European attempts for the standardisation of the antiphospholipid antibodies

Abstract

According to the Sydney criteria, antiphospholipid syndrome (APS) diagnosis is closely related to the demonstration of antiphospholipid antibodies (aPL) in patients sera. For this purpose, three different assays are conventionally accepted: lupus anticoagulant (LA), anticardiolipin (aCL) and anti-β2 glycoprotein I (β₂GPI) antibodies. LA, described in the 1950s is a coagulation-based functional assay, which indirectly detects the presence of aPL. The aCL ELISA was developed in 1985; the identification of β₂GPI as a major target of aPL, allowed the introduction of anti-β₂GPI ELISA. Even if the diagnostic criteria for APS have been well defined, the laboratory detection of aPL is not always reproducible for many reasons. To achieve a univocal diagnostic definition of APS, efforts were made to reduce the inter- and/or intra-laboratory variability of the diagnostic tests. In this article, we analyse the studies performed to standardise aPL assays that were developed within the European Forum on Antiphospholipid Antibodies.