5014 – DotDiver CeliAK IgA

Highlights

• Determination of IgA antibodies against tissue transglutaminase (tTG) and deamidated gliadin (DG)
• Supports the diagnosis of celiac disease in combination with clinical and laboratory findings
• Semi-automated use with the DotDiver instrument for standardized processing
• High diagnostic specificity and sensitivity for detecting celiac disease
• Ready-to-use test strips and cartridges for efficient workflow
• Reliable and reproducible results for routine laboratory testing
• Suitable for monitoring disease progression and gluten-related immune response
• CE marked
• Automatable

Intended Use

The DotDiver CeliAK IgA is a qualitative dot immunoassay for the determination of IgA antibodies against tissue transglutaminase (tTG) and deamidated gliadin (DG) in human serum. The DotDiver CeliAK IgA 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. DotDiver CeliAK IgA 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.