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Evaluation of four automated clinical analyzers for the determination of total 25(OH)D in comparison to a certified LC-MS/MS

  • Julien Favresse EMAIL logo , Marco Fangazio , Frédéric Cotton and Fleur Wolff
Published/Copyright: February 15, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 61 Issue 8

Abstract

Objectives

The aim of this study was to compare the results of five methods for the determination of total 25(OH)D. For that purpose, two mass spectrometry and three immunoassay methods were used.

Methods

A total of 124 serum samples were analyzed on five different methods (i.e., a reference LC-MS/MS, Cascadion, Lumipulse, Roche Elecsys II and Roche Elecsys III). Analytical performance against LC-MS/MS was evaluated and compared to the Milan models 1 (analytical performance based on the clinical outcome using thresholds of 12, 20 and 30 ng/mL) and 2 (analytical performance based on biological variation). Additionally, imprecision studies and accuracy using NIST SRM972a samples were carried out.

Results

Compared to the reference LC-MS/MS method, the Lumipulse and the Roche Elecsys III assays reached the optimal criterion for bias, while the Cascadion met the desirable one. The Roche Elecsys II was not able to reach the minimal criteria. The proportion of correctly classified patients was higher using the Cascadion (95.2%) compared to the three immunoassays. In addition to its better precision, the Cascadion was not impacted by a high concentration of 3-epi-25(OH)D3 compared to the three immunoassays.

Conclusions

Compared to the LC-MS/MS reference method, the Cascadion presented the highest level of concordance at medical decision cut-offs for total 25(OH)D and reached the desirable specification for bias. Moreover, the presence of 3-epi-25(OH)D3 in enriched samples was only problematic in immunoassay methods, and especially considering Roche Elecsys methods. The release of performant fully automated mass spectrometry assays with high throughput might therefore facilitate the wide scale adoption of LC-MS/MS, even in non-specialized clinical laboratories.

Keywords: 25(OH)D; CDC; immunoassay; LC-MS/MS; Milan model 1; Vitamin D Standardization-Certification Program (VDSCP); vitamin D
Corresponding author: Julien Favresse, Department of Laboratory Medicine, Clinique St-Luc Bouge, Namur, Belgium; and Department of Pharmacy, NAmur Research Institute for LIfe Sciences, University of Namur, Namur, 5004 Bouge, Belgium, Phone: +32 81 20 91 44, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was not required.

  5. Ethical approval: The local Institutional Review Board deemed the study exempt from review.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2022-1129).

Received: 2022-11-07
Accepted: 2023-02-06
Published Online: 2023-02-15
Published in Print: 2023-07-26

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2022-1129
Keywords for this article
25(OH)D; CDC; immunoassay; LC-MS/MS; Milan model 1; Vitamin D Standardization-Certification Program (VDSCP); vitamin D

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Addressing standardized definitions of post-COVID and long-COVID
  4. Reviews
  5. The chitinases as biomarkers in immune-mediate diseases
  6. Pitfalls in the diagnosis of hematuria
  7. Opinion Papers
  8. Remote decentralized clinical trials: a new opportunity for laboratory medicine
  9. Striving for a pragmatic contribution of biomarkers results to lifelong health care
  10. IFCC Paper
  11. External quality assessment practices in medical laboratories: an IFCC global survey of member societies
  12. Guidelines and Recommendations
  13. Antibody-mediated interferences affecting cardiac troponin assays: recommendations from the IFCC Committee on Clinical Applications of Cardiac Biomarkers
  14. General Clinical Chemistry and Laboratory Medicine
  15. Evaluation of four automated clinical analyzers for the determination of total 25(OH)D in comparison to a certified LC-MS/MS
  16. Standard −20 °C freezer storage protocols may cause substantial plasma renin cryoactivation
  17. Lower accuracy of testosterone, cortisol, and free T4 measurements using automated immunoassays in people undergoing hemodialysis
  18. Multicenter study to compare the diagnostic performance of CLIA vs. FEIA transglutaminase IgA assays for the diagnosis of celiac disease
  19. Imprecision remains to be improved in the measurement of serum cystatin C with heterogeneous systems
  20. Analytical validation of the modified Westergren method on the automated erythrocyte sedimentation rate analyzer CUBE 30 touch
  21. Reference Values and Biological Variations
  22. Systematic review and meta-analysis of within-subject and between-subject biological variation data of coagulation and fibrinolytic measurands
  23. Biological variation estimates for spot urine analytes and analyte/creatinine ratios in 33 healthy subjects
  24. Short-term biological variation of plasma uracil in a Caucasian healthy population
  25. Cardiovascular Diseases
  26. Elevated Hemolysis Index is associated with higher risk of cardiovascular diseases
  27. Infectious Diseases
  28. Clinical assessment of SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay
  29. Pre-analytical considerations in the development of a prototype SARS-CoV-2 antigen ARCHITECT automated immunoassay
  30. SARS CoV-2 spike protein-guided exosome isolation facilitates detection of potential miRNA biomarkers in COVID-19 infections
  31. Monocyte distribution width alterations and cytokine storm are modulated by circulating histones
  32. Letters to the Editor
  33. Letter to the Editor regarding the article by Wayne J. Dimech et al. Time to address quality control processes applied to antibody testing for infectious diseases. Clin Chem Lab Med 2023; 61(2):205–212
  34. Response to Tony Badrick regarding “Letter to the Editor regarding the article by Wayne J. Dimech et al. Time to address quality control processes applied to antibody testing for infectious diseases. Clin Chem Lab Med 2023; 61(2):205–212 by”
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