Department of Clinical Immunology and Rheumatology, Christian Medical College , Vellore, India.
Department of Biostatistics, Christian Medical College , Vellore, India.
Clin Rheumatol. 2019 Feb;38(2):545-553. doi: 10.1007/s10067-018-4301-1. Epub 2018 Sep 26.
Antiphospholipid syndrome (APS) is the most common acquired pro-thrombotic disorder, also associated with obstetric complications. Phosphatidylserine/Prothrombin complex antibody (aPSPT) though associated with various APS manifestations, is not included in the revised Sapporo Criteria. To study the prevalence of aPSPT in Asian-Indian patients with suspected APS and compare its performance with the criteria anti-phospholipid antibodies (APLs). Electronic charts of 372 individuals whose sera was tested for aPSPT in suspected APS between June 2014 and May 2016 were retrieved and analyzed. aPSPT was assayed by ELISA. aPSPT tested individuals were categorized into cases-seropositive and seronegative APS (SNAPS) and controls. aPSPT was positive in 24/58 (41.3%) cases and 17/314 (5.4%) controls (p < 0.001). aPSPT positivity was seen in 44.5%, 38.7%, and 58.4% in primary, secondary and SNAPS patients respectively. aPSPT had the best performance among all APLs, in obstetric APS with 31% sensitivity, 97.7% specificity, and an odds ratio of 18.8. It showed 41.4% sensitivity, 94.6% specificity for the classification/diagnosis of primary APS and 38.7% sensitivity, 91.5% specificity for secondary APS. Addition of aPSPT to current APS criteria to SNAPS patients led to reclassification of additional 12.1% patients as APS overall and 42.8% in obstetric APS category. In Asian-Indian patients with suspected APS, aPSPT outperformed all classical APLs in diagnosis/classification of obstetric APS and both isotypes of beta 2-glycoprotein-I antibodies in diagnosis/classification of APS. aPSPT could reclassify additional 12.1 and 42.8% patients as APS overall and obstetric APS respectively, over and above the cases satisfying revised Sapporo criteria.
抗磷脂综合征（APS）是最常见的获得性促血栓形成疾病，也与产科并发症有关。磷脂酰丝氨酸/凝血酶原复合物抗体（aPSPT）虽然与各种 APS 表现有关，但不包括在修订后的 Sapporo 标准中。本研究旨在调查疑似 APS 的亚洲印度患者中 aPSPT 的流行率，并比较其与抗磷脂抗体（APLs）标准的性能。检索并分析了 2014 年 6 月至 2016 年 5 月间在疑似 APS 患者中检测 aPSPT 的 372 例个体的电子病历。通过 ELISA 法检测 aPSPT。将 aPSPT 检测个体分为病例-抗磷脂抗体阳性和阴性 APS（SNAPS）和对照组。24/58（41.3%）例和 17/314（5.4%）对照组 aPSPT 阳性（p<0.001）。原发性、继发性和 SNAPS 患者的 aPSPT 阳性率分别为 44.5%、38.7%和 58.4%。在产科 APS 中，aPSPT 具有最佳性能，敏感性为 31%，特异性为 97.7%，优势比为 18.8。它对原发性 APS 的分类/诊断的敏感性为 41.4%，特异性为 94.6%，对继发性 APS 的敏感性为 38.7%，特异性为 91.5%。将 aPSPT 添加到当前的 APS 标准中，可使 SNAPS 患者中另外 12.1%的患者被重新分类为 APS 总体，42.8%的患者被重新分类为产科 APS 类别。在疑似 APS 的亚洲印度患者中，aPSPT 在诊断/分类产科 APS 方面优于所有经典 APLs，在诊断/分类 APS 方面也优于β2-糖蛋白-I 抗体的两种同种型。aPSPT 可使另外 12.1%和 42.8%的患者分别被重新分类为 APS 总体和产科 APS，超过了满足修订后的 Sapporo 标准的病例。
