4202 – CeliAK IgG LINE

Highlights

• Use of IgG antibodies against deamidated gliadin and tissue transglutaminase (tTG)
• 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 Use

The CeliAK IgG LINE is a qualitative line immunoassay for the determination of IgG antibodies against deamidated gliadin (d-gliadin) and tissue transglutaminase (tTG) 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 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 show the highest predictive value; therefore, clinicians can diagnose patients with IgA deficiency a frequent comorbidity in celiac disease, using IgG antibodies instead.

Publications

• Knütter et al., (2012) Automated interpretation of ANCA patterns-a new approach in the serology of ANCA associated vasculitis