{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T19:20:54Z","timestamp":1790882454164,"version":"4.1.0"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T00:00:00Z","timestamp":1657152000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Serum ferritin is considered a suitable biomarker of iron-related disorders. However, data about the comparability of results among commercial measuring systems (MSs) are contradictory. We performed an intercomparison study aimed at verifying the current interassay variability and its impact on clinical application of the test. Obtaining this information is vital because manufacturers continue to claim calibration alignment to different WHO preparations, which are not related to each other in terms of traceability.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Four widely used MSs were evaluated. The interassay agreement was verified using 39 human serum pools. The recovery of WHO International Standard (IS) 94\/572 (the only reference material available at the time of the study) was evaluated, after assessing the material commutability. Finally, an approach for harmonizing ferritin results was proposed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Highly significant differences (P\u2009&amp;lt;\u20090.00001) among ferritin concentrations assayed by different MSs were detected and the interassay CV (median 22.9%; interquartile range 21.8\u201325.5) overlapped the desirable intermethod bias (24.6%). IS 94\/572 was commutable for use only with Access and Centaur, with Access being the only MS correctly recovering its assigned value. Accordingly, we used regression data against Access to recalibrate MSs, indirectly aligning them to IS 94\/572, with a substantial improvement in degree of harmonization and traceability to higher-order reference.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The harmonization among evaluated ferritin MSs is far from optimal, with the implementation of traceability to different WHO ISs being a factor of confusion. A recalibration approach, however, would permit measurement harmonization, allowing the use of common decision thresholds.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/clinchem\/hvac099","type":"journal-article","created":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T02:37:19Z","timestamp":1657161439000},"page":"1202-1210","source":"Crossref","is-referenced-by-count":42,"title":["Harmonization Status of Serum Ferritin Measurements and Implications for Use as Marker of Iron-Related Disorders"],"prefix":"10.1093","volume":"68","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3562-7180","authenticated-orcid":false,"given":"Federica","family":"Braga","sequence":"first","affiliation":[{"name":"Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), Universit\u00e0 degli Studi di Milano , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Pasqualetti","sequence":"additional","affiliation":[{"name":"Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), Universit\u00e0 degli Studi di Milano , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika","family":"Frusciante","sequence":"additional","affiliation":[{"name":"Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), Universit\u00e0 degli Studi di Milano , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Borrillo","sequence":"additional","affiliation":[{"name":"Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), Universit\u00e0 degli Studi di Milano , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariia","family":"Chibireva","sequence":"additional","affiliation":[{"name":"Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), Universit\u00e0 degli Studi di Milano , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauro","family":"Panteghini","sequence":"additional","affiliation":[{"name":"Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), Universit\u00e0 degli Studi di Milano , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,7,7]]},"reference":[{"key":"2022101810062732600_hvac099-B1","doi-asserted-by":"crossref","first-page":"770","DOI":"10.1136\/jcp.26.10.770","article-title":"Serum ferritin concentration and iron stores in normal subjects","volume":"26","author":"Walters","year":"1973","journal-title":"J Clin Pathol"},{"key":"2022101810062732600_hvac099-B2","doi-asserted-by":"crossref","first-page":"786","DOI":"10.1182\/blood.V56.5.786.786","article-title":"Utility of serum ferritin as a measure of iron deficiency in normal males undergoing repetitive phlebotomy","volume":"56","author":"Jacob","year":"1980","journal-title":"Blood"},{"key":"2022101810062732600_hvac099-B3","first-page":"719","volume-title":"Tietz textbook of clinical chemistry and molecular diagnostics","author":"Cappellini","year":"2018","edition":"6th Ed"},{"key":"2022101810062732600_hvac099-B4","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1016\/S0002-9343(02)01226-3","article-title":"Prospective evaluation of a clinical guideline for the diagnosis and management of iron deficiency anemia","volume":"113","author":"Ioannou","year":"2002","journal-title":"Am J Med"},{"key":"2022101810062732600_hvac099-B5","author":"Ministry of Health (British Columbia)"},{"key":"2022101810062732600_hvac099-B6","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1016\/j.jhep.2010.03.001","article-title":"EASL clinical practice guidelines for HFE hemochromatosis","volume":"53","author":"European Association for the Study of the Liver","year":"2010","journal-title":"J Hepatol"},{"key":"2022101810062732600_hvac099-B7","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1016\/j.biologicals.2010.02.007","article-title":"The development and role of international biological reference materials in the diagnosis of anaemia","volume":"38","author":"Thorpe","year":"2010","journal-title":"Biologicals"},{"key":"2022101810062732600_hvac099-B8","first-page":"177","article-title":"International Committee for Standardization in Haematology (Expert Panel on Iron). 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