Abstract Number: PB0623
Meeting: ISTH 2020 Congress
Background: In our Institution, 24h measurement of DOACs plasma levels is available. Due to the relevant number of samples tested daily in our lab, an internal quality control (IQC) material is required for all DOACs and LMWH. If valid for all anti-Xa and anti-IIa assays, such IQC material may be highly cost-effective in the coagulation laboratory.
Aims: To produce and validate a universal IQC plasma for anti-Xa and anti-IIa assays.
Methods: We routinely use as control plasma citrated pooled plasma (NPP, ca. 2 liters) collected every 6 months from >100 apparently healthy volunteers who belong to the staff of our Institution. Before storing at -80°C, we added fondaparinux (Arixtra®, 625 ng/ml fc.) and dabigatran (Sigma, ca. 100 ng/ml f.c) to 100 ml of NPP, which, after thorough mixing, was separated in 0.4 ml aliquots. We report on the imprecisions observed with 6 lots of the IQC plasma used daily since 2017.
Results: A standard curve with commercially available calibrators (Stago, France) is obtained on average every 2 months on all coagulometers (STA-R Max®). Within-calibration imprecisions with all lots of the IQC plasma ranged from 11.2% to 15.3% for dabigatran (n=839, 90-121 ng/ml), 1.4% to 14.8% for apixaban (n=855, 62-93 ng/ml), 4.3% to 9.0% for rivaroxaban (n=811, 67-103 ng/ml), 9.4% to 10.5% for edoxaban (n=808, 58-88 ng/ml), and 3.3% to 10.0% for LMWH (n=663, 0.77-0.93 IU/ml). There was no clear trend for instability of the IQC material. The IQC plasma permits comparison of the potencies of the anti-Xa drugs. Thus, the anti-Xa activity of 0.5 IU/ml of enoxaparin appears to correspond to the activity of 45, 47, and 43 ng/ml of apixaban, rivaroxaban, and edoxaban, respectively.
Conclusions: Our universal IQC plasma for anti-Xa and anti-IIa commercial assays results in acceptable imprecision and permits comparison of the relative potency of anti-Xa drugs.
To cite this abstract in AMA style:Pozzi L, Pattarini E, Della Valle P, D'Angelo A. A Universal Quality Control Plasma for Anti-Xa and Anti-IIa Drugs [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/a-universal-quality-control-plasma-for-anti-xa-and-anti-iia-drugs/. Accessed November 26, 2020.
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