The Pointy End of Point-of-Care Testing for Direct Oral Anticoagulants

Favaloro, Emmanuel J.; Lippi, Giuseppe

doi:10.1055/s-0039-1700874

Cited by 4 publications

(4 citation statements)

References 18 publications

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“…A rapid qualitative assay that can reliably determine whether DOACs are present in circulation would help treat patients on DOACs in emergency situations. 12 The in vitro diagnostic DOAC Dipstick (DOASENSE GmbH, Heidelberg, Germany) was recently developed to qualitatively detect DOACs in urine samples. 13 14 The DOAC Dipstick strip can detect the direct thrombin inhibitor (DTI) dabigatran on a thrombin inhibitor (THR) pad and the direct factor Xa inhibitors (DXIs) rivaroxaban, apixaban, and edoxaban on a factor Xa inhibitor (FXA) pad.…”

Section: Introductionmentioning

confidence: 99%

DOAC Dipstick Testing Can Reliably Exclude the Presence of Clinically Relevant DOAC Concentrations in Circulation

Margetić¹,

Ćelap²,

Huzjan³

et al. 2022

Thromb Haemost

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In certain clinical situations, it is necessary to determine whether clinically relevant plasma levels of direct oral anticoagulants (DOACs) are present. We examined whether qualitative testing of DOACs in urine samples can exclude DOAC plasma concentrations of >30 ng/mL. This prospective single centre cohort study included consecutive patients treated with an oral direct factor Xa inhibitor (DXI) (apixaban, n=31, rivaroxaban, n=53) and direct thrombin inhibitor (DTI) (dabigatran, n=44). We aimed to define the negative predictive value (NPV) and other statistical parameters of detecting DXIs and DTIs by DOAC Dipstick at plasma concentrations of >30 ng/mL. We also determined the best-fit threshold plasma levels using chromogenic substrate assays by logistic regression analysis. Between July 2020 and July 2021, 128 eligible patients (mean age 66 years, 55 females) were included into the study. The NPVs and sensitivities for DXI and DTI of DOAC Dipstick were 100% at >30 ng/ml plasma, for specificities 6% and 21% and for positive predictive values 62% and 72%, respectively. All diagnostic statistical tests improved to values between 86% and 100% at best fitting plasma thresholds of >14 ng/mL for DXI and >19 ng/mL for DTI. Visual analysis using the DOAC Dipstick was 100% in agreement with that of the optoeletronic DOASENSE Reader for all three DOACs. DOAC Dipstick testing can reliably exclude the presence of DOACs in urine samples at best fitting thresholds of >14 and >19 ng/mL in plasma. The performance of the DOAC Dipstick at detecting lower DOAC concentrations in plasma requires confirmation.

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Section: Introductionmentioning

confidence: 99%

DOAC Dipstick Testing Can Reliably Exclude the Presence of Clinically Relevant DOAC Concentrations in Circulation

Margetić¹,

Ćelap²,

Huzjan³

et al. 2022

Thromb Haemost

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“…38 39 Despite their beneficial application in the clinic, anticoagulant therapy can interfere with all clot-based assays, including those used to investigate thrombophilia, leading to misinterpretation of the final results. 40 41 42 43 For example, heparin derivatives (unfractionated heparin and low molecular weight heparin) affect various clotting assays, while vitamin K antagonists prolong clotting times for tests that involve vitamin K-dependent clotting factors (II, VII, IX, and X), such as aPTT and RVVT. Assay manufacturers have overcome the interference of these classical antithrombotic drugs with some APCR tests by the inclusion of heparin neutralizers and/or predilution step with FVD plasma in the test procedure.…”

Section: Activated Protein C Resistance Testing In Patients Taking Or...mentioning

confidence: 99%

“…35 With respect to the thrombophilia tests (especially RVVT, APCR, and PC/PS clot-based assays), their test performance is often even more problematic in patients on DOACs than in the presence of classical anticoagulants. 43 The general recommendation is against performing clot-based tests, including thus assessing APCR, in patients taking DOACs. If required, it has been suggested to adopt a DOAC-insensitive method (e.g., Pefakit) or to perform direct genetic testing for FVL.…”

Section: Activated Protein C Resistance Testing In Patients Taking Or...mentioning

confidence: 99%

Laboratory Diagnosis of Activated Protein C Resistance and Factor V Leiden

Bahraini

Fazeli

Dorgalaleh

2023

Semin Thromb Hemost

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The factor V Leiden (FVL) polymorphism is known as the most common inherited risk factor for venous thrombosis. In turn, FVL is the leading cause of an activated protein C resistance (APCR) phenotype, in which the addition of exogenous activated protein C to plasma does not result in the expected anticoagulant effect. In the routine laboratory approach to the formal diagnosis of FVL, an initial positive screening plasma-based method for APCR is often performed, and only if needed, this is followed by a confirmatory DNA-based assay for FVL. Multiple methods with accepted sensitivity and specificity for determining an APCR/FVL phenotype are commonly categorized into two separate groups: (1) screening plasma-based assays, including qualitative functional clot-based assays, for APCR, and (2) confirmatory DNA-based molecular assays, entailing several tests and platforms, including polymerase chain reaction-based and non-PCR-based techniques, for FVL. This review will describe the methodological aspects of each laboratory test and prepare suggestions on the indication of APCR and FVL testing and method selection.

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“…The thrombin inhibitor pads can also detect r-hirudin and argatroban at high concentrations, so these may be confused with dabigatran when interpreting the test result but this is highly unlikely to occur. [5][6][7][8][9] A recent multicenter study showed that the DOAC Dipstick can detect DXIs and DTIs with an accuracy of 97.3% and 99.3%, respectively and that sensitivity, specificity, and negative and positive predictive values for the DOAC Dipstick were all 95% or higher. 9 A threshold plasma DOAC concentration of ≥30 ng/mL has been regarded as important for supporting clinical decision making in patients admitted to hospital for stroke, major hemorrhage or major joint injury.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of DOAC Dipstick Test for Detecting Direct Oral Anticoagulants in Urine Compared with a Clinically Relevant Plasma Threshold Concentration

Örd

Märk

Raidjuk

et al. 2022

Clin Appl Thromb Hemost

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Measuring direct oral anticoagulant (DOAC) concentrations might be necessary in certain clinical situations but is not routinely performed. The DOAC Dipstick is a new rapid test for detecting DOACs in urine. The aim of this study was to evaluate the possible uses and limitations of the DOAC Dipstick and to compare visual analysis and DOASENSE Reader analysis of DOAC Dipstick pads. Plasma and urine samples were collected from 23 patients taking DOACs. DOAC concentrations in plasma and urine were measured by chromogenic substrate assays and in urine also by the DOAC Dipstick. Plasma concentrations were dichotomized at a threshold of ≥30 ng/mL. Patient samples were compared with samples from control individuals not using anticoagulants (n = 10) and with DOASENSE control urines. The Combur-10 test was used to measure parameters that may affect urine color and hence the interpretation of the DOAC Dipstick result. DOAC Dipstick test results were positive in 21/23 patient urine samples at a plasma DOAC concentration of ≥30 ng/mL and in 2/23 patient urine samples at a plasma DOAC concentration of <30 ng/mL. Inter-observer agreement was above 90% for visual analysis of patient urine samples and was 100% for DOASENSE Reader analysis of patient urines and for analysis of control group urines and DOASENSE control urines. Abnormalities in urine color detected by the Combur-10 test did not affect the DOAC Dipstick results. DOAC Dipstick detects DOACs in urine at a plasma threshold of ≥30 ng/mL. Positive DOAC Dipstick results should be confirmed by measuring DOAC plasma concentration.

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The Pointy End of Point-of-Care Testing for Direct Oral Anticoagulants

Cited by 4 publications

References 18 publications

DOAC Dipstick Testing Can Reliably Exclude the Presence of Clinically Relevant DOAC Concentrations in Circulation

DOAC Dipstick Testing Can Reliably Exclude the Presence of Clinically Relevant DOAC Concentrations in Circulation

Laboratory Diagnosis of Activated Protein C Resistance and Factor V Leiden

Evaluation of DOAC Dipstick Test for Detecting Direct Oral Anticoagulants in Urine Compared with a Clinically Relevant Plasma Threshold Concentration

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