Detection of moderate to high antiphospholipid antibodies by chemiluminescence meets 2023 APS classification criteria

Abstract The 2023 ACR/EULAR criteria for antiphospholipid syndrome (APS) have modified the laboratory domain. However, enzyme-linked immunosorbent assay (ELISA) remains the sole specified method for antiphospholipid antibody detection. This study aims to establish moderate and high levels of anticar...

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Main Authors: Haiyue Jiang, Yaqing Yang, Zihan Tang, Haoyu Pan, Honglei Liu, Xiaobing Cheng, Yutong Su, Junna Ye, Qiongyi Hu, Jianfen Meng, Huihui Chi, Zhuochao Zhou, Jinchao Jia, Hui Shi, Chengde Yang, Jialin Teng, Tingting Liu
Format: Article
Language:English
Published: Nature Portfolio 2025-05-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-025-04097-y
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author Haiyue Jiang
Yaqing Yang
Zihan Tang
Haoyu Pan
Honglei Liu
Xiaobing Cheng
Yutong Su
Junna Ye
Qiongyi Hu
Jianfen Meng
Huihui Chi
Zhuochao Zhou
Jinchao Jia
Hui Shi
Chengde Yang
Jialin Teng
Tingting Liu
author_facet Haiyue Jiang
Yaqing Yang
Zihan Tang
Haoyu Pan
Honglei Liu
Xiaobing Cheng
Yutong Su
Junna Ye
Qiongyi Hu
Jianfen Meng
Huihui Chi
Zhuochao Zhou
Jinchao Jia
Hui Shi
Chengde Yang
Jialin Teng
Tingting Liu
author_sort Haiyue Jiang
collection DOAJ
description Abstract The 2023 ACR/EULAR criteria for antiphospholipid syndrome (APS) have modified the laboratory domain. However, enzyme-linked immunosorbent assay (ELISA) remains the sole specified method for antiphospholipid antibody detection. This study aims to establish moderate and high levels of anticardiolipin(aCL) and anti-β2-glycoprotein I antibodies (anti-β2GPI) using chemiluminescence assay (CIA) and to investigate the diagnostic efficiency and risk stratification capabilities of CIA in comparison to ELISA. We conducted a comprehensive analysis involving 166 APS patients, 194 disease controls, and 120 healthy controls. Our assessment entailed the utilization of both ELISA and CIA to detect aCL IgG/IgM and anti-β2GPI IgG/IgM. We established distinct moderate and high semi-quantitative thresholds for CIA corresponding to ELISA. Additionally, we computed the likelihood ratios at various thresholds and compared them with ELISA. The qualitative agreement and quantitative correlation between CIA and ELISA were robust. When applying the established moderate and high thresholds of aCL/aβ2GPI IgG/IgM in CIA according to the equal ROC specificity corresponding to ELISA, the diagnostic efficiency and risk stratification capabilities of CIA aligned comparably with those of ELISA. Although IgM exhibited poorer performance in risk assessment compared to IgG, it still played as risk factors for thrombosis and obstetrical manifestations. Utilizing the established moderate/high thresholds for aCL/aβ2GPI IgG/IgM by CIA, effectively addressing both diagnostic and risk stratification requirements comparable to ELISA, signifies that the CIA has emerged as an alternative for aPL detection. The high specificity and clinical relevance of aCL/aβ2GPI IgM in clinical events highlight its importance in clinical practice.
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spelling doaj-art-3b2ed77f10164f5c9a29f1f9343104722025-08-20T02:03:35ZengNature PortfolioScientific Reports2045-23222025-05-0115111210.1038/s41598-025-04097-yDetection of moderate to high antiphospholipid antibodies by chemiluminescence meets 2023 APS classification criteriaHaiyue Jiang0Yaqing Yang1Zihan Tang2Haoyu Pan3Honglei Liu4Xiaobing Cheng5Yutong Su6Junna Ye7Qiongyi Hu8Jianfen Meng9Huihui Chi10Zhuochao Zhou11Jinchao Jia12Hui Shi13Chengde Yang14Jialin Teng15Tingting Liu16Department of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineDepartment of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineAbstract The 2023 ACR/EULAR criteria for antiphospholipid syndrome (APS) have modified the laboratory domain. However, enzyme-linked immunosorbent assay (ELISA) remains the sole specified method for antiphospholipid antibody detection. This study aims to establish moderate and high levels of anticardiolipin(aCL) and anti-β2-glycoprotein I antibodies (anti-β2GPI) using chemiluminescence assay (CIA) and to investigate the diagnostic efficiency and risk stratification capabilities of CIA in comparison to ELISA. We conducted a comprehensive analysis involving 166 APS patients, 194 disease controls, and 120 healthy controls. Our assessment entailed the utilization of both ELISA and CIA to detect aCL IgG/IgM and anti-β2GPI IgG/IgM. We established distinct moderate and high semi-quantitative thresholds for CIA corresponding to ELISA. Additionally, we computed the likelihood ratios at various thresholds and compared them with ELISA. The qualitative agreement and quantitative correlation between CIA and ELISA were robust. When applying the established moderate and high thresholds of aCL/aβ2GPI IgG/IgM in CIA according to the equal ROC specificity corresponding to ELISA, the diagnostic efficiency and risk stratification capabilities of CIA aligned comparably with those of ELISA. Although IgM exhibited poorer performance in risk assessment compared to IgG, it still played as risk factors for thrombosis and obstetrical manifestations. Utilizing the established moderate/high thresholds for aCL/aβ2GPI IgG/IgM by CIA, effectively addressing both diagnostic and risk stratification requirements comparable to ELISA, signifies that the CIA has emerged as an alternative for aPL detection. The high specificity and clinical relevance of aCL/aβ2GPI IgM in clinical events highlight its importance in clinical practice.https://doi.org/10.1038/s41598-025-04097-yAntiphospholipid syndromeAntiphospholipid autoantibodiesIgMChemiluminescence assayEnzyme-linked immunosorbent assay
spellingShingle Haiyue Jiang
Yaqing Yang
Zihan Tang
Haoyu Pan
Honglei Liu
Xiaobing Cheng
Yutong Su
Junna Ye
Qiongyi Hu
Jianfen Meng
Huihui Chi
Zhuochao Zhou
Jinchao Jia
Hui Shi
Chengde Yang
Jialin Teng
Tingting Liu
Detection of moderate to high antiphospholipid antibodies by chemiluminescence meets 2023 APS classification criteria
Scientific Reports
Antiphospholipid syndrome
Antiphospholipid autoantibodies
IgM
Chemiluminescence assay
Enzyme-linked immunosorbent assay
title Detection of moderate to high antiphospholipid antibodies by chemiluminescence meets 2023 APS classification criteria
title_full Detection of moderate to high antiphospholipid antibodies by chemiluminescence meets 2023 APS classification criteria
title_fullStr Detection of moderate to high antiphospholipid antibodies by chemiluminescence meets 2023 APS classification criteria
title_full_unstemmed Detection of moderate to high antiphospholipid antibodies by chemiluminescence meets 2023 APS classification criteria
title_short Detection of moderate to high antiphospholipid antibodies by chemiluminescence meets 2023 APS classification criteria
title_sort detection of moderate to high antiphospholipid antibodies by chemiluminescence meets 2023 aps classification criteria
topic Antiphospholipid syndrome
Antiphospholipid autoantibodies
IgM
Chemiluminescence assay
Enzyme-linked immunosorbent assay
url https://doi.org/10.1038/s41598-025-04097-y
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