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CC BY-NC-ND 4.0 · Thromb Haemost 2022; 122(10): 1723-1731
DOI: 10.1055/s-0042-1750327
New Technologies, Diagnostic Tools and Drugs

Performance of a Qualitative Point-of-Care Strip Test to Detect DOAC Exposure at the Emergency Department: A Cohort-Type Cross-Sectional Diagnostic Accuracy Study

Anne E. Merrelaar 
1   Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria
,
Magdalena S. Bögl
1   Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria
,
Nina Buchtele
2   Department of Medicine I, Medical University of Vienna, Vienna, Austria
,
Marieke Merrelaar
1   Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria
,
Harald Herkner
1   Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria
,
Christian Schoergenhofer
3   Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
,
Job Harenberg
4   Ruprecht-Karls-University, Heidelberg, Germany
5   Doasense GmbH, Heidelberg, Germany
,
Jonathan Douxfils 
6   Department of Pharmacy, Namur Thrombosis and Hemostasis Center, University of Namur, Namur, Belgium
7   Qualiblood s.a., Department of Research and Development, Namur, Belgium
,
Romain Siriez
6   Department of Pharmacy, Namur Thrombosis and Hemostasis Center, University of Namur, Namur, Belgium
,
Bernd Jilma
3   Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
,
Alexander O. Spiel
1   Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria
8   Department of Emergency Medicine, Klinik Ottakring, Vienna, Austria
,
Michael Schwameis
1   Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria
› Author Affiliations Funding This study was an academic research project without any direct or indirect commercial purpose. The study received no funding from industry or pharmaceutical companies. Dr. Christian Schoergenhofer received funding from the Medical Scientific Fund of the Mayor of the City of Vienna (project number 19049). Dr. Nina Buchtele was funded by the Austrian Science Fund (FWF grant SFB54/APF05404FW). Dr. Michael Schwameis received an unrestricted grant from the Rosiny Foundation.
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Abstract

An accurate point-of-care test for detecting effective anticoagulation by direct oral anticoagulants (DOACs) in emergencies is an unmet need. We investigated the accuracy of a urinary qualitative strip test (DOAC Dipstick) to detect relevant DOAC exposure in patients who presented to an emergency department. In this prospective single-center cohort-type cross-sectional study, adults on DOAC treatment were enrolled. We assessed clinical sensitivity and specificity of DOAC Dipstick factor Xa and thrombin inhibitor pads to detect DOAC plasma levels ≥30 ng/mL using urine samples as the testing matrix. Liquid chromatography coupled with tandem-mass spectrometry was used as the reference standard method for plasma and urine measurement of DOAC concentrations. Of 293 patients enrolled, 265 patients were included in the analysis, of whom 92 were treated with rivaroxaban, 65 with apixaban, 77 with edoxaban, and 31 with dabigatran. The clinical sensitivity and specificity of the dipstick on urine samples to detect ≥30 ng/mL dabigatran plasma levels were 100% (95% confidence interval [CI]: 87–100%) and 98% (95% CI: 95–99%), respectively. The sensitivity and specificity of the dipstick to detect ≥30 ng/mL factor Xa inhibitor plasma levels were 97% (95% CI: 94–99%) and 69% (95% CI: 56–79%), respectively. The DOAC Dipstick sensitively identified effective thrombin and factor Xa inhibition in a real-world cohort of patients presenting at an emergency department. Therefore, the dipstick might provide a valuable test to detect relevant DOAC exposure in emergencies, although further studies will be needed to confirm these findings.

Keywords

cohort study - anticoagulants - direct thrombin inhibitor - direct factor Xa inhibitors - point-of-care-test

Supplementary Material



Publication History

Received: 20 January 2022

Accepted: 10 April 2022

Article published online:
04 July 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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