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Peer-reviewedCC BY-NCBleeding, Thrombosis and Vascular Biology

CO100 | ANTIPHOSPHATIDYLSERINE–PROTHROMBIN ANTIBODIES IN ANTIPHOSPHOLIPID SYNDROME: CLINICAL ASSOCIATIONS AND DIAGNOSTIC GAPS MAPPED BY A SCOPING REVIEW

Abstract

Background and Aims. Antiphospholipid syndrome (APS) is a systemic autoimmune thromboinflammatory disorder characterized by thrombosis and/or pregnancy morbidity in association with antiphospholipid antibodies (aPL). As no single laboratory test serves as a diagnostic gold standard, non-criteria antibodies such as antiphosphatidylserine–prothrombin (aPS/PT) have been proposed to complement conventional testing, though their clinical utility remains inconsistently reported. This scoping review mapped the clinical and laboratory relevance of aPS/PT in APS, including seronegative APS, while identifying diagnostic gaps, methodological heterogeneity, and key uncertainties. Methods. A scoping review was conducted in accordance with PRISMA-ScR guidance and prospectively registered on the Open Science Framework (OSF; doi:10.17605/OSF.IO/FSJ8Z). A systematic search of PubMed, Scopus, Embase, and Web of Science identified 1,540 records using predefined strategies. After removal of 1,080 duplicates, title/abstract screening, and full-text review, 58 studies were selected for data extraction. Screening was performed using the Rayyan software. Data were extracted using a structured electronic form and synthesized descriptively. Results. A total of fifty-eight studies were incorporated, predominantly single-center (53 out of 58) and retrospective (34/58), spanning 1988–2023. The majority examined IgG and IgM aPS/PT (52/58), exhibiting considerable geographic and methodological heterogeneity. Only fourteen studies distinctly distinguished primary antiphospholipid syndrome (APS), secondary APS, non-APS, and disease controls, whereas most investigations depended on mixed or outcome-driven cohorts. Commercial assays were predominant (42 out of 58), primarily from Werfen; however, cut-off definitions varied considerably, even within identical kit types. Persistence and titers of aPS/PT were infrequently evaluated. Lupus anticoagulant was assessed in fifty-five studies employing diverse methodologies. Among thirty-five studies assessing concordance, aPS/PT demonstrated a positive correlation with lupus anticoagulant in thirty-one, although multivariable adjustment was uncommon. Associations with thrombosis and pregnancy morbidity were frequently reported but lacked consistent definitions and analytical approaches. Conclusions. aPS/PT demonstrates a reproducible trend toward association with APS-related laboratory and clinical outcomes; however, marked heterogeneity in cohort definitions, patient selection, assay platforms, cut-off determination, and limited multivariable analyses underscores substantial scope for methodological harmonization and standardized statistical approaches to improve confidence in interpreting this widely discussed non-criteria antibody.

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BibTeX
@article{hoxha2026co100,
  title = {{CO100 | ANTIPHOSPHATIDYLSERINE–PROTHROMBIN ANTIBODIES IN ANTIPHOSPHOLIPID SYNDROME: CLINICAL ASSOCIATIONS AND DIAGNOSTIC GAPS MAPPED BY A SCOPING REVIEW}},
  author = {Ariela Hoxha},
  journal = {Bleeding, Thrombosis and Vascular Biology},
  year = {2026},
  month = oct,
  url = {https://www.btvb.org/btvb/article/view/802},
  note = {CC BY-NC},
}
RIS
TY  - JOUR
TI  - CO100 | ANTIPHOSPHATIDYLSERINE–PROTHROMBIN ANTIBODIES IN ANTIPHOSPHOLIPID SYNDROME: CLINICAL ASSOCIATIONS AND DIAGNOSTIC GAPS MAPPED BY A SCOPING REVIEW
AU  - Ariela Hoxha
PY  - 2026
DA  - 2026/10/26
JO  - Bleeding, Thrombosis and Vascular Biology
UR  - https://www.btvb.org/btvb/article/view/802
AB  - Background and Aims. Antiphospholipid syndrome (APS) is a systemic autoimmune thromboinflammatory disorder characterized by thrombosis and/or pregnancy morbidity in association with antiphospholipid antibodies (aPL). As no single laboratory test serves as a diagnostic gold standard, non-criteria antibodies such as antiphosphatidylserine–prothrombin (aPS/PT) have been proposed to complement conventional testing, though their clinical utility remains inconsistently reported. This scoping review mapped the clinical and laboratory relevance of aPS/PT in APS, including seronegative APS, while identifying diagnostic gaps, methodological heterogeneity, and key uncertainties. Methods. A scoping review was conducted in accordance with PRISMA-ScR guidance and prospectively registered on the Open Science Framework (OSF; doi:10.17605/OSF.IO/FSJ8Z). A systematic search of PubMed, Scopus, Embase, and Web of Science identified 1,540 records using predefined strategies. After removal of 1,080 duplicates, title/abstract screening, and full-text review, 58 studies were selected for data extraction. Screening was performed using the Rayyan software. Data were extracted using a structured electronic form and synthesized descriptively. Results. A total of fifty-eight studies were incorporated, predominantly single-center (53 out of 58) and retrospective (34/58), spanning 1988–2023. The majority examined IgG and IgM aPS/PT (52/58), exhibiting considerable geographic and methodological heterogeneity. Only fourteen studies distinctly distinguished primary antiphospholipid syndrome (APS), secondary APS, non-APS, and disease controls, whereas most investigations depended on mixed or outcome-driven cohorts. Commercial assays were predominant (42 out of 58), primarily from Werfen; however, cut-off definitions varied considerably, even within identical kit types. Persistence and titers of aPS/PT were infrequently evaluated. Lupus anticoagulant was assessed in fifty-five studies employing diverse methodologies. Among thirty-five studies assessing concordance, aPS/PT demonstrated a positive correlation with lupus anticoagulant in thirty-one, although multivariable adjustment was uncommon. Associations with thrombosis and pregnancy morbidity were frequently reported but lacked consistent definitions and analytical approaches. Conclusions. aPS/PT demonstrates a reproducible trend toward association with APS-related laboratory and clinical outcomes; however, marked heterogeneity in cohort definitions, patient selection, assay platforms, cut-off determination, and limited multivariable analyses underscores substantial scope for methodological harmonization and standardized statistical approaches to improve confidence in interpreting this widely discussed non-criteria antibody.
SN  - 2785-5309
ER  -