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CC BY 4.0 · TH Open 2021; 05(03): e438-e448
DOI: 10.1055/s-0041-1732437
Original Article

Detection of Direct Oral Anticoagulants in Patient Urine Samples by Prototype and Commercial Test Strips for DOACs – A Systematic Review and Meta-analysis

Andrea Martini
1   Department of Medical Statistics and Biomathematics, Medical Faculty Mannheim, Ruprecht-Karls-University Heidelberg, Mannheim, Germany
,
Job Harenberg
2   Ruprecht-Karls-University, Heidelberg, Germany
3   DOASENSE GmbH, Heidelberg, Germany
,
Rupert Bauersachs
4   Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt, Germany
,
Jan Beyer-Westendorf
5   Thrombosis Research Unit, Department of Medicine I, Division Hematology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany
,
Mark Crowther
6   Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada
,
Jonathan Douxfils 
7   Department of Pharmacy, Namur Thrombosis and Hemostasis Centre (NTHC), Namur Research Institute for Life Sciences (NARILIS), University of Namur, Namur, Belgium
8   Qualiblood sa, Namur, Belgium
,
Ismail Elalamy
9   Hematology and Thrombosis Centre, Hôpital Tenon, INSERM U938, Sorbonne Université, AP-HP, France
10   I M Sechenov First Moscow State Medical University, Department of Obstetrics and Gynecology, Russia
,
Christel Weiss
1   Department of Medical Statistics and Biomathematics, Medical Faculty Mannheim, Ruprecht-Karls-University Heidelberg, Mannheim, Germany
,
Svetlana Hetjens
1   Department of Medical Statistics and Biomathematics, Medical Faculty Mannheim, Ruprecht-Karls-University Heidelberg, Mannheim, Germany
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Abstract

The DOAC Dipstick accurately detects the presence or absence of factor Xa (DXI) and thrombin inhibitor (DTI) classes of direct oral anticoagulants (DOACs) in patients' urine samples on DOAC treatment. The aim of the study was to systematically review the literature and compare the performance of prototype and commercial test strips with a meta-analysis.

A systematic literature search of electronic databases PubMed (MEDLINE) and Cochrane Library was performed. Heterogeneity between studies was calculated using the Chi-squared test and the I2 index. A random effects model was used to pool data to compare the performance of prototype and commercial test strips.

Using PRISMA reporting guidelines, four of 1,081 publications were eligible for inclusion in the meta-analysis: three reporting on prototype (DXI n = 658, DTI n = 586) and one on commercial test strips (DXI n = 451, DTI n = 429). Sensitivity and specificity of DXI and DTI detection did not differ significantly between the prototype and commercial test strips. Odds ratios were 0.718 and 0.365 for sensitivity and 1.211 and 1.072 for specificity of DXI and DTI (p-values between 0.3334 and 1.000), respectively. The pooled sensitivity and specificity values for DXI were 0.968 (p = 0.1290, I2 47.1%) and 0.979 (p = 0.1965, I2 35.9%), and for DTI 0.993 (p = 0.1870, I2 37.5%) and 0.993 (p = 0.7380, I2 0%), respectively.

Prototype and commercial DOAC test strips did not differ in their ability to detect DXI and DTI in patient urine samples. This supports the confidence in use of the DOAC Dipstick test, although it needs to be validated in specific patient populations.

Keywords

meta-analysis - DOAC Dipstick - direct oral anticoagulants - point-of-care test

Disclosure of Conflict of Interest

AM, SH, CW: no conflict to disclose.


JBW: Grants and personal fees from Bayer, grants and personal fees from Daiichi Sankyo, grants and personal fees from DOASENSE, grants and personal fees from Portola, grants from Pfizer.


JH: Founder and managing director of DOASENSE, GmbH. Not related to this work: a patent US 9,133,501 licensed, a patent EU 2643475 licensed, a patent US 9,944,971 licensed, and a patent EU 2723886 licensed.


IE: Grants and personal fees from Boehringer Ingelheim, grants and personal fees from Bayer, grants and personal fees from Pfizer, grants and personal fees from Bristol Myers Squibb.


MC: Grants from Bayer, personal fees from Shionogi, personal fees from Alexion, grants from Leo pharma, personal fees from Pfizer and Daiichi, grants from Heart and Stroke Foundation, other funding from Alnylam, personal fees from Octapharma, personal fees from Bristol Myers Squibb Canada, personal fees from CSL Behring, personal fees from Alexion, personal fees from Servier Canada, personal fees from Diagnostica Stago, personal fees from Asahi Kasei.


RB: Personal fees from DOASENSE GmbH, personal fees from Bayer AG, personal fees from Bristol Myers Squibb, personal fees from Daichii Sankyo, personal fees from Pfizer.




Publication History

Received: 17 June 2021

Accepted: 28 June 2021

Article published online:
24 September 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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