Abstract：
Diagnosis of antiphospholipid syndrome (APS) requires the presence of a clinical criterion (thrombosis and/or pregnancy morbidity), combined with persistently circulating antiphospholipid antibodies (aPL). Currently, laboratory criteria aPL consist of lupus anticoagulant (LAC), anticardiolipin antibodies (aCL) IgG/IgM, and anti-β2 glycoprotein I antibodies (aβ2GPI) IgG/IgM. Diagnosis and risk stratification of APS are complex and efforts to standardize and optimize laboratory tests have been ongoing since the initial description of the syndrome. LAC detection is based on functional coagulation assays, while aCL and aβ2GPI are measured with immunological solid-phase assays. LAC assays are especially prone to interference by anticoagulation therapy, but strategies to circumvent this interference are promising. Alternative techniques such as thrombin generation for LAC detection and to estimate LAC pathogenicity have been suggested, but are not applicable yet in routine setting. For aCL and aβ2GPI, a lot of different assays and detection techniques such as enzyme-linked immunosorbent and chemiluminescent assays are available. Furthermore, a lack of universal calibrators or standards results in high variability between the different solid-phase assays. Other non-criteria aPL such as anti-domain I β2 glycoprotein I and antiphosphatidylserine/prothrombin antibodies have been suggested for risk stratification purposes in APS, while their added value to diagnostic criteria seems limited. In this review, we will describe laboratory assays for diagnostic and risk evaluation in APS, integrating applicable guidelines and classification criteria. Current insights and hindrances are addressed with respect to both laboratory and clinical implications.
摘要：
抗磷脂综合征（APS）的诊断需要临床标准（血栓形成和/或妊娠发病率）的存在，结合持续循环的抗磷脂抗体（aPL）。目前,实验室标准aPL包括狼疮抗凝物（LAC），抗心磷脂抗体（aCL）IgG/IgM，和抗β2糖蛋白I抗体(aβ2GPI)IgG/IgM。APS的诊断和风险分层是复杂的，并且自最初描述该综合征以来，一直在努力标准化和优化实验室测试。LAC检测是基于功能性凝血检测，而aCL和aβ2GPI是用免疫固相测定法测量的。LAC分析特别容易受到抗凝治疗的干扰，但是规避这种干扰的策略是有希望的。已经提出了替代技术，例如用于LAC检测和估计LAC致病性的凝血酶生成。但在常规设置中还不适用。对于aCL和aβ2GPI，许多不同的分析和检测技术，如酶联免疫吸附和化学发光分析是可用的。此外，缺乏通用校准物或标准品导致不同固相测定之间的高度差异。其他非标准aPL如抗结构域Iβ2糖蛋白I和抗磷脂酰丝氨酸/凝血酶原抗体已被建议用于APS的风险分层目的。虽然它们对诊断标准的附加价值似乎有限。在这次审查中,我们将描述APS中诊断和风险评估的实验室测定，整合适用的指南和分类标准。目前的见解和障碍都在实验室和临床意义上得到了解决。
