Abstract Number: PB0520
Meeting: ISTH 2020 Congress
Background: Chromogenic anti-Xa activity assays with substance-specific calibrations are used for quantitative measurement of apixaban, edoxaban, and rivaroxaban. Recently, a novel hybrid calibrator setting was developed for the Biophen® Heparin LRT assay, which only requires one single calibrator set for the measurement of apixaban, edoxaban, and rivaroxaban.
Aims: Aim of this study was to perform an analytical evaluation of the Biophen® Heparin LRT assay using this novel hybrid calibrator setting as well as a method comparison with the HemosIL® Liquid Anti-Xa assay.
Methods: All measurements with the Biophen® Heparin LRT as well as the HemosIL® Liquid Anti-Xa assay were performed on the same ACL Top 750® analyser. For the method comparison study 159 patients on anticoagulation treatment (n=80 for apixaban, n=23 for edoxaban, and n=55 for rivaroxaban) were measured in parallel with the respective the Biophen® Heparin LRT and the HemosIL® Liquid Anti-Xa assays.
Results: The detection limit for the Biophen® Heparin LRT apixaban, edoxaban, and rivaroxaban assays were 6.6 ng/ml, 7.5 ng/ml, and 9.7 ng/ml, respectively. Within-run and total coefficients of variation were ≤3.8% and ≤5.6% for the apixaban, ≤5.2% and ≤5.6% for the edoxaban, and ≤5.4% and ≤6.1% for the rivaroxaban assay. The method comparison study showed a very strong correlation between the Biophen® Heparin LRT and the HemosIL® Liquid Anti-Xa assays for apixaban (rs=0.996; p< 0.001), edoxaban (rs=0.994; p< 0.001), and rivaroxaban
(rs=0.986; p< 0.001). Passing and Bablok regression analyses revealed only a rather small, clinically not relevant constant bias as well as proportional difference between the two methods.
Conclusions: The Biophen® Heparin LRT assay using the novel hybrid calibrator setting for measurement of apixaban, edoxaban, and rivaroxaban meets the needs of quality specifications of laboratory medicine. The test results of the Biophen® Heparin LRT assays and the HemosIL® Liquid Anti-Xa assays were comparable for apixaban, edoxaban, and rivaroxaban.
To cite this abstract in AMA style:
Bundschuh C, Egger M, Wiesinger K, Dieplinger B. Comparison of the Biophen® Heparin LRT with the HemosIL® Liquid Anti-Xa Assay for the Measurement of Apixaban, Edoxaban and Rivaroxaban [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/comparison-of-the-biophen-heparin-lrt-with-the-hemosil-liquid-anti-xa-assay-for-the-measurement-of-apixaban-edoxaban-and-rivaroxaban/. Accessed September 22, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/comparison-of-the-biophen-heparin-lrt-with-the-hemosil-liquid-anti-xa-assay-for-the-measurement-of-apixaban-edoxaban-and-rivaroxaban/