{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T09:55:44Z","timestamp":1790589344840,"version":"4.1.0"},"reference-count":17,"publisher":"Walter de Gruyter GmbH","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2026-0408_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Point-of-care (POC) International Normalised Ratio (INR) testing provides rapid anticoagulation monitoring. Still, it is susceptible to systematic bias, particularly at supratherapeutic levels, which can lead to inappropriate warfarin dose adjustments and increased thrombotic risk. This study evaluated bias trends between Abbott and Roche POC INR devices.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0408_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Bias trends were assessed using Royal College of Pathologists of Australasia Quality Assurance Programs survey data (2023\u20132025), in-house verification, and patient sample comparisons against laboratory instrument testing used as a comparative reference mark (Werfen ACL\u00a0TOP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0408_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Abbott PT INR cartridges demonstrated a shift from negative bias in 2023 to pronounced positive bias in 2024, with discrepancies most evident at INR &gt;4.0. The introduction of Abbott PT Plus cartridges in 2025 significantly reduced bias, achieving near alignment with Roche CoaguChek Pro II and laboratory methods tested in this study. Comparative reagent analysis highlighted the influence of thromboplastin source and ISI values on harmonisation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0408_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Findings reinforce the need for confirmatory venous testing when POC INR exceeds critical thresholds, and emphasise the importance of ongoing performance monitoring, structured escalation policies, and transparent communication with manufacturers.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2026-0408","type":"journal-article","created":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T08:55:51Z","timestamp":1783587351000},"page":"2580-2589","source":"Crossref","is-referenced-by-count":0,"title":["Systematic bias in point-of-care INR testing: comparative analysis of Abbott and Roche devices"],"prefix":"10.1515","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-1656-2349","authenticated-orcid":false,"given":"Sandya","family":"Arunachalam","sequence":"first","affiliation":[{"name":"Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) , St Leonards , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4846-9134","authenticated-orcid":false,"given":"Tony","family":"Badrick","sequence":"additional","affiliation":[{"name":"Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) , St Leonards , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2103-1661","authenticated-orcid":false,"given":"Emmanuel J.","family":"Favaloro","sequence":"additional","affiliation":[{"name":"Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), Sydney Centres for Thrombosis and Haemostasis, NSW Health Pathology, Westmead Hospital , Westmead , NSW , Australia"},{"name":"Sydney Centres for Thrombosis and Haemostasis, Research and Education Network (REN), Westmead Hospital , Westmead , NSW , Australia"},{"name":"Faculty of Medicine and Health , School of Medical Sciences, University of Sydney, Westmead Hospital , Sydney , NSW , Australia"},{"name":"Faculty of Science and Health , School of Dentistry and Medical Sciences, Charles Sturt University , Wagga Wagga , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4899-3294","authenticated-orcid":false,"given":"Piet","family":"Meijer","sequence":"additional","affiliation":[{"name":"ECAT Foundation , Voorschoten , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elysse","family":"Dean","sequence":"additional","affiliation":[{"name":"Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) , St Leonards , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahzuza","family":"Salwa","sequence":"additional","affiliation":[{"name":"Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) , St Leonards , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rogers","family":"Wei","sequence":"additional","affiliation":[{"name":"Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) , St Leonards , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,7,10]]},"reference":[{"key":"2026092809015488811_j_cclm-2026-0408_ref_001","doi-asserted-by":"crossref","unstructured":"Heneghan, C, Ward, A, Perera, R, Bankhead, C, Fuller, A, Stevens, R, et al.. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 2012;379:322\u201334. https:\/\/doi.org\/10.1016\/s0140-6736(11)61294-4.","DOI":"10.1016\/S0140-6736(12)60758-2"},{"key":"2026092809015488811_j_cclm-2026-0408_ref_002","doi-asserted-by":"crossref","unstructured":"Wool, GD. Benefits and pitfalls of point-of-care coagulation testing for anticoagulation management: an ACLPS critical review. Am J Clin Pathol 2019;151:1\u201317. https:\/\/doi.org\/10.1093\/ajcp\/aqy087.","DOI":"10.1093\/ajcp\/aqy087"},{"key":"2026092809015488811_j_cclm-2026-0408_ref_003","doi-asserted-by":"crossref","unstructured":"Mohammadi Aria, M, Erten, A, Yalcin, O. Technology advancements in blood coagulation measurements for point-of-care diagnostic testing. 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Thromb Res 2004;113:35\u201340. https:\/\/doi.org\/10.1016\/j.thromres.2004.01.009.","DOI":"10.1016\/j.thromres.2004.01.009"},{"key":"2026092809015488811_j_cclm-2026-0408_ref_006","doi-asserted-by":"crossref","unstructured":"Bonar, R, Mohammed, S, Favaloro, EJ. International normalized ratio monitoring of vitamin K antagonist therapy: comparative performance of point-of-care and laboratory-derived testing. Semin Thromb Hemost 2015;41:279\u201386. https:\/\/doi.org\/10.1055\/s-0035-1549091.","DOI":"10.1055\/s-0035-1549091"},{"key":"2026092809015488811_j_cclm-2026-0408_ref_007","unstructured":"Clinical and Laboratory Standards Institute. H57-A: protocol for the evaluation, validation, and implementation of coagulometers; approved guideline. Wayne, PA: CLSI; 2008."},{"key":"2026092809015488811_j_cclm-2026-0408_ref_008","unstructured":"ISO 17593:2022. Clinical laboratory testing and in\u00a0vitro medical devices\u00a0\u2013\u00a0requirements for in\u00a0vitro monitoring systems for self-testing of oral anticoagulant therapy. Geneva: International Organization for Standardization; 2022."},{"key":"2026092809015488811_j_cclm-2026-0408_ref_009","doi-asserted-by":"crossref","unstructured":"Houdijk, WP, Van Den Besselaar, AM. International multicenter international sensitivity index (ISI) calibration of a new human tissue factor thromboplastin reagent derived from cultured human cells. J\u00a0Thromb Haemostasis 2004;2:266\u201370. https:\/\/doi.org\/10.1111\/j.1538-7836.2004.00434.x.","DOI":"10.1111\/j.1538-7836.2004.00434.x"},{"key":"2026092809015488811_j_cclm-2026-0408_ref_010","unstructured":"Kitchen, S, McCraw, A, Echenagucia, M. International normalized ratio (INR): the effect of thromboplastin, instrument, and ISI calibration on interlaboratory variation. Semin Thromb Hemost 2014;40:186\u201395."},{"key":"2026092809015488811_j_cclm-2026-0408_ref_011","doi-asserted-by":"crossref","unstructured":"Fitzmaurice, DA, Geersing, GJ, Armoiry, X, Machin, S, Kitchen, S, Mackie, I. ICSH guidance for INR and D-dimer testing using point of care testing in primary care. Int J Lab Hematol 2023;45:276\u201381. https:\/\/doi.org\/10.1111\/ijlh.14051.","DOI":"10.1111\/ijlh.14051"},{"key":"2026092809015488811_j_cclm-2026-0408_ref_012","doi-asserted-by":"crossref","unstructured":"Favaloro, EJ, Arunachalam, S, Chapman, K, Pasalic, L. Continued harmonization of INR across a large laboratory network following instrumentation change. Am J Clin Pathol 2025;163:28\u201341.","DOI":"10.1093\/ajcp\/aqae090"},{"key":"2026092809015488811_j_cclm-2026-0408_ref_014","unstructured":"McGlasson, DL. A comparison of INRs after local calibration of thromboplastin international sensitivity indexes. 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J\u00a0Thromb Haemostasis 2020;18:1986\u201394. https:\/\/doi.org\/10.1111\/jth.14873.","DOI":"10.1111\/jth.14873"},{"key":"2026092809015488811_j_cclm-2026-0408_ref_016","doi-asserted-by":"crossref","unstructured":"van den Besselaar, A, Stavelin, A, Kitchen, S, Bryant, M, Tripodi, A, Scalambrino, E, et al.. Defining a metrologically traceable and sustainable calibration hierarchy of international normalized ratio for monitoring of vitamin K antagonist treatment in accordance with International Organization for Standardization (ISO) 17511:2020 standard: communication from the International Federation of Clinical Chemistry and Laboratory Medicine-SSC\/ISTH working group on prothrombin time\/international normalized ratio standardization. J\u00a0Thromb Haemostasis 2024;22:1236\u201348. https:\/\/doi.org\/10.1016\/j.jtha.2023.12.013.","DOI":"10.1016\/j.jtha.2023.12.013"},{"key":"2026092809015488811_j_cclm-2026-0408_ref_017","unstructured":"World Health Organization. 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