3810 – GliaDea IgG

Highlights

• Use of deamidated gliadin antigens
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Incubation at room temperature
• Quantitative determination of IgG antibodies against deamidated gliadin
• Calibrated with an internal reference sample
• Results expressed in U/mL
• Excellent diagnostic sensitivity and specificity
• High precision within the measurement range
• CE marked
• Designed for manual in vitro diagnostic use


Intended Use

The GliaDea IgG is a quantitative immunoassay for the determination of IgG antibodies against deamidated gliadin in human serum. The GliaDea IgG 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 show the highest predictive value; therefore, clinicians diagnose patients with IgA deficiency, a frequent concomitant condition in celiac disease, using IgG antibodies.

Publications

Product Specifications

Title GliaDea IgG
Product code 3810
Indication Celiac disease
Description Enzyme immunoassay for the quantitative determination of IgG 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.