{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,5,3]],"date-time":"2024-05-03T15:10:57Z","timestamp":1714749057950},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2024,2,1]],"date-time":"2024-02-01T00:00:00Z","timestamp":1706745600000},"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":[[2024,5,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>An erroneously high tacrolimus level was reported to a clinician. A root cause analysis investigation failed to determine the cause of the error. It was suspected that the incorrect preanalytical extraction reagent and procedure was used during testing; however, how this would affect the assayed drug concentration was unclear. Here we investigated the effect of the substitution of sirolimus, tacrolimus, and cyclosporine extraction reagents on assayed drug concentration.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Tacrolimus, sirolimus, and cyclosporine concentration were measured on the Abbott Architect i2000 analyzer. Each assay requires a preanalytical extraction step, with a distinct reagent. We investigated the effect of the substitution of the extraction reagents and procedure between the 3 assays on the measured drug concentration. Two experiments were performed, one on samples of known drug concentration and one on samples with no drug present.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Substituting cyclosporine and sirolimus extraction procedures increased assayed tacrolimus concentrations from 5.6 to 8.47 (+51.25%) and 8.13 (+45.18%) ng\/mL, respectively. Extraction procedure substitutions decreased assayed sirolimus from 13.63 to 4.60 (\u221266.25%) and 8.07 (\u221240.79%) ng\/mL for cyclosporine and tacrolimus. Cyclosporine concentration increased from 274.60 to 391.30 (+42.50%) ng\/mL using sirolimus extraction reagents and to 757.30 (+175.78%) ng\/mL using tacrolimus extraction reagents. Cross-reactivity was observed between the tacrolimus assay and sirolimus and cyclosporine extraction reagents.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Significant changes, both positive and negative, are observed in assayed drug concentration when incorrect extraction procedures are used in the Abbott i2000 tacrolimus, sirolimus, and cyclosporine assays. Preanalytic extraction procedures should be investigated when performing root cause analysis for erroneous therapeutic drug values.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jalm\/jfad128","type":"journal-article","created":{"date-parts":[[2023,12,16]],"date-time":"2023-12-16T04:19:33Z","timestamp":1702700373000},"page":"573-578","source":"Crossref","is-referenced-by-count":0,"title":["Effect of Extraction Procedure Substitution on Automated Tacrolimus, Sirolimus, and Cyclosporine Assays"],"prefix":"10.1093","volume":"9","author":[{"given":"Athanasia","family":"Chandras","sequence":"first","affiliation":[{"name":"Department of Pathology, Molecular & Cell Based Medicine, Mount Sinai Hospital , New York, NY , United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Damodara R","family":"Mendu","sequence":"additional","affiliation":[{"name":"Department of Pathology, Molecular & Cell Based Medicine, Mount Sinai Hospital , New York, NY , United States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel C","family":"Kirchhoff","sequence":"additional","affiliation":[{"name":"Department of Pathology, Molecular & Cell Based Medicine, Mount Sinai Hospital , New York, NY , United States"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2024,2,1]]},"reference":[{"key":"2024050218413938500_jfad128-B1","volume-title":"Abbott Architect tacrolimus","author":"Abbott Laboratories","year":"2015"},{"key":"2024050218413938500_jfad128-B2","volume-title":"Abbott Architect sirolimus","author":"Abbott Laboratories","year":"2015"},{"key":"2024050218413938500_jfad128-B3","volume-title":"Abbott Architect cyclosporine","author":"Abbott Laboratories","year":"2015"},{"key":"2024050218413938500_jfad128-B4","doi-asserted-by":"crossref","first-page":"332","DOI":"10.2215\/CJN.08570814","article-title":"Immunosuppressive medications","volume":"11","author":"Wiseman","year":"2016","journal-title":"Clin J Am Soc Nephrol"},{"key":"2024050218413938500_jfad128-B5","doi-asserted-by":"crossref","first-page":"1679","DOI":"10.1111\/ajt.15809","article-title":"Tacrolimus- versus sirolimus-based immunosuppression after simultaneous pancreas and kidney transplantation: 5-year results of a randomized trial","volume":"20","author":"Cantarovich","year":"2020","journal-title":"Am J Transplant"},{"key":"2024050218413938500_jfad128-B6","doi-asserted-by":"crossref","first-page":"1110","DOI":"10.1056\/NEJM199410273311702","article-title":"A comparison of tacrolimus (FK 506) and cyclosporine for immunosuppression in liver transplantation","volume":"331","author":"U.S. Multicenter FK506 Liver Study Group","year":"1994","journal-title":"N Engl J Med"},{"key":"2024050218413938500_jfad128-B7","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1111\/j.1600-6143.2005.00748.x","article-title":"Pharmacokinetic principles of immunosuppressive drugs","volume":"5","author":"Srinivas","year":"2005","journal-title":"Am J Transplant"},{"key":"2024050218413938500_jfad128-B8","doi-asserted-by":"crossref","first-page":"901","DOI":"10.1208\/s12248-013-9500-8","article-title":"Population pharmacokinetics of cyclosporine in transplant recipients","volume":"15","author":"Han","year":"2013","journal-title":"AAPS J"},{"key":"2024050218413938500_jfad128-B9","doi-asserted-by":"crossref","first-page":"573","DOI":"10.2165\/00003088-200140080-00002","article-title":"Clinical pharmacokinetics of sirolimus","volume":"40","author":"Mahalati","year":"2001","journal-title":"Clin Pharmacokinet"},{"key":"2024050218413938500_jfad128-B10","doi-asserted-by":"crossref","first-page":"506","DOI":"10.1097\/00007691-200410000-00008","article-title":"Changes in tacrolimus distribution in blood and plasma protein binding following liver transplantation","volume":"26","author":"Zahir","year":"2004","journal-title":"Ther Drug Monit"},{"key":"2024050218413938500_jfad128-B11","doi-asserted-by":"crossref","first-page":"420","DOI":"10.1177\/000456329403100503","article-title":"Methodological and clinical aspects of cyclosporin monitoring: report of the Association of Clinical Biochemists task force","volume":"31","author":"Holt","year":"1994","journal-title":"Ann Clin Biochem"},{"key":"2024050218413938500_jfad128-B12","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1097\/00007691-199504000-00010","article-title":"Tacrolimus analysis: a comparison of different methods and matrices","volume":"17","author":"Warty","year":"1995","journal-title":"Ther Drug Monit"},{"key":"2024050218413938500_jfad128-B13","doi-asserted-by":"crossref","first-page":"2158","DOI":"10.1093\/clinchem\/44.10.2158","article-title":"Cyclosporin whole blood immunoassays (AxSYM, CEDIA, and Emit): a critical overview of performance characteristics and comparison with HPLC","volume":"44","author":"Sch\u00fctz","year":"1998","journal-title":"Clin Chem"},{"key":"2024050218413938500_jfad128-B14","doi-asserted-by":"crossref","first-page":"19","DOI":"10.5858\/2003-127-19-LOSOC","article-title":"Lack of specificity of cyclosporine immunoassays. Results of a College of American Pathologists study","volume":"127","author":"Soldin","year":"2003","journal-title":"Arch Pathol Lab Med"},{"key":"2024050218413938500_jfad128-B15","doi-asserted-by":"crossref","first-page":"268","DOI":"10.1093\/labmed\/lmw032","article-title":"Evaluation of 2 batched pretreatment systems for the measurement of whole blood tacrolimus on the ARCHITECT immunoassay analyzer","volume":"47","author":"Albeiroti","year":"2016","journal-title":"Lab Med"}],"container-title":["The Journal of Applied Laboratory Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/9\/3\/573\/57388911\/jfad128.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jalm\/article-pdf\/9\/3\/573\/57388911\/jfad128.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T14:42:22Z","timestamp":1714660942000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jalm\/article\/9\/3\/573\/7595927"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,1]]},"references-count":15,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2024,2,1]]},"published-print":{"date-parts":[[2024,5,2]]}},"URL":"https:\/\/doi.org\/10.1093\/jalm\/jfad128","relation":{},"ISSN":["2475-7241"],"issn-type":[{"value":"2475-7241","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2024,5]]},"published":{"date-parts":[[2024,2,1]]}}}