3710 – GliaDea IgA

Highlights

• Use of glycoprotein 2 (GP2) antigens
• Ready-to-use (exception: conjugate and wash buffer) and barcoded reagents
• Quality assured handling in routine laboratories
• Incubation at room temperature
• Quantitative determination of IgA antibodies against deamidated gliadin
• Calibrated with internal standard preparation
• Results expressed in U/L
• Excellent diagnostic sensitivity and specificity
• High precision within the measurement range
• CE marked
• Automatable

Intended Use

The GliaDea IgA is a quantitative enzyme-linked immunosorbent assay (ELISA) 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, also known as gluten-sensitivity, is characterized by damage to the small intestine, which leads to a so-called “flat” mucosa. These extensive lesions frequently cause malabsorption, which leads to a depletion of key nutrients. The alcohol-soluble fraction of gluten, gliadin, is a substrate of tissue transglutaminase (tTG) and a causative agent of celiac disease because it stimulates an inflammatory process in the small intestine. 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, clinicians can use IgG antibodies for diagnosis.