4117 – AKLIDES^® AMA

Highlights

• Slides coated with rat kidney tissue sections
• Screening test to support the diagnosis of primary biliary cirrhosis (PBC)
• Ready-to-use reagents (exception: wash buffer)
• Quality assured handling in routine laboratories
• Short incubation times (30 min / 30 min) at room temperature
• 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

Intened Use

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 target the body’s own cells and cause a variety of 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 AMA titres commonly occur in non-suppurative gallbladder infections and primary biliary cirrhosis, with positive results in approximately 90% of cases. In these patients, antibodies often appear before clinical symptoms and typically remain unaffected by therapy during disease progression. Lower AMA titres occur in 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.