Comparison of the DOAC Dipstick Test on Urine Samples With Chromogenic Substrate Methods on Plasma Samples in Outpatients Treated With Direct Oral Anticoagulants
Identifying adherence to direct oral anticoagulants (DOACs) plays a major role in treatment efficacy and safety. The DOAC Dipstick can detect DOACs in urine samples of acutely diseased patients at plasma thresholds of about 30 ng/mL. A prospective observational consecutive cohort study was performed...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2023-06-01
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| Series: | Clinical and Applied Thrombosis/Hemostasis |
| Online Access: | https://doi.org/10.1177/10760296231179684 |
| _version_ | 1797742582840688640 |
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| author | Loula Papageorgiou MD, MS Svetlana Hetjens PhD Jawed Fareed PhD Sanny Auge RN Laetitia Tredler RN Job Harenberg MD, PhD Christel Weiss PhD Ismail Elalamy MD, PhD Grigorios T. Gerotziafas MD, PhD |
| author_facet | Loula Papageorgiou MD, MS Svetlana Hetjens PhD Jawed Fareed PhD Sanny Auge RN Laetitia Tredler RN Job Harenberg MD, PhD Christel Weiss PhD Ismail Elalamy MD, PhD Grigorios T. Gerotziafas MD, PhD |
| author_sort | Loula Papageorgiou MD, MS |
| collection | DOAJ |
| description | Identifying adherence to direct oral anticoagulants (DOACs) plays a major role in treatment efficacy and safety. The DOAC Dipstick can detect DOACs in urine samples of acutely diseased patients at plasma thresholds of about 30 ng/mL. A prospective observational consecutive cohort study was performed on outpatients taking DOACs. The presence of direct oral factor Xa inhibitors (DXIs) in patient urine samples were independently evaluated by visual interpretation of the DOAC Dipstick pad colors. DOAC plasma concentration was assessed using STA®-Liquid Anti-Xa and STA®-Liquid Anti-IIa chromogenic substrate assays. Positive DOAC Dipstick results were compared with a threshold plasma of DOAC concentration ≥30 ng/mL. Of 120 patients (age 55.4 + 16.1 years, female n = 63), 77 were on rivaroxaban and 43 on apixaban. Plasma concentrations were 129 ± 118 ng/mL for rivaroxaban, and 163 ± 130 ng/mL for apixaban, DOAC Dipstick test has a sensitivity of 97.2% and a positive predictive value of 89.5% at 30 ng/mL. No differences occurred between DXIs. Specificity and negative predictive value could not be determined due to the low number of true negative values. There were no differences in the interpretation of rivaroxaban and apixaban pad colors between observers (Kappa 1.0). Results show that DOAC Dipstick may be a useful tool for identifying DXIs in urine samples in an outpatient setting at a plasma threshold ≥ 30 ng/mL. Further studies should include patients treated with dabigatran, vitamin K antagonists, or other anticoagulants. |
| first_indexed | 2024-03-12T14:43:43Z |
| format | Article |
| id | doaj.art-2bde56fec2854edd86c7ece0edb59ad4 |
| institution | Directory Open Access Journal |
| issn | 1938-2723 |
| language | English |
| last_indexed | 2024-03-12T14:43:43Z |
| publishDate | 2023-06-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Clinical and Applied Thrombosis/Hemostasis |
| spelling | doaj.art-2bde56fec2854edd86c7ece0edb59ad42023-08-16T03:33:32ZengSAGE PublishingClinical and Applied Thrombosis/Hemostasis1938-27232023-06-012910.1177/10760296231179684Comparison of the DOAC Dipstick Test on Urine Samples With Chromogenic Substrate Methods on Plasma Samples in Outpatients Treated With Direct Oral AnticoagulantsLoula Papageorgiou MD, MS0Svetlana Hetjens PhD1Jawed Fareed PhD2Sanny Auge RN3Laetitia Tredler RN4Job Harenberg MD, PhD5Christel Weiss PhD6Ismail Elalamy MD, PhD7Grigorios T. Gerotziafas MD, PhD8 Département Interdisciplinaire d’Organisation du Parcours Patient (DIOPP), , Villejuif, France Institute for Biometrie and Biiostatstics, Medical Faculty Mannheim University of Heidelberg, Mannheim, Germany Hemostasis and Thrombosis Research Laboratories, Cardiovascular Institute, Vascular Biology Loyola University Medical Center, Mannheim, Germany Service de Médecine Interne, , Hôpitaux Universitaires de l’Est Parisien, Assistance Publique Hôpitaux de Paris, Faculté de Médecine Sorbonne Université, Paris, France Service de Médecine Interne, , Hôpitaux Universitaires de l’Est Parisien, Assistance Publique Hôpitaux de Paris, Faculté de Médecine Sorbonne Université, Paris, France DOASENSE GmbH, Heidelberg, Germany Institute for Biometrie and Biiostatstics, Medical Faculty Mannheim University of Heidelberg, Mannheim, Germany INNOVTE, FCRIN, Paris, France Sorbonne University, INSERM UMRS-938, Team “Cancer Vessels, Biology and Therapeutics,” Group “Cancer – Angiogenesis – Thrombosis,” Institut Universitaire de Cancérologie, Centre de Recherche Saint Antoine, Hôpital Saint Antoine, Assistance Publique – Hôpitaux de Paris, Paris, FranceIdentifying adherence to direct oral anticoagulants (DOACs) plays a major role in treatment efficacy and safety. The DOAC Dipstick can detect DOACs in urine samples of acutely diseased patients at plasma thresholds of about 30 ng/mL. A prospective observational consecutive cohort study was performed on outpatients taking DOACs. The presence of direct oral factor Xa inhibitors (DXIs) in patient urine samples were independently evaluated by visual interpretation of the DOAC Dipstick pad colors. DOAC plasma concentration was assessed using STA®-Liquid Anti-Xa and STA®-Liquid Anti-IIa chromogenic substrate assays. Positive DOAC Dipstick results were compared with a threshold plasma of DOAC concentration ≥30 ng/mL. Of 120 patients (age 55.4 + 16.1 years, female n = 63), 77 were on rivaroxaban and 43 on apixaban. Plasma concentrations were 129 ± 118 ng/mL for rivaroxaban, and 163 ± 130 ng/mL for apixaban, DOAC Dipstick test has a sensitivity of 97.2% and a positive predictive value of 89.5% at 30 ng/mL. No differences occurred between DXIs. Specificity and negative predictive value could not be determined due to the low number of true negative values. There were no differences in the interpretation of rivaroxaban and apixaban pad colors between observers (Kappa 1.0). Results show that DOAC Dipstick may be a useful tool for identifying DXIs in urine samples in an outpatient setting at a plasma threshold ≥ 30 ng/mL. Further studies should include patients treated with dabigatran, vitamin K antagonists, or other anticoagulants.https://doi.org/10.1177/10760296231179684 |
| spellingShingle | Loula Papageorgiou MD, MS Svetlana Hetjens PhD Jawed Fareed PhD Sanny Auge RN Laetitia Tredler RN Job Harenberg MD, PhD Christel Weiss PhD Ismail Elalamy MD, PhD Grigorios T. Gerotziafas MD, PhD Comparison of the DOAC Dipstick Test on Urine Samples With Chromogenic Substrate Methods on Plasma Samples in Outpatients Treated With Direct Oral Anticoagulants Clinical and Applied Thrombosis/Hemostasis |
| title | Comparison of the DOAC Dipstick Test on Urine Samples With Chromogenic Substrate Methods on Plasma Samples in Outpatients Treated With Direct Oral Anticoagulants |
| title_full | Comparison of the DOAC Dipstick Test on Urine Samples With Chromogenic Substrate Methods on Plasma Samples in Outpatients Treated With Direct Oral Anticoagulants |
| title_fullStr | Comparison of the DOAC Dipstick Test on Urine Samples With Chromogenic Substrate Methods on Plasma Samples in Outpatients Treated With Direct Oral Anticoagulants |
| title_full_unstemmed | Comparison of the DOAC Dipstick Test on Urine Samples With Chromogenic Substrate Methods on Plasma Samples in Outpatients Treated With Direct Oral Anticoagulants |
| title_short | Comparison of the DOAC Dipstick Test on Urine Samples With Chromogenic Substrate Methods on Plasma Samples in Outpatients Treated With Direct Oral Anticoagulants |
| title_sort | comparison of the doac dipstick test on urine samples with chromogenic substrate methods on plasma samples in outpatients treated with direct oral anticoagulants |
| url | https://doi.org/10.1177/10760296231179684 |
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