4052 – Anti-M2
The Anti-M2 is a quantitative immunoassay for the determination of IgG antibodies against mitochondrial M2 in human serum. The Anti-M2 is intended as an aid in the diagnosis of primary biliary cirrhosis (PBC) in conjunction with other clinical and laboratory findings.
Circulating M2 autoantibodies are serological markers for PBC, a chronic inflammatory disorder of the small and medium bile ducts. M2 autoantibodies occur in up to 96% of PBC patients, hence the strong base for its use as serological marker.
The ELISA (Enzyme Linked Immunosorbent Assay) is an immunoassay for the determination of specific antibodies. The strips of the microtiter plate are coated with test-specific antigens. If antibodies are present in the patient´s sample, they bind to the antigens. A secondary antibody conjugated with the enzyme peroxidase detects the generated immune complex. A colorless substrate is converted into the colored product. The signal intensity of the reaction product is proportional to the antibody activity in the sample. After stopping the signal intensity of the reaction product is measured photometrically.
The immunoassay is designed for manual professional in vitro diagnostic use.
|Indication||Primary biliary cirrhosis (PBC)|
|Description||Enzyme immunoassay for the quantitative determination of IgG antibodies against mitochondrial M2 antigen in human serum|
|Format||Microtiter plate coated with recombinant recombinant human PDC-E2, OGDC-E2, and BCOADC-E2|
|Total incubation time||105 min.|
|Sample volume||10 µL serum|
|No. of determinations||96 (89 x 1) + 5 x Calibrators + 2 x Controls|