Comparative analysis of UPLC-MS/MS and chemiluminescence microparticle immunoassay for serum methotrexate measurement in pediatric intracranial tumor patients

doi:10.5246/jcps.2025.05.032

Abstract

Abstract:

This study aimed to establish a highly accurate method for quantifying methotrexate (MTX) concentrations in serum using an ultra-high performance liquid chromatography-tandem mass spectrometry system (UPLC-MS/MS) and to compare its performance with the chemiluminescence microparticle immunoassay (CMIA). A total of 211 serum samples from pediatric patients with intracranial tumors undergoing high-dose MTX treatment were analyzed using both techniques. Correlation and agreement analyses were performed to assess the level of concordance between these methods. The results demonstrated a significant correlation (P < 0.05) between the two methods, with correlation coefficients of 0.9913 and 0.9893, respectively. However, a statistical difference was noted in MTX serum concentrations at lower levels (0.04–1.5 μmol/L), while no significant difference was observed at higher concentrations (1.5–400 μmol/L). Specifically, in the 0.04–1.5 μmol/L range (107 cases), Bland-Altman analysis indicated a bias of 0.018 between the two methods. Given the observed discrepancies, particularly at lower concentrations, it is advised that the UPLC-MS/MS method should not be used interchangeably with the CMIA assay for therapeutic drug monitoring in patients receiving high-dose MTX treatment.

Key words: Methotrexate, Therapeutic drug monitoring, UPLC-MS/MS, Chemiluminescence microparticle immunoassay

Supporting:

Zhengyuan Shi, Jingfeng Li, Chunjing Yang, Xiqiao Xu, Dechun Jiang. Comparative analysis of UPLC-MS/MS and chemiluminescence microparticle immunoassay for serum methotrexate measurement in pediatric intracranial tumor patients[J]. Journal of Chinese Pharmaceutical Sciences, 2025, 34(5): 423-431.

Figures/Tables 4

References 25

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