5015 – DotDiver CeliAK IgG

Highlights

• Determination of IgG antibodies against tissue transglutaminase (tTG) and deamidated gliadin (DG)
• Qualitative dot immunoassay supporting the diagnosis of celiac disease in combination with clinical and laboratory findings
• Semi-automated processing using the DotDiver instrument for standardized, reproducible results
• Allows simultaneous detection of multiple antigens on one test strip
• High diagnostic relevance with established serological markers for celiac disease
• Ready-to-use test strips, cartridges, and reagents for efficient workflow
• Suitable for monitoring celiac disease progression and gluten-free diet compliance
• Automatable
• CE marked

Intended Use

The DotDiver CeliAK IgG is a qualitative dot immunoassay for the determination of IgG antibodies against tissue transglutaminase (tTG) and deamidated gliadin (DG) 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

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.