83048 – AMA IFA

Highlights

• Slides coated with rat kidney tissue sections containing mitochondrial antigens for accurate AMA detection
• Qualitative and semi-quantitative determination of IgG antibodies against mitochondrial antigens
• Supports the diagnosis of primary biliary cholangitis (PBC) alongside clinical and laboratory findings
• Detects anti-mitochondrial antibodies (AMA) with high clinical relevance (≈90% positivity in PBC)
• Clear visualization of fine granular cytoplasmic fluorescence, especially in distal renal tubules
• Ready-to-use slides, positive and negative controls, FITC-conjugated anti-human IgG, and mounting medium included
• Compatible with standard fluorescence microscopy (FITC, 490 nm excitation / 520 nm emission)
• Designed for manual professional in vitro diagnostic use
• CE-marked

Intended Use

The AMA IFA is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum against mitochondrial antigens on tissue sections of rat kidney. The assay is intended as an aid in the diagnosis of primary biliary cholangitis (PBC) in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Disorders of cellular and humoral immune responses can lead to autoimmune diseases. These immune responses are directed against the body’s own cells and tissues. Anti-mitochondrial antibodies (AMA) predominantly react with the inner membrane of the mitochondria (rich in phospholipids). Anti-mitochondrial antibodies (AMA) are most commonly associated with primary biliary cholangitis (PBC) but may also occur in a limited number of other autoimmune liver diseases and related conditions.High-titre AMA are detected in approximately 90% of patients with primary biliary cholangitis (PBC).

In these cases, patients develop antibodies before clinical symptoms appear, and therapy rarely affects antibody levels during the course of the disease. Scleroderma, Sjögren syndrome, rheumatoid arthritis, and other autoimmune diseases typically show lower antibody titres. 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.