4121, 4122 – AKLIDES® Triple

Intended Purpose

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

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 obstruct the cellular and/or humoral immunological reaction, which normally occur against external influences, and may under certain circumstances turn against the body itself and thereby cause various disorders – autoimmune diseases.  Anti-mitochondrial antibodies (AMA) majorly interact with the inner membrane of the mitochondria, which is rich in phospholipids. The appearance of AMA is mostly evident with diseases such as primary biliary cirrhosis, pseudo-lupus-erythematosus-syndrome and different forms of chronic aggressive hepatitis. As a diagnostic hint, elevated AMA titres are mainly found with non-suppurating gallbladder infections or primary biliary. In such cases, antibodies are seen prior to the clinical manifestations and will hardly be influenced by therapy during the course of the disease. Reduced antibody titres are observed with scleroderma, Sjörgen syndrome, rheumatoid arthritis and other autoimmune disorders. Antibodies against smooth, unstriated muscle occur in different liver diseases, especially in acute and chronic hepatitis, primary biliary cirrhosis and other forms of liver cirrhosis. In addition, the detection of ASMA supports the diagnosis of SLE, breast and ovarian carcinoma, infectious mononucleosis, and malignant melanomas. Pernicious anaemia is generally due to circulating antibodies against the structures of the parietal cell of the gastric mucosa. In any case, they may also be detected with other diseases of the stomach such as chronic atrophic gastritis, gastric ulcer, diseases of the thyroid (Hashimoto´s thyroiditis, myxoedema), and rarely with hypoferric anaemia, diabetes mellitus and in older patients.

Product Specifications

Title AKLIDES® Triple
Product code 4121 or 4122
Indication Autoimmune diseases
Description Indirect immunofluorescence assay for the determination of IgG antibodies in human serum against smooth muscle
Format Slides coated with cryostat tissue sections of rat liver, stomach and kidney
Incubation time 60 min.
Sample volume 10 µL serum
No. of determinations 48 (12 x 4) or 96 (12 x 8)

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  SDS [REF 4121, 4122][eng]   SDS [REF 4121, 4122][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.