{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,9]],"date-time":"2026-11-09T05:22:47Z","timestamp":1794201767793,"version":"4.8.0"},"reference-count":24,"publisher":"Walter de Gruyter GmbH","issue":"8","license":[{"start":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T00:00:00Z","timestamp":1773619200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,24]]},"DOI":"10.1515\/cclm-2026-0267","type":"journal-article","created":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T22:07:04Z","timestamp":1773785224000},"page":"e171-e174","source":"Crossref","is-referenced-by-count":1,"title":["Reply: Be aware of legally required metrology and higher-order reference measurement services run in calibration laboratories"],"prefix":"10.1515","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4750-1606","authenticated-orcid":false,"given":"Michelle P.","family":"van der Helm","sequence":"first","affiliation":[{"name":"Coagulation Reference Laboratory (CRL), Department of Clinical Chemistry and Laboratory Medicine , 4501 Leiden University Medical Center (LUMC) , Leiden , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia J.J.","family":"van Rijn","sequence":"additional","affiliation":[{"name":"Coagulation Reference Laboratory (CRL), Department of Clinical Chemistry and Laboratory Medicine , 4501 Leiden University Medical Center (LUMC) , Leiden , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shanti S.","family":"Baktawar","sequence":"additional","affiliation":[{"name":"Coagulation Reference Laboratory (CRL), Department of Clinical Chemistry and Laboratory Medicine , 4501 Leiden University Medical Center (LUMC) , Leiden , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charmane F.","family":"Abdoel","sequence":"additional","affiliation":[{"name":"Coagulation Reference Laboratory (CRL), Department of Clinical Chemistry and Laboratory Medicine , 4501 Leiden University Medical Center (LUMC) , Leiden , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silva","family":"Ohanesian","sequence":"additional","affiliation":[{"name":"Coagulation Reference Laboratory (CRL), Department of Clinical Chemistry and Laboratory Medicine , 4501 Leiden University Medical Center (LUMC) , Leiden , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibtissem","family":"Sabbar","sequence":"additional","affiliation":[{"name":"Coagulation Reference Laboratory (CRL), Department of Clinical Chemistry and Laboratory Medicine , 4501 Leiden University Medical Center (LUMC) , Leiden , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonius M.H.P.","family":"van den Besselaar","sequence":"additional","affiliation":[{"name":"Coagulation Reference Laboratory (CRL), Department of Clinical Chemistry and Laboratory Medicine , 4501 Leiden University Medical Center (LUMC) , Leiden , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christa M.","family":"Cobbaert","sequence":"additional","affiliation":[{"name":"Coagulation Reference Laboratory (CRL), Department of Clinical Chemistry and Laboratory Medicine , 4501 Leiden University Medical Center (LUMC) , Leiden , the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,3,16]]},"reference":[{"key":"2026110905014417593_j_cclm-2026-0267_ref_001","unstructured":"BIPM. https:\/\/www.bipm.org\/en\/ [Accesed 27 Jan 2026]."},{"key":"2026110905014417593_j_cclm-2026-0267_ref_002","doi-asserted-by":"crossref","unstructured":"van Schrojenstein Lantman, M, Cobbaert, C, Panteghini, M, van Berkel, M, Smeets, RL, van Hellemond, JJ, et al.. Why metrological traceability matters in medical laboratory diagnostics. J\u00a0Appl Lab Med 2026. https:\/\/doi.org\/10.1093\/jalm\/jfaf203.","DOI":"10.1093\/jalm\/jfaf203"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_003","doi-asserted-by":"crossref","unstructured":"Cobbaert, C. Time for a holistic approach and standardization education in laboratory medicine. Clin Chem Lab Med 2017;55:311\u20133. https:\/\/doi.org\/10.1515\/cclm-2016-0952.","DOI":"10.1515\/cclm-2016-0952"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_004","doi-asserted-by":"crossref","unstructured":"van der Helm, MP, Ruhaak, LR, Cobbaert, CM. Mass spectrometry based precision diagnostics: on the cusp of selective testing. Clin Chem Lab Med 2026;64:539\u201354.","DOI":"10.1515\/cclm-2025-0461"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_005","doi-asserted-by":"crossref","unstructured":"Buchta, C, Benka, B, Delatour, V, Fa\u00e9, I, Griesmacher, A, Hellbert, K, et al.. Reference, calibration and referral laboratories\u2013a look at current European provisions and beyond. Clin Chem Lab Med 2025;63:656\u201369. https:\/\/doi.org\/10.1515\/cclm-2024-1066.","DOI":"10.1515\/cclm-2024-1066"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_006","doi-asserted-by":"crossref","unstructured":"Hoelzel, W, Weykamp, C, Jeppsson, J-O, Miedema, K, Barr, JR, Goodall, I, et al.. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United\u00a0States, Japan, and Sweden: a method-comparison study. Clin Chem 2004;50:166\u201374. https:\/\/doi.org\/10.1373\/clinchem.2003.024802.","DOI":"10.1373\/clinchem.2003.024802"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_007","doi-asserted-by":"crossref","unstructured":"Weykamp, C, John, WG, Mosca, A, Hoshino, T, Little, R, Jeppsson, J-O, et al.. The IFCC Reference Measurement System for HbA1c: a 6-year progress report. Clin Chem 2008;54:240\u20138. https:\/\/doi.org\/10.1373\/clinchem.2007.097402.","DOI":"10.1373\/clinchem.2007.097402"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_008","doi-asserted-by":"crossref","unstructured":"Jeppsson, J-O, Kobold, U, Barr, J, Finke, A, Hoelzel, W, Hoshino, T, et al.. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med 2002;40:78\u201389.","DOI":"10.1515\/CCLM.2002.016"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_009","doi-asserted-by":"crossref","unstructured":"Infusino, I, Frusciante, E, Braga, F, Panteghini, M. Progress and impact of enzyme measurement standardization. Clin Chem Lab Med 2017;55:334\u201340. https:\/\/doi.org\/10.1515\/cclm-2016-0661.","DOI":"10.1515\/cclm-2016-0661"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_010","doi-asserted-by":"crossref","unstructured":"Cobbaert, CM, Althaus, H, Begcevic Brkovic, I, Ceglarek, U, Coassin, S, Delatour, V, et al.. Towards an SI-Traceable reference measurement system for seven serum apolipoproteins using Bottom-Up quantitative proteomics: conceptual approach enabled by cross-disciplinary\/cross-sector collaboration. Clin Chem 2021;67:478\u201389. https:\/\/doi.org\/10.1093\/clinchem\/hvaa239.","DOI":"10.1093\/clinchem\/hvaa239"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_011","unstructured":"Pi\u00e9roni, L, Bargnoux, AS, Cristol, JP, Cavalier, E, Delanaye, P. Did creatinine standardization give benefits to the evaluation of glomerular filtration rate? eJIFCC 2017;28:251\u20137."},{"key":"2026110905014417593_j_cclm-2026-0267_ref_012","doi-asserted-by":"crossref","unstructured":"Dodder, NG, Tai, SS-C, Sniegoski, LT, Zhang, NF, Welch, MJ. Certification of creatinine in a human serum reference material by GC-MS and LC-MS. Clin Chem 2007;53:1694\u20139. https:\/\/doi.org\/10.1373\/clinchem.2007.090027.","DOI":"10.1373\/clinchem.2007.090027"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_013","doi-asserted-by":"crossref","unstructured":"van den Besselaar, AMHP, 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\u2013SSC\/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":"2026110905014417593_j_cclm-2026-0267_ref_014","doi-asserted-by":"crossref","unstructured":"van den Besselaar, AM, van Rijn, CJ, Abdoel, CF, Chantarangkul, V, Scalambrino, E, Kitchen, S, et al.. Paving the way for establishing a reference measurement system for standardization of plasma prothrombin time: harmonizing the manual tilt tube method. J\u00a0Thromb Haemostasis 2020;18:1986\u201394. https:\/\/doi.org\/10.1111\/jth.14873.","DOI":"10.1111\/jth.14873"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_015","doi-asserted-by":"crossref","unstructured":"van Rijn, C, Abdoel, C, Baktawar, S, Herbel, P, J\u00fcnschke, A, Bryant, M, et al.. External quality assessment of the manual tilt tube technique for prothrombin time testing: a report from the IFCC-SSC\/ISTH Working Group on the Standardization of PT\/INR. Clin Chem Lab Med 2025;63:1327\u201335.","DOI":"10.1515\/cclm-2024-1446"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_016","doi-asserted-by":"crossref","unstructured":"Favaloro, EJ. Manual tilt tube method for prothrombin time: a commentary on contemporary relevance. Clin Chem Lab Med 2025;63:1239\u201342. https:\/\/doi.org\/10.1515\/cclm-2025-0157.","DOI":"10.1515\/cclm-2025-0157"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_017","doi-asserted-by":"crossref","unstructured":"van der Helm, MP, van Rijn, CJJ, Baktawar, SS, Abdoel, CF, Kitchen, S, Bryant, M, et al.. Measurement uncertainty of ISO 17511:2020 compliant and globally standardized PT\/INR test results. Res Pract Thromb Haemostasis 2026:103385. https:\/\/doi.org\/10.1016\/j.rpth.2026.103385.","DOI":"10.1016\/j.rpth.2026.103385"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_018","doi-asserted-by":"crossref","unstructured":"Hermans, J, Van den Besselaar, A, Loeliger, E, Van der Velde, E. A collaborative calibration study of reference materials for thromboplastins. Thromb Haemost 1983;50:712\u20137. https:\/\/doi.org\/10.1055\/s-0038-1665293.","DOI":"10.1055\/s-0038-1665293"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_019","unstructured":"WHO Expert Committee on Biological Standardization. Meeting World Health Organization World Health Organization. Expert Committee on Biological Standardization: sixty-second report. Geneva, Switzerland: World Health Organization; 2013, vol CMLXXIX."},{"key":"2026110905014417593_j_cclm-2026-0267_ref_020","doi-asserted-by":"crossref","unstructured":"Houdijk, W, Van Den Besselaar, A. 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":"2026110905014417593_j_cclm-2026-0267_ref_021","unstructured":"Poller, L, Van Den Besselaar, A, Jespersen, J, Tripodi, A, Houghton, D. The European Concerted Action on Anticoagulation (ECAA): field studies of coagulometer effects on the ISI of ECAA thromboplastins. Thromb Haemost 1998;80:615\u201323."},{"key":"2026110905014417593_j_cclm-2026-0267_ref_022","doi-asserted-by":"crossref","unstructured":"Van den Besselaar, A, Houbouyan, L, Aillaud, M, Denson, K, Johnston, M, Kitchen, S, et al.. Influence of three types of automated coagulometers on the International Sensitivity Index (ISI) of rabbit, human, and recombinant human tissue factor preparations. Thromb Haemost 1999;81:66\u201370. https:\/\/doi.org\/10.1055\/s-0037-1614420.","DOI":"10.1055\/s-0037-1614420"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_023","doi-asserted-by":"crossref","unstructured":"McBane, IIRD, O\u2019Connor, C, Lutz, J, Blanco, J, Hartman, LA, Kramer, A, et al.. CoaguChek and Coag-sense PT2 meter point of care INR device validation. Mayo Clin Proc 2024;99:1091\u2013100.","DOI":"10.1016\/j.mayocp.2023.10.006"},{"key":"2026110905014417593_j_cclm-2026-0267_ref_024","unstructured":"Regulation (EU) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on in\u00a0vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU. https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj (Accessed January 27, 2026)."}],"container-title":["Clinical Chemistry and Laboratory Medicine (CCLM)"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.degruyterbrill.com\/document\/doi\/10.1515\/cclm-2026-0267\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyterbrill.com\/document\/doi\/10.1515\/cclm-2026-0267\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,11,9]],"date-time":"2026-11-09T05:02:13Z","timestamp":1794200533000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyterbrill.com\/document\/doi\/10.1515\/cclm-2026-0267\/html"}},"subtitle":["A report from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)\u2013Scientific and Standardization Committee (SSC)\/ International Society on Thrombosis and Haemostasis (ISTH) working group on PT\/INR standardization"],"short-title":[],"issued":{"date-parts":[[2026,3,16]]},"references-count":24,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,4,13]]},"published-print":{"date-parts":[[2026,7,24]]}},"alternative-id":["10.1515\/cclm-2026-0267"],"URL":"https:\/\/doi.org\/10.1515\/cclm-2026-0267","relation":{},"ISSN":["1434-6621","1437-4331"],"issn-type":[{"value":"1434-6621","type":"print"},{"value":"1437-4331","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,16]]}}}