4119 – AKLIDES^® ASMA

Highlights

• Slides coated with rat stomach tissue sections
• Screening test to support the diagnosis of autoimmune liver diseases
• Detects IgG antibodies against smooth muscle
• Ready-to-use reagents (exception: wash buffer)
• Fine granular fluorescence indicates smooth muscle and parietal cell antibodies
• Consistent processing for the parallel use of multiple AKLIDES® IFA assays
• Excellent diagnostic sensitivity and specificity
• Imaging by use of AKLIDES® or akiron® systems
• CE marked

Intended Use

The AKLIDES® ASMA is an indirect immunofluorescence assay (IFA) for the qualitative determination of IgG antibodies in human serum against smooth muscle on tissue sections of rat stomach. The assay is intended as an aid in the diagnosis of autoimmune liver diseases, including acute and chronic hepatitis, primary biliary cirrhosis (PBC), and other forms of liver cirrhosis, when used alongside clinical evaluation and other laboratory findings. The immunoassay is designed for both manual processing and automated imaging using the AKLIDES® or akiron^® system, providing standardized and reproducible results The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Autoimmune liver diseases often involve the production of autoantibodies directed against smooth, unstriated muscle fibers, making the detection of anti-smooth muscle antibodies (ASMA) a key diagnostic tool. ASMA is also observed in systemic autoimmune disorders, such as Systemic Lupus Erythematosus (SLE). It may also support the diagnosis of other conditions, including infectious mononucleosis, breast and ovarian carcinoma, and malignant melanomas.

Detection of ASMA using indirect immunofluorescence on rat stomach sections relies on the visualization of characteristic fluorescence patterns. Smooth muscle fibers in the muscularis mucosa, the tunica muscularis ventriculi, and the inter-glandular contractile fibers of the stomach mucosa show positive staining. The intensity and distribution of fluorescence provide important qualitative information regarding the presence of ASMA in patient serum. The AKLIDES® ASMA assay allows for reliable, reproducible, and high-throughput analysis, facilitating early diagnosis, disease monitoring, and supporting clinical decision-making in autoimmune liver disorders.