4052 – Anti-M2

Intended Purpose

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. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

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.

Product Specifications

Title Anti-M2
Product code 4052
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

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  SDS [REF 4052][eng]   SDS [REF 4052][deu]

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.