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Peer-reviewedCC BY 4.0PLOS One

Identifying diagnostic testing gaps for antiphospholipid syndrome within a single healthcare system

4 affiliations
  1. 1Geisinger Medical Laboratories, Geisinger, Danville, Pennsylvania, United States of America
  2. 2Thermofisher Scientific, Philadelphia, Pennsylvania, United States of America
  3. 3Geisinger Commonwealth School of Medicine, Scranton, Pennsylvania, United States of America
  4. 4Obstetrics and Gynecology, Maternal and Fetal Medicine, Geisinger, Danville, Pennsylvania, United States of America

Abstract

Antiphospholipid antibody syndrome (APS) is a rare disease with significant morbidity and the possibility of mortality. While there are no established diagnostic criteria for use in clinical settings, there is a large body of global research organized by the American College of Rheumatology and European Alliance of Associations for Rheumatology (ACR/EULAR) into accepted research guidelines, developed for identifying probable APS cases. The research guidelines were used in this study as a surrogate approach for evaluating diagnostic testing patterns, with the aim of identifying potential gaps in patient evaluation for APS in clinical settings. For this study, suggested testing for APS characterization included IgG (Immunoglobulin G) and IgM (Immunoglobulin M) anti-cardiolipin antibodies; IgG and IgM anti-beta-2 glycoprotein I antibodies; and Lupus Anticoagulant. This retrospective cross-sectional study identified patients from the electronic medical records of a regional health system with International Classification of Diseases (ICD) diagnostic codes for APS-associated conditions, signs, symptoms, and/or testing collected for antiphospholipid antibodies in selected medical and surgical specialty locations, from 01/01/2011 to 12/31/2020. These data were used to assess how closely the clinical testing patterns followed the 2023 ACR/EULAR criteria for laboratory evaluation. The data showed that 80.70% of 16679 patients with antiphospholipid antibody tests collected did not include all antiphospholipid antibody testing described in 2023 ACR/EULAR research criteria guidelines. These findings may represent common suboptimal ordering practices in evaluations for APS, highlighting the need for peer comparison and the development of future clinical laboratory guidance to support more complete assessment for APS.

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BibTeX
@article{novak2026identifying,
  title = {{Identifying diagnostic testing gaps for antiphospholipid syndrome within a single healthcare system}},
  author = {Deborah J. Novak and Michelle Grant and Ann Marie Tice and Veena Joy and A. Dhanya Mackeen and Donna M. Wolk},
  journal = {PLOS One},
  year = {2026},
  month = oct,
  doi = {10.1371/journal.pone.0359712},
  url = {https://doi.org/10.1371/journal.pone.0359712},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Identifying diagnostic testing gaps for antiphospholipid syndrome within a single healthcare system
AU  - Deborah J. Novak
AU  - Michelle Grant
AU  - Ann Marie Tice
AU  - Veena Joy
AU  - A. Dhanya Mackeen
AU  - Donna M. Wolk
PY  - 2026
DA  - 2026/10/16
JO  - PLOS One
DO  - 10.1371/journal.pone.0359712
UR  - https://doi.org/10.1371/journal.pone.0359712
AB  - Antiphospholipid antibody syndrome (APS) is a rare disease with significant morbidity and the possibility of mortality. While there are no established diagnostic criteria for use in clinical settings, there is a large body of global research organized by the American College of Rheumatology and European Alliance of Associations for Rheumatology (ACR/EULAR) into accepted research guidelines, developed for identifying probable APS cases. The research guidelines were used in this study as a surrogate approach for evaluating diagnostic testing patterns, with the aim of identifying potential gaps in patient evaluation for APS in clinical settings. For this study, suggested testing for APS characterization included IgG (Immunoglobulin G) and IgM (Immunoglobulin M) anti-cardiolipin antibodies; IgG and IgM anti-beta-2 glycoprotein I antibodies; and Lupus Anticoagulant. This retrospective cross-sectional study identified patients from the electronic medical records of a regional health system with International Classification of Diseases (ICD) diagnostic codes for APS-associated conditions, signs, symptoms, and/or testing collected for antiphospholipid antibodies in selected medical and surgical specialty locations, from 01/01/2011 to 12/31/2020. These data were used to assess how closely the clinical testing patterns followed the 2023 ACR/EULAR criteria for laboratory evaluation. The data showed that 80.70% of 16679 patients with antiphospholipid antibody tests collected did not include all antiphospholipid antibody testing described in 2023 ACR/EULAR research criteria guidelines. These findings may represent common suboptimal ordering practices in evaluations for APS, highlighting the need for peer comparison and the development of future clinical laboratory guidance to support more complete assessment for APS.
SN  - 1932-6203
ER  -