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Measurement of rivaroxaban (Xarelto) in plasma using an automated analyser

In certain circumstances there may be clinical need to assess the plasma DOACs status of a patient. Here, Aine McCormick, Dervilla Gorman and Gary Moore report on an initial retrospective study of automated and manual assays.

Patients requiring anticoagulant therapy are increasingly prescribed direct oral anticoagulants (DOACs). Advantages include the ability to prescribe a fixed oral dose with little requirement for close monitoring and dose adjustment. There are certain clinical situations in which circulating concentration values are required, including prior to surgery, in cases of bleeding, suspected drug overdose, impaired renal function and in the presence of interfering drugs. Here, the availability of an accurate and sensitive assay for DOACs is critical.

Presently, the direct Xa inhibitor rivaroxaban is prescribed increasingly at Guy’s and St Thomas’ NHS Foundation Trust. To facilitate clinical need, the Stago STA-Liquid anti-Xa kit in conjunction with Stago calibrators and controls were validated to measure plasma rivaroxaban. The protocol was modified for use on the Sysmex CS2100i.

The calibration curve maintained linearity to approx. 17 ng/mL, prompting the introduction of dilutions between 100 ng/mL and 20 ng/mL to improve accuracy. Validation experiments generated inter-assay precision of 4% (n=5) and intra-assay precision of 5.7% (n=9). Furthermore, the assay was shown to maintain stability for at least a week.

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