Anti beta 2 Glycoprotein 1 IgM

Key Features and Values

– Same sample type can be used across all assays to simplify inclusion into routine serology work-up
– Ready to use reagents reduces hands-on time for assay preparation
– Long shelf life cost-effective solution by reducing wastage due to expired kits
– Suitable for inclusion on automated plate systems simplifies scale-up of test volume
– Supported by a complete panel of assays for diagnosis of thrombosis risk associated with SLE and APS

Product Description

Anti beta 2 Glycoprotein 1 IgM kit is an indirect enzyme linked immunosorbent assay (ELISA) designed for the quantitative measurement of IgM class antibodies directed against the β2-Glycoprotein 1 in human serum or plasma.  Anti beta 2 Glycoprotein 1 IgM kit is intended for laboratory use only.

Scientific Description
The antiphospholipid syndrome (APS) is a disorder that presents peculiar symptoms: arterial and venous thrombosis, thrombocytopenia, ulcers of the lower limbs,hemolytic anemia, loss of the fetus during pregnancy and is associated with the presence of antiphospholipid antibodies.  Antiphospholipid antibodies represent a large and heterogeneous immunoglobulins group, including anticardiolipin antibodies and lupus anticoagulant.  The former are diagnosed by on their reactivity with cardiolipin or other anionic phospholipids in ELISA test, while the latter is detected in phospholipid-dependent coagulation tests (aPTT, KCT, dRVVT).
In early ’90s it was observed that antiphospholipid antibodies are not directed against anionic phospholipids, as long it was considered, but they react with plasma proteins bound to anionic (phospholipidic) surfaces.  In fact about cardiolipin, it was observed the need of a cofactor for antibodies binding, this cofactor was identified in β2 glycoprotein 1 (β2-GP1).  The β2 glycoprotein 1 is a plasma glycoprotein of molecular weight of 50 kD, which is complexed to lipoproteins for 40%.  A patient with clinical suspicion of APS, who has an high titre of anti-beta2GP1 antibodies, even if LAC or anticardiolipin antibodies are negative, has a strong chance of having the antiphospholipid syndrome, because these antibodies recognise β2-GP1 bound to the surface of phospholipid (cardiolipin).  These proteins seem to express their antigenicity only after contact with specific areas such as the anionic phospholipid surface or very hydrophilic plastic surfaces.
The importance of ELISA anti-phospholipids test, including the anti-β2-GP1 test, lies in the fact that a positive test if associated with one or more of the symptoms can confirm a diagnosis of APS.
Publications

1. Hughes GRV. The antiphospholipid Syndrome. Ten years on. Lancet 1993: 342; 341-344.
2. Wilson WA, Gharavi AE, Koike T, Lockshin MD, Branch DW, Piette JC, Brey R, Derksen R, Harris EN, Hughes GRV, Triplett DA, Khamashta MA. International consensus statement on preliminary classification criteria for definite antiphospholipid syndrome. Arthritis Rheum 1999;42:1309-11.
3. Mc Neil HP, Simpson RJ, Chesterman CN, Krilis SA. Anti-phospholipid antibodies are directed against a complex antigen that includes a lipid binding inhibitor of coagulation: β2-Glycoprotein 1 (Apolipoprotein H). Proc Natl Acad Sci 1990;87:4120-4.
4. Matsuura E, Igarashi Y, Fujimoto M, Ichikawa K, Koike T. Anticardiolipin cofactor(s) and differential diagnosis of autoimmune disease. Lancet 1990;336:177-8
5. Pengo V, Biasiolo A, Fior MG. Autoimmune antiphospholipid antibodies are directed against a cryptic epitope expressed when β2-glycoprotein 1 is
bound to a suitable surface. Thromb Haemost 1995:73:29-34
6. Arvieux J, Roussel B, Jacob MC, Colomb MG. Measurement of antiphospholipid antibodies by ELISA using β2-glycoprotein 1 as an antigen. J Immunol
Methods 1991;143:223-9.
7. Tsutsumi A, Matsuura E, Ichikawa K, Fujisaku A, Mukai M, Kobayashi S, Koike T. Antibodies to β2-glycoprotein 1 and clinical manifestation in patients with systemic lupus erythemotosus. Arthritis Rheum 1996;39:1466-74.
8. Pengo V, Biasiolo A. The risk of overdiagnosis of antiphospholipid antibody syndrome. Throm Haemost 2001;86:933 (letter).

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Code: DKO111
Clinical Area: ,
Incubation: 60+30+15 min
Sensitivity: >99%
Specificity: >99%
Classification: IVD, CE
Number of Tests: 96
Sample Type: Seruma/Plasma
Sample Volume: 10 μL (1:100 predilution)
Assay Range: N/A