Enzyme immunoassay for the detection of autoantibodies IgM against Cardiolipin (CL).
The anti-phospholipid syndrome (APS) is an autoimmune disorder which can comprise clinical conditions such as venous and arterial thrombosis, thrombocytopenia, myocardial infarction, recurrent spontaneous abortion and neurological complications.
Cardiolipin (CL) is the most common, negatively charged, acid phospholipid. Autoantibodies correlated with APS are directed not only against CL and similar phospholipides but also against phospholipid/protein complexes. ß2-glycoprotein 1 (ß2-GP-1; = apolipoprotein H) has been identified as such a natural and essential co-antigen for CL-autoantibodies. The occurrence of CL/ß2-GP-1 autoantibodies is associated with a tendency towards thrombosis. Besides this diagnostic significance, these antibodies are believed to be directly involved in the pathogenesis of APS.
The EULISA Cardiolipin IgM is intended for the quantitative or qualitative determination of IgM antibodies in human serum, directed against CL/ß2-GP-1. The immobilised antigen is a combination of CL, isolated from bovine heart, and a highly purified preparation of native ß2-GP-1. The test is fast (incubation time 30 - 30 - 30 minutes) and flexible (break apart wells, ready-to-use reagents). Six calibrators allow quantitative measurements; a negative and a positive control are used to check the assay performance.
Contents of the kit
All kit components are stored at 2 - 8°C.