86048 – EmA IFA

Intended Purpose

The EmA IFA is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgA antibodies in human serum against endomysium on tissue sections of monkey esophagus. The EmA IFA is intended as an aid in the diagnosis of celiac disease conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use only.

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. Damage of the enterocytic membrane, including decrease in activity of the brush border enzyme leads to the activation of the local immune response leading to villious atrophy. Dermatitis herpetiformis, an autoimmune chronic relapsing skin diseases, 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.