4208 – CeliAK IgA LINE

Intended Purpose

The CeliAK IgA LINE is a qualitative line immunoassay for the determination of IgA antibodies against deamidated gliadin (d-gliadin) and tissue transglutaminase (tTG) in human serum. The CeliAK IgA LINE 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.

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.