Abstract Number: PB0071
Meeting: ISTH 2021 Congress
Theme: Coagulation and Natural Anticoagulants » Coagulation Factors and Inhibitors
Background: Apixaban (Eliquis) is a direct factor Xa inhibitor used in the prevention of thrombotic diseases. Due to its predictable pharmacokinetics and wide therapeutic window, no therapeutic range in which the clinical outcome is optimized has been established within market approval. Since hemostasis is a balance between the tendency to clot and the risk of bleeding, anticoagulants have an inherent risk of causing bleeding, which is the most common side effect of apixaban. Although, according to the manufacturer of apixaban regular monitoring is not needed, quantitative assays should be available to aid in the assessment of a patient’s anticoagulant status.
Aims: Performance evaluation of the INNOVANCE® Anti-Xa assay for the quantitative determination of apixaban on the Sysmex® CS-2500 / CS-5100 System, Atellica® COAG 360 System*, and BCS® XP System.
Methods: The following studies were conducted: limit of quantitation (LoQ), linearity, precision, dilution recovery, and method comparison.
Results: Based on the results from studies for each application mentioned above, the analytical measuring interval (20–350 ng/mL) was defined. An extended measuring interval (1:2 sample dilution) of 350–700 ng/mL was demonstrated. Good comparability of the INNOVANCE Anti-Xa assay on the Sysmex CS-2500 System versus the STA- Liquid Anti-Xa assay on the STA COMPACT MAX system could be shown. The INNOVANCE Anti-Xa assay compares well on the Sysmex CS-5100 System, BCS XP System, and Atellica COAG 360 System versus the Sysmex CS-2500 System.
Conclusions: The INNOVANCE Anti-Xa assay demonstrates good performance on the Sysmex CS-2500 / CS-5100 System, BCS XP System, and Atellica COAG 360 System and can be used for the quantitative determination of apixaban in human citrated plasma. Disclaimer: Atellica COAG 360 System is not available in the US. INNOVACE Anti-Xa is under development and not commercially available. Its future availability cannot be ensured.
To cite this abstract in AMA style:
Wilkens M, Doimo A, Wilhelm A, Birschmann I, Hod E, Madlener K, Merz M, Bussfeld D, Schobel U-. Performance Evaluation of the INNOVANCE Anti-Xa Assay for the Quantitative Determination of Apixaban [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/performance-evaluation-of-the-innovance-anti-xa-assay-for-the-quantitative-determination-of-apixaban/. Accessed September 24, 2023.« Back to ISTH 2021 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/performance-evaluation-of-the-innovance-anti-xa-assay-for-the-quantitative-determination-of-apixaban/