83048 – AMA IFA

Highlights

  • Slides coated with rat kidney tissue sections containing mitochondrial antigens for accurate AMA detection
  • Specific detection of IgG antibodies against double-stranded DNA (dsDNA) and 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 Purpose

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 AMA IFA 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 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 occur mainly in patients with non-suppurating gallbladder infections or primary biliary cirrhosis, with approximately 90% testing positive.

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.

Product Specifications

Title AMA IFA
Product code 83048
Indication Primary biliary cirrhosis (PBC)
Description Indirect immunofluorescence assay for the qualitative and semi-quantitative determination of IgG antibodies in human serum against mitochondrial antigens
Format Slides well coated with cryostat tissue sections of rat kidney
Total 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.