3710 – GliaDea IgA

Intended Purpose

The GliaDea IgA is a quantitative immunoassay for the determination of IgA antibodies against deamidated gliadin in human serum. The GliaDea IgA is intended as an aid in the diagnosis of celiac disease in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Celiac disease or gluten-sensitivity is characterized by small intestinal damages leading to a so-called “flat” mucosa. Due to this extensive lesions, malabsorption occurs frequently accompanied with a depletion of key nutrients. The alcohol soluble fraction of gluten, gliadin, a substrate of tissue transglutaminase (tTG), represents a causative agent of celiac disease, by stimulating an inflammatory process in the small intestine. Cellular and humoral immune responses are probably triggered by the cross linking of gliadin into high molecular complexes. Serological method of celiac disease diagnosis includes the detection of IgA and IgG antibodies to tissue transglutaminase and deamidated gliadin. IgA antibodies to tissue transglutaminase are considered to have the highest predictive value, thus patients suffering from IgA deficiency, a frequent concomitant disease in celiac patients, can be diagnosed using IgG type antibodies.

Product Specifications

Title GliaDea IgA
Product code 3710
Indication Celiac disease
Description Enzyme immunoassay for the quantitative determination of IgA antibodies against deamidated gliadin in human serum
Format Microtiter plate coated with deamidated gliadin
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (89 x 1) + 5 x Calibrators and 2 x Controls

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.