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Laboratory testing for activated protein C resistance: rivaroxaban induced interference and a comparative evaluation of andexanet alfa and DOAC Stop to neutralise interference

Favaloro, E.J., Gilmore, G., Bonar, R., Dean, E., Arunachalam, S., Mohammed, S. and Baker, R. (2020) Laboratory testing for activated protein C resistance: rivaroxaban induced interference and a comparative evaluation of andexanet alfa and DOAC Stop to neutralise interference. Clinical Chemistry and Laboratory Medicine, 58 (8).

Link to Published Version: https://doi.org/10.1515/cclm-2019-1160
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Abstract

Background
Investigation of hemostasis is problematic when patients are on anticoagulant therapy. Rivaroxaban especially causes substantial interference, extending many clot-based tests, thereby leading to false positive or negative events. In particular, rivaroxaban affects some assays for activated protein C resistance (APCR).

Methods
We assessed, in an international setting, cross laboratory (n = 31) testing using four samples to evaluate rivaroxaban induced interference in APCR testing, and whether this interference could be neutralised. The samples comprised: (A) pool of normal plasma (APCR-negative control); (B) this normal pool spiked with rivaroxaban (200 ng/mL) to create rivaroxaban-induced interference (potential ‘false’ positive APCR event sample); (C) the rivaroxaban sample subsequently treated with a commercial direct oral anticoagulant ‘DOAC-neutraliser’ (DOAC Stop), or (D) treated with andexanet alfa (200 μg/mL). Testing was performed blind to sample type.

Results
The rivaroxaban-spiked sample generated false positive APCR results for some, but unexpectedly not most APCR-tests. The sample treated with DOAC Stop evidenced a correction in the rivaroxaban-affected APCR assays, and did not otherwise adversely affect the rivaroxaban ‘unaffected’ APCR assays. The andexanet alfa-treated sample did not evidence correction of the false positive APCR, and instead unexpectedly exacerbated false positive APCR status with many tests.

Conclusions
DOAC Stop was able to neutralise any APCR interference induced by rivaroxaban. In contrast, andexanet alfa did not negate such interference, and instead unexpectedly created more false-positive APCR events.

Item Type: Journal Article
Murdoch Affiliation: Western Australian Centre for Thrombosis and Haemostasis (WACTH)
Publisher: De Gruyter
Copyright: © 2020 Walter de Gruyter GmbH
URI: http://researchrepository.murdoch.edu.au/id/eprint/55279
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