4131 – AKLIDES^® EmA

Intended Purpose

The AKLIDES^® EmA is an immunofluorescence assay (IFA) for the qualitative determination of IgA antibodies in human serum against endomysium antigens (EmA) on monkey esophagus sections. The AKLIDES^® EmA 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.

Diagnostic Relevance

Celiac disease 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. Dermatitis herpetiformis, a skin manifestation of celiac disease which occurs in phases, has been shown to demonstrate celiac like changes in the intestine, resembling the inflammatory process in celiac patients. This disease is characterized by formation of sub-epidermal blisters, in which IgA antibodies are found in the basal membrane associated with neutrophils and eosinophil infiltration. Determination of IgG and IgA to deamidated gliadin as well as the detection of EmA IgA has been considered as the main serological parameters for celiac disease so far. EmA IgA shows a diagnostic specificity of about 98 % and a diagnostic sensitivity of greater 95 %.