Evaluation of DOAC Dipstick Performance for Plasma Concentration Thresholds of 50, 70, and 100 ng/mL.
Abstract
Introduction Rapid and reliable determination of direct oral anticoagulants (DOACs) remains a major challenge in emergency care and prior to urgent surgical interventions. The DOAC Dipstick has demonstrated good performance characteristics for detecting direct factor Xa (DXI) and thrombin inhibitors (DTI) in urine samples at a plasma threshold of 30 ng/mL. However, the clinically relevant plasma threshold values of DOACs that best support medical decision-making remain controversial. The objective of this investigation was to review publications that allowed calculation of sensitivity, specificity, negative and positive predictive values (NPV, PPV) with 95% confidence intervals (CI) for the DXI and DTI pads of the DOAC Dipstick at plasma thresholds above 30 ng/mL. Method We identified studies that included patients on DOAC therapy in whom DOAC plasma concentrations were measured using chromogenic assays or liquid chromatography-mass spectrometry, and in whom DOAC Dipstick testing of urine samples was performed. Studies were eligible if they reported DOAC Dipstick performance at plasma thresholds above 30 ng/mL for DXI and/or DTI pads. Where data were unavailable from publications, individual patient-level data were analyzed. Performance values with 95% CI for DXI and DTI pads were calculated at plasma thresholds of 50, 70, and 100 ng/mL (reference 1) with SAS software, release 9.4, and at 50 ng/mL as published (reference 2). Results The data of two publications fulfilled the inclusion criteria Ref. ([ 1 ] [ 2 ]), while three did not ([ 3 ] [ 4 ] [ 5 ]). The first study (1) included patients (n=265, DXI n=234, DTI n=31) admitted to an internal medicine emergency department; the calculated results are summarized in the table. The second study (2) included patients (DXI, n=64, DTI, not available) undergoing elective hip and knee surgery ([ Fig. 1 ]). Across thresholds up to 100 ng/mL, sensitivity and NPV consistently exceeded 95%, including the lower bounds of the 95% CI, in emergency department patients with DXI or DTI therapy. The surgical cohort showed similarly high values for DXI; the number of dabigatran-treated patients was too low to allow reliable calculation of DTI performance. Specificity and PPV values decreased when increasing the threshold concentrations of DXI and DTI. Fig. 1 Performance characteristics of FXA and DTI pads of DOAC Dipstick for patients' plasma concentration thresholds above 30 ng/mL Conclusion The consistently high NPV of the DOAC Dipstick at DOAC plasma concentrations up to 100 ng/mL may assist and accelerate medical decision-making for patients in emergency situations by ruling out the presence of clinically relevant DOAC concentrations. Specific patient populations and care units lacking rapid laboratory assays may particularly benefit from this patient-near method. Publication History Article published online: 17 February 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Fields of Study & Subjects
Atrial Fibrillation Management and Outcomes
Clinical Laboratory Practices and Quality Control
Venous Thromboembolism Diagnosis and Management
Publication details
- Journal / source
- Hämostaseologie
- Volume
- 46
- Issue
- S 01
- Pages
- S27–S28
- Publication date
- 1 February 2026
- Language
- DE