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

  • Mingpeng Fu , Shanchun Chen , Xianliang Zheng , Xuehong Li , Honggao Sun , Jin Chen EMAIL logo and Hua Pei EMAIL logo
Published/Copyright: July 16, 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 11

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.

Keywords: tacrolimus measurement; chemiluminescence immunoassay; analytical performance; method comparison
Corresponding authors: Jin Chen, Institute of Clinical Medicine, The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, 570311, China, E-mail: ; and Hua Pei, Department of Clinical Laboratory, The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, 571199, China; and NHC Key Laboratory of Tropical Disease Control, School of Tropical Medicine & The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, 571199, China, E-mail:
Mingpeng Fu, Shanchun Chen, and Xianliang Zheng contributed equally to this work.

Funding source: Key Research and Development Project of Hainan Province

Award Identifier / Grant number: ZDYF2022SHFZ100

  1. 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).

  2. Informed consent: Not applicable.

  3. 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.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. 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.

  7. Data availability: Not applicable.

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Received: 2025-02-14
Accepted: 2025-04-14
Published Online: 2025-07-16
Published in Print: 2025-10-27

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2025-0181
Keywords for this article
tacrolimus measurement; chemiluminescence immunoassay; analytical performance; method comparison

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Advancing diagnostic stewardship through claims-based utilization analysis: toward a system-wide vision of diagnostic excellence
  4. Review
  5. Biomarkers in body fluids and their detection techniques for human intestinal permeability assessment
  6. Mini Review
  7. Challenges of using natriuretic peptides to screen for the risk of developing heart failure in patients with diabetes: a report from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Committee on Clinical Applications of Cardiac Bio-Markers (C-CB)
  8. Opinion Papers
  9. Reference intervals in value-based laboratory medicine: a shift from single-point measurements to metabolic variation-based models
  10. Overview of laboratory diagnostics for immediate management of patients presenting to the emergency department with acute bleeding
  11. What Matters Most: an Age-Friendly approach to pathology and laboratory medicine
  12. No fault or negligence after an adverse analytical finding due to a contaminated supplement: mission impossible. Two examples involving trimetazidine
  13. General Clinical Chemistry and Laboratory Medicine
  14. Utilization analysis of laboratory tests using health insurance claims data: advancing nationwide diagnostic stewardship monitoring systems
  15. Evaluating large language models as clinical laboratory test recommenders in primary and emergency care: a crucial step in clinical decision making
  16. A novel corrective model based on red blood cells indices and haemolysis index enables accurate unhaemolysed potassium determination in haemolysed samples – Hemokalc project
  17. Validation of (self-collected) capillary blood using a topper collection system as alternative for venous sampling for 15 common clinical chemistry analytes
  18. Acoustophoresis-based blood sampling and plasma separation for potentially minimizing sampling-related blood loss
  19. Clinical validation of a liquid chromatography single quadrupole mass spectrometry (LC-MS) method using Waters Kairos™ Amino Acid Kit reagents
  20. Robustness of steroidomics-based machine learning for diagnosis of primary aldosteronism: a laboratory medicine perspective
  21. Investigation of the possible cause of over-estimation of human aldosterone in plasma, using a unique, non-synthetic human aldosterone-free matrix
  22. Performance of afternoon (16:00 h) serum cortisol for the diagnosis of Cushing’s syndrome
  23. MAGLUMI® Tacrolimus (CLIA) assay: analytical performances and comparison with LC-MS/MS and ARCHITECT Tacrolimus (CMIA) assay
  24. Assessment of 2023 ACR/EULAR antiphospholipid syndrome classification criteria in a Spanish cohort
  25. Comprehensive evaluation of antiphospholipid antibody testing methodologies in APS diagnosis: performance comparisons across assay systems and clinical subtypes
  26. Candidate Reference Measurement Procedures and Materials
  27. Exploring commutable materials for serum folate measurement: challenges in cross-method harmonization
  28. Reference Values and Biological Variations
  29. Reference ranges for ionized calcium in plasma in Danish children aged 0 days to 3 years using laboratory registry data
  30. A step forward in pediatric hemophagocytic lymphohistiocytosis and autoimmune disease: pediatric reference interval for serum soluble IL-2 receptor and soluble CD163
  31. Cancer Diagnostics
  32. Cellular expression of PD-1, PD-L1 and CTLA-4 in patients with JAK2V617F mutated myeloproliferative disorders
  33. Diabetes
  34. Serum N-glycans as independent predictors of the incidence of type 2 diabetes: a prospective investigation in the AEGIS cohort
  35. Infectious Diseases
  36. An assessment of molecular diagnosis of tuberculosis and multi-drug resistant tuberculosis testing and quality assessment: findings of an international survey
  37. Letters to the Editor
  38. Targeting low-value laboratory care
  39. Is time a significant factor in the release of potassium from lithium heparin plasma and serum?
  40. External quality assessment in resource-constrained laboratories: a survey of practices and perceptions in Nepal
  41. Is successfulness of platelet clump disaggregation by vortexing influenced by platelet measurement methods?
  42. Oligoclonal banding analysis: assessing plasma use and time interval requirements for paired CSF and blood
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