Evaluation of DOAC measurement on the CS-5100 using the INNOVANCE® Heparin and INNOVANCE® DTI reagent

Excerpt

Direct oral anticoagulants (DOACs) are well established in clinical practice and a common alternative to vitamin K antagonists. Products currently on the market are the direct factor IIa inhibitor (aIIa) dabigatran (Pradaxa®) and the factor Xa inhibitors (aXa) rivaroxaban (Xarelto®), apixaban (Eliquis®) and edoxaban (Lixiana®). Unlike warfarin, DOACs do not need to be monitored through laboratory testing, and no dose adjustment is required. Nevertheless, there are situations in which laboratory measurement of DOAC concentration may be preferable, such as treatment failure, bleeding, urgency surgery, consideration of a reversal agent, evaluation for thrombolysis in a patient with acute ischemic stroke, extreme body weight, renal insufficiency, or drug interactions [1]. DOAC measurement is therefore a particularly advisable option in clinics with neurological and surgical emergency patients. The gold standard for the measurement is mass spectrometry, which, however, requires a lot of time, and not every laboratory has access to such a method. Mass spectrometric measurements of DOACs were performed by ultra-performance liquid chromatography-tandem mass spectrometry as described previously in detail (Kuhn et al. [2]) measuring the following m/z transitions: 472.2 > 289.1 for dabigatran and 478.2 > 295.2 for its internal standard (IS) [13C6]-dabigatran, 436.1 > 145.0 for rivaroxaban and 442.2 > 145.1 for its IS [13C6]-rivaroxaban, 460.3 > 443.1 for apixaban and 468.3 > 451.1 for its IS [13C,2H7]-apixaban, as well as 548.3 > 366.1 for edoxaban and 554.3 > 372.1 for its IS [2H6]-edoxaban [2]. …