4208 – CeliAK IgA LINE

Highlights

•Detects IgG antibodies against deamidated gliadin and tissue transglutaminase (tTG)
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Combines multiple disease-specific antigens on one test strip
• Provides clear visual results using an interpretation template
• Ensures reliable performance in routine laboratory workflows
• Supports serological screening and diagnosis of celiac disease
• CE marked
• Manual in vitro diagnostic use

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 show the highest predictive value; therefore, clinicians diagnose patients with IgA deficiency, a frequent comorbidity in celiac disease using IgG antibodies.

Publications

• Conrad et al., (2012) A new dot immunoassay for simultaneous detection of celiac specific antibodies and IgA-deficiency
• Knütter et al., (2012) Automated interpretation of ANCA patterns-a new approach in the serology of ANCA associated vasculitis