2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants.

In 2018, the International Council for Standardization in Haematology (ICSH) published a consensus document providing guidance for laboratories on measuring direct oral anticoagulants (DOACs). Since that publication, several significant changes related to DOACs have occurred, including the approval of a new DOAC by the Food and Drug Administration, betrixaban, and a specific DOAC reversal agent intended for use when the reversal of anticoagulation with apixaban or rivaroxaban is needed due to life-threatening or uncontrolled bleeding, andexanet alfa. In addition, this ICSH Working Party recognized areas where additional information was warranted, including patient population considerations and updates in point-of-care testing. The information in this manuscript supplements our previous ICSH DOAC laboratory guidance document. The recommendations provided are based on (1) information from peer-reviewed publications about laboratory measurement of DOACs, (2) contributing author's personal experience/expert opinion and (3) good laboratory practice.
Competing Interests: Among the authors, J.D. is the CEO and founder of QUALIblood s.a., a contract research organization manufacturing the DP-Filter, is a co-inventor of the DP-Filter (patent application number: PCT/ET2019/052903) and reports personal fees from Daiichi Sankyo, Mithra Pharmaceuticals, Stago, Roche and Roche Diagnostics outside the submitted work. E.L.-L received lecture fees and consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb-Pfizer, Daiichi Sankyo, Portola, CSL Behring, Leo and Aspen. She received external funds for conducting a clinical contract study from Bayer and Daiichi Sankyo, for a research project that she initiated from Bayer AG, Bristol-Myers Squibb-Pfizer, Daiichi Sankyo and CSL Behring. E.J.F. and S.M.B. have no conflict of interest. I.G.T. received consulting fees from Bayer, Boehringer Ingelheim and Bristol-Myers Squibb-Pfizer. R.C.G. reports personal fees from Diagnostica Grifols, Siemens Healthcare Diagnostics and Diagnostica Stago, and has provided expert testimony on dabigatran and rivaroxaban testing.
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