{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T02:52:12Z","timestamp":1767840732996,"version":"3.49.0"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T00:00:00Z","timestamp":1695081600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,1,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>This study evaluated the suitability and accuracy of the automated Roche Elecsys tacrolimus electrochemiluminescence immunoassay (ECLIA) by comparing it with a current laboratory-developed test by liquid chromatography\u2013tandem mass spectrometry (LC-MS\/MS).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The tacrolimus ECLIA was evaluated for precision, linearity, interference, and postextraction stability. Accuracy was compared with LC-MS\/MS.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The tacrolimus ECLIA assay is precise, exhibits a measuring range of 0.75 to 30 ng\/mL, and is tolerant of significant interferences (plasma indices: hemolysis &amp;lt;2306, icterus &amp;lt;55, lipemia &amp;lt;1427, and biotin &amp;lt;1200 ng\/mL). Comparison with LC-MS\/MS revealed a 26% proportional bias in patient samples evaluated for tacrolimus concentration (y = 1.26x + 0.08; r2 = 0.97; Sy\/x = 0.94; n = 43) and an absolute mean (SD) bias of 2.2 (1.7) ng\/mL. Postextraction studies confirmed that samples were stable for up to 30 minutes under routine laboratory conditions.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The 2 major challenges for implementation of the tacrolimus ECLIA assay are the postextraction sample stability and the significant proportional bias observed compared with the LC-MS\/MS reference method. The 30-minute window for analysis of extracted samples is a practical challenge to the routine workflow of the core laboratory. In addition, disagreement between the immunoassay and LC-MS\/MS methods can lead to discordant clinical interpretations and ultimately affect patient care.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ajcp\/aqad114","type":"journal-article","created":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T08:23:49Z","timestamp":1695111829000},"page":"97-106","source":"Crossref","is-referenced-by-count":6,"title":["Is the automated Elecsys tacrolimus assay on the Roche cobas e 602 analyzer an acceptable replacement for a liquid chromatography\u2013tandem mass spectrometry\u2013based assay?"],"prefix":"10.1093","volume":"161","author":[{"given":"Anastasia","family":"Gant Kanegusuku","sequence":"first","affiliation":[{"name":"Department of Pathology, University of Chicago , Chicago, IL , US"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4708-8420","authenticated-orcid":false,"given":"Kiang-Teck J","family":"Yeo","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Chicago , Chicago, IL , US"},{"name":"Pritzker School of Medicine, University of Chicago , Chicago, IL , US"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2023,9,19]]},"reference":[{"key":"2024010408030121900_CIT0001","first-page":"1249","article-title":"FK-506, A novel immunosuppressant isolated from a Streptomyces, I. fermentation, isolation, and physio-chemical and biological characteristics","volume-title":"J Antibiotics.","author":"Kino","year":"1987"},{"key":"2024010408030121900_CIT0002","doi-asserted-by":"crossref","first-page":"757","DOI":"10.1016\/B978-0-323-24485-5.00028-0","article-title":"Tacrolimus","volume-title":"Saunders Handbook of Veterinary Drugs.","author":"Papich","year":"2016","edition":"4"},{"key":"2024010408030121900_CIT0003","first-page":"139","article-title":"Opportunities to optimize tacrolimus 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obtained by the CMIA tacrolimus assay and a liquid chromatography combined with tandem mass spectrometric method","volume":"46","author":"Dasgupta","year":"2016","journal-title":"Ann Clin Lab Sci."},{"key":"2024010408030121900_CIT0019","first-page":"85","article-title":"Multi-center performance evaluations of tacrolimus and cyclosporine electrochemiluminescence immunoassays in the Asia-pacific region","volume-title":"Ann Lab Med.","author":"Qin","year":"2018"},{"key":"2024010408030121900_CIT0020","first-page":"1069","article-title":"Multi-center analytical evaluation of a novel automated tacrolimus immunoassay","volume-title":"Clin Biochem.","author":"Shipkova","year":"2014"},{"key":"2024010408030121900_CIT0021","first-page":"1832","article-title":"Evaluation of electrochemiluminescence immunoassays for immunosuppressive drugs on the Roche cobas e411 analyzer","volume-title":"F1000Res.","author":"Fung","year":"2017"},{"key":"2024010408030121900_CIT0022","first-page":"10","article-title":"Analytical performance evaluation of the Elecsys\u00ae Cyclosporine and Elecsys\u00ae Tacrolimus assays on the cobas e411 analyzer","volume-title":"Pract Lab Med.","author":"Sasano","year":"2017"},{"key":"2024010408030121900_CIT0023","first-page":"431","article-title":"Accuracy evaluation of Roche and Siemens tacrolimus and cyclosporine assays in comparison with liquid chromatography-tandem mass spectrometry","volume-title":"Scand J Clin Lab Invest.","author":"Ko","year":"2018"},{"key":"2024010408030121900_CIT0024","first-page":"270","article-title":"Clinical evaluation of the QMS\u00ae Tacrolimus Immunoassay","volume-title":"Clin Chim Acta.","author":"Leung","year":"2014"},{"key":"2024010408030121900_CIT0025","author":"Roche Elecsys Tacrolimus. 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