{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T02:12:16Z","timestamp":1793153536221,"version":"4.5.0"},"reference-count":35,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Clinica Chimica Acta"],"published-print":{"date-parts":[[2026,6]]},"DOI":"10.1016\/j.cca.2026.120944","type":"journal-article","created":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T00:17:33Z","timestamp":1773361053000},"page":"120944","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"special_numbering":"C","title":["Recommendations for establishing metrological traceability for in vitro diagnostic measurement procedures intended to be used for whole blood samples"],"prefix":"10.1016","volume":"588","author":[{"given":"Jesper V.","family":"Johansen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cas","family":"Weykamp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Barczak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Horan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sverre","family":"Sandberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liesbet","family":"Deprez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Delatour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauro","family":"Panteghini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil","family":"Greenberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Budd","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Finlay","family":"MacKenzie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. Greg","family":"Miller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.cca.2026.120944_bb0005","series-title":"In vitro diagnostic medical devices \u2014 Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples","first-page":"2020","author":"ISO 17511","year":"2020"},{"key":"10.1016\/j.cca.2026.120944_bb0010","series-title":"In vitro diagnostic medical devices \u2014 Measurement of quantities in samples of biological origin \u2014 Requirements for certified reference materials and the content of supporting documentation","first-page":"2009","author":"ISO 15194","year":"2009"},{"key":"10.1016\/j.cca.2026.120944_bb0015","series-title":"International vocabulary of metrology \u2014 Basic and general concepts and associated terms (VIM)","first-page":"2007","author":"ISO\/IEC Guide 99","year":"2007"},{"key":"10.1016\/j.cca.2026.120944_bb0020","doi-asserted-by":"crossref","first-page":"392","DOI":"10.3389\/fphys.2020.00392","article-title":"Heterogeneity of red blood cells: causes and consequences","volume":"11","author":"Bogdanova","year":"2020","journal-title":"Front. Physiol."},{"key":"10.1016\/j.cca.2026.120944_bb0025","doi-asserted-by":"crossref","first-page":"2617","DOI":"10.1007\/s00216-025-05751-0","article-title":"Commutability study on three CRMs evaluating their suitability for calibration, trueness verification and statistical quality control of methods measuring metal concentrations in human blood","volume":"417","author":"Linsinger","year":"2025","journal-title":"Anal. Bioanal. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0030","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1016\/j.cca.2008.12.037","article-title":"Assay-related issues in the measurement of cardiac troponins","volume":"402","author":"Panteghini","year":"2009","journal-title":"Clin. Chim. Acta"},{"key":"10.1016\/j.cca.2026.120944_bb0035","doi-asserted-by":"crossref","DOI":"10.1002\/bimj.70032","article-title":"Quantification of difference in nonselectivity between in vitro diagnostic medical devices","volume":"67","author":"Fauskanger","year":"2025","journal-title":"Biom. J."},{"key":"10.1016\/j.cca.2026.120944_bb0040","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1080\/10408363.2024.2434562","article-title":"Establishing, evaluating and monitoring analytical quality in the traceability era","volume":"62","author":"Panteghini","year":"2025","journal-title":"Crit. Rev. Clin. Lab. Sci."},{"key":"10.1016\/j.cca.2026.120944_bb0045","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1016\/j.clinbiochem.2018.03.007","article-title":"Defining permissible limits for the combined uncertainty budget in the implementation of metrological traceability","volume":"57","author":"Braga","year":"2018","journal-title":"Clin. Biochem."},{"key":"10.1016\/j.cca.2026.120944_bb0050","doi-asserted-by":"crossref","DOI":"10.1515\/cclm-2014-1240","article-title":"Performance criteria for combined uncertainty budget in the implementation of metrological traceability","volume":"53","author":"Braga","year":"2015","journal-title":"Clin. Chem. Lab. Med. (CCLM)."},{"key":"10.1016\/j.cca.2026.120944_bb0055","doi-asserted-by":"crossref","first-page":"1590","DOI":"10.1093\/clinchem\/hvab178","article-title":"Optimizing available tools for achieving result standardization: value added by joint committee on traceability in laboratory medicine (JCTLM)","volume":"67","author":"Panteghini","year":"2021","journal-title":"Clin. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0060","doi-asserted-by":"crossref","first-page":"1321","DOI":"10.1093\/clinchem\/hvae131","article-title":"Feasibility of metrological traceability implementation using the joint committee on traceability in laboratory medicine database entries including the fulfillment of \u201cfit-for-purpose\u201d maximum allowable measurement uncertainty","volume":"70","author":"Panteghini","year":"2024","journal-title":"Clin. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0065","doi-asserted-by":"crossref","first-page":"1497","DOI":"10.1515\/cclm-2023-1325","article-title":"Analytical performance specifications for combined uncertainty budget in the implementation of metrological traceability","volume":"62","author":"Panteghini","year":"2024","journal-title":"Clin. Chem. Lab. Med. (CCLM)."},{"key":"10.1016\/j.cca.2026.120944_bb0070","doi-asserted-by":"crossref","first-page":"55","DOI":"10.1016\/j.cca.2013.11.022","article-title":"Verification of in vitro medical diagnostics (IVD) metrological traceability: responsibilities and strategies","volume":"432","author":"Braga","year":"2014","journal-title":"Clin. Chim. Acta"},{"key":"10.1016\/j.cca.2026.120944_bb0075","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1093\/clinchem\/hvaa048","article-title":"IFCC working group recommendations for correction of Bias caused by noncommutability of a certified reference material used in the calibration hierarchy of an end-user measurement procedure","volume":"66","author":"Miller","year":"2020","journal-title":"Clin. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0080","unstructured":"JCTLM Databasehigher-order reference materials, measurement methods and services. 2026."},{"key":"10.1016\/j.cca.2026.120944_bb0085","doi-asserted-by":"crossref","DOI":"10.1515\/CCLM.2002.016","article-title":"Approved IFCC reference method for the measurement of HbA1c in human blood","volume":"40","author":"Jeppsson","year":"2002","journal-title":"Clin. Chem. Lab. Med."},{"key":"10.1016\/j.cca.2026.120944_bb0090","series-title":"Certification of the amount-of-substance fraction of HbA1c versus the sum of HbA0 and HbA1c in haemoglobin: ERM AD500\/IFCC","author":"European Commission. Joint Research Centre. Institute for Reference Materials and Measurements., Streekziekenhuis Koningin Beatrix., Universit\u00e0 degli Studi di Milano. Department of Physiopathology and Transplantation., and Roche Diagnostic GmbH","year":"2016"},{"key":"10.1016\/j.cca.2026.120944_bb0095","unstructured":"The Production and Certification of an Incurred Human Blood Certified Reference Material for Tacrolimus Content LGC8272 Batch 1, 2025 May 2025 LGC\/R\/2025\/922 (Supersedes report LGC\/R\/2024\/888) - Public Access Report."},{"key":"10.1016\/j.cca.2026.120944_bb0100","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1373\/clinchem.2017.277525","article-title":"IFCC working group recommendations for assessing commutability part 1: general experimental design","volume":"64","author":"Miller","year":"2018","journal-title":"Clin. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0105","doi-asserted-by":"crossref","first-page":"455","DOI":"10.1373\/clinchem.2017.277541","article-title":"IFCC working group recommendations for assessing commutability part 2: using the difference in Bias between a reference material and clinical samples","volume":"64","author":"Nilsson","year":"2018","journal-title":"Clin. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0110","doi-asserted-by":"crossref","first-page":"465","DOI":"10.1373\/clinchem.2017.277558","article-title":"IFCC working group recommendations for assessing commutability part 3: using the calibration effectiveness of a reference material","volume":"64","author":"Budd","year":"2018","journal-title":"Clin. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0115","doi-asserted-by":"crossref","first-page":"966","DOI":"10.1093\/clinchem\/hvad104","article-title":"Recommendations for setting a criterion for assessing commutability of secondary calibrator certified reference materials","volume":"69","author":"Miller","year":"2023","journal-title":"Clin. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0120","series-title":"Blood Gas and pH Analysis and Related Measurements","first-page":"2009","author":"CLSI C46-A2","year":"2009"},{"key":"10.1016\/j.cca.2026.120944_bb0125","series-title":"Implementation of Metrological Traceability in Laboratory Medicine","first-page":"2025","author":"CLSI EP32-ED2","year":"2025"},{"key":"10.1016\/j.cca.2026.120944_bb0130","series-title":"Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood","first-page":"2000","author":"CLSIH15-A3","year":"2000"},{"key":"10.1016\/j.cca.2026.120944_bb0135","doi-asserted-by":"crossref","first-page":"1314","DOI":"10.1515\/cclm-2019-1177","article-title":"Total haemoglobin \u2013 a reference measuring system for improvement of standardisation","volume":"58","author":"Grote-Koska","year":"2020","journal-title":"Clin. Chem. Lab. Med. (CCLM)."},{"key":"10.1016\/j.cca.2026.120944_bb0140","doi-asserted-by":"crossref","DOI":"10.1515\/CCLM.2006.275","article-title":"Approved IFCC recommendation on reporting results for blood glucose: International Federation of Clinical Chemistry and Laboratory Medicine Scientific Division, working group on selective electrodes and point-of-care testing (IFCC-SD-WG-SEPOCT)","volume":"44","author":"D'Orazio","year":"2006","journal-title":"Clin. Chem. Lab. Med. (CCLM)."},{"key":"10.1016\/j.cca.2026.120944_bb0145","series-title":"Effects of Different Sample Types on Glucose Measurements","first-page":"2015","author":"CLSI POCT06-ED1","year":"2015"},{"key":"10.1016\/j.cca.2026.120944_bb0150","doi-asserted-by":"crossref","first-page":"1031","DOI":"10.1021\/ac50043a059","article-title":"Generalized standard addition method","volume":"51","author":"Saxberg","year":"1979","journal-title":"Anal. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0155","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1016\/j.trac.2016.12.013","article-title":"The standard addition method revisited","volume":"89","author":"Andersen","year":"2017","journal-title":"TrAC Trends Anal. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0160","doi-asserted-by":"crossref","first-page":"2749","DOI":"10.1007\/s00216-019-01754-w","article-title":"Origins of the method of standard additions and of the use of an internal standard in quantitative instrumental chemical analyses","volume":"411","author":"Burns","year":"2019","journal-title":"Anal. Bioanal. Chem."},{"key":"10.1016\/j.cca.2026.120944_bb0165","doi-asserted-by":"crossref","first-page":"992","DOI":"10.1039\/b717660k","article-title":"Standard additions: myth and reality","volume":"133","author":"Ellison","year":"2008","journal-title":"Analyst"},{"key":"10.1016\/j.cca.2026.120944_bb0170","unstructured":"ISO 21151:2020. In vitro diagnostic medical devices \u2014 Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples. International Organization for Standardization. 2020."},{"key":"10.1016\/j.cca.2026.120944_bb0175","doi-asserted-by":"crossref","first-page":"1067","DOI":"10.1373\/clinchem.2008.107052","article-title":"Traceability in laboratory medicine","volume":"55","author":"Vesper","year":"2009","journal-title":"Clin. Chem."}],"container-title":["Clinica Chimica Acta"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0009898126001269?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0009898126001269?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T00:49:04Z","timestamp":1778892544000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0009898126001269"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6]]},"references-count":35,"alternative-id":["S0009898126001269"],"URL":"https:\/\/doi.org\/10.1016\/j.cca.2026.120944","relation":{},"ISSN":["0009-8981"],"issn-type":[{"value":"0009-8981","type":"print"}],"subject":[],"published":{"date-parts":[[2026,6]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Recommendations for establishing metrological traceability for in vitro diagnostic measurement procedures intended to be used for whole blood samples","name":"articletitle","label":"Article Title"},{"value":"Clinica Chimica Acta","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.cca.2026.120944","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"simple-article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"120944"}}