am Fam Physician. 2014 Jan 15;89(2):99-105. PMID: 24444577.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Reagent Cartridge with specific reagents for the assay
• magnetic particles
• calibrators