4125 – AKLIDES^® ASA

Highlights

• Use of monkey esophagus tissue sections as solid-phase antigen
• Quantitative IFA for the qualitative determination of IgG autoantibodies in human serum
• Supports the diagnosis of autoimmune skin diseases such as pemphigus and bullous pemphigoid in combination with clinical and laboratory findings
• High diagnostic relevance for detecting pathogenic antibodies responsible for intraepidermal and subepidermal blistering
• Ready-to-use reagents including slides, controls, conjugate, and mounting medium
• Reliable and reproducible results suitable for routine laboratory testing
• Enables monitoring of disease activity and response to therapy
• automated imaging using the AKLIDES® or akiron® system
• CE marked

Intended Use

The AKLIDES^® ASA is an immunofluorescence assay (IFA) for the qualitative determination of IgG antibodies in human serum against skin antigens on monkey esophagus sections. The AKLIDES^® ASA is intended as an aid in the diagnosis of autoimmune skin diseases 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

Pemphigus, a group of chronic autoimmune skin disorders, causes intraepidermal blistering and carries a significant risk if left untreated. The disease typically appears in middle-aged adults, but transplacental antibody transfer can affect neonates as well.    . Autoantibodies, mostly of the IgG class, target intercellular epithelial antigens, primarily desmoglein III and I, which are crucial for maintaining the structural integrity of the epidermis. Indirect immunofluorescence tests on epithelial tissue sections and immunohistological analysis of skin biopsies allow the detection of circulating autoantibodies. The presence and titer of these antibodies correlate closely with disease activity, increasing during flares and decreasing with effective therapy. Detection of these antibodies enables clinicians to differentiate pemphigus from other blistering disorders, monitor disease progression, and evaluate therapeutic responses.

Bullous pemphigoid, another autoimmune blistering disease, mainly affects older adults and is characterized by subepidermal blistering. In this condition, autoantibodies target hemidesmosomal structures within basal keratinocytes at the epithelial basement membrane. The IFA allows identification of these basement membrane antibodies, which are highly specific for the disease and absent in healthy individuals. Monitoring antibody titers can provide insight into disease activity and treatment efficacy. The AKLIDES® ASA assay provides a sensitive and reliable method for detecting pathogenic IgG antibodies, producing distinct fluorescent staining patterns that enable precise interpretation. By combining manual processing with optional automated imaging, this assay supports standardized, reproducible results suitable for routine laboratory diagnostics.