Intended use

Enzyme immunoassay for the detection of autoantibodies IgM against ?2-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. ?2-glycoprotein 1 (?2-GP-1; = apolipoprotein H) has been identified as a natural and essential co-antigen for CL-autoantibodies. The occurrence of CL/?2-GP-1 autoantibodies is associated with a tendency towards thrombosis.

Technical information

The EULISA ?2-Glycoprotein-1 IgM is intended for the quantitative or qualitative determination of IgM antibodies in human serum, directed against ?2-GP-1. The immobilised antigen is a highly purified preparation of human ?2-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

1. 1 microwell plate, coated with ?2-GP-1 and hermetically packed in a foil laminate pouch together with a desiccant bag.

2. Sample buffer, 100 mL, ready-to-use, orange coloured.

3. Wash buffer, 100 mL, 10 x-concentrate, blue coloured.

4. 6 calibrators, 2.0 mL each, 0, 3.0, 8.0, 18, 45 and 100 U ?2-GP-1-Ab (IgM)/ mL, ready-to-use, gradually blue coloured.

5. Negative and positive control, 2.0 mL each, ready-to-use, green and red coloured, respectively.

6. Anti-human IgM HRP conjugate, 14 mL, ready-to-use, red coloured.

7. Substrate solution, 14 mL, ready-to-use, colourless.

8. Stop solution (0.5 M H2SO4), 14 mL, colourless, ready-to-use.

9. Directions for use

10. Lot-specific certificate of analysis

All kit components are stored at 2 - 8°C.