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
• Automatable

Intended Use

The GliaDea IgG is a quantitative Enzyme-Linked Immunosorbent Assay (ELISA) 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, also known as gluten sensitivity, is characterized by damage to the small intestine, resulting in a “flat” mucosa. These extensive lesions often result in malabsorption and a depletion of key nutrients. The alcohol-soluble fraction of gluten, gliadin, stimulates an inflammatory process in the small intestine because it is a substrate of tissue transglutaminase (tTG) and a causative agent of celiac disease. Cellular and humoral immune responses are likely triggered by gliadin cross-linking into high-molecular-weight complexes.

The serological algorithm for diagnosing celiac disease includes detecting IgA and IgG antibodies to tissue transglutaminase and deamidated gliadin. For patients with IgA deficiency, a common condition among those with celiac disease, IgG antibodies can be used by clinicians for diagnosis.