Antiphospholipid Standardization Laboratory, Division of Rheumatology, Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX 77555-0883, USA.
Lupus. 2011 Feb;20(2):182-90. doi: 10.1177/0961203310395055.
Current classification criteria for definite antiphospholipid syndrome (APS) mandate the use of one or more of three positive 'standardized' laboratory assays to detect antiphospholipid antibodies (aPL) (viz: anticardiolipin [aCL] IgG and IgM; anti-β(2)glycoprotein I [anti-β(2)GPI] antibodies IgG and IgM; and/or a lupus anticoagulant [LAC]), when at least one of the two major clinical manifestations (thrombosis or pregnancy losses) are present. Although, efforts of standardization for these 'criteria' aPL tests have been conducted over the last 27 years, reports of inconsistencies, inter-assay and inter-laboratory variation in the results of aCL, LAC, and anti-β(2)GPI, and problems with the interpretation and the clinical value of the tests still exist, which affect the consistency of the diagnosis of APS. A Task Force of scientists and pioneers in the field from different countries, subdivided in three working groups, discussed and analyzed critical questions related to 'criteria' aPL tests in an evidence-based manner, during the 13(th) International Congress on Antiphospholipid Antibodies (APLA 2010, April 13-16, 2010, Galveston, TX). These included: review of the standardization and the need for international consensus protocol for aCL and anti-β(2)GPI tests; the use of monoclonal and/or polyclonal standards in the calibration curve of those tests; and the need for establishment of international units of measurement for anti-β(2)GPI tests. The group also reviewed the recently updated guidelines for LAC testing, and analyzed and discussed the possibility of stratification of 'criteria' aPL tests as risk factors for APS, as well as the clinical value of single positive vs. multiple aPL positivity. The group members presented, discussed, analyzed data, updated and re-defined those critical questions at a preconference workshop that was open to congress attendees. This report summarizes the findings, conclusions, and recommendations of this Task Force.
目前,明确抗磷脂综合征(APS)的分类标准要求使用一种或多种三种阳性“标准化”实验室检测方法来检测抗磷脂抗体(aPL)(即:抗心磷脂[ACL] IgG 和 IgM;抗β2糖蛋白 I [抗β2GPI]抗体 IgG 和 IgM;和/或狼疮抗凝物[LAC]),当存在至少两种主要临床表现之一(血栓形成或妊娠丢失)时。尽管过去 27 年来一直在为这些“标准”aPL 检测进行标准化努力,但仍有报道称 ACL、LAC 和抗β2GPI 的检测结果存在不一致性、检测内和检测间差异,以及检测结果的解释和临床价值存在问题,这些问题影响了 APS 的诊断一致性。来自不同国家的科学家和该领域的先驱者组成了一个工作组,在第 13 届国际抗磷脂抗体大会(APLA 2010 年,2010 年 4 月 13 日至 16 日,德克萨斯州加尔维斯顿)上,以循证的方式讨论和分析了与“标准”aPL 检测相关的关键问题。这些问题包括:ACL 和抗β2GPI 检测的标准化和国际共识方案的需求;这些检测校准曲线中使用单克隆和/或多克隆标准;以及为抗β2GPI 检测建立国际测量单位的必要性。该小组还审查了最近更新的 LAC 检测指南,并分析和讨论了将“标准”aPL 检测分层为 APS 风险因素的可能性,以及单一阳性与多个 aPL 阳性的临床价值。小组成员在向大会代表开放的会前研讨会上展示、讨论、分析数据,更新和重新定义了这些关键问题。本报告总结了该工作组的发现、结论和建议。