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Two-site evaluation of the Roche Elecsys Vitamin D total III assay

  • Julien Favresse EMAIL logo , Johan Schiettecatte , Fleur Wolff , Frederic Cotton , Marc Elsen , Christine Eucher , Catherine Rosseels and Ellen Anckaert
Published/Copyright: July 15, 2022
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 10

Abstract

Objectives

The high request for vitamin D testing in the last decades has led manufacturers to develop assays on automated immunoassay platforms. The objective of this study was to evaluate the performance of the new Elecsys Vitamin D total III assay for the measurement of total 25(OH)D.

Methods

A total of 844 serum samples collected in two clinical laboratories were used to evaluate the new Roche Elecsys Vitamin D total III assay. Comparisons with Roche Elecsys Vitamin D total II and liquid chromatography tandem mass spectrometry (LC-MS/MS) were carried out. Additionally, assay imprecision, linearity, matrix effects, biotin interference, cross-reactivity with 24,25(OH)2D3 and 3-epi-25(OH)D3, and outlier rate were evaluated for the Elecsys Vitamin D total III assay.

Results

Only the comparison between LC-MS/MS and Roche Elecsys Vitamin D total III achieved the optimal specification for bias (i.e., <3.4%). Imprecision, linearity and matrix effects showed acceptable results. The biotin interference threshold was increased up to 1,200 ng/mL and the outlier rate was low (0.26%). The cross-reactivity with 24,25(OH)2D3 and 3-epi-25(OH)D3 was weak or modest in available patient samples. However, using SRM972a with a high level of 3-epi-25(OH)D3 (enriched) revealed an important cross-reactivity with both Roche Elecsys Vitamin D total II and III assays (+74.7% and +73.7%).

Conclusions

In conclusion, the Roche Elecsys Vitamin D total III assay presents several advantages compared to the previous assay generation: higher biotin interference threshold, broader measuring range, and better comparability with LC-MS/MS. However, the cross-reactivity toward 3-epi-25(OH)D3 is still problematic in high titer samples.

Keywords: 25(OH)D; immunoassay; liquid chromatography tandem mass spectrometry (LC-MS/MS); vitamin D
Corresponding author: Julien Favresse, Department of Laboratory Medicine, Clinique Saint-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 is not required for the evaluation of a new generation of assay.

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

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0177).

Received: 2022-02-25
Accepted: 2022-07-03
Published Online: 2022-07-15
Published in Print: 2022-09-27

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2022-0177
Keywords for this article
25(OH)D; immunoassay; liquid chromatography tandem mass spectrometry (LC-MS/MS); vitamin D

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. The relevance of establishing method-dependent decision thresholds of serum folate in pregnancy and lactation: when the laboratory stewardship meets the health-care needs
  4. Reviews
  5. Strategies to minimise the current disadvantages experienced by women in faecal immunochemical test-based colorectal cancer screening
  6. What is the impact of circulating histones in COVID-19: a systematic review
  7. Mini Review
  8. Diagnostic utility of pleural cell-free nucleic acids in undiagnosed pleural effusions
  9. Guidelines and Recommendations
  10. Evaluation of the cardiovascular risk in patients undergoing major non-cardiac surgery: role of cardiac-specific biomarkers
  11. Genetics and Molecular Diagnostics
  12. Detection of DNA copy number alterations by matrix-assisted laser desorption/ionization time-of-flight mass spectrometric analysis of single nucleotide polymorphisms
  13. General Clinical Chemistry and Laboratory Medicine
  14. Fifty years of newborn screening for congenital hypothyroidism: current status in Australasia and the case for harmonisation
  15. Commutability assessment of reference materials for homocysteine
  16. External quality assessment for detection of methylated Syndecan 2 (SDC2) in China
  17. Patient-based real-time quality control for quantitative hepatitis B virus DNA test using moving rate of positive and negative patient results
  18. Performance of HDL-C measurements assessed by a 4-year trueness-based EQA/PT program in China
  19. Two-site evaluation of the Roche Elecsys Vitamin D total III assay
  20. A novel point-of-care device accurately measures thyrotropin in whole blood, capillary blood and serum
  21. IgA rheumatoid factor in rheumatoid arthritis
  22. Reference Values and Biological Variations
  23. Reference intervals of 14 biochemical markers for children and adolescence in China: the PRINCE study
  24. Chinese normotensive and essential hypertensive reference intervals for plasma aldosterone and renin activity by liquid chromatography-tandem mass spectrometry
  25. Biological variation estimates obtained from Chinese subjects for 32 biochemical measurands in serum
  26. Cancer Diagnostics
  27. Testosterone analysis in castrated prostate cancer patients: suitability of the castration cut-off and analytical accuracy of the present-day clinical immunoassays
  28. Cardiovascular Diseases
  29. Point-of-care high-sensitivity troponin-I analysis in capillary blood for acute coronary syndrome diagnostics
  30. Platelet count and clinical outcomes among ischemic stroke patients with endovascular thrombectomy in DIRECT-MT
  31. Infectious Diseases
  32. Measurement of anti SARS-CoV-2 RBD IgG in saliva: validation of a highly sensitive assay and effects of the sampling collection method and correction by protein
  33. Letters to the Editors
  34. The simple reproducibility of a measurement result does not equal its overall measurement uncertainty
  35. Complexity of serological assays and misunderstandings of WHO International Units
  36. Ct values of different SARS CoV2 variants: a single center observational study from Innsbruck, Austria
  37. Alignment of the new generation of Abbott Alinity γ-glutamyltransferase assay to the IFCC reference measurement system should be improved
  38. Thermal and chronological stability of monocyte distribution width (MDW), the new biomarker for sepsis
  39. Two comments for the current commutability assessment
  40. Plasma neurofilament light chain in Chinese children with later-onset spinal muscular atrophy
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