4052 – Anti-M2

Highlights

• Use of recombinant mitochondrial M2 antigens (PDC-E2, OGDC-E2, BCOADC-E2)
• Quantitative ELISA for detection of IgG antibodies against mitochondrial M2 antigen in human serum
• Supports the diagnosis of primary biliary cirrhosis (PBC) in combination with clinical and laboratory findings
• High diagnostic relevance, as M2 autoantibodies occur in up to 96% of PBC patients
• Reliable and reproducible antibody quantification with calibrators and controls included
• Manual test for professional in vitro diagnostic use
• CE marked

Intended Use

The Anti-M2 is a quantitative enzyme immunoassay for the determination of IgG antibodies directed against mitochondrial M2 antigens in human serum. The assay supports the serological detection and measurement of M2 autoantibodies and is intended to aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with clinical presentation, biochemical liver parameters, imaging studies, and other laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Primary biliary cirrhosis (PBC) is a chronic autoimmune liver disease that causes progressive inflammation and destruction of small and medium-sized intrahepatic bile ducts and can ultimately progress to fibrosis, cirrhosis, and liver failure. Serological testing strongly links PBC to anti-mitochondrial antibodies (AMA), particularly M2 autoantibodies.

M2 autoantibodies target components of the mitochondrial α-keto acid dehydrogenase complexes, predominantly the E2 subunits of the pyruvate dehydrogenase complex (PDC-E2), the oxoglutarate dehydrogenase complex (OGDC-E2), and the branched-chain oxoacid dehydrogenase complex (BCOADC-E2). Up to 96% of patients with PBC carry these antibodies, which makes them one of the most sensitive and specific serological markers for the disease.

The quantitative determination of anti-M2 IgG antibodies enables reliable laboratory support of PBC diagnosis, facilitates differentiation from other autoimmune or chronic liver diseases, and may assist in disease monitoring and patient management.