Standardization challenges in antipsychotic drug monitoring: insights from a national survey in Chinese TDM practices
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Weiyan Zhou
,
Jie Zeng
,
Wenxiang Chen
und
Jie Ma
Abstract
Objectives
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.
Methods
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.
Results
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 %. Others, especially olanzapine (CVs: 43.48–45.30 %), had poor precision (CVs>15 %). The study revealed that commercial in vitro 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.
Conclusions
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.
Award Identifier / Grant number: 2024ZD0523702
Funding source: Capital’s Funds for Health Improvement and Research
Award Identifier / Grant number: 2024-2-4059
Funding source: Shanghai Innovation Medical Device Application Demonstration Projec
Award Identifier / Grant number: No. 23SHS06200
Funding source: National High Level Hospital Clinical Research Funding
Award Identifier / Grant number: BJ-2023-094
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Research ethics: This study has received permission from the Ethics Committee of Beijing Hospital, with exemption for obtaining informed consent (approval No. 2021BJYYEC-234-02).
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Informed consent: Not applicable.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Use of Large Language Models, AI and Machine Learning Tools: None declared.
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Conflict of interest: The authors state no conflict of interest.
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Research funding: This work was supported by the Noncommunicable Chronic Diseases-National Science and Technology Major Project (2024ZD0523702), the Capital’s Funds for Health Improvement and Research (2024-2-4059), the Shanghai Innovation Medical Device Application Demonstration Project (No. 23SHS06200), and the National High Level Hospital Clinical Research Funding (BJ-2023-094).
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Data availability: Not applicable.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2025-0186).
© 2025 Walter de Gruyter GmbH, Berlin/Boston
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- Frontmatter
- Editorial
- Macroprolactinaemia – some progress but still an ongoing problem
- Review
- Understanding the circulating forms of cardiac troponin: insights for clinical practice
- Opinion Papers
- New insights in preanalytical quality
- IFCC recommendations for internal quality control practice: a missed opportunity
- Genetics and Molecular Diagnostics
- Evaluation of error detection and treatment recommendations in nucleic acid test reports using ChatGPT models
- General Clinical Chemistry and Laboratory Medicine
- Pre-analytical phase errors constitute the vast majority of errors in clinical laboratory testing
- Improving the efficiency of quality control in clinical laboratory with an integrated PBRTQC system based on patient risk
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- Prevalence and re-evaluation of macroprolactinemia in hyperprolactinemic patients: a retrospective study in the Turkish population
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