5015 – DotDiver CeliAK IgG

Highlights

• Detection of IgG antibodies against deamidated gliadin (d-gliadin) and tissue transglutaminase (tTG)
• 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 deamidated gliadin (d-gliadin) and tissue transglutaminase (tTG) 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 small intestinal damage that leads to a “flat” mucosa. This damage often results in malabsorption and deficiencies of essential nutrients. Diagnosis traditionally involves a small intestine biopsy demonstrating the flattened mucosa before initiating a gluten-free diet, followed by mucosal recovery upon dietary intervention.

Gliadin, the alcohol-soluble fraction of gluten, acts as the primary trigger for celiac disease. As a substrate of tissue transglutaminase, gliadin forms high-molecular-weight complexes that stimulate both cellular and humoral immune responses. Serological testing for IgG and IgA antibodies to deamidated gliadin, alongside the detection of human endomysial IgA antibodies (EmA), remains a key component in the diagnosis and monitoring of celiac disease. These markers provide reliable insights into disease presence and progression, complementing clinical evaluation and histological findings.