Presentation Details
| Novel Point-of-Care (POC) platform for direct oral anticoagulants (DOAC) and vitamin K antagonists (AVK) testing: microDOAC and microINR assays Tamara Montes, Mikel Santiago, Irene Mijangos. R&D Department, iLine Microsystems S.L., San Sebastián/Donostia, Spain |
Abstract
Background: The Point-of-Care (POC) assessment of oral anticoagulation therapy brings great value in patient monitoring as well as within critical clinical scenarios such as life-threatening hemorrhage or urgent surgical interventions. A cutting-edge POC device utilizing microfluidic technology has been developed, enabling the evaluation of both direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs). This novel platform will be suitable to run two assays: microDOAC assay, sensitive to clinically relevant DOAC levels for guiding treatment in rapid decision-making environments and a PT/INR assay. Objectives: We aim to analyze the accuracy, sensitivity, and specificity of a POC platform that performs a microINR assay in warfarin patients, as well as a microDOAC assay designed for the semiquantitative evaluation of apixaban, rivaroxaban, dabigatran, or edoxaban. Methods: microDOAC assay was performed with normal donor whole blood samples obtained by venipuncture in a plastic tube without anticoagulant that were spiked with increasing DOAC concentrations (0-500 ng/mL). The remaining volume was appropriately citrated for measuring DOAC levels by anti-FXa and anti-FIIa activity (Diagnostica Stago). Receiver operator characteristic (ROC) curves were used to identify the assay values (in seconds) that best discriminate clinically relevant DOAC thresholds; additionally, sensitivity, specificity and agreement values were calculated. microINR assay evaluation was performed with warfarin patients to assess the accuracy and precision against a reference laboratory method, using capillary blood samples, and a venous blood sample for the laboratory reference (ACL TOP 500 with HemosIL RecombiPlasTin 2G reagent). Passing–Bablok regression analysis was performed to analyze results. Results: 160 apixaban, rivaroxaban, edoxaban and dabigatran spiked samples were tested (80 samples ranging 0-100 ng/mL; 80 samples from 100-500 ng/mL) for microDOAC assay evaluation. ROC curves were generated to determine sensitivity and specificity at the clinically relevant DOAC concentrations where the area under the curve (AUC) was above 99% for apixaban and 95% for dabigatran (Fig. 1 and 2) for all clinically relevant thresholds. Both sensitivity and specificity values of microDOAC test for apixaban samples were high (>96%) at clinically relevant thresholds. Similar results were obtained with rivaroxaban, edoxaban and dabigatran samples. microINR analysis was performed in 68 normal non-anticoagulated donors and 245 patients anticoagulated with warfarin. Regression analysis between the results of the microINR assay and the reference system showed a strong correlation, showing a total equivalence with a slope coefficient of 1.00, an intercept of 0.08, and a correlation coefficient r of 0.973.Conclusions: A novel Point-of-Care platform has been developed to enhance the quality management of patients on oral anticoagulation therapy (DOACs and VKAs) in various clinical environments. This new analyzer provides lab-quality results based on microfluidic technology, enabling real-time patient monitoring across diverse clinical setting with rapid results (<2 minutes), portable design, user-friendly interface, and connectivity for patient traceability.
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No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.