4121, 4122 – AKLIDES^® Triple

Highlights

• Combined IFA screening assay for ANA, AMA, ASMA and APCA in human serum
• Triple tissue substrate: rat liver, stomach and kidney on one slide
• Supports the diagnosis of a broad range of autoimmune diseases
• Enables differentiation of multiple autoantibody patterns in a single test field
• Automated imaging using AKLIDES® or akiron® systems
• Reliable and reproducible results for routine laboratory testing
• High diagnostic sensitivity and specificity through established IFA methodology
• Manual, professional in vitro diagnostic use
• CE marked

Intended Use

The AKLIDES^® Triple is an immunofluorescence assay (IFA) for the qualitative determination of IgG antibodies (ANA / AMA / ASMA / APCA) in human serum on rat liver, stomach and kidney tissue sections. The AKLIDES^® Triple is intended as an aid in the diagnosis of autoimmune 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

Autoantibodies in Systemic Autoimmune Diseases

The appearance of autoantibodies directed against components of the cell nucleus are characteristic features of systemic autoimmune diseases, especially systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA) and dermatomyositis. These antibodies interfere with normal cellular and humoral immune responses and, under certain conditions, target endogenous structures, leading to autoimmune disease.

Anti-Mitochondrial Antibodies (AMA)

Anti-mitochondrial antibodies (AMA) primarily interact with the inner mitochondrial membrane, which is rich in phospholipids. AMA occur predominantly in primary biliary cirrhosis, pseudo-lupus erythematosus syndrome and various forms of chronic aggressive hepatitis. Elevated AMA titres mainly occur in non-suppurative gallbladder infections and primary biliary cirrhosis. In these conditions, antibodies often appear before clinical symptoms and usually show limited response to therapy over the course of the disease. Lower AMA titres occur in scleroderma, Sjögren syndrome, rheumatoid arthritis and other autoimmune disorders.

Anti-Smooth Muscle Antibodies (ASMA)

Antibodies against smooth, unstriated muscle occur in various liver diseases, particularly acute and chronic hepatitis, primary biliary cirrhosis and other forms of liver cirrhosis. In addition, detection of ASMA supports the diagnosis of systemic lupus erythematosus, infectious mononucleosis, breast and ovarian carcinoma, and malignant melanomas.

Anti-Parietal Cell Antibodies (APCA)

Circulating antibodies against parietal cell structures of the gastric mucosa are typically associated with pernicious anaemia. They may also be detected in other gastric disorders, including chronic atrophic gastritis and gastric ulcer, as well as thyroid diseases such as Hashimoto’s thyroiditis and myxoedema. In rare cases, APCA occur in hypoferric anaemia, diabetes mellitus and in older individuals.