Human AMA-M2 ELISA kit is designed for detecting in vitro quantitative concentrations of IgG autoantibodies against mitochondrial M2 subtype antigen (anti-mitochondrial antibodies, AMA-M2) in human plasma and serum samples. This assay has a minimum analytical sensitivity limit of 1.0 IU/ml.


Anti-mitochondrial antibodies (AMA) are made up immunoglobulins that are formed against mitochondria which are primarily located in cells of the liver. These have been associated to many different conditions such as anti M2, M4, M8 and M9 are predominately linked to biliary cirrhosis, M1 to syphilis, M2 to autoimmune hepatitis, M3 to drug-induced lupus erythematosus, M6 to drug-induced hepatitis, M7 to myocarditis and cardiomyopathy and M5 to undifferentiated collagenosis, systemic lupus erythematosus and autoimmune haemolytic anaemia. Anti-mitochondrial antibodies have also been identified in systemic sclerosis, Sjögren’s syndrome, asymptomatic recurrent bacteriuria and pulmonary tuberculosis.

The presence of AMA in serum or blood can indicate the potential of developing primary biliary cholangitis (PBC). PBC has been found in causes of scarring to liver tissue and AMA is also found in more than 95% of these cases. Beginning cases of symptomatic PBC usually display only AMA-M2 subtype antibodies, whereas progressive cases and mixed syndromes are linked with AMA-M2, -M4 and -M8 antibody subtypes. Therefore, profiling the AMA subtypes can allow the determination of an immunological and prognostic classification of the primary biliary cirrhosis.

AMA have been identified as antigenic components that are directed against the cell mitochondria (usually the inner membrane proteins, especially the E2 subunits that are present within the pyruvate dehydrogenase complex [PDC]) that can be present in various human tissues and organs, there are instances where it is also found within the mitochondria of many species that are non-human.

Various procedures have been used to detect AMAs for example: ELISA (enzyme-linked immunoasay), IB (western immunoblotting), CFTs (complement fixation tests) and IFL (immunofluorescence). For laboratories involved in diagnostics the preferred method is the IFL that is usually supported by ELISAs. In other laboratories that are investigating PBC (primary biliary cirrhosis) then the preferred protocol is ELISAs, whereas in a research laboratory setting then ELISAs or IB are used with a combination of synthetic peptides, recombinant or purified antigens. There is evidence to indicate that other autoimmune diseases (for example: scleroderma, rheumatoid arthritis, thyroiditis and systemic lupus erythematosus) may result in a positive AMA test result. Also, other liver conditions or diseases are found to display low levels of AMA. A positive AMA test is often found when the bile duct has been obstructed by other factors for example sclerosing cholangitis (both primary and secondary).


All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • Divisible Microplate: Highly purified mitochondrial M2 subtype (PDC-E2, BCOADC-E2, OGDC-E2) antigen is bound to microwells.
  • Calibrator A-F: Concentration 0, 12.5, 25, 50, 100, 200 IU/ml.
  • Control Positive and Control Negative: Consisting of anti AMA-M2 antibodies in a serum/buffer matrix.
  • Sample Buffer (5x).
  • Enzyme Conjugate: Containing anti-human IgG antibodies, HRP labelled.
  • TMB Substrate.
  • Stop Solution.
  • Wash Buffer (50x).
  • Instruction for Use.
  • Certificate of Analysis.


The minimum detection sensitivity level of IgG against anti-mitochondrial antibodies M2 subtype using current human AMA-M2 ELISA kit was 1.0 IU/ml. The dynamic range for this assay is 12.5 – 200.0 IU/ml.


– Anti-Mitochondrial Antibodies M2 (AMA-M2): ELISA
– Measuring Range: 0 – 200 IU/ml
– Expected Values: In a normal range = Cut-off 10 IU/ml, Negative = < 10 IU/ml, Positive = ≥ 20 IU/ml.
– Linearity: 95 – 102%
– Intra Assay Precision: 3.6 – 7.0%
– Inter Assay Precision: 3.8 – 11.8%
– Clinical Diagnosis: Sensitivity (97.2%), Specificity (94.2%), Overall agreement (95.1%).


  1. Clinical relevance of combined anti-mitochondrial M2 detection assays for primary biliary cirrhosis. Clin Chim Acta. (2017) 464: 113-117. Han E., et al.
  2. Clinical evaluation of serum antimitochondrial antibody-negative primary biliary cirrhosis. Hepatobiliary Pancreat Dis Int. (2004) 3 (2): 288-91. Zhang F.K., et al.
  3. Detection of AMA-M2 in human saliva: Potentials in diagnosis and monitoring of primary biliary cholangitis. Sci Rep. (2017) 7 (1): 796. Lu C., et al.
  4. The accuracy of the anti-mitochondrial antibody and the M2 subtype test for diagnosis of primary biliary cirrhosis: a meta-analysis. Clin Chem Lab Med. (2014) 52 (11): 1533-42. Review. Hu S., et al.


  • Full Name: AMA-M2 ELISA Kit
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 1.0 IU/ml



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