MAGLUMI®他克莫司（CLIA）法：分析性能及与LC-MS/MS和ARCHITECT他克莫司（CMIA）法的比较。

IF 3.8 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry and laboratory medicine Pub Date : 2025-07-16 DOI:10.1515/cclm-2025-0181

Mingpeng Fu, Shanchun Chen, Xianliang Zheng, Xuehong Li, Honggao Sun, Jin Chen, Hua Pei

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引用次数: 0

摘要

目的：在过去的二十年中，他克莫司一直是免疫抑制治疗的基石。由于其狭窄的治疗窗口和药代动力学变异性，药物监测对于提高治疗过程中的有效性和安全性至关重要。在本研究中，我们评估了基于化学发光免疫分析法（CLIA）的MAGLUMI®他克莫司检测方法的分析性能，并与LC-MS/MS和先前验证的基于化学发光微粒免疫分析法（CMIA）的ARCHITECT他克莫司检测方法进行了比较。方法：采用患者全血标本，对MAGLUMI®他克莫司检测方法的精密度、空白限（LoB）、定量限（LoQ）、检出限（LoD）和线性度进行评价。通过将潜在干扰物引入临床样本来评估干扰。我们还分析了金标准法（LC-MS/MS）和另一种先前验证的高效ARCHITECT他克莫司（CMIA）测定法的相关性和一致性，包括125份患者全血样本和44份加标样本。结果：MAGLUMI®他克莫司（CLIA）检测具有较高的精密度，重复性变异系数（cv）为0.55 ~ 3.63 %，运行间精密度为2.18 ~ 5.14 %。LoB和LoQ分别为0.1 和0.5 μg/L。所有LoD验证样品他克莫司浓度均高于LoB。该方法线性良好（r=0.99990, 0.5 ~ 50 μg/L），无干扰。此外，MAGLUMI®他克莫司（CLIA）检测结果与LC-MS/MS和CMIA检测结果具有很强的相关性和一致性。结论：MAGLUMI®他克莫司（CLIA）法具有优良的性能，与LC-MS/MS和ARCHITECT法具有较强的一致性，是他克莫司测定的良好替代方法。

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MAGLUMI^® Tacrolimus (CLIA) assay: analytical performances and comparison with LC-MS/MS and ARCHITECT Tacrolimus (CMIA) assay.

Objectives: Tacrolimus has been a cornerstone of immunosuppressive therapy over the past two decades. Due to its narrow therapeutic window and pharmacokinetic variability, drug monitoring is vital for enhancing the efficacy and safety during therapy. In the present study, we evaluated the analytical performances of the MAGLUMI^® Tacrolimus assay based on chemiluminescent immunoassay (CLIA), and compared with LC-MS/MS and the previously validated ARCHITECT Tacrolimus assay based on chemiluminescent microparticle immunoassay (CMIA).

Methods: We assessed the precision, limit of blank (LoB), limit of quantification (LoQ), limit of detection (LoD) and linearity of the MAGLUMI^® Tacrolimus assay using patient whole blood samples. Interference was assessed by introducing potential interferents into clinical samples. We also analyzed the correlation and agreement with the gold standard method (LC-MS/MS) and another previously validated high-performing ARCHITECT Tacrolimus (CMIA) assay by including 125 whole blood samples from patients and 44 spiked samples.

Results: MAGLUMI^® Tacrolimus (CLIA) assay exhibits superior precision, as coefficients of variation (CVs) for reproducibility and between-run precision were 0.55-3.63 % and 2.18-5.14 %, respectively. The LoB and LoQ were 0.1 μg/L and 0.5 μg/L. All samples in LoD verification had tacrolimus concentrations above LoB. The assay exhibited excellent linearity (r=0.99990, 0.5-50 μg/L) with no interference. Additionally, the results of the MAGLUMI^® Tacrolimus (CLIA) assay showed strong correlation and concordance with LC-MS/MS and the CMIA assay.

Conclusions: The MAGLUMI^® Tacrolimus (CLIA) assay has excellent performance and strong concordance with LC-MS/MS and the ARCHITECT assay, making it a good alternative for tacrolimus measurement.

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来源期刊

Clinical chemistry and laboratory medicine 医学-医学实验技术

CiteScore

11.30

自引率

16.20%

发文量

306

审稿时长

3 months

期刊介绍： Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!