Special Precautions/Comments:

Method: Fluorescence Enzyme Immunoassay (FEIA). Calibration: N/A. EQA scheme: UK NEQAS scheme for Phospholipid Antibodies. IQC: Commercial preparation.

Interference: None known

Interpretation: ACA are not diagnostic in themselves and can be found without a clinical antiphospholipid syndrome. Lupus anticoagulant (DRVVT) must also be checked and an APS can be present with an isolated LA and no ACA. Cardiolipin antibodies should be repeated at least 12 weeks apart to provide evidence of a persistent autoantibody.

Additional Information:

Indication: Anti-phospholipid syndrome (APL). Can be transiently elevated so recommend repeat at >12 weeks.

Background Information: Anti-cardiolipin antibodies (ACA) are associated with anti-phospholipid syndrome, idiopathic spontaneous abortion and systemic lupus erythematosus (SLE). The international consensus statement clarifies that anti-phospholipid syndrome can be diagnosed with: vascular thrombosis (blood clots) in any organ or tissue or pregnancy event (one or more miscarriages after 10th week of gestation, three or more miscarriages before 10th week of gestation, or one or more premature births before 34th week of gestation due to eclampsia) and persistently positive IgG or IgM anti-phospholipid antibodies at moderate-high titer (>40 GPL or MPL U/mL), or moderate-to-high titer beta-2 glycoprotein antibodies [1]. Anti-cardiolipin antibodies should be positive on at two occasions at least 12 weeks apart. IgG anti-cardiolipin antibodies are the most prevalent and demonstrate the greatest clinical correlation. The significance of IgM anti-cardiolipin antibodies is uncertain [3]. ACA are frequently detected in syphilis, HIV infected patients and other viral, bacterial and parasitic infections but are not correlated with the thrombosis risk or haematological manifestations of anti-phospholipid syndrome [2].

References: Tuthill JI, K Hamashta. Management of antiphospholipid syndrome. Journal of Autoimmunity. 2009. 33:92-98. Sene D, Piette JC, Cacoub P. Antiphospholipid antibodies, antiphospholipid syndrome and infections. Autoimmunity reviews. 2008. 7(4):272-277. [Ref 2] PRU Handbook of Autoimmunity. 4th Edition. 2007. [Ref 3]. Miyakis S, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006. 4:295-306. [Ref 1] Lim W, Crowther MA, Eikelboom JW. Management of Antiphospholipid Antibody Syndrome; A systematic review. JAMA. 2006. 295(9):1050-1057. Marai I, et al. Anticardiolipin and anti-beta-2-glycoprotein I antibodies. Autoimmunity. 2005. 38(1):33-38

See Also: BETA 2 GLYCOPROTEIN IgG AND IgM

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