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Abstract：
Despite expansion in the 2006 Sydney antiphospholipid syndrome (APS) classification criteria to include IgG/IgM anti-β2-glycoprotein (aβ2GPI) antibodies in addition to IgG/IgM anti-cardiolipin antibodies (aCL) and lupus anticoagulant (LAC), some individuals with clinical features of APS remain seronegative (seronegative APS or SNAPS) and are at risk of recurrent thrombosis and pregnancy morbidities. Our aim was to assess the value of \"non-criteria\" aPL antibodies to detect these SNAPS patients.
One hundred ninety-two APS patients, 90 SNAPS patients, 193 autoimmune disease controls, and 120 healthy controls were evaluated. Ten antiphospholipid antibodies (aPLs) were tested using commercial kits, including 5 non-criteria aPLs: anti-phosphatidylserine/prothrombin antibodies (aPS/PT) IgG/IgM, aCL IgA, aβ2GPI IgA, and anti-β2GPI Domain 1 (aβ2GPI-D1) IgG.
Up to 60.9% of the SNAPS and 93.5% of APS patients were detected by at least one non-criteria aPL. aPS/PT IgG had the highest Youden index in classifying APS and SNAPS from controls. aPS/PT IgG and aβ2GPI Domain 1 IgG seem to be the most significant risk factors for thrombotic events and pregnancy morbidity, respectively. aPS/PT IgG/IgM and aβ2GPI-D1 IgG were detected in some SNAPS patients, while IgA isotypes of aCL/aβ2GPI tended to appear together with other biomarkers. The combined analysis showed enhanced diagnostic performance with the inclusion of non-criteria aPLs.
Recognition of SNAPS patients is critical for clinical management and prevention of potential thrombotic and obstetric adverse events. The non-criteria antiphospholipid antibodies help to identify a considerable portion (60.9%) of these patients who otherwise may remain untreated and at clinical risk.
One hundred ninety-two APS patients, 90 SNAPS patients, 193 autoimmune disease controls, and 120 healthy controls were evaluated. Ten antiphospholipid antibodies (aPLs) were tested using commercial kits, including 5 non-criteria aPLs: anti-phosphatidylserine/prothrombin antibodies (aPS/PT) IgG/IgM, aCL IgA, aβ2GPI IgA, and anti-β2GPI Domain 1 (aβ2GPI-D1) IgG.
Up to 60.9% of the SNAPS and 93.5% of APS patients were detected by at least one non-criteria aPL. aPS/PT IgG had the highest Youden index in classifying APS and SNAPS from controls. aPS/PT IgG and aβ2GPI Domain 1 IgG seem to be the most significant risk factors for thrombotic events and pregnancy morbidity, respectively. aPS/PT IgG/IgM and aβ2GPI-D1 IgG were detected in some SNAPS patients, while IgA isotypes of aCL/aβ2GPI tended to appear together with other biomarkers. The combined analysis showed enhanced diagnostic performance with the inclusion of non-criteria aPLs.
Recognition of SNAPS patients is critical for clinical management and prevention of potential thrombotic and obstetric adverse events. The non-criteria antiphospholipid antibodies help to identify a considerable portion (60.9%) of these patients who otherwise may remain untreated and at clinical risk.
摘要：
尽管在2006年悉尼抗磷脂综合征（APS）分类标准中，除了IgG/IgM抗心磷脂抗体（aCL）和狼疮抗凝药（LAC）外，还包括IgG/IgM抗β2-糖蛋白（aβ2GPI）抗体，一些具有APS临床特征的个体保持血清阴性(血清阴性APS或SNAPS),并且有反复血栓形成和妊娠发病的风险.我们的目的是评估“非标准”aPL抗体检测这些SNAPS患者的价值。
一百九十二位APS患者，90名SNAPS患者，193个自身免疫性疾病对照，对120名健康对照进行了评估。使用商业试剂盒测试了十种抗磷脂抗体(aPL)，包括5个非标准aPLs：抗磷脂酰丝氨酸/凝血酶原抗体（aPS/PT）IgG/IgM，aCLIgA,αβ2GPIIgA，和抗β2GPI结构域1(aβ2GPI-D1)IgG。
通过至少一种非标准aPL检测到高达60.9%的SNAPS和93.5%的APS患者。aPS/PTIgG在将APS和SNAPS与对照分类方面具有最高的Youden指数。aPS/PTIgG和aβ2GPI结构域1IgG似乎是血栓形成事件和妊娠发病率的最重要风险因素，分别。在一些SNAPS患者中检测到aPS/PTIgG/IgM和aβ2GPI-D1IgG，而aCL/aβ2GPI的IgA同种型倾向于与其他生物标志物一起出现。组合分析显示，纳入非标准aPL的诊断性能增强。
识别SNAPS患者对于临床管理和预防潜在的血栓形成和产科不良事件至关重要。非标准抗磷脂抗体有助于鉴定这些患者中相当一部分(60.9%),否则这些患者可能仍未治疗并处于临床风险中。
一百九十二位APS患者，90名SNAPS患者，193个自身免疫性疾病对照，对120名健康对照进行了评估。使用商业试剂盒测试了十种抗磷脂抗体(aPL)，包括5个非标准aPLs：抗磷脂酰丝氨酸/凝血酶原抗体（aPS/PT）IgG/IgM，aCLIgA,αβ2GPIIgA，和抗β2GPI结构域1(aβ2GPI-D1)IgG。
通过至少一种非标准aPL检测到高达60.9%的SNAPS和93.5%的APS患者。aPS/PTIgG在将APS和SNAPS与对照分类方面具有最高的Youden指数。aPS/PTIgG和aβ2GPI结构域1IgG似乎是血栓形成事件和妊娠发病率的最重要风险因素，分别。在一些SNAPS患者中检测到aPS/PTIgG/IgM和aβ2GPI-D1IgG，而aCL/aβ2GPI的IgA同种型倾向于与其他生物标志物一起出现。组合分析显示，纳入非标准aPL的诊断性能增强。
识别SNAPS患者对于临床管理和预防潜在的血栓形成和产科不良事件至关重要。非标准抗磷脂抗体有助于鉴定这些患者中相当一部分(60.9%),否则这些患者可能仍未治疗并处于临床风险中。
