4271 – AKLIDES^® CytoBead^® CeliAK

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 endomyium, tTG and dG in case of IgA deficiency. The AKLIDES^® 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 processing and automated imaging using the AKLIDES^® or akiron^® system. The immunoassay is designed for professional in vitro diagnostic use only.

Diagnostic Relevance

Celiac disease (CD) or gluten-sensitivity is characterized by small intestinal damages leading to a so-called “flat” mucosa. Due to this 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.