Reference Values

Interpretive data for IgG: Anticardiolipin antibodies are associated with certain clinical events including unexplained arterial and venous thromboemboli, and unexplained pregnancy morbidity. However, detection of low levels of anticardiolipin antibodies occurs in both healthy individuals and patients with co-morbidities not associated with the antiphospholipid antibody (APA) syndrome including inflammatory and infectious conditions. In order to improve specificity, the International Congress on Antiphospholipid Antibodies recommends ACL antibodies of IgG or IgM isotype present in medium or high titer (e.g. > 40 GPL, or >the 99th percentile), on two or more occasions, at least 12 weeks apart, to support a diagnosis of antiphospholipid syndrome. The cutoff for this assay was developed from data based on the 99th percentile. In addition, the International Congress on Antiphospholipid Antibodies does not recommend testing for IgA ACA. The ACL IgM test can produce false positive results due to cross reactivity with Rheumatoid factor, dsDNA or certain infectious disease antibodies. These results were obtained with the BioRad BioPlex 2200 System. Cardiolipin IgM values obtained with different manufacturers' assay methods may not be used interchangeably.

Reference Interval Literature References:

Miyakis S, Lockshin MD, Atsumi T, Branch DW, Brey RS et al. International consensus statement on and update of the classification criteria for definite antiphospholipid syndrome. J Thromb Heamost 2006; 4:295-306

Package Insert: BioPlex 2200 APLS IgG kit. BioRad Laboratories, Inc. 10/2013