8064 – CytoBead^® CeliAK

Intended Purpose

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) or gluten-sensitivity is characterized by small intestinal damages leading to a so-called “flat” mucosa. Due to these extensive lesions, malabsorption occurs frequently accompanied with a depletion of key nutrients. This condition is characterized by highly specific autoantibodies directed against the common CD autoantigen tTG, and by antibodies against DG. EmA are directed against extracellular tTG. Except for DG antibodies, these antibodies are typically of the IgA class. In IgA deficient patients with celiac disease, the same type of antibodies in IgG class can be detected for diagnosis.