Department of Pathology, University of Utah, Salt Lake City, USA; ARUP Laboratories, Institute of Clinical and Experimental Pathology, Salt Lake City, USA.
Rheumatology/Internal Medicine, University of Texas Medical Branch, Galveston, USA.
Clin Chim Acta. 2016 Sep 1;460:107-13. doi: 10.1016/j.cca.2016.06.025. Epub 2016 Jun 23.
The objective of this investigation was to examine the clinical significance of IgA anti-β2 glycoprotein I (anti-β2GPI) antibodies and the inter-assay relationships between kits for their determination.
Serum samples from 269 patients with clinical diagnoses of systemic lupus erythematosus (SLE) and/or antiphospholipid syndrome (APS), individuals positive for antiphospholipid antibodies (aPL) with or without APS or SLE, and 182 controls were tested for anti-β2GPI IgA antibodies using kits from four manufacturers.
The positivity rates for the different IgA anti-β2GPI antibody kits varied in the disease groups; 7.8-14.7% (SLE only), 12.0-15.7% (SLE and APS/aPL), 14.7-58.8% (APS only), and 17.4-52.2% (aPL only). Kappa agreements between any 2 kits within disease groups were also variable and ranged from 0.25-1.00 (SLE), 0.18-1.00 (SLE and APS/aPL), 0.22-0.94 (APS only), and 0.32-0.91 (aPL only). Univariate analyses also showed variable relative risks for specific APS clinical manifestations with the different kits evaluated. Overall, diagnostic and predictive values for IgA anti-β2GPI antibodies are kit-dependent; therefore results are not interchangeable. While all 4 kits seem able to predict venous thrombosis tolerably well, there was a variable performance in predicting pregnancy related morbidity.
Efforts to standardize these assays are highly needed prior to their formal adoption in routine clinical evaluation.
本研究旨在探讨 IgA 型抗β2 糖蛋白 I（anti-β2GPI）抗体的临床意义，以及用于检测该抗体的试剂盒之间的实验室内相关性。
采用四家制造商生产的试剂盒，对 269 例临床诊断为系统性红斑狼疮（SLE）和/或抗磷脂综合征（APS）的患者、抗磷脂抗体（aPL）阳性且伴有或不伴有 APS 或 SLE 的个体，以及 182 例对照者的血清样本进行 IgA 型抗β2GPI 抗体检测。
不同 IgA 型抗β2GPI 抗体试剂盒在疾病组中的阳性率有所不同：7.8-14.7%（仅 SLE）、12.0-15.7%（SLE 和 APS/aPL）、14.7-58.8%（仅 APS）和 17.4-52.2%（仅 aPL）。疾病组内任意两种试剂盒之间的kappa 一致性也各不相同，范围在 0.25-1.00（SLE）、0.18-1.00（SLE 和 APS/aPL）、0.22-0.94（仅 APS）和 0.32-0.91（仅 aPL）之间。单变量分析还显示，不同试剂盒评估的特定 APS 临床表现的相对风险也存在差异。总体而言，IgA 型抗β2GPI 抗体的诊断和预测价值取决于试剂盒；因此结果不可互换。虽然所有 4 种试剂盒似乎都能较好地预测静脉血栓形成，但在预测妊娠相关发病率方面表现存在差异。
在将这些检测方法正式纳入常规临床评估之前，非常需要努力对其进行标准化。
