MESACUP-2 TEST Mitochondria M2

IVD-In Vitro Diagnostic Use CE marked

Instructions for use

The MESACUP-2 TEST Mitochondria M2 is semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Mitochondrial antibodies in human serum.

Background:

Primary biliary cirrhosis (PBC) is an autoimmune liver disease named in 1950 by Ahrens et al. PBC is a disease caused by chronic inflammation of thin bile duct of the liver, making it difficult for the bile to flow, and the bile remains in the liver. Anti Mitochondrial antibodies occur frequently in patients with PBC and their presence constitutes one of the diagnostic criteria of the disease. Berg et al. classified corresponding antigen to AMA into M1-M9 and found anti M2 antibody is the most specific antibody to PBC. In 1988, it was reported by Gershwin, et al. that main corresponding antigen to anti M2 antibody is E2 component of pyruvate dehydrogenase complex (PDC). It is further reported that subunit (BCOADC-E2, OGDC-E2) of the enzyme which belongs to 2-acid dehydrogenase complex is also a corresponding antigen to M2 antibodies, and reported by Motegi et al. that antibodies which react only to one of them is present in approximately 5-6 % of sera from patient with PBC.

The MESACUP-2 Test Mitochondria M2 is for measuring anti- mitochondrial antibodies present in the serum with high sensitivity by ELISA.

Principle:

The MESACUP-2 TEST Mitochondria M2 measures anti-Mitochondrial antibodies present in the serum by ELISA. Calibrators, Controls and patient serum are added to microwell coated with mitochondrial M2 antigens, allowing anti-Mitochondrial antibody to react with the immobilized antigen (Sample incubation). After wash to remove any unbound serum proteins, horseradish peroxidase conjugated anti human IgG, IgA and IgM are added and incubated (Conjugate incubation). Following another washing step, the peroxidase substrate is added and incubated for an additional period of time (Substrate incubation). Acid solution is then added to each well to terminate the enzyme reaction and to stabilize the color development. The assay can be quantified by measuring the reaction photometrically and plotting the results.

Size: 96 wells

Method: ELISA

Antigen: recombinant

Availability: all regions