Mitochondrial (AMA)-M2-Ab ELISA
- Regulatory Status
- EU: CE
- Kit size
- 12 x 8
- Method
- ELISA
- Incubation time
- 3 x 30 min
- Standard range
- 0 - 300 U/mL, cut-off 15 U/mL
- Specimen / Volumes
- 10 µL serum
- Substrate / isotope
- TMB 450 nm
Intended Use
The Mitochondrial (AMA)-M2-Ab ELISA is a solid phase enzyme immunoassay employing native mitochondial M2 antigen for the quantitative and qualitative detection of IgG antibodies against M2 in human serum.
The assay is a tool in the diagnosis of the primary biliary cirrhosis (PBC).
Clinical Application and Principle of the Assay
Primary biliary cirrhosis (PBC) is a chronic inflammatory disorder of the small and medium bile ducts and serologically characterized by the presence of circulating M2 autoantibodies. Anti-M2 autoantibodies belong to the group of anti mitochondrial antibodies (AMA). The heterogeneously reacting specific AMA of the M2 subtype are directed against three related proteins of the α-keto acid dehydrogenase complex, which is located at the inner mitochondrial membrane. The major epitope recognized is located on the E2 subunit and the protein X of the pyruvate dehydrogenase complex (PDC). Additionally, AMA-M2-G autoantibodies recognize the (E1α and E1β) subunits of the same complex and the E2 subunit of several other multienzyme complexes, such as the 2-oxo-glutarate dehydrogenase complex (OGDC) and the branched chain 2-oxo acid dehydrogenase complex (BCOADC).
The determination of AMA-M2-G is a powerful tool in diagnosing PBC.
Principle of the test
Serum samples diluted 1:101 are incubated in the microplates coated with the specific antigen. Patient´s antibodies, if present in the specimen, bind to the antigen. The unbound fraction is washed off in the following step. Afterwards anti-human immunoglobulins conjugated to horseradish peroxidase (conjugate) are incubated and react with the antigen-antibody complex of the samples in the microplates. Unbound conjugate is washed off in the following step. Addition of TMB-substrate generates an enzymatic colorimetric (blue) reaction, which is stopped by diluted acid (color changes to yellow). The intensity of color formation from the chromogen is a function of the amount of conjugate bound to the antigen-antibody complex and this is proportional to the initial concentration of the respective antibodies in the patient sample.
For concrete data please consult the Instruction for Use in the download box on the top right side.
- Berg PA, Klein R (1989). Heterogeneity of antimitochondrial antibodies. Seminars in liver disease 9: 103-116.
- Berg, P.A., Klein, R., Lindenborn-Fotinos, J.,Klöppel,G. (1982). ATPase associated antigen (M2): marker antigen for serological diagnosis of primary biliary cirrhosis. Lancet 2: 1423-1426.
- Manns M, Meyer zum Büschenfelde K-H (1989). Primäre biliäre Zirrhose. In: Hepatologie und Praxis, Meyer zum Büschenfelde K-H, Arnold W, Hüttenroth TH eds. Georg Thieme Verlag stuttgart, New York, 350-358.
- Coppel RL, Gershwin ME (1995). Primary biliary cirrhosis: The molecule and the mimic. Immunological Reviews 44: 17-49.
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Our comprehensive immunoassay portfolio includes a number of specialty diagnostic immunoassays for endocrinology, immunology and autoimmunity, as well as for diagnosis of multiple infectious diseases. We are pioneers and market leaders in saliva diagnostics, with over 40 years of experience supplying a broad portfolio of luminescence- and ELISA-based tests, including our highly acclaimed HMGB1 and MuSK-Ab ELISAs.
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As part of the Tecan Group, we have a leading market position in diagnostics and research, with over 40 years of experience in the development, manufacture and supply of enzyme-, radiolabel- and luminescence-based immunoassays.
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