Performance of direct oral anticoagulant (DOAC) testing by hemostasis laboratories: The Australasian/Asia‐Pacific experience

Author:

Favaloro Emmanuel J.123ORCID,Arunachalam Sandya4,Dean Elysse4

Affiliation:

1. Department of Haematology, Sydney Centres for Thrombosis and Haemostasis Institute of Clinical Pathology and Medical Research (ICPMR), NSW Health Pathology, Westmead Hospital Westmead New South Wales Australia

2. Faculty of Science and Health Charles Sturt University Wagga Wagga New South Wales Australia

3. School of Medical Sciences, Faculty of Medicine and Health University of Sydney, Westmead Hospital Westmead New South Wales Australia

4. RCPAQAP Haematology St Leonards New South Wales Australia

Abstract

AbstractIntroductionDirect oral anticoagulants (DOACs) reflect anticoagulation agents given to treat or prevent thrombosis, having largely replaced vitamin K antagonists (VKAs) such as warfarin. DOACs are given in fixed daily doses and generally do not need monitoring. However, there may be a variety of reasons that justify measurement of plasma DOAC levels in individual patients.MethodsWe report updated findings for DOAC testing in our geographic region, using recent data from the RCPAQAP, an international external quality assessment (EQA) program, currently with some 40–60 participants in each of the different DOAC (rivaroxaban, apixaban, dabigatran) modules, to assess laboratory performance in this area. Data has been assessed for the past 5 years (2019–2023 inclusive), with 20 samples each per DOAC.ResultsData shows a limited repertoire of assays in use, and mostly consistency in reported numerical values when assessing proficiency samples. Available assays mostly comprised reagents from four manufacturing suppliers. There was good consistency across what participants identified as ‘DOAC detected’, but some variability when participants attempted to grade DOAC levels as low vs moderate vs high. Inter‐laboratory/method coefficient of variation (CVs) were generally <15% for each DOAC, when present at >100 ng/mL.ConclusionWe hope our findings, reflecting on mostly consistent reporting of DOAC levels and interpretation provides reassurance for clinicians requesting these measurements, and helps support their implementation in regions where there is a paucity of test availability.

Publisher

Wiley

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