{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:50:04Z","timestamp":1792788604249,"version":"4.5.0"},"reference-count":16,"publisher":"Walter de Gruyter GmbH","issue":"9","funder":[{"DOI":"10.13039\/501100018537","name":"Noncommunicable Chronic Diseases-National Science and Technology Major Project","doi-asserted-by":"publisher","award":["2024ZD0523702"],"award-info":[{"award-number":["2024ZD0523702"]}],"id":[{"id":"10.13039\/501100018537","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Capital\u2019s Funds for Health Improvement and Research","award":["2024-2-4059"],"award-info":[{"award-number":["2024-2-4059"]}]},{"name":"Shanghai Innovation Medical Device Application Demonstration Projec","award":["No. 23SHS06200"],"award-info":[{"award-number":["No. 23SHS06200"]}]},{"name":"National High Level Hospital Clinical Research Funding","award":["BJ-2023-094"],"award-info":[{"award-number":["BJ-2023-094"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,8,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2025-0186_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Therapeutic drug monitoring (TDM) is critical for optimizing antipsychotic therapy, yet inter-laboratory comparability in China remains poor. Unstandardized practices risk suboptimal dosing and adverse effects, highlighting the need for standardization. This study evaluated TDM practices for six antipsychotics (olanzapine, clozapine, risperidone, quetiapine, aripiprazole, and paliperidone), focusing on inter-laboratory variability, quality control material suitability, and measurement system differences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0186_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Four processed serum samples (two frozen, two lyophilized) containing the six antipsychotic drugs were distributed to over 100 laboratories. The analyses utilized LC-MS\/MS, chemiluminescence immunoassays, and HPLC. Sample homogeneity, stability, matrix effects, and method precision, and accuracy were assessed systematically.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0186_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Significant inter-laboratory variability occurred for six antipsychotics. Only quetiapine met the external quality assessment (EQA) requirements, with inter-laboratory coefficients of variation (CVs) ranging from 12.08 to 15.23\u202f%. Others, especially olanzapine (CVs: 43.48\u201345.30\u202f%), had poor precision (CVs&gt;15\u202f%). The study revealed that commercial\n                      <jats:italic>in\u00a0vitro<\/jats:italic>\n                      diagnostic kits generally provided more consistent results compared to laboratory-developed tests. However, even with commercial kits, some drugs, such as aripiprazole, still showed substantial deviations. Lyophilized samples surpassed frozen ones in stability and EQA suitability, which exhibited comparable matrix effects across most assay systems.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0186_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Urgent standardization of Chinese TDM practices is needed, including harmonized systems and traceable calibrators. While commercial kits enhance result consistency, further efforts are required to harmonize performance across manufacturers. Lyophilized materials are optimal for EQA due to their stability and ease of transport. These findings offer actionable insights to improve the quality and comparability of antipsychotic TDM in clinical practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2025-0186","type":"journal-article","created":{"date-parts":[[2025,5,21]],"date-time":"2025-05-21T11:57:50Z","timestamp":1747828670000},"page":"1800-1813","source":"Crossref","is-referenced-by-count":3,"title":["Standardization challenges in antipsychotic drug monitoring: insights from a national survey in Chinese TDM practices"],"prefix":"10.1515","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4174-6047","authenticated-orcid":false,"given":"Weiyan","family":"Zhou","sequence":"first","affiliation":[{"name":"National Center for Clinical Laboratories , Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital\/ National Center of Gerontology , Beijing , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Zeng","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories , Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital\/ National Center of Gerontology , Beijing , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linhui","family":"Zhang","sequence":"additional","affiliation":[{"name":"Hangzhou Calibra Diagnostics , Hangzhou , P.R. China"},{"name":"Key Laboratory of Digital Technology in Medical Diagnostics of Zhejiang Province , Hangzhou , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiangtao","family":"Zhang","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories , Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital\/ National Center of Gerontology , Beijing , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4910-0267","authenticated-orcid":false,"given":"Yuhang","family":"Deng","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories , Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital\/ National Center of Gerontology , Beijing , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qianwen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Hangzhou Calibra Diagnostics , Hangzhou , P.R. China"},{"name":"Key Laboratory of Digital Technology in Medical Diagnostics of Zhejiang Province , Hangzhou , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haoyu","family":"Deng","sequence":"additional","affiliation":[{"name":"Hangzhou Calibra Diagnostics , Hangzhou , P.R. 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China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0754-7511","authenticated-orcid":false,"given":"Chuanbao","family":"Zhang","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories , Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital\/ National Center of Gerontology , Beijing , P.R. China"},{"name":"National Center for Clinical Laboratories and Beijing Engineering Research Center of Laboratory Medicine , Beijing Hospital, National Center of Gerontology , Beijing , P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenxiang","family":"Chen","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories , Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital\/ National Center of Gerontology , Beijing , P.R. 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