4271 – AKLIDES^® CytoBead^® CeliAK

Highlights

• Slides coated with cryostat tissue sections of monkey esophagus and beads coated with tissue transglutaminase (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 by use of akiron® or AKLIDES® systems
• CE marked

Intended Purpose

The AKLIDES^® CytoBead^® CeliAK is an immunofluorescence assay (IFA) for the qualitative determination of IgA antibodies in human serum against endomysium (EmA) as well as for the quantitative determination of IgA antibodies against tissue transglutaminase (tTG) and deamidated gliadin (dG) as well as for control of IgA antibodies. The IgG conjugate allows for the qualitative determination of IgG antibodies against endomysium, tTG and DG in case of IgA deficiency. The AKLIDES® CytoBead® CeliAK helps clinicians diagnose celiac disease alongside other clinical and laboratory findings. Laboratory staff perform the assay manually, and the akiron® or AKLIDES® systems handle automated imaging. The immunoassay is designed for professional in vitro diagnostic use only.

Diagnostic Relevance

Celiac disease (CD) (also known as gluten sensitivity) is characterized by damage to the small intestine, which leads to a condition known as flat mucosa. Due to these extensive lesions, malabsorption frequently occurs, accompanied by a depletion of key nutrients. Highly specific autoantibodies target the common CD autoantigen tTG, along with antibodies against DG. EmA target extracellular tTG. Autoantibodies in celiac disease are typically IgA class antibodies. In patients with an IgA deficiency, IgG antibodies can be used as a diagnostic tool.