The EULISA ß2-Glycoprotein-1 IgM is intended for determination of IgM antibodies against ß2-Glycoprotein in human serum. The occurrence of these antibodies is associated with anti-phospholipid syndrome (APS), an autoimmune disorder characterised by thrombosis in both arteries and veins. Antibodies against ß2-Glycoprotein are also believed to be directly involved in the pathogenesis of APS.
Intended use
Enzyme immunoassay for the detection of autoantibodies IgM against ß2-Glycoprotein-1.
Background
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 a common, negatively charged, acid phospholipid. Autoantibodies associated 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 a natural and essential co-antigen for CL-autoantibodies. The occurrence of CL/ß2-GP-1 autoantibodies is associated with a tendency towards thrombosis.
Technical information
The EULISA ß2-Glycoprotein-1 IgM is intended for the quantitative or qualitative determination of IgM antibodies in human serum, directed against ß2-GP-1. The immobilised antigen is a highly purified preparation of human 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 assay performance.
Kit components and storage of reagents
Contents of the kit
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1 microwell plate, coated with ß2-GP-1 and hermetically packed in a foil laminate pouch together with a desiccant bag.
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Sample buffer, 100 mL, ready-to-use, orange coloured.
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Wash buffer, 100 mL, 10 x-concentrate, blue coloured.
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6 calibrators, 2.0 mL each, 0, 3.0, 8.0, 18, 45 and 100 U ß2-GP-1-Ab (IgM)/ mL, ready-to-use, gradually blue coloured.
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Negative and positive control, 2.0 mL each, ready-to-use, green and red coloured, respectively.
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Anti-human IgM HRP conjugate, 14 mL, ready-to-use, red coloured.
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Substrate solution, 14 mL, ready-to-use, colourless.
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Stop solution (0.5 M H2SO4), 14 mL, colourless, ready-to-use.
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Directions for use
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Lot-specific certificate of analysis
All kit components are stored at 2 - 8°C.
