The presence of antiphospholipid (aPL) antibodies has been associated
with thrombosis, pregnancy loss and thrombocytopenia in the antiphosph
olipid syndrome (APS). The anticardiolipin and the lupus anticoagulant
tests are frequently used to detect aPL antibodies. The anticardiolip
in ELISA utilizes cardiolipin coated on polystyrene plates as antigen
and is a very sensitive test but lacks specificity? since it can be po
sitive in a number of infectious (such as syphilis, HIV) and autoimmun
e diseases other than APS. In an effort to improve specificity, new EL
ISA techniques that employ alternative antigens (such as beta(2)-glyco
protein 1, particularly when coated onto oxidized microtiter plates or
mixture of phospholipids) have been developed. Several investigators
have reported that these new assays enable more specific determination
of aPL antibodies and thus can be used more reliably for the diagnosi
s and confirmation of APS. This article examines the results of those
studies, including data that shows correlations of these assays with c
linical manifestations of APS, and proposes a new protocol for the use
of laboratory tests in the diagnosis of APS.