{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T07:00:48Z","timestamp":1767942048061,"version":"3.49.0"},"reference-count":33,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T00:00:00Z","timestamp":1767744000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: atrial fibrillation (AF) patients with obesity and high thromboembolic risk need oral anticoagulant therapy. Limited data are available on direct oral anticoagulants (DOACs) in this population, and a point-of-care method has been validated to support rapid clinical decisions and to identify on-off plasma concentration thresholds. Methods: This is a monocentric, cross-sectional diagnostic accuracy study on obese AF outpatients referred to Policlinico Umberto I of Rome. Urinary Dipsticks were assessed with separate pads for factor Xa (FXA-i) and thrombin inhibitor (THR-i) and compared to the reference standard of trough and peak plasma concentrations with chromogenic assays\/dTT and prespecified plasma thresholds for each DOAC. Study endpoints were the sensitivity, specificity, positive and negative predictive values (PPV and NPV) of DOACs Dipstick compared to plasma concentrations. Sub-analyses according to obesity severity and type of DOAC were performed. Results: 320 paired plasma and urine samples were available from 160 enrolled patients (mean age 73.2 \u00b1 9.1 years). Compared to trough plasma concentrations, DOACs Dipstick showed a sensitivity of 99.24% (mean, 95% confidence interval, CI 95.82\u201399.98), specificity of 6.89% (0.85\u201322.76), PPV 82.80% (81.32\u201384.18), NPV 66.67% (15.79\u201395.52). On the other hand, compared to peak plasma concentrations, DOACs Dipstick showed a sensitivity of 97.8% (93.7\u201399.5), specificity of 0% (0.0\u201315.4), and PPV of 85.9% (85.6\u201386.2). Urinary Dipstick showed a sensitivity of 99.10% (95.4\u2013100.0), specificity of 4.70% (0.60\u201316.20) and a PPV and NPV of 74.50% (73.2\u201375.8) and 66.70 (15.7\u201395.6), compared to plasma thresholds &gt; 30 ng\/mL of FXA-I and THR-I. Sub-analyses showed similar results between FXA-i and THR-i. Conclusions: The urine point-of-care has high sensitivity, acceptable PPV, but low specificity and NPV in AF obese patients and may be useful only in selected clinical scenarios.<\/jats:p>","DOI":"10.3390\/jcm15020466","type":"journal-article","created":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T11:46:43Z","timestamp":1767786403000},"page":"466","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Diagnostic Performance of a DOAC Urine Dipstick in Obese Outpatients with Atrial Fibrillation: Comparison with Plasma Concentrations"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4901-7626","authenticated-orcid":false,"given":"Arianna","family":"Pannunzio","sequence":"first","affiliation":[{"name":"Department of General Surgery, Surgical Specialty and Anaesthesiology, Sapienza University of Rome, 00185 Rome, Italy"},{"name":"Department of Medical and Cardiovascular Sciences, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6455-4828","authenticated-orcid":false,"given":"Valentina","family":"Castellani","sequence":"additional","affiliation":[{"name":"Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erminia","family":"Baldacci","sequence":"additional","affiliation":[{"name":"Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1966-5945","authenticated-orcid":false,"given":"Vittoria","family":"Cammisotto","sequence":"additional","affiliation":[{"name":"Department of Medical and Cardiovascular Sciences, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosaria","family":"Mormile","sequence":"additional","affiliation":[{"name":"Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-5749-786X","authenticated-orcid":false,"given":"Ilaria Maria","family":"Palumbo","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Surgical Specialty and Anaesthesiology, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicola","family":"Porcu","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Surgical Specialty and Anaesthesiology, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2593-1376","authenticated-orcid":false,"given":"Antonio","family":"Chistolini","sequence":"additional","affiliation":[{"name":"Department of Translational and Precision Medicine, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Graziella","family":"Bernardini","sequence":"additional","affiliation":[{"name":"U.O.S.D. Medicina Rigenerativa DAI, Medicina Diagnostica e Radiologia, Policlinico Umberto 1, 00161 Roma, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9467-5903","authenticated-orcid":false,"given":"Danilo","family":"Menichelli","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Surgical Specialty and Anaesthesiology, Sapienza University of Rome, 00185 Rome, Italy"},{"name":"Department of Medical and Cardiovascular Sciences, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6357-5213","authenticated-orcid":false,"given":"Daniele","family":"Pastori","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Surgical Specialty and Anaesthesiology, Sapienza University of Rome, 00185 Rome, Italy"},{"name":"Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Neuromed, 86077 Pozzilli, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Job","family":"Harenberg","sequence":"additional","affiliation":[{"name":"Medical Faculty Mannheim, Ruprecht Karls University of Heidelberg, 69117 Heidelberg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Violi","sequence":"additional","affiliation":[{"name":"Department of Medical and Cardiovascular Sciences, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2265-7455","authenticated-orcid":false,"given":"Pasquale","family":"Pignatelli","sequence":"additional","affiliation":[{"name":"Department of Medical and Cardiovascular Sciences, Sapienza University of Rome, 00185 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,1,7]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1161\/01.CIR.84.1.40","article-title":"Prognostic significance of atrial fibrillation in advanced heart failure. A study of 390 patients","volume":"84","author":"Middlekauff","year":"1991","journal-title":"Circulation"},{"key":"ref_2","unstructured":"NCD Risk Factor Collaboration (NCD-RisC) (2017). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: A pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet, 390, 2627\u20132642."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"288","DOI":"10.1038\/s41574-019-0176-8","article-title":"Obesity: Global epidemiology and pathogenesis","volume":"15","author":"Bluher","year":"2019","journal-title":"Nat. Rev. Endocrinol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"642","DOI":"10.1002\/jcb.21206","article-title":"Pravastatin induces thrombomodulin expression in TNFalpha-treated human aortic endothelial cells by inhibiting Rac1 and Cdc42 translocation and activity","volume":"101","author":"Lin","year":"2007","journal-title":"J. Cell. Biochem."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"295","DOI":"10.1093\/eurpub\/ckx143","article-title":"Prevalence of adult overweight and obesity in 20 European countries, 2014","volume":"28","author":"Marques","year":"2018","journal-title":"Eur. J. Public Health"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1477","DOI":"10.1161\/CIRCRESAHA.120.316101","article-title":"Obesity Phenotypes, Diabetes, and Cardiovascular Diseases","volume":"126","author":"Piche","year":"2020","journal-title":"Circ. Res."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1016\/S2213-8587(22)00033-X","article-title":"Body-mass index and risk of obesity-related complex multimorbidity: An observational multicohort study","volume":"10","author":"Kivimaki","year":"2022","journal-title":"Lancet Diabetes Endocrinol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"163","DOI":"10.1001\/jamacardio.2018.4537","article-title":"Cardiovascular Risk Factors Associated with Venous Thromboembolism","volume":"4","author":"Gregson","year":"2019","journal-title":"JAMA Cardiol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"460","DOI":"10.1111\/jth.15168","article-title":"Overall and abdominal obesity in relation to venous thromboembolism","volume":"19","author":"Yuan","year":"2021","journal-title":"J. Thromb. Haemost."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"e032277","DOI":"10.1161\/JAHA.123.032277","article-title":"Impact of Obesity on Atrial Fibrillation Pathogenesis and Treatment Options","volume":"13","author":"Sha","year":"2024","journal-title":"J. Am. Heart Assoc."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1093\/eurheartj\/ehaa612","article-title":"2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC","volume":"42","author":"Hindricks","year":"2021","journal-title":"Eur. Heart J."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"2288","DOI":"10.1016\/S0140-6736(14)61943-7","article-title":"Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: An analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial","volume":"385","author":"Ruff","year":"2015","journal-title":"Lancet"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1016\/j.jacc.2013.07.104","article-title":"The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: The RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy)","volume":"63","author":"Reilly","year":"2014","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Dunois, C. (2021). Laboratory Monitoring of Direct Oral Anticoagulants (DOACs). Biomedicines, 9.","DOI":"10.3390\/biomedicines9050445"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"4032","DOI":"10.1182\/blood-2012-12-453076","article-title":"The laboratory and the direct oral anticoagulants","volume":"121","author":"Tripodi","year":"2013","journal-title":"Blood"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"3","DOI":"10.5603\/KP.a2018.0197","article-title":"How can we reverse bleeding in patients on direct oral anticoagulants?","volume":"77","author":"Crowther","year":"2019","journal-title":"Kardiol. Pol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1055\/a-1450-8178","article-title":"2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants","volume":"121","author":"Douxfils","year":"2021","journal-title":"Thromb. Haemost."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1612","DOI":"10.1093\/europace\/euab065","article-title":"2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation","volume":"23","author":"Steffel","year":"2021","journal-title":"Europace"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"770","DOI":"10.1055\/a-2261-1811","article-title":"Algorithm for Rapid Exclusion of Clinically Relevant Plasma Levels of Direct Oral Anticoagulants in Patients Using the DOAC Dipstick: An Expert Consensus Paper","volume":"124","author":"Harenberg","year":"2024","journal-title":"Thromb. Haemost."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1515\/cclm-2015-0389","article-title":"Measurement of dabigatran, rivaroxaban and apixaban in samples of plasma, serum and urine, under real life conditions. An international study","volume":"54","author":"Harenberg","year":"2016","journal-title":"Clin. Chem. Lab. Med."},{"key":"ref_21","first-page":"453","article-title":"Plasma Concentrations of Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Different Degrees of Obesity","volume":"64","author":"Menichelli","year":"2025","journal-title":"Clin. Pharmacokinet."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"437","DOI":"10.1055\/s-0038-1627480","article-title":"International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants","volume":"118","author":"Gosselin","year":"2018","journal-title":"Thromb. Haemost."},{"key":"ref_23","first-page":"462","article-title":"Position Paper on laboratory testing for patients on direct oral anticoagulants. A Consensus Document from the SISET, FCSA, SIBioC and SIPMeL","volume":"16","author":"Tripodi","year":"2018","journal-title":"Blood Transfus."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1076029621993550","DOI":"10.1177\/1076029621993550","article-title":"Performance Characteristics of DOAC Dipstick in Determining Direct Oral Anticoagulants in Urine","volume":"27","author":"Harenberg","year":"2021","journal-title":"Clin. Appl. Thromb. Hemost."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"1542","DOI":"10.1055\/a-1753-2748","article-title":"DOAC Dipstick Testing Can Reliably Exclude the Presence of Clinically Relevant DOAC Concentrations in Circulation","volume":"122","author":"Margetic","year":"2022","journal-title":"Thromb. Haemost."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1055\/s-0038-1668098","article-title":"Detecting Anti-IIa and Anti-Xa Direct Oral Anticoagulant (DOAC) Agents in Urine using a DOAC Dipstick","volume":"45","author":"Harenberg","year":"2019","journal-title":"Semin. Thromb. Hemost."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1055\/s-0039-1700545","article-title":"Accuracy of a Rapid Diagnostic Test for the Presence of Direct Oral Factor Xa or Thrombin Inhibitors in Urine-A Multicenter Trial","volume":"120","author":"Harenberg","year":"2020","journal-title":"Thromb. Haemost."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1007\/s11239-012-0811-x","article-title":"Comparison of initial warfarin response in obese patients versus non-obese patients","volume":"36","author":"Wallace","year":"2013","journal-title":"J. Thromb. Thrombolysis"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1846","DOI":"10.1182\/bloodadvances.2023012408","article-title":"Thrombotic events associated with low baseline direct oral anticoagulant levels in atrial fibrillation: The MAS study","volume":"8","author":"Testa","year":"2024","journal-title":"Blood Adv."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"4913","DOI":"10.1182\/bloodadvances.2024013126","article-title":"More early bleeds associated with high baseline direct oral anticoagulant levels in atrial fibrillation: The MAS study","volume":"8","author":"Palareti","year":"2024","journal-title":"Blood Adv."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"10760296231179684","DOI":"10.1177\/10760296231179684","article-title":"Comparison of the DOAC Dipstick Test on Urine Samples with Chromogenic Substrate Methods on Plasma Samples in Outpatients Treated with Direct Oral Anticoagulants","volume":"29","author":"Papageorgiou","year":"2023","journal-title":"Clin. Appl. Thromb. Hemost."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"10760296221084307","DOI":"10.1177\/10760296221084307","article-title":"Evaluation of DOAC Dipstick Test for Detecting Direct Oral Anticoagulants in Urine Compared with a Clinically Relevant Plasma Threshold Concentration","volume":"28","author":"Ord","year":"2022","journal-title":"Clin. Appl. Thromb. Hemost."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"1723","DOI":"10.1055\/s-0042-1750327","article-title":"Performance of a Qualitative Point-of-Care Strip Test to Detect DOAC Exposure at the Emergency Department: A Cohort-Type Cross-Sectional Diagnostic Accuracy Study","volume":"122","author":"Merrelaar","year":"2022","journal-title":"Thromb. Haemost."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/2\/466\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T05:14:13Z","timestamp":1767935653000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/2\/466"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,7]]},"references-count":33,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2026,1]]}},"alternative-id":["jcm15020466"],"URL":"https:\/\/doi.org\/10.3390\/jcm15020466","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,7]]}}}