CLIA Gliadin DA IgG
Chemiluminiscence immunoassay for the detection of IgG antibodies to deamidated gliadin in human serum or plasma.
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This kit in detail
- Detection of IgG antibodies to deamidated gliadin (Gliadin DA)
- Evaluate celiac disease-suspected patients including patients with atypical symptoms
- Evaluating individuals at (hereditary) increased risk of celiac disease
- Investigate celiac disease-suspected patients having low IgA or being IgA-deficient
- Monitoring of the gluten-free diet effects in celiac disease patients
- Intended for human serum and plasma
- Deamidated gliadin peptide DGPx1 antigen used
Description
Blood tests are the first step in diagnosing celiac disease and can help determine the need for further evaluation for confirmation 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 gliadin DA and tissue transglutaminase antibodies. Positivity for deamidated gliadin 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.
Gliadin DA antibody levels decrease over time in patients who have been following a gluten-free diet and are used for monitoring of gluten-free diet effects.
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-GDG100
- Size: 100 tests
- Regulatory status: CE IVD
- Clinical topic: Immunology & Autoimmune Diseases
- Diagnostic panel: Gastrointestinal Diseases
- Producer: TestLine Clinical Diagnostics s.r.o.
References
- 11673371,10934583,16436335,21063208,18803427,15472035,20042872
- 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.
- Villalta D, Tonutti E, Prause C, Koletzko S, Uhlig HH, Vermeersch P, Bossuyt X, Stern M, Laass MW, Ellis JH, Ciclitira PJ, Richter T, Daehnrich C, Schlumberger W, Mothes T. IgG antibodies against deamidated gliadin peptides for diagnosis of celiac disease in patients with IgA deficiency. Clin Chem. 2010 Mar;56(3):464-8. doi: 10.1373/clinchem.2009.128132. Epub 2009 Dec 18. PMID: 20022984.
- Rashtak S, Ettore MW, Homburger HA, Murray JA. Comparative usefulness of deamidated gliadin antibodies in the diagnosis of celiac disease. Clin Gastroenterol Hepatol. 2008 Apr;6(4):426-32; quiz 370. doi: 10.1016/j.cgh.2007.12.030. Epub 2008 Mar 4. PMID: 18304884; PMCID: PMC2440671.
- Sugai E, Vázquez H, Nachman F, Moreno ML, Mazure R, Smecuol E, Niveloni S, Cabanne A, Kogan Z, Gómez JC, Mauriño E, Bai JC. Accuracy of testing for antibodies to synthetic gliadin-related peptides in celiac disease. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1112-7. doi: 10.1016/j.cgh.2006.05.004. Epub 2006 Jul 24. PMID: 16860613.
- Reagent Cartridge with specific reagents for the assay
- magnetic particles
- calibrators
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Safety information
Product brochure
Declaration of conformity
Frequently paired with this kit
Other assays and instruments lab teams add alongside the CLIA Gliadin DA IgG.
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