AMA-M2 ELISA

Enzyme immunoassay for the quantitative measurement of IgG class autoantibodies against mitochondrial M2 subtype antigen in human serum or plasma

INTENDED USE:AMA-M2 is an ELISA test system for the quantitative measurement of IgG class autoantibodies against mitochondrial M2 subtype antigen in human serum or plasma. This product is intended for professional in vitro diagnostic use only. The test is used as an aid in the differential diagnosis of primary biliary cirrhosis (PBC). In patients with other autoimmune diseases occurrence of AMA antibodies may be related to the development or association of PBC. Evaluation of a test result should always take into account all clinical and laboratory diagnostic findings.

GENERAL INFORMATION:Highly purified mitochondrial M2 subtype (PDC-E2, BCOADC-E2, OGDC-E2) antigen is bound to microwells. The determination is based on an indirect enzyme linked immune reaction with the following steps: Specific antibodies in the patient sample bind to the antigen coated on the surface of the reaction wells. After incubation, a washing step removes unbound and unspecifically bound serum or plasma components. Subsequently added enzyme conjugate binds to the immobilized antibodyantigen-complexes. After incubation, a second washing step removes unbound enzyme conjugate. After addition of substrate solution the bound enzyme conjugate hydrolyses the substrate forming a blue coloured product. Addition of an acid stops the reaction generating a yellow end-product. The intensity of the yellow color correlates with the concentration of the antibody-antigen-complex and can be measured photometrically at 450 nm.

KIT CHARACTERISTICS:
- Method: ELISA;
- 96 tests
- Incubation Time / Conditions: 30, 15, 15, 5 min (RT)
- Standard Range: 12.5 - 200 IU/ml
- Sensitivity analytical: 1 IU/ml
- Final Sample Volume: 100 µl
- Sample Type: serum, plasma
- Sample Pretreatment: 1:100 diluted
- Isotope / Substrate: TMB 450 nm
- Internal Controls: 2
- Regulatory Status: CE