Evaluation of the DOAC-Stop® Procedure to Overcome the Effect of DOACs on Several Thrombophilia Screening Tests

Favresse, Julien; Lardinois, Benjamin; Sabor, Lina; Devalet, Bérangère; Vandepapelière, J; Braibant, Maximilien; Lessire, Sarah; Châtelain, Bernard; Jacqmin, Hugues; Douxfils, Jonathan; Mullier, François

doi:10.1055/s-0038-1657785

Cited by 62 publications

(95 citation statements)

References 35 publications

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“…DOAC Stop has been assessed for DOAC neutralization in several studies, but mostly related to assessment of thrombophilia, 18,19,[26][27][28][29][30][31] and included in only a few studies related to factor assays. 30,32 To our knowledge, no study has previously assessed the effect of andexanet alfa on factor levels and DOAC interference.…”

Section: Discussionmentioning

confidence: 99%

Reducing the effect of DOAC interference in laboratory testing for factor VIII and factor IX: A comparative study using DOAC Stop and andexanet alfa to neutralize rivaroxaban effects

et al. 2020

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Introduction Investigation of factors (F) VIII and IX is common, with testing important for diagnosis or exclusion of haemophilia A or B, associated acquired conditions and factor inhibitors. Rivaroxaban, a common direct anti‐Xa agent, causes significant interference in clotting assays, including substantial false reduction of factor levels. Aim To assess whether rivaroxaban‐induced interference of FVIII and FIX testing could be neutralized. Materials and methods An international, cross‐laboratory exercise for FVIII (n = 84) and FIX (n = 74), using four samples: (A) pool of normal plasma; (B) pool spiked with rivaroxaban (200 ng/mL); (C) rivaroxaban sample subsequently treated with ‘DOAC Stop’ and; (D) rivaroxaban sample treated with andexanet alfa (200 μg/mL). Testing performed blind to sample type. Results All laboratories reported normal FIX and 94% reported normal FVIII in the pool sample. Instead, 55% and 95%, respectively, reported abnormal FIX and FVIII levels for the rivaroxaban sample. DOAC Stop treatment evidenced a correction in most laboratories (100% reported normal FIX and 86% normal FVIII). Andexanet alfa provided intermediate results, with many laboratories still reporting abnormal results (59% for FVIII, 18% for FIX). We also identified reagent‐specific issues. Conclusions As expected, rivaroxaban caused false low values of FVIII and FIX. This might lead to increased testing to identify the cause of low factor levels and potentially lead to false identification of (mild) haemophilia A or B if unrecognized by clinicians/laboratories. DOAC Stop effectively neutralized the rivaroxaban effect, but andexanet alfa less so, with reagent‐related effects evident, and thus, false low values sometimes persisted.

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Section: Discussionmentioning

confidence: 99%

Reducing the effect of DOAC interference in laboratory testing for factor VIII and factor IX: A comparative study using DOAC Stop and andexanet alfa to neutralize rivaroxaban effects

et al. 2020

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“…DOAC‐Stop: (Haematex Research, Hornsby NSW, Australia) The impact of direct oral anticoagulants (DOACs) on laboratory assays used for thrombophilia testing (eg, antithrombin, protein S, protein C, lupus anticoagulant, and activated protein C resistance) is a well‐known issue and may cause false‐positive and false‐negative results. Therefore, the correct interpretation of tests that are performed in patients taking DOACs is mandatory to prevent misclassification and the subsequent clinical consequences.…”

Section: Laboratory Doac Testing: the Game Changers?mentioning

confidence: 99%

An update on laboratory assessment for direct oral anticoagulants (DOACs)

Gosselin

Adcock²,

Douxfils

2019

Int J Lab Hematology

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108

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The first direct oral anticoagulant (DOAC) to be approved for clinical use was dabigatran, a direct thrombin inhibitor, in 2010. Since that time, four additional DOACs, all direct anti‐Xa inhibitors, have been approved, including rivaroxaban, apixaban, edoxaban and betrixaban. Our knowledge about the effect of DOACs on laboratory testing, as well as the use of the laboratory for measuring DOACs has been an evolving process. These drugs are not routinely monitored in the same fashion as coumadin, but there is an increasing demand on the laboratory to have the capacity to adequately assess DOAC anticoagulant effect (pharmacodynamics) or levels (pharmacokinetics) in either emergent or the routine situations. This manuscript provides an update on laboratory guidance and progress of methods for measuring DOACs.

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“…One such product, marketed as DOAC Stop (adsorbing agent, Hematex Research, Australia) was recently reported by its inventor, Thomas Exner, as “a simple method for removing DOACs” . Other independent workers have further verified these findings for a range of laboratory assays, of course including the RVVT . In our own recently published experience, DOAC Stop was more effective in neutralizing rivaroxaban induced false positive LA in a range of laboratory assays than was andexanet alfa …”

Section: Solutions To Anticoagulant Interference In La (Including Rvvmentioning

confidence: 88%

The Russell viper venom time (RVVT) test for investigation of lupus anticoagulant (LA)

Favaloro

2019

American J Hematol

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Lupus anticoagulants (LAs) are a laboratory representation of the clinical syndrome of antiphospholipid syndrome (APS), and can also arise in other pathological states. Laboratory testing for LA is complex and three separate recent guidelines have been published. One test, the Russell viper venom time (RVVT), is the mandated laboratory test for inclusion in LA identification/exclusion in all three guidance documents. This is because the the RVVT is recognized to have great sensitivity for LA, with this generally recognized to be greater than that of most other LA screening assays. However, the RVVT is also very sensitive to the presence of many anticoagulant drugs, which diminishes its specificity for LA. Various strategies can be used to improve LA specificity and reduce anticoagulant assay interference.

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Evaluation of the DOAC-Stop® Procedure to Overcome the Effect of DOACs on Several Thrombophilia Screening Tests

Cited by 62 publications

References 35 publications

Reducing the effect of DOAC interference in laboratory testing for factor VIII and factor IX: A comparative study using DOAC Stop and andexanet alfa to neutralize rivaroxaban effects

Reducing the effect of DOAC interference in laboratory testing for factor VIII and factor IX: A comparative study using DOAC Stop and andexanet alfa to neutralize rivaroxaban effects

An update on laboratory assessment for direct oral anticoagulants (DOACs)

The Russell viper venom time (RVVT) test for investigation of lupus anticoagulant (LA)

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