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Cholin IgG/IgM ELISA

Catalog no.RE70461
Regulatory Status
EU: CE
Kit size
12x8
Method
ELISA
Incubation time
3x30min
Standard range
0-300 U/mL, cutoff 12 U/mL
Specimen / Volumes
10 µL serum
Substrate / isotope
TMB 450 nm
instructions for usecertificate

Intended Use

Cholin IgG/IgM ELISA is a solid phase enzyme immunoassay with highly purified phosphatidyl-cholin and native human ß2-glycoprotein I for the quantitative and qualitative detection of IgG and/or IgM antibodies against phosphatidyl cholin in human serum. These antibodies recognize specific epitopes on a complex composed out of phosphatidyl-cholin and ß2-glyco-protein I.

The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE) and the antiphospholipid syndrome (APS).

Clinical Application and Principle of the Assay

Antibodies against phosphatidyl-choline belong to the group of anti-phospholipid antibodies specific for phospholipids such as cardiolipin, phosphatidyl- serine, -inositol, sphingomyelin and phosphatidic acid. Phospholipids are components of biological membranes.

Anti-phospholipid antibodies are frequently found in sera of patients with systemic lupus erythematosus (SLE) and related diseases. The occurrence of anti-phospholipid antibodies in patients with SLE and related diseases is typical for a secondary anti-phospholipid syndrome (APS). In contrast, anti-phospholipid antibodies in patients with no other autoimmune diseases characterize the primary APS.

Many studies have shown a correlation between these autoantibodies and an enhanced incidence of thrombosis, thrombocytopenia and habitual abortions (as a consequence of placental infarction). The exact mechanisms by which pathogenic anti-phospholipid antibodies induce thrombosis is not yet revealed fully.

Principle of the test

Serum samples diluted 1:101 are incubated in the microplates coated with the specific antigen. Patient´s antibodies, if present in the specimen, bind to the antigen. The unbound fraction is washed off in the following step. Afterwards anti-human immunoglobulins conjugated to horseradish peroxidase (conjugate) are incubated and react with the antigen-antibody complex of the samples in the microplates. Unbound conjugate is washed off in the following step. Addition of TMB-substrate generates an enzymatic colorimetric (blue) reaction, which is stopped by diluted acid (color changes to yellow). The intensity of color formation from the chromogen is a function of the amount of conjugate bound to the antigen-antibody complex and this is proportional to the initial concentration of the respective antibodies in the patient sample.

For concrete data please consult the Instruction for Use in the download box on the top right side.

  • Noori EB. Phospholipid autoantibodies-Phosphatidylserine. In: Peter JB, Shoenfeld Y, eds. Autoantibodies. Elsevier Science BV 1996: 630-634.
  • Boey, M.L., Colaco, C.B., Gharavi, A.E., et al. (1983). Thrombosis in systemic lupus erythematosus: striking association with the presence of circulating lupus anticoagulant. Br. Med. J. 287: 1021-1023.
  • Gastineau, D.A., Kazmier, F.J., Nichols, W.L., Bowie, E.J. (1985). Lupus anticoagulant: an analysis of the clinical and laboratory features of 219 cases. Am. J. Hematol. 19: 265-267.
  • McNeil HP, Simpson RJ, Chesterman CN, Kirilis SA (1990). Anti-phospholipid antibodies are directed against a complex antigen that includes a lipuid-binding inhibitor of coagulation: ß2-Glycoprotein I (apolipoprotein H). Proc Natl Acad Sci USA 87: 4120-4124.
  • Wöhrle R, Matthias T, von Landenberg P, Oppermann M, Helmke K, Förger F (2000). Clinical relevance of antibodies against different phospholipids. Journal of Autoimmunity 15: A60

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Our comprehensive immunoassay portfolio includes a number of specialty diagnostic immunoassays for endocrinology, immunology and autoimmunity, as well as for diagnosis of multiple infectious diseases. We are pioneers and market leaders in saliva diagnostics, with over 40 years of experience supplying a broad portfolio of luminescence- and ELISA-based tests, including our highly acclaimed HMGB1 and MuSK-Ab ELISAs.

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All products are only available for sale to laboratory professionals and may not be available in all countries. Availability and regulatory status may vary across regions depending on local country-specific registration. Please always read and follow the instructions for use. 

All of our assays have been designed and manufactured to meet the highest global regulatory requirements and quality standards. Tecan is certified under ISO 9001:2015, ISO 13485:2016 and is audited by a notified body according to Medical Device Single Audit Program (MDSAP).

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