Lauro Meneghel1, Amelia Ruffatti2, Sabrina Gavasso3, Marta Tonello2, Elena Mattia2, Luca Spiezia3, Daniela Tormene3, Ariela Hoxha2, Marny Fedrigo4, Paolo Simioni3. 1. Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani 2, 35128 Padua, Italy. Electronic address: lauro.meneghel@studenti.unipd.it. 2. Rheumatology Unit, Department of Medicine, University of Padua, Via Giustiniani 2, 35128 Padua, Italy. 3. Chair of Internal Medicine, Department of Medicine, University of Padua, Via Giustiniani 2, 35128 Padua, Italy. 4. Chair of Cardiovascular Pathology, Department of Cardiological, Thoracic and Vascular Sciences, University of Padua, Via Giustiniani 2, 35128 Padua, Italy.
Abstract
BACKGROUND: IgG anti-Domain I (anti-DI) β2 Glycoprotein I (β2GPI) antibodies are associated to thrombotic risk in antiphospholipid syndrome (APS), but their detection is technically difficult. In this study, a chemiluminescent immunoassay (CLIA) was used to evaluate the clinical significance of IgG anti-DI in a large cohort of patients with primary APS (PAPS). METHODS: The study population included 88 patients with PAPS, 63 ELISA-negative subjects and 166 controls. IgG anti-DI, IgG anticardiolipin (aCL) and IgG anti-β2GPI antibodies were assayed using CLIA (HemosIL AcuStar®). RESULTS: The sensitivity and specificity of IgG anti-DI antibodies were comparable to those of IgG aCL and IgG anti-β2GPI antibodies. There was a significant agreement, association and titre correlation between IgG anti-DI and IgG aCL as well as IgG anti-β2GPI antibodies (p<0.001 for all). IgG anti-DI antibody showed lesser prevalence and mean titres in the pregnancy morbidity than in thrombotic and PAPS patients with both involvements (p<0.001). Regarding the conventional aPL antibody profiles, the triple positivity group had higher prevalence and mean titres than single and double positivity ones (p<0.001). CONCLUSIONS: This study provides further evidence that anti-DI antibodies can be considered a promising biomarker for risk assessment particularly in patients having vascular thrombosis and triple conventional aPL positivity.
BACKGROUND: IgG anti-Domain I (anti-DI) β2 Glycoprotein I (β2GPI) antibodies are associated to thrombotic risk in antiphospholipid syndrome (APS), but their detection is technically difficult. In this study, a chemiluminescent immunoassay (CLIA) was used to evaluate the clinical significance of IgG anti-DI in a large cohort of patients with primary APS (PAPS). METHODS: The study population included 88 patients with PAPS, 63 ELISA-negative subjects and 166 controls. IgG anti-DI, IgG anticardiolipin (aCL) and IgG anti-β2GPI antibodies were assayed using CLIA (HemosIL AcuStar®). RESULTS: The sensitivity and specificity of IgG anti-DI antibodies were comparable to those of IgG aCL and IgG anti-β2GPI antibodies. There was a significant agreement, association and titre correlation between IgG anti-DI and IgG aCL as well as IgG anti-β2GPI antibodies (p<0.001 for all). IgG anti-DI antibody showed lesser prevalence and mean titres in the pregnancy morbidity than in thrombotic and PAPS patients with both involvements (p<0.001). Regarding the conventional aPL antibody profiles, the triple positivity group had higher prevalence and mean titres than single and double positivity ones (p<0.001). CONCLUSIONS: This study provides further evidence that anti-DI antibodies can be considered a promising biomarker for risk assessment particularly in patients having vascular thrombosis and triple conventional aPL positivity.
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