TECHNOCHROM anti-Xa and Technoview Rivaroxaban - Evaluation of assay performance on different analyzers
M. Leitner1, V. Kaufmann1, J. Mager1, S. Geiter1, A. Siegemund2, E. Lindhoff-Last3, L. Wagner1
1Technoclone GmbH, 2Labor Reising-Ackermann, Leipzig, 3 Department of Internal Medicine, Division of Vascular Medicine, Johann Wolfgang Goethe-University Hospital Frankfurt/Main, Germany
The increasing use of the new oral direct Factor Xa (FXa) inhibitor rivaroxaban creates the need of its measurement in the clinical routine. Technoview Rivaroxaban Calibrators and the Technochrom anti-Xa assay are available, but to be suitable for the routine clinical laboratory a validated system of calibrators, assay and analyzer protocols is necessary.
The aim of this study was to establish application protocols for Technochrom anti-Xa and Technoview Rivaroxaban on the main coagulation analyzers and evaluate their performance.
TECHNOCHROM anti-Xa is a one stage chromogenic assay for the determination of Xa inhibitor activity in human citrated plasma. The assay is based on the inhibition of activated factor X (FXa) by indirect or direct Xa inhibitors like Rivaroxaban as measured by a chromogenic FXa substrate.
Calibrators and Controls: TECHNOVIEW Rivaroxaban calibrators were used for assay calibration. The assay was performed on coagulation analyzers: Ceveron alpha, ACL-TOP, STAR, Thrombolyzer XRC and BCS with adapted settings for each analyzer and for 2 measurement ranges. Controls in 3 ranges were measured to calculate recovery and precision.
Calibration curves with R2=1.0±0.1 were obtained for rivaroxaban in the range of 0-150ng/mL, as well as for the range of 0-500ng/mL on all analyzers. The recovery of control was ± 10% of target value on all analyzers and precision was very good with intra-assay variations between 0.9%-4.2% and inter-assay variations between 1.8-4.9%. The detection limit for rivaroxaban was 10ng/mL.
Our data demonstrate that TECHNOCHROM anti-Xa and TECHNOVIEW Rivaroxaban can be used with adapted settings on different analyzers with very good results.
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