PB0111 - Performance evaluation of INNOVANCE Anti-Xa assay for the quantitative determination of edoxaban

Background: Direct oral anticoagulants (DOACs) have become attractive agents in the prevention and treatment of several cardiovascular conditions. Although laboratory monitoring of DOACs is not required according to manufacturers, in specific clinical situations and for particular patient populations, testing may be helpful for patient management. For the quantitative determination of factor Xa-directed DOACs (i.e., rivaroxaban, apixaban, edoxaban), chromogenic anti-Xa assays originally developed for the quantitative determination of heparins are proven valuable tools. In combination with drug-specific calibrators, they allow quantification over a wide concentration range.

Aims: INNOVANCE® Anti-Xa assay in combination with drug-specific standards and controls is used for the quantitative determination of heparins (UFH, LMWH), rivaroxaban, and apixaban in human citrated plasma. Respective applications for CS-2500, CS-5100, and CN-3000/CN-6000 Systems are based on a chromogenic assay principle. New applications for the quantitative determination of edoxaban employing edoxaban-containing standards and controls are available now for these analyzers. The studies aimed to assess the performance of these new applications.

Methods: These studies were conducted using INNOVANCE Anti-Xa assay on CS-2500 and CN-3000/CN-6000 Systems: linearity, limit of quantitation (LoQ), precision, and dilution recovery.
In addition, these method comparison studies were performed: CS-2500 System vs. STA-Liquid Anti-Xa assay on STA Compact Max System, CS-5100 System vs. CS-2500 System, and CN-3000 System vs. CS-2500 System.

Results: Results from the linearity, LoQ, and precision studies support analytical measuring intervals of 20–350 ng/mL for all analyzers.
Results from the dilution-recovery studies (1:2 sample dilution) demonstrate extended measuring intervals of 350–700 ng/mL.
Method comparison studies reveal good comparability between the tested analyzers.

Conclusion(s): INNOVANCE Anti-Xa assay in combination with INNOVANCE Edoxaban Standards and INNOVANCE Edoxaban Controls demonstrates good performance on CS-2500, CS-5100, and CN-3000/6000 Systems and can be used for the quantitative determination of edoxaban in human citrated plasma.