Quality performance for indirect Xa inhibitor monitoring in patients using international external quality data

An evaluation was performed on the results of indirect Xa inhibitors (UFH, LMWH, Fondaparinux and Danaparoid) in the ECAT extrenal qualoity assessment programme. The result of this evaluation has been published in the publication below.

Abstract

Objectives: Chromogenic anti-activated factor X (FXa) assays are currently the “gold standard” for monitoring indirect anticoagulants. However, anti-FXa has been shown to vary according to the choice of reagents. In the present study, the performance of anti-FXa measurement was evaluated in order to gain more insight into the clinical applications. Furthermore, the longitudinal coefficient of variation (CV) was studied to investigate whether there is improvement over time.

Methods: Laboratory tests results were evaluated for samples spiked with unfractionated heparin (UFH), lowmolecular-weight-heparin (LMWH), fondaparinux and danaparoid sodium. External quality assessment (EQA) data from multiple years were used from more than 100 laboratories.

Results: Comparison of the results for all methods showed significant differences in measured values between the frequently used methods (ANOVA: p < 0.001). The largest differences were observed for LMWH and UFH measurements. These differences may be caused by differences in method composition, such as the addition of dextran sulphate. Substantial interlaboratory variation in anti-FXa monitoring was observed for all parameters, particularly at low concentrations. Our results showed that below 0.35 IU/mL, the CVs for UFH and LMWH increase dramatically and results below this limit should be used with caution.

Conclusions: Our study demonstrates that the choice of the anti-FXa method is particularly important for UFH and LMWH measurement. The variation in measurements may have an effect on clinical implications, such as therapeutic ranges. Furthermore, the longitudinal EQA data demonstrated a constant performance and, in at least 50% of the cases, improvement in the CV% of the anti-Xa results over time.

 

Clin Chem Lab Med 2020; 58(11): 1921–1930

This is publication can be approached via the following link: https://www.degruyter.com/document/doi/10.1515/cclm-2020-0130/html

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