MAGLUMI® Tacrolimus (CLIA) assay: analytical performances and comparison with LC-MS/MS and ARCHITECT Tacrolimus (CMIA) assay
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Mingpeng Fu
and
Hua Pei
Abstract
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.
Funding source: Key Research and Development Project of Hainan Province
Award Identifier / Grant number: ZDYF2022SHFZ100
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Research ethics: Collection and experiments of clinical samples were approved by the Ethics Committee of the Second Affiliated Hospital of Hainan Medical University (2024-K47-01).
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Informed consent: Not applicable.
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Author contributions: HP and JC: study design; MF, SC and XZ: drafted the manuscript; XZ, HS and XL: samples collection; MF, SC and XZ: conducted the experiments; MF and SC: statistical analysis; HP and JC: revised the manuscript. 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 project was funded by the Key Research and Development Project of Hainan Province (ZDYF2022SHFZ100) and Shenzhen Snibe Co., Ltd. Financial support did not affect the results of the present study.
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Data availability: Not applicable.
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