{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T10:56:07Z","timestamp":1790592967869,"version":"4.1.0"},"reference-count":42,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T00:00:00Z","timestamp":1787961600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T00:00:00Z","timestamp":1787961600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Separation Science"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Infliximab (IFX) is a cornerstone biologic for pediatric inflammatory bowel disease, where therapeutic drug monitoring (TDM) is essential but complicated by inter\u2010platform variability. Systematic comparison of automated immunoassays with reference methods is therefore warranted. This study aimed to validate an in\u2010house chemiluminescence immunoassay (CLIA) for IFX quantification and evaluate its agreement with liquid chromatography\u2010tandem mass spectrometry (LC\u2010MS\/MS). A CLIA kit was validated by assessing the limit of blank, specificity, linearity, accuracy, precision, matrix equivalence, and stability. IFX concentrations in 52 pediatric plasma samples were measured by CLIA and a reference LC\u2010MS\/MS method. Comparability was evaluated using linear regression, Passing\u2010Bablok regression, and Bland\u2010Altman analysis. CLIA showed excellent performance (lower limit of quantification: 0.640 \u00b5g\/mL; specificity &lt;10.0% interference; reportable range: 0.640\u2013462 \u00b5g\/mL). LC\u2010MS\/MS yielded higher concentrations than the CLIA (median: 6.25 vs. 2.87 \u00b5g\/mL). Strong correlation was observed (\n                    <jats:italic>r<\/jats:italic>\n                    = 0.9101) with no significant deviation from linearity (Passing\u2010Bablok,\n                    <jats:italic>p<\/jats:italic>\n                    &gt; 0.05). However, Bland\u2010Altman revealed substantial mean relative bias (67.9%) and poor categorical agreement (52% concordance) within the therapeutic range (3\u20137 \u00b5g\/mL), indicating non\u2010interchangeability. We validated a rapid, automated CLIA suitable for high\u2010throughput TDM. Despite strong correlation, significant quantitative differences preclude direct result substitution, underscoring the need for method\u2010specific therapeutic thresholds.\n                  <\/jats:p>","DOI":"10.1002\/jssc.70515","type":"journal-article","created":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T13:01:10Z","timestamp":1788008470000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Bridging the Gap Between Chemiluminescence Immunoassay and Liquid Chromatography\u2010Tandem Mass Spectrometry for Infliximab Monitoring: Method Validation and Clinical Comparability Study"],"prefix":"10.1002","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1207-7692","authenticated-orcid":false,"given":"Ying","family":"Xia","sequence":"first","affiliation":[{"name":"Department of Pharmacy Children's Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming\u2010Mei","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Children's Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meng\u2010Qing","family":"Xiao","sequence":"additional","affiliation":[{"name":"Shanghai AB Sciex Co., Ltd.  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen\u2010Chun","family":"Zhong","sequence":"additional","affiliation":[{"name":"Shanghai AB Sciex Co., Ltd.  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu\u2010Jun","family":"Zhou","sequence":"additional","affiliation":[{"name":"Diagreat Biotechnologies Co., Ltd.  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi\u2010Hao","family":"Xue","sequence":"additional","affiliation":[{"name":"Diagreat Biotechnologies Co., Ltd.  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shi\u2010Wei","family":"Zheng","sequence":"additional","affiliation":[{"name":"Diagreat Biotechnologies Co., Ltd.  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Li","sequence":"additional","affiliation":[{"name":"The Scientific Research Department Children's Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Children's Hospital of Nanjing Medical University  Nanjing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,29]]},"reference":[{"key":"e_1_2_12_2_1","article-title":"Inflammatory Bowel Disease in Children: Current Diagnosis and Treatment Strategies","volume":"17","author":"Bhalla A.","year":"2025","journal-title":"Cureus"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468\u20101253(23)00011\u20100"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild\u20102023\u2010325668"},{"key":"e_1_2_12_5_1","article-title":"Biologics Targeting in the Treatment of Inflammatory Bowel Disease: A Conundrum","volume":"12","author":"Rehman M.","year":"2020","journal-title":"Cureus"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v29.i18.2784"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12876\u2010022\u201002347\u20101"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm12103378"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10787\u2010024\u201001508\u2010w"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2017.07.032"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.21316"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa020888"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.10302"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14062"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.22214"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2011.08.022"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2012.06.002"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/FTD.0b013e31828d23c3"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2015.07.007"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cyto.2019.154859"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1515\/cclm\u20102015\u20100987"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.4155\/bio\u20102022\u20100057"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmsacl.2024.01.007"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2021.462489"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinbiochem.2023.110618"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics15192447"},{"key":"e_1_2_12_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-0716-1186-9"},{"key":"e_1_2_12_28_1","unstructured":"CLSI \u201cEvaluation of Precision of Quantitative Measurement Procedures.\u201d Approved Guideline EP05Ed4E. 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