Radin Massimo, Cecchi Irene, Foddai Silvia Grazietta, Rubini Elena, Barinotti Alice, Ramirez Carlos, Seaman Andrea, Roccatello Dario, Mahler Michael, Sciascia Savino
Center of Research of Immunopathology and Rare Diseases-Coordinating Center of Piemonte and Valle d'Aosta Network for Rare Diseases, S. Giovanni Bosco Hospital, Department of Clinical and Biological Sciences, University of Turin, 10154 Turin, Italy.
School of Specialization of Clinical Pathology, Department of Clinical and Biological Sciences, University of Turin, 10125 Turin, Italy.
Biomedicines. 2020 Dec 17;8(12):622. doi: 10.3390/biomedicines8120622.
Among "extra-criteria" antiphospholipid antibodies (aPL), anti-phosphatidylserine/prothrombin (aPS/PT) antibodies, are considered a part of risk assessment strategies when investigating patients suspected of having antiphospholipid syndrome (APS). aPL detection is currently performed by solid-phase assays to identify anti-cardiolipin (aCL), anti-β2glycoprotein I (aβ2GPI) and aPS/PT antibodies, but new techniques are emerging. Among these, particle-based multi-analyte technology (PMAT), which allows the full automation and simultaneous digital detection of autoantibodies and proteins, including IgG, IgA and IgM isotypes of aCL, aβ2GPI and aPS/PT. The aim of this study was to investigate the agreement of aPS/PT testing between enzyme-linked immunosorbent assay (ELISA) and the PMAT platform. A total of 94 patients were enrolled in the study, including 71 patients with confirmed APS and 23 "aPL carriers". aPS/PT IgG showed a moderate binomial agreement between ELISA and PMAT (k = 0.57, 95% CI 0.45-0.75), and aPS/PT IgM showed a moderate agreement (k = 0.60, 95% CI 0.45-0.75). Moreover, when considering the continuous agreement, both aPS/PT IgG and IgM showed a statistically significant correlation between ELISA and PMAT (Spearman's correlation = 0.69, < 0.001 and 0.72, < 0.001, respectively). This study demonstrates that PMAT technology is a reliable method for aPS/PT IgG and IgM testing when compared to the available commercial ELISA kit.
在“额外标准”抗磷脂抗体（aPL）中，抗磷脂酰丝氨酸/凝血酶原（aPS/PT）抗体在调查疑似抗磷脂综合征（APS）的患者时被视为风险评估策略的一部分。目前，aPL检测通过固相测定法进行，以识别抗心磷脂（aCL）、抗β2糖蛋白I（aβ2GPI）和aPS/PT抗体，但新技术正在不断涌现。其中，基于颗粒的多分析物技术（PMAT）能够实现自身抗体和蛋白质的全自动化及同步数字检测，包括aCL、aβ2GPI和aPS/PT的IgG、IgA和IgM同种型。本研究的目的是调查酶联免疫吸附测定（ELISA）和PMAT平台之间aPS/PT检测结果的一致性。共有94名患者参与了该研究，其中包括71名确诊的APS患者和23名“aPL携带者”。aPS/PT IgG在ELISA和PMAT之间显示出中等程度的二项一致性（k = 0.57，95%可信区间0.45 - 0.75），aPS/PT IgM显示出中等程度的一致性（k = 0.60，95%可信区间0.45 - 0.75）。此外，在考虑连续一致性时，aPS/PT IgG和IgM在ELISA和PMAT之间均显示出具有统计学意义的相关性（Spearman相关性分别为0.69，< 0.001和0.72，< 0.001）。本研究表明，与现有的商业ELISA试剂盒相比，PMAT技术是一种用于aPS/PT IgG和IgM检测的可靠方法。
