4202 – CeliAK IgG LINE

Highlights

• Use of IgG antibodies against tissue transglutaminase (tTG) and deamidated gliadin (DG)
• Ready-to-use test strips and reagents (exception: wash buffer)
• Quality assured handling in routine laboratories
• Clear visual interpretation using an evaluation template
• Simultaneous detection of multiple celiac disease–specific antibodies on one test strip
• High diagnostic relevance for celiac disease, including IgA-deficient patients
• CE marked
• Manual in vitro diagnostic use

Intended Purpose

The CeliAK IgG LINE is a qualitative line immunoassay for the determination of IgG antibodies against tissue transglutaminase (tTG) and deamidated gliadin (DG) in human serum. The CeliAK IgG 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 damage to the small intestine, which leads to a “flat” mucosa. Due to these extensive lesions, malabsorption occurs frequently and is accompanied by a depletion of key nutrients. The alcohol-soluble fraction of gluten, gliadin, is a substrate of tissue transglutaminase and a causative agent of celiac disease because it stimulates an inflammatory process in the small intestine.

The serological method for diagnosing celiac disease includes detecting IgA and IgG antibodies to tissue transglutaminase (tTG) and deamidated gliadin (DG). While IgA antibodies to tissue transglutaminase have the highest predictive value, clinicians can diagnose patients with IgA deficiency, a frequent comorbidity of celiac disease, using IgG antibodies.