4045 – CeliAK EmA human IgG

Intended Purpose

The CeliAK EmA human IgG is a quantitative immunoassay for the determination of IgG antibodies against endomysial antigens (EmA) in human serum. The CeliAK EmA human IgG is intended as an aid in the diagnosis of celiac disease and dermatitis herpetiformis in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual 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, 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. The diagnosis of celiac disease involves small intestine biopsy showing a “flat” mucosa prior to a gluten-free diet, which is then followed by 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. Patients suffering from IgA deficiency, a frequent concomitant disease in celiac patients, can be diagnosed using IgG type antibodies. Thus, the detection of IgG autoantibodies to endomysial antigens further deepens the diagnostic procedure of serologic parameters for the diagnosis of celiac diseases.

Product Specifications

Title CeliAK EmA human IgG
Product code 4045
Indication Celiac disease
Description Enzyme immunoassay for the quantitative determination of IgG antibodies against endomysial antigens in human serum
Format Microtiter plate coated with purified human endomysial antigens and gliadin fragments
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (89 x 1) + 5 x Calibrators + 2 x Controls

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  SDS [REF 4045][eng]   SDS [REF 4045][deu]

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.