5015 – DotDiver CeliAK IgG

Intended Purpose

The DotDiver CeliAK IgG is a qualitative dot immunoassay for the determination of IgG antibodies against deamidated gliadin (d-gliadin) and tissue transglutaminase (tTG) in human serum. The DotDiver CeliAK 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 semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Small intestinal damages leading to a so-called “flat” mucosa is characteristics of celiac disease or gluten-sensitivity. Due to these extensive lesions, malabsorption occurs frequently accompanied with a depletion of key nutrients. The diagnosis of celiac disease involves small intestine biopsy showing a “flat” mucosa prior to a gluten-free diet, which is then followed by reconstitution of the mucosa after onset of the diet.

The alcohol soluble fraction of gluten, gliadin, a substrate of tissue transglutaminase, which cross-links into high molecular complexes triggering probably both cellular and humoral immune responses, is the causative agent of celiac disease. Determination of IgG and IgA to deamidated gliadin as well as the detection of human endomysial autoantigens (EmA) IgA is considered as the main serological parameters for celiac disease so far.