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Diagnostic Performance of a DOAC Urine Dipstick in Obese Outpatients with Atrial Fibrillation: Comparison with Plasma

Arianna Pannunzio1,2, Valentina Castellani3, Erminia Baldacci3

  • 1Department of General Surgery, Surgical Specialty and Anaesthesiology, Sapienza University of Rome, 00185 Rome, Italy.

Journal of Clinical Medicine
|January 28, 2026
PubMed

Insights

A new urine point-of-care test for direct oral anticoagulants (DOACs) shows high sensitivity but low specificity in obese atrial fibrillation (AF) patients. This diagnostic tool may only be useful in specific clinical situations for managing anticoagulation.

Area of Science:

  • Cardiology
  • Pharmacology
  • Clinical Diagnostics

Background:

  • Obese patients with atrial fibrillation (AF) require oral anticoagulant therapy due to high thromboembolic risk.
  • Limited data exist on direct oral anticoagulants (DOACs) in this specific patient group.
  • A validated point-of-care (POC) method is needed for rapid clinical decisions and to establish plasma concentration thresholds.

Purpose of the Study:

  • To evaluate the diagnostic accuracy of a urinary DOACs Dipstick test compared to plasma concentrations in obese AF outpatients.
  • To determine the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the POC test.
  • To perform sub-analyses based on obesity severity and DOAC type.

Main Methods:

  • A monocentric, cross-sectional diagnostic accuracy study involving 160 obese AF outpatients.
  • Paired urine and plasma samples were collected.
  • Urinary Dipsticks (for Factor Xa inhibitors and thrombin inhibitors) were compared against reference standard plasma concentrations (trough and peak) using chromogenic assays/dTT.

Main Results:

  • The DOACs Dipstick demonstrated high sensitivity (99.24% vs. trough, 97.8% vs. peak) but low specificity (6.89% vs. trough, 0% vs. peak) when compared to plasma concentrations.
  • Compared to plasma thresholds > 30 ng/mL, the test showed 99.10% sensitivity and 4.70% specificity.
  • Positive predictive values were acceptable (82.80% vs. trough, 85.9% vs. peak), but negative predictive values were low (66.67% vs. trough, not provided vs. peak).

Conclusions:

  • The urine POC test exhibits high sensitivity and acceptable PPV in obese AF patients.
  • However, the test's low specificity and NPV limit its broad clinical utility.
  • The DOACs Dipstick may be valuable only in selected clinical scenarios for managing anticoagulation in this population.

Keywords:
DOACsnon-valvular atrial fibrillationobesityplasma concentrationsurine dipstick

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