4131, 4132 – AKLIDES^® EmA

Highlights

•  Use of monkey esophagus sections as solid-phase substrate
• Indirect immunofluorescence assay (IFA) for the qualitative determination of IgA antibodies in human serum
• Supports the diagnosis of celiac disease and related manifestations such as dermatitis herpetiformis in combination with clinical and laboratory findings
• Ready-to-use reagents including slides, controls, conjugate, PBS buffer, and mounting medium
• Reliable and reproducible results for routine laboratory testing
• Manual processing and automated imaging compatible with AKLIDES® or akiron® systems
• Suitable for monitoring disease activity and treatment response
• Manual, professional in vitro diagnostic use
• CE marked

Intended Use

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, also known as gluten sensitivity, leads to damage of the small intestinal mucosa, resulting in malabsorption and often a depletion of essential nutrients. Dermatitis herpetiformis, a skin manifestation of celiac disease, shows intestinal changes similar to those seen in celiac patients, reflecting the underlying inflammatory process. This autoimmune skin disorder is characterized by subepidermal blisters containing IgA antibodies in the basement membrane, along with neutrophil and eosinophil infiltration.

Serological testing remains a critical component for the diagnosis of celiac disease. Detection of IgA antibodies to the endomysium (EmA) provides one of the most specific and sensitive markers, with diagnostic specificity around 98% and sensitivity exceeding 95%. Combined determination of IgG and IgA antibodies to deamidated gliadin further supports diagnosis and helps monitor disease activity. The AKLIDES® EmA assay enables reliable and reproducible detection of these pathogenic antibodies, facilitating timely clinical decision-making and guiding patient management.