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The influence of antiphospholipid antibodies on prothrombin time and international normalized ratio: a scoping review
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DOI：10.1080/10408363.2025.2584522.png)
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Abstract
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Antiphospholipid antibodies (aPL) may interfere with prothrombin time (PT) and international normalized ratio (INR) assays. Patients with antiphospholipid syndrome (APS) are often treated with vitamin K antagonists and require therapeutic monitoring with the INR. However, it remains unclear to what extent these assays are influenced by aPL and the consequent clinical relevance. This scoping review aimed to map the available evidence on the impact of APS and aPL on PT/INR assays, describe the methods used in research in this area, and identify gaps to guide future investigations. Two databases (MEDLINE and Embase) were searched, in the date range of 1 January 1984 to 10 June 2025, for reports describing clinical or in vitro research involving human subjects with APS or aPL that were analyzed with INR/PT assays. Results were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews (PRISMA-Scr) guideline. 3,824 records were retrieved and after deduplication, title/abstract screening, and full-text screening, 39 studies were included in the review. Based on study design, we identified 23 observational clinical studies, 11 case reports/series, and 5 studies reporting in vitro aPL investigations with one report also including a case-control study. Observational studies showed that INR assays utilizing thromboplastin with recombinant human tissue factor (TF), including point-of-care tests (POCT), are more influenced by aPL than assays based on tissue-derived thromboplastins, although not consistently. Case reports described patients, mostly with the presence of multiple aPL, with clinically significant misinterpretation of their anticoagulation status. In vitro studies demonstrated reagent- and antibody-dependent effects, with anti-beta 2-glycoprotein I and antiprothrombin immunoglobulin G antibodies variably prolonging or shortening the PT. Evidence from both clinical and in vitro studies indicates that INR results in APS patients may be unreliable, particularly with specific recombinant human TF-based and POCT reagents, although not systematically. Interference is antibody profile-, antibody level-, and reagent-dependent. However, studies remain heterogeneous, often small in scale, and methodologically inconsistent with variable evaluation criteria. Well-defined future research should aim to identify in which APS patient subgroups an INR would not be reliable with specific assays.
Keywords:
Antiphospholipid antibodies
antiphospholipid syndrome
international normalized ratio
interference
prothrombin time
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