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CLIA Gliadin DA IgA

Chemiluminiscence immunoassay for the detection of IgA antibodies to deamidated gliadin in human serum or plasma.

Available
Catalog Number: CL-GDA100
Size: 100 tests
Regulatory status: CE IVD
Clinical topic: Immunology & Autoimmune Diseases
Diagnostic panel: Gastrointestinal Diseases
CLIA Gliadin DA IgA
  • Detection of IgA 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
  • Monitoring of the gluten-free diet effects in celiac disease patients
  • Intended for human serum and plasma
  • Deamidated gliadin peptide DGPx1 antigen used

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 specifications

Technical data
References
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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
Note

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

References

References to CLIA Gliadin DA IgA

  • Green PH, Cellier C. Celiac disease. N Engl J Med. 2007 Oct 25;357(17):1731-43. doi: 10.1056/NEJMra071600. PMID: 17960014.
    See more on PubMed
  • 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.
    See more on PubMed
  • Pelkowski TD, Viera AJ. Celiac disease: diagnosis and management. Am Fam Physician. 2014 Jan 15;89(2):99-105. PMID: 24444577.
    See more on PubMed
  • 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.
    See more on PubMed
  • 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.
    See more on PubMed
  • 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.
    See more on PubMed
  • 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.
    See more on PubMed
  • 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.
    See more on PubMed

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