PB0556 - Performance Evaluation of the INNOVANCE Anti-Xa Assay for the Quantitative Determination of Rivaroxaban on the Sysmex CN-3000/CN-6000 Systems

Monday, July 11, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Co-Author(s)

DP

Dominik Pahren

Lab technician
Siemens Healthineers
Marburg, Hessen, Germany
Matthias L. Wilkens

Lab Head
Siemens Healthineers
Marburg, Hessen, Germany
UG

Uwe Groß

Lab Head
Siemens Healthineers
Marburg, Hessen, Germany

Presenting Author(s)

Mechthild Merz, PhD

Senior Manager
Siemens Healthineers
Marburg, Hessen, Germany

Co-Author(s)

DB

Delia Bußfeld

Director Assay Development Hemostasis
Siemens Healthineers
Marburg, Hessen, Germany

Background: Rivaroxaban (Xarelto) 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 in conjunction with rivaroxaban market approval. However, because hemostasis is a balance between the tendency to clot and the risk of bleeding, anticoagulants have an inherent risk of causing bleeding, which indeed is the most common side effect of rivaroxaban. Although the manufacturer of rivaroxaban has stated that regular monitoring is not needed, quantitative assays should be available to aid in the assessment of a patient’s anticoagulant status.

Aims: The INNOVANCE Anti-Xa assay for the quantitative determination of rivaroxaban is a chromogenic assay for which a new application for the Sysmex® CN-3000/CN-6000 Systems was developed. The aim of the studies was to assess the performance of this application.

Methods: The following studies were conducted using the Sysmex CN-6000 System: limit of quantitation (LoQ), linearity, precision, dilution recovery, and method comparison versus the Sysmex CS-5100 System. Performance characteristics were confirmed for the Sysmex CN-3000 System by method comparison versus the Sysmex CN-6000 System.

Results: Based on the results from the LoQ, linearity, and precision studies, the analytical measuring interval for the application was defined to be 20–350 ng/mL. An extended measuring interval (1:2 sample dilution) of 350–700 ng/mL was demonstrated by dilution-recovery studies. Good comparability of the INNOVANCE Anti-Xa assay on the Sysmex CN-6000 System versus the INNOVANCE Anti-Xa assay on the Sysmex CS-5100 System could also be shown.

Conclusion(s): The INNOVANCE Anti-Xa assay demonstrates good performance on the Sysmex CN-3000/CN-6000 System and can be used for the quantitative determination of rivaroxaban in human citrated plasma.