4035 – CeliAK EmA human

Intended Purpose

The CeliAK EmA human is a quantitative immunoassay for the determination of IgA antibodies against endomysial antigens (EmA) in human serum. The CeliAK EmA human is intended as an aid in the diagnosis of diagnosis of celiac disease and dermatitis herpetiformis in conjunction with other clinical and laboratory findings.

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, 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 diseases is characterized by formation of sub-epidermal blisters, in which IgA antibodies are found in the basal membrane associated with neutrophils and eosinophil infiltration.

Diagnosis of celiac disease and dermatitis herpetiformis comprises small intestine biopsy demonstrating a “flat” mucosa prior to a gluten-free diet and the following reconstitution of the mucosa after onset of the diet. Determination of IgG and IgA to deamidated gliadin by ELISA as well as the detection of Human endomysial autoantigens (EmA) IgA has been considered as the main serological parameters for celiac disease so far.

The ELISA (Enzyme Linked Immunosorbent Assay) is an immunoassay for the determination of specific antibodies. The strips of the microtiter plate are coated with test-specific antigens. If antibodies are present in the patient´s sample, they bind to the antigens. A secondary antibody conjugated with the enzyme peroxidase detects the generated immune complex. A colorless substrate is converted into the colored product. The signal intensity of the reaction product is proportional to the antibody activity in the sample. After stopping the signal intensity of the reaction product is measured photometrically.

The immunoassay is designed for manual professional in vitro diagnostic use.