{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T17:11:33Z","timestamp":1790097093958,"version":"4.0.1"},"reference-count":26,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T00:00:00Z","timestamp":1788998400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Clin Biochem"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Serum carbohydrate antigen 19-9 (CA19-9) is widely used in the management of pancreatic diseases, but results often vary across immunoassay platforms. This study sought to describe how the values obtained by chemiluminescent immunoassay (CLIA) and electrochemiluminescent immunoassay (ECLIA) differ, to assess whether discrepancies vary across concentration ranges, and to identify clinical factors potentially contributing to this variability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We examined 1,760 paired samples measured simultaneously by CLIA (Abbott Alinity i) and ECLIA (Roche Cobas e801) during a transition period. To assess agreement between assays, correlation analysis, Passing\u2013Bablok regression, and Bland\u2013Altman analysis were performed on log\n                      <jats:sub>10<\/jats:sub>\n                      -transformed data.\n                    <\/jats:p>\n                    <jats:p>Subgroup comparisons were made by CA19-9 concentration, disease category, and hepatobiliary enzyme status. Multivariable regression was used to explore independent factors associated with the magnitude of inter-assay differences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Correlation between CLIA and ECLIA was strong (r = 0.94, \u03c1 = 0.89) although a concentration-dependent bias was observed with CLIA yielding higher values at higher concentrations, whereas ECLIA tended to yield higher values at lower concentrations. Discrepancies were greater in pancreatic cancer samples in those with elevated ALP or \u03b3-GT, and at higher concentrations (CLIA \u2265 1000\u00a0U\/mL). Older age, female sex, pancreatic cancer, and elevated hepatobiliary enzymes were independently associated with larger assay differences (adjusted R\n                      <jats:sup>2<\/jats:sup>\n                      = 0.13).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Despite good overall agreement, the two methods showed variability that could affect clinical interpretation, especially in low or high concentration ranges. When assay changes are unavoidable, using method-specific reference ranges or confirming results near decision thresholds may help ensure consistent interpretation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/00045632261491148","type":"journal-article","created":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T13:16:03Z","timestamp":1789046163000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Clinical significance of inter-assay discrepancies in serum CA19-9 values: A comparison between CLIA and ECLIA"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-8861-6055","authenticated-orcid":false,"given":"Ling","family":"Zhang","sequence":"first","affiliation":[{"name":"Fujita Nurse Practitioner Office, Fujita Health University Hospital, Toyoake, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichiro","family":"Uchida","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery, Fujita Health University Hospital, Toyoake, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Midori","family":"Saito","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery, Fujita Health University Hospital, Toyoake, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hayato","family":"Ichikawa","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery, Fujita Health University Hospital, Toyoake, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kunpei","family":"Hada","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery, Fujita Health University Hospital, Toyoake, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masato","family":"Hoshi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery, Fujita Health University Hospital, Toyoake, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Takahara","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery, Fujita Health University Hospital, Toyoake, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyasu","family":"Ito","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery, Fujita Health University Hospital, Toyoake, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koichi","family":"Suda","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery, Fujita Health University Hospital, Toyoake, Aichi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,9,10]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.18.6288"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.3390\/biomedicines12122840"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2025.1555963"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.4240\/wjgs.v12.i12.468"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/hvae005"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.5455\/aim.2018.26.235-239"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1177\/030089169508100209"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.3389\/fmolb.2024.1401619"},{"key":"e_1_3_5_10_2","volume-title":"Clinical practice guidelines for pancreatic cancer 2022","author":"Japanese Pancreas Society","year":"2022","unstructured":"Japanese Pancreas Society. Clinical practice guidelines for pancreatic cancer revision committee. Clinical practice guidelines for pancreatic cancer 2022: Kanehara & Co., Ltd., 2022."},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cca.2008.10.033"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1309\/H52VET3M6P7GYWG1"},{"key":"e_1_3_5_13_2","doi-asserted-by":"publisher","DOI":"10.3390\/biomedicines13061386"},{"key":"e_1_3_5_14_2","doi-asserted-by":"publisher","DOI":"10.1515\/cclm-2012-0744"},{"key":"e_1_3_5_15_2","doi-asserted-by":"publisher","DOI":"10.1515\/cclm-2026-0155"},{"key":"e_1_3_5_16_2","doi-asserted-by":"publisher","DOI":"10.4318\/tjg.2011.0186"},{"key":"e_1_3_5_17_2","doi-asserted-by":"publisher","DOI":"10.1515\/CCLM.2009.152"},{"issue":"1","key":"e_1_3_5_18_2","first-page":"S49","article-title":"Limit of blank, limit of detection and limit of quantitation","volume":"29","author":"Armbruster DA","year":"2008","unstructured":"Armbruster DA, Pry T. Limit of blank, limit of detection and limit of quantitation. Clin Biochem Rev 2008; 29(Suppl 1): S49\u2013S52.","journal-title":"Clin Biochem Rev"},{"key":"e_1_3_5_19_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-020-65720-8"},{"key":"e_1_3_5_20_2","doi-asserted-by":"publisher","DOI":"10.1515\/cclm-2013-0075"},{"key":"e_1_3_5_21_2","first-page":"105","article-title":"Interferences in immunoassay","volume":"25","author":"Tate J","year":"2004","unstructured":"Tate J, Ward G. Interferences in immunoassay. Clin Biochem Rev 2004; 25: 105\u2013120.","journal-title":"Clin Biochem Rev"},{"key":"e_1_3_5_22_2","doi-asserted-by":"publisher","DOI":"10.1373\/clinchem.2007.094144"},{"key":"e_1_3_5_23_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdp332"},{"key":"e_1_3_5_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.pan.2018.09.004"},{"key":"e_1_3_5_25_2","doi-asserted-by":"publisher","DOI":"10.1309\/AJCPOPNPLLCYR07H"},{"key":"e_1_3_5_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2022.100552"},{"key":"e_1_3_5_27_2","doi-asserted-by":"publisher","DOI":"10.3945\/ajcn.115.110387"}],"container-title":["Annals of Clinical Biochemistry: International Journal of Laboratory Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/00045632261491148","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/00045632261491148","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/00045632261491148","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T16:50:12Z","timestamp":1790095812000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/00045632261491148"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,10]]},"references-count":26,"alternative-id":["10.1177\/00045632261491148"],"URL":"https:\/\/doi.org\/10.1177\/00045632261491148","relation":{},"ISSN":["0004-5632","1758-1001"],"issn-type":[{"value":"0004-5632","type":"print"},{"value":"1758-1001","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,10]]},"article-number":"00045632261491148"}}