Antiphospholipid Syndrome

Antiphospholipid SyndromeA comprehensive range of Enzyme Immunoassays help clarify the investigation of Antiphospholipid syndrome.

Antiphospholipid syndrome (APS), also known as Hughes syndrome, is an autoimmune condition associated with reccurring vascular thrombosis and pregnancy morbidity. APS is divided up into primary APS where the condition occurs alone, and secondary APS where the condition occurs in association with another autoimmune disease such as systemic lupus erythematosus (SLE).

Clinical Significance

Antibodies targeting cardiolipin, β2-glycoprotein-1 (β2GP-1) and phosphatidylserine are commonly found in patients with the clinical symptoms of APS. Specifically, antibodies to cardiolipin are found in up to 77 % of patients with primary APS. Evidence has demonstrated that the antibodies target a complex of the phospholipid and the plasma binding protein β2GP-1. The exact mechanism by which antiphospholipid antibodies cause thrombosis is unknown but possible mechanisms include the activation of the tissue factor pathway and the inhibition of the protein C pathway.

Diagnostic Criteria

For a patient to be diagnosed with APS they must first meet one of the clinical criteria which are:

i) one or more episodes of arterial, venous, or small vessel thrombosis in any tissue or organ

ii) pregnancy morbidity including foetal death, premature birth and spontaneous abortion.

Once a patient's clinical symptoms fulfil the clinical criteria, diagnosis of APS can be confirmed if one of the laboratory criteria is met. In 2006 the laboratory criteria were revised and now include a positive β2GP-1 IgG or IgM EIA test alongside a positive cardiolipin IgG or IgM test. The laboratory criteria also include the non-EIA lupus anticoagulant test which measures the in vitro activation of the coagulation cascade. Laboratory tests should be performed on two or more occasions at least 12 weeks apart. Transient increases in antibodies to cardiolipin and β2GP-1 may be detected in patients with bacterial infections although these are not usually associated with thrombosis.

 

Proposed Testing Protocol 

Sapporo Standards

The Standardization Committee of the European Forum for Antiphospholipid Antibodies have supported the introduction of HCAL and EY2C9 IgG and IgM standards. These standards are monoclonal antibodies that have dual functionality for both cardiolipin and β2GP-1 (results expressed in μg/mL). The monoclonal nature of these standard preparations ensures reproducibility1-3

The BINDAZYME Anti Cardiolipin and Anti β2GP-1 S range IgG and IgM assays are calibrated against these Sapporo reference preparations.

 

Ordering Information

Bindazyme
Description Pack Code
Anti Cardiolipin IgG EIA 96 test MK027
Anti Cardiolipin IgA EIA 96 test MK028
Anti Cardiolipin IgM EIA 96 test MK029
Anti Cardiolipin IgG/IgM COMBI EIA EIA 96 test MK071
Anti Cardiolipin IgGAM Screen EIA 96 test MK030
Anti β2GP-1 IgG EIA 96 test MK040
Anti β2GP-1 IgA EIA 96 test MK041
Anti β2GP-1 IgM EIA 96 test MK042
Anti β2GP-1 IgGAM Screen EIA 96 test MK043
NEW Anti Cardiolipin IgG S Kit 96 test MK127
NEW Anti Cardiolipin IgA S Kit 96 test MK128
NEW Anti Cardiolipin IgM S Kit 96 test MK129
NEW Anti Cardiolipin IgGAM Screening S Kit 96 test MK130
NEW Anti β2GP-1 IgG S Kit 96 test MK140
NEW Anti β2GP-1 IgA S Kit 96 test MK141
NEW Anti β2GP-1 IgM S Kit 96 test MK142
NEW Anti β2GP-1 IgGAM Screening S Kit 96 test MK143
Anti Phosphatidylserine IgG EIA 96 test MK050
Anti Phosphatidylserine IgA EIA 96 test MK051
Anti Phosphatidylserine IgM EIA 96 test MK052

1. Ichikawa, K. et al. A chimeric antibody with the human y1 constant region as a putative standard for assays to detect IgG β2-glycoprotein 1-dependent anticardiolipin and anti-β2-glycoprotein 1 antibodies. Arthritis Rheum 1999; 42:2461-2470.

2. Fontain, M. et al. Persistent Problems with Standardization of Immunoassays for Anti-Cardiolipin Antibodies Thromb Haemost 2001; 86:1123-1124

3. Tincani, A. et al. Anticardiolipin Antibody Assay: a Methodological Analysis for a better Consensus in Routine Determinations. A Cooperative Project of the European Antiphospholipid Forum. Thromb Haemost 2001; 86 575-583