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Interlaboratory Performance in Measurement of Dabigatran and Rivaroxaban.

Oksana Volod1, Marian Rollins-Raval2, Andrew J Goodwin3

  • 1From the Department of Pathology, Cedars-Sinai Medical Center, Los Angeles, California (Volod).

Archives of Pathology & Laboratory Medicine
|June 16, 2021
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Summary

Direct oral anticoagulant (DOAC) drug monitoring requires reliable assays. While DOAC-specific tests performed well, routine clotting assays like PT and aPTT are not suitable for determining anticoagulation levels.

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Area of Science:

  • Clinical Chemistry
  • Pharmacology
  • Hematology

Background:

  • Accurate measurement of direct oral anticoagulant (DOAC) drug levels is crucial for patient safety and effective treatment.
  • Existing laboratory assays for DOACs vary in performance and interlaboratory reproducibility.
  • Routine clotting assays may offer insights but require careful evaluation for DOAC monitoring.

Purpose of the Study:

  • To evaluate the performance of DOAC-specific assays across different concentrations of dabigatran and rivaroxaban.
  • To assess interlaboratory variability in the measurement of these DOACs.
  • To investigate the responsiveness of routine clotting assays to varying concentrations of dabigatran and rivaroxaban.

Main Methods:

  • Analysis of College of American Pathologists proficiency testing survey data from 2013 to 2016.
  • Evaluation of interlaboratory coefficients of variation (CV) for ecarin chromogenic assay, diluted thrombin time, and rivaroxaban-calibrated anti-Xa assay.
  • Assessment of prothrombin time (PT) and activated partial thromboplastin time (aPTT) responsiveness to DOACs.

Main Results:

  • DOAC-specific assays demonstrated reasonable performance, though interlaboratory CVs showed variability.
  • Ecarin chromogenic assay and rivaroxaban-calibrated anti-Xa assays exhibited notable variability in CVs across different drug concentrations.
  • PT and aPTT showed dose- and reagent-dependent responsiveness, with PT being more sensitive to rivaroxaban and aPTT to dabigatran.
  • Undiluted thrombin time was overly sensitive for monitoring dabigatran levels but useful for qualitative screening.

Conclusions:

  • DOAC-specific assays are generally reliable for therapeutic drug monitoring.
  • Routine clotting assays, including PT and aPTT, are not sufficiently reliable for quantifying DOAC anticoagulation.
  • A normal thrombin time can effectively exclude the presence of dabigatran.