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. The presence of them in serum or blood can indicate the potential of developing primary biliary cholangitis (PBC). This has been found in causes of scarring to liver tissue and it 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 subtypes can allow the determination of an immunological and prognostic classification of the primary biliary cirrhosis.
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.
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 antigen is bound to microwells.
- Calibrator A-F: Concentration 0, 12.5, 25, 50, 100, 200 IU/ml.
- Control Positive and Control Negative.
- 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 AMA-M2 ELISA kit was 1.0 IU/ml. The dynamic range for this assay is 12.5 – 200.0 IU/ml.
– 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%).
- Clinical relevance of combined anti-mitochondrial M2 detection assays for primary biliary cirrhosis. Clin Chim Acta. (2017) 464: 113-117. Han E., et al.
- Clinical evaluation of serum antimitochondrial antibody-negative primary biliary cirrhosis. Hepatobiliary Pancreat Dis Int. (2004) 3 (2): 288-91. Zhang F.K., et al.
- 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.
- 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 (Anti-Mitochondrial Antibodies M2)
- Reactivity: Human
- Sample Type: Serum, Plasma
- Sensitivity: 1.0 IU/ml
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