Intened Purpose

The AKLIDES® AMA is an immunofluorescence assay (IFA) for the qualitative determination of IgG antibodies in human serum against mitochondrial antigens on tissue sections of rat kidney. The AKLIDES® AMA is intended as an aid in the diagnosis of diagnosis of primary biliary cirrhosis (PBC) 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

Disorder of the cellular and/or humoral immunological reaction lead to autoimmune diseases. These reactions are directed against the body cells itself and thereby cause various diseases. Anti-mitochondrial antibodies (AMA) predominantly react with the inner membrane of the mitochondria (rich in phospholipids). AMA mostly appear with diseases such as primary biliary cirrhosis, pseudo-LE syndrome and various forms of chronic aggressive hepatitis. High titre AMA results are mainly found with non-suppurating gallbladder infections or primary biliary cirrhosis (positive results at about 90%). In these cases, antibodies appear before the clinical symptoms and will hardly be influenced by therapy during the course of the disease. Low antibody titres are observed with scleroderma, Sjögren syndrome, rheumatoid arthritis and other autoimmune diseases.

Mitochondria are components of different cells; detection of AMA by indirect immunofluorescence is therefore possible on several tissues. Rat kidney is used as reference substrate showing a characteristic pattern: a fine granular fluorescence in the cytoplasm of the kidney tubules. Distal tubules have a higher content of mitochondria and therefore display a more intensive fluorescence pattern in contrast to the proximal tubules.

Product Specifications

Product code 4117
Indication Primary biliary cirrhosis (PBC)
Description Indirect immunofluorescence assay for the determination of IgG antibodies against mitochondrial antigens in human serum
Format Slides coated with cryostat tissue sections of rat kidney
Incubation time 60 min.
Sample volume 10 µL serum
No. of determinations 48 (12 x 4)

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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.