8064 – CytoBead^® CeliAK

Highlights

• Slides coated with cryostat tissue sections of monkey esophagus and beads coated with tTG, deamidated gliadin (DG), and anti-human IgA
• Sensitive detection of IgA or IgG antibodies for celiac disease diagnosis
• Ready-to-use reagents (exception: PBS buffer)
• Quality assured handling in routine laboratories
• Short incubation times (30 min / 30 min) at room temperature
• Consistent processing for parallel use of multiple IF assays
• High diagnostic sensitivity and specificity
• Automated imaging using the AKLIDES® or akiron® systems
• CE marked

Intended Use

The CytoBead^® CeliAK is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgA or IgG antibodies in human serum against endomysium, tissue transglutaminase (tTG) and deamidated gliadin (DG) as well as for control of IgA antibodies. The CytoBead^® CeliAK 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 (CD) is an immune-mediated disorder triggered by ingestion of gluten, leading to damage of the small intestinal mucosa and the formation of a so-called “flat” mucosa. This tissue damage often results in malabsorption of nutrients, causing deficiencies in iron, calcium, and vitamins, and can manifest with gastrointestinal and systemic symptoms.

The immune system in CD produces highly specific autoantibodies, including anti-tTG antibodies, anti-DG antibodies, and endomysial antibodies (EmA). EmA specifically recognize extracellular tTG, a key autoantigen in the disease. Most of these antibodies are of the IgA class, but in patients with IgA deficiency, IgG antibodies of the same specificity can be measured to ensure accurate diagnosis. By detecting these antibodies simultaneously, the CytoBead® CeliAK assay provides a comprehensive overview of the serological profile, supporting early and accurate diagnosis, guiding clinical management, and helping monitor dietary adherence and treatment response in patients with celiac disease.