Abstract
Background:
Increasing evidence has highlighted the role of non-criteria antiphospholipid antibodies (aPLs) as important supplements to the current criteria aPLs for the diagnosis of antiphospholipid syndrome (APS). In this retrospective study, we evaluated the clinical relevance of antibodies to phosphatidylserine/prothrombin (aPS/PT) in Chinese patients with APS.
Methods:
A total of 441 subjects were tested, including 101 patients with primary APS (PAPS), 140 patients with secondary APS (SAPS), 161 disease controls (DCs) and 39 healthy controls (HCs). Serum IgG/IgM aPS/PT was determined by ELISA.
Results:
The levels of IgG/IgM aPS/PT were significantly increased in patients with APS compared with DCs and HCs. IgG and IgM aPS/PT were present in 29.7% and 54.5% of PAPS, and 42.1% and 53.6% of SAPS, respectively. For diagnosis of APS, IgG aCL exhibited the highest positive likelihood ratio (LR+) of 21.60, followed by LA (13.84), IgG aβ2GP1 (9.19) and IgG aPS/PT (8.49). aPS/PT was detected in 13.3% of seronegative PAPS patients and 31.3% of seronegative SAPS patients. LA exhibited the highest OR of 3.64 in identifying patients with thrombosis, followed by IgG aCL (OR, 2.63), IgG aPS/PT (OR, 2.55) and IgG aβ2GP1 (OR, 2.33). LA and IgG aCL were correlated with both arterial and venous thrombosis, whereas IgG aPS/PT and IgG aβ2GP1 correlated with venous or arterial thrombosis, respectively.
Conclusions:
Our findings suggest that the inclusion of IgG/IgM aPS/PT may enhance the diagnostic performance for APS, especially in those in whom APS is highly suspected, but conventional aPLs are repeatedly negative. In addition, IgG aPS/PT may contribute to identify patients at risk of thrombosis.
Acknowledgments
We thank all the people from the Department of Rheumatology and Clinical Immunology, PUMCH, for their assistance during this study.
Author contributions: SZ, FZ and YL designed the study. SZ, ZW, WZ, JZ, XZ, GLN and YL performed the experiments and analyzed the data. SZ, GLN, FZ and YL wrote the manuscript. All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: This work was supported in part by the National Natural Science Foundation of China, Funder ID: 10.13039/501100001809; grant nos. 81373188, 81671618/81172857 (to YL) and 81771661 (to SZ); Chinese Academy of Medical Sciences (CAMS) Initiative for Innovative Medicine (CAMS-I2M) grant no. 2017-I2M-3-001 (to SZ and YL); and The National Key Research and Development Program of China grant no. 2016YFC0903900 (to YL).
Employment or leadership: Gary L. Norman is an employee of Inova Diagnostics.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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