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Comparison of Visual Interpretation of the DOAC Dipstick Test with a Reader System for Rapid and Accurate Detection of Direct Oral Anticoagulants in Neurology and Cardiology – Interim Data from a Prospective Consecutive Comparative Study

1Sestre milosrdnice University Hospital Center, Department of Clinical Chemistry, Zagreb, Croatia, 2Sestre Milosrdnice University Hospital Center, Department of Cardiovascular Diseases,, Zagreb, Croatia, 3Heidelberg University, Heidelberg, Germany, 4DOASENSE GmbH, Heidelberg, Germany, 5Sestre Milosrdnice University Hospital Center, Department of Neurology, Zagreb, Croatia, 6Sestre Milosrdnice University Hospital Center, Department of Cardiovascular Diseases, Zagreb, Croatia, 7Sestre Milosrdnice University Hospital Center, Faculty of Pharmacy and Biochemistry, Zagreb, Croatia

Abstract Number: PB0383

Meeting: ISTH 2021 Congress

Theme: Diagnostics and OMICs » Laboratory Diagnostics

Background: Direct oral anticoagulants (DOACs) are detected in patient urine samples by DOAC DipstickTM test based on color changes in pads that contain specific chemical components. However, identification of these color changes may vary between observers and the test instructions may be difficult to follow in emergency situations.

Aims: The objective of this ongoing study is to examine whether DOAC Dipstick results can be used to exclude the presence of clinically relevant concentrations of dabigatran, rivaroxaban and apixaban in patients admitted to a neurology and cardiology department for elective or emergency interventions.

Methods: In this interim analysis, we compared the inter-observer variability of DOAC Dipstick results obtained by medical personnel with those obtained by a semi-automatic reader. This single-center study will include between 120 and 180 patients with neurologic and cardiovascular diseases treated with rivaroxaban, apixaban and dabigatran who are admitted to Sestre Milosrdnice University Hospital Center in Zagreb. Factor Xa and thrombin inhibitor pads of the DOAC Dipstick were incubated in patient urine samples and evaluated visually by two independent observers and by a DOASENSE Reader. Here, we report interim descriptive results on variability of two observer and as compared to DOASENSE Reader results. We will compare plasma DOAC concentrations with DOAC Dipstick results after termination of the study.

Results: So far, 45 patients have been included (rivaroxaban n=20, apixaban n=9, dabigatran n=10, and switching from rivaroxaban to dabigatran=6). No differences in color interpretation for presence or absence of direct oral factor Xa or thrombin inhibitors have been detected between visual inspection of pads of the test strips between the two observers and the results obtained DOASENSE Reader.

Conclusions: 

These interim data suggest low inter-observer variability of visual evaluation of DOAC Dipstick colors for presence or absence of DOACs and indicate a very high agreement with results of DOASENSE Reader

To cite this abstract in AMA style:

Margetić S, Ćelap I, Delić-Brkljačić D, Harenberg J, Lovrenčić-Huzjan A, Mioč P, Šupraha Goreta S. Comparison of Visual Interpretation of the DOAC Dipstick Test with a Reader System for Rapid and Accurate Detection of Direct Oral Anticoagulants in Neurology and Cardiology – Interim Data from a Prospective Consecutive Comparative Study [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/comparison-of-visual-interpretation-of-the-doac-dipstick-test-with-a-reader-system-for-rapid-and-accurate-detection-of-direct-oral-anticoagulants-in-neurology-and-cardiology-interim-data-fro/. Accessed November 30, 2023.

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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/comparison-of-visual-interpretation-of-the-doac-dipstick-test-with-a-reader-system-for-rapid-and-accurate-detection-of-direct-oral-anticoagulants-in-neurology-and-cardiology-interim-data-fro/