Home Performance characteristics of the VIDAS® 25-OH Vitamin D Total assay – comparison with four immunoassays and two liquid chromatography-tandem mass spectrometry methods in a multicentric study
Article
Licensed
Unlicensed Requires Authentication

Performance characteristics of the VIDAS® 25-OH Vitamin D Total assay – comparison with four immunoassays and two liquid chromatography-tandem mass spectrometry methods in a multicentric study

  • Emmanuel Moreau EMAIL logo , Silvia Bächer , Sophie Mery , Caroline Le Goff , Nadia Piga , Michael Vogeser , Michael Hausmann and Etienne Cavalier
Published/Copyright: June 27, 2015
Become an author with De Gruyter Brill
Submit Manuscript Author Information
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 1

Abstract

Background: The study was conducted to evaluate the analytical and clinical performance of the VIDAS® 25-OH Vitamin D Total assay. The clinical performance of the assay was compared with four other immunoassays against the results of two different liquid chromatography/mass spectrometry methods (LC-MS/MS) standardized to NIST reference materials.

Methods: VIDAS® 25-OH Vitamin D Total assay precision, linearity, detection limits and sample matrix comparison were assessed following CLSI guidelines. For method comparison, a total of 150 serum samples ranging from 7 to 92 ng/mL were analyzed by all the methods. Correlation was studied using Passing-Bablok regression and Bland-Altman analysis. The concordance correlation coefficient (CCC) was calculated to evaluate agreement between immunoassays and the reference LC-MS/MS method. In addition, samples containing endogenous 25(OH)D2 were used to assess each immunoassay’s ability to detect this analyte. Pregnancy and hemodialysis samples were used to the study the effect of vitamin D binding protein (DBP) concentration over VIDAS® assay performance.

Results: The VIDAS® 25-OH Vitamin D Total assay showed excellent correlation to the LC-MS/MS results (y=1.01x+0.22 ng/mL, r=0.93), as obtained from two different sites and distinct LC-MS/MS methods. The limit of quantification was determined at 8.1 ng/mL. Cross-reactivity for 25(OH)D2 was over 80%. At concentrations of 10.5, 26 and 65.1 ng/mL, within-run CVs were 7.9%, 3.6% and 1.7%, while total CVs (between runs, calibrations, lots and instruments) were 16.0%, 4.5% and 2.8%. The VIDAS® performance was not influenced by altered DBP levels, though under-recovery of 25(OH)D as compared to LC-MS/MS was observed for hemodialysis samples.

Conclusions: The VIDAS® 25-OH Vitamin D Total assay is therefore considered suitable for assessment of vitamin D status in clinical routine.

Keywords: assay performance; liquid chromatography/mass spectrometry; standardization; 25-OH vitamin D
Corresponding author: Emmanuel Moreau, bioMérieux, R&D Immunoassays, Marcy l’Etoile, France, E-mail:

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

  2. Research funding: Etienne Cavalier is consultant for IDS and Diasorin and has received lecture fees from Abbott, IDS, DiaSorin and Roche. Michael Vogeser has received research funding from Institut Mérieux.

  3. Employment or leadership: Emmanuel Moreau, Nadia Piga and Michael Hausmann are employees of bioMerieux Inc.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. Holick MF. Vitamin D deficiency. N Engl J Med 2007;357: 266–81.10.1056/NEJMra070553Search in Google Scholar

2. Lips P, van Schoor NM. The effect of vitamin D on bone and osteoporosis. Best Pract Res Clin Endocrinol Metab 2011;25:585–91.10.1016/j.beem.2011.05.002Search in Google Scholar

3. Prentice A, Schoenmakers I, Laskey MA, de Bono S, Ginty F, Goldberg GR. Nutrition and bone growth and development. Proc Nutr Soc 2006;65:348–60.10.1079/PNS2006519Search in Google Scholar

4. Autier P, Gandini S. Vitamin D supplementation and total mortality: a meta-analysis of randomized controlled trials. Arch Intern Med 2007;167:1730–7.10.1001/archinte.167.16.1730Search in Google Scholar

5. Hypponen E, Laara E, Reunanen A, Jarvelin MR, Virtanen SM. Intake of vitamin D and risk of type 1 diabetes: a birth-cohort study. Lancet 2001;358:1500–3.10.1016/S0140-6736(01)06580-1Search in Google Scholar

6. Souberbielle JC, Body JJ, Lappe JM, Plebani M, Shoenfeld Y, Wang TJ, et al. Vitamin D and musculoskeletal health, cardiovascular disease, autoimmunity and cancer: recommendations for clinical practice. Autoimmun Rev 2010;9:709–15.10.1016/j.autrev.2010.06.009Search in Google Scholar PubMed

7. Pludowski P, Holick MF, Pilz S, Wagner CL, Hollis BW, Grant WB, et al. Vitamin D effects on musculoskeletal health, immunity, autoimmunity, cardiovascular disease, cancer, fertility, pregnancy, dementia and mortality – a review of recent evidence. Autoimmun Rev 2013;12:976–89.10.1016/j.autrev.2013.02.004Search in Google Scholar PubMed

8. Bikle DD. Vitamin D metabolism, mechanism of action, and clinical applications. Chem Biol 2014;21:319–29.10.1016/j.chembiol.2013.12.016Search in Google Scholar PubMed PubMed Central

9. Phinney KW, Bedner M, Tai SS, Vamathevan VV, Sander LC, Sharpless KE, et al. Development and certification of a standard reference material for vitamin D metabolites in human serum. Anal Chem 2012;84:956–62.10.1021/ac202047nSearch in Google Scholar PubMed PubMed Central

10. Sempos CT, Vesper HW, Phinney KW, Thienpont LM, Coates PM. Vitamin D status as an international issue: national surveys and the problem of standardization. Scand J Clin Lab Invest Suppl 2012;243:32–40.Search in Google Scholar

11. Farrell CJ, Soldo J, McWhinney B, Bandodkar S, Herrmann M. Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D. Clin Chem Lab Med 2014;52:1579–87.10.1515/cclm-2014-0111Search in Google Scholar PubMed

12. NCCLS. Interference testing in clinical chemistry, approved guideline EP07-A2, ISBN 1-56238-584-4.Search in Google Scholar

13. NCCLS. Evaluation of precision performance of quantitative measurement methods, approved guideline, EP05-A2, ISBN 1-56238-542-9.Search in Google Scholar

14. NCCLS. Evaluation of the linearity of quantitative measurement procedures: a statistical approach, approved guideline EP06-A, ISBN 1-56238-498-8.Search in Google Scholar

15. NCCLS. Protocols for determination of limits of detection and limits of quantitation, approved guideline EP17-A, ISBN 1-56238-551-8.Search in Google Scholar

16. Heijboer AC, Blankenstein MA, Kema IP, Buijs MM. Accuracy of 6 routine 25-hydroxyvitamin D assays: influence of vitamin D binding protein concentration. Clin Chem 2012;58:543–8.10.1373/clinchem.2011.176545Search in Google Scholar PubMed

17. Cavalier E, Rousselle O, Ferrante N, Carlisi A, Le Goff C, Souberbielle JC. Technical and clinical evaluation of the VITROS(R) immunodiagnostic products 25-OH vitamin D total assay – comparison with marketed automated immunoassays and a liquid chromatography-tandem mass spectrometry method. Clin Chem Lab Med 2013;51:1983–9.10.1515/cclm-2013-0138Search in Google Scholar PubMed

18. Herrmann M. The measurement of 25-hydroxy vitamin D – an analytical challenge. Clin Chem Lab Med 2012;50:1873–5.10.1515/cclm-2012-0526Search in Google Scholar PubMed

19. Binkley N, Sempos CT. Standardizing vitamin D assays: the way forward. J Bone Miner Res 2014;29:1709–14.10.1002/jbmr.2252Search in Google Scholar PubMed PubMed Central

20. Grebe SK, Singh RJ. LC-MS/MS in the clinical laboratory – where to from here? Clin Biochem Rev 2011;32:5–31.Search in Google Scholar

21. Singh RJ. Are clinical laboratories prepared for accurate testing of 25-hydroxy vitamin D? Clin Chem 2008;54:221–3.10.1373/clinchem.2007.096156Search in Google Scholar PubMed

22. Fraser CG, Petersen PH. Analytical performance characteristics should be judged against objective quality specifications. Clin Chem 1999;45:321–3.10.1093/clinchem/45.3.321Search in Google Scholar

23. Fuentes-Arderiu X, Miro-Balague J. State of the art instead of biological variation to set requirements for imprecision. Clin Chem 2000;46:1715–7.10.1093/clinchem/46.10.1715Search in Google Scholar

24. Viljoen A, Singh DK, Farrington K, Twomey PJ. Analytical quality goals for 25-vitamin D based on biological variation. J Clin Lab Anal 2011;25:130–3.10.1002/jcla.20446Search in Google Scholar PubMed PubMed Central

25. Stockl D, Sluss PM, Thienpont LM. Specifications for trueness and precision of a reference measurement system for serum/plasma 25-hydroxyvitamin D analysis. Clin Chim Acta 2009;408:8–13.10.1016/j.cca.2009.06.027Search in Google Scholar PubMed

26. Carter GD, Jones JC, Berry JL. The anomalous behaviour of exogenous 25-hydroxyvitamin D in competitive binding assays. J Steroid Biochem Mol Biol 2007;103:480–2.10.1016/j.jsbmb.2006.11.007Search in Google Scholar PubMed

27. Horst RL. Exogenous versus endogenous recovery of 25-hydroxyvitamins D2 and D3 in human samples using high-performance liquid chromatography and the DiaSorin LIAISON Total-D Assay. J Steroid Biochem Mol Biol 2010;121:180–2.10.1016/j.jsbmb.2010.03.010Search in Google Scholar PubMed

28. Le Goff C, Peeters S, Crine Y, Lukas P, Souberbielle JC, Cavalier E. Evaluation of the cross-reactivity of 25-hydroxyvitamin D2 on seven commercial immunoassays on native samples. Clin Chem Lab Med 2012;50:2031–2.10.1515/cclm-2012-0164Search in Google Scholar PubMed

29. Cavalier E, Wallace AM, Carlisi A, Chapelle JP, Delanaye P, Souberbielle JC. Cross-reactivity of 25-hydroxy vitamin D2 from different commercial immunoassays for 25-hydroxy vitamin D: an evaluation without spiked samples. Clin Chem Lab Med 2011;49:555–8.10.1515/CCLM.2011.072Search in Google Scholar PubMed

30. Shu I, Pina-Oviedo S, Quiroga-Garza G, Meng QH, Wang P. Influence of vitamin D2 percentage on accuracy of 4 commercial total 25-hydroxyvitamin D assays. Clin Chem 2013;59:1273–5.10.1373/clinchem.2013.206128Search in Google Scholar PubMed

31. Cavalier E, Lukas P, Crine Y, Peeters S, Carlisi A, Le Goff C, et al. Evaluation of automated immunoassays for 25(OH)-vitamin D determination in different critical populations before and after standardization of the assays. Clin Chim Acta 2014;431:60–5.10.1016/j.cca.2014.01.026Search in Google Scholar PubMed

32. Depreter B, Heijboer AC, Langlois MR. Accuracy of three automated 25-hydroxyvitamin D assays in hemodialysis patients. Clin Chim Acta 2013;415:255–60.10.1016/j.cca.2012.10.056Search in Google Scholar PubMed

Supplemental Material

The online version of this article (DOI: 10.1515/cclm-2014-1249) offers supplementary material, available to authorized users.

Received: 2014-12-16
Accepted: 2015-5-22
Published Online: 2015-6-27
Published in Print: 2016-1-1

©2016 by De Gruyter

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Building a bridge to safe diagnosis in health care. The role of the clinical laboratory
  4. Capillary electrophoresis for the screening and diagnosis of inherited hemoglobin disorders. Ready for prime time?
  5. Reviews
  6. Hyperuricemia as risk factor for coronary heart disease incidence and mortality in the general population: a systematic review and meta-analysis
  7. Towards biomarker-based tests that can facilitate decisions about prevention and management of preeclampsia in low-resource settings
  8. Mini Review
  9. Clinical relevance of sST2 in cardiac diseases
  10. General Clinical Chemistry and Laboratory Medicine
  11. Preservation of urine free catecholamines and their free O-methylated metabolites with citric acid as an alternative to hydrochloric acid for LC-MS/MS-based analyses
  12. Performance characteristics of the VIDAS® 25-OH Vitamin D Total assay – comparison with four immunoassays and two liquid chromatography-tandem mass spectrometry methods in a multicentric study
  13. Differentiation of acute pyelonephritis from other febrile states in children using urinary neutrophil gelatinase-associated lipocalin (uNGAL)
  14. Early postoperative C-terminal agrin fragment (CAF) serum levels predict graft loss and proteinuria in renal transplant recipients
  15. Homocitrulline: a new marker for differentiating acute from chronic renal failure
  16. Hematology and Coagulation
  17. Development of hemoglobin typing control materials for laboratory investigation of thalassemia and hemoglobinopathies
  18. Comparison of capillary electrophoresis and high performance liquid chromatography for detection and quantification of hemoglobin New York
  19. Prevalence of hemostatic alterations in patients with recurrent spontaneous subconjunctival hemorrhage
  20. Reference Values and Biological Variations
  21. Reference intervals for 24 laboratory parameters determined in 24-hour urine collections
  22. First trimester PAPP-A2, PAPP-A and hCGβ in small-for-gestational-age pregnancies
  23. Cancer Diagnostics
  24. Clinical utility of one versus two faecal immunochemical test samples in the detection of advanced colorectal neoplasia in symptomatic patients
  25. Cardiovascular Diseases
  26. Time from symptom onset influences high-sensitivity troponin T diagnostic accuracy for the diagnosis of acute myocardial infarction
  27. Prognostic significance of serum albumin level changes in acute ischemic stroke: the role of biological and analytical variation
  28. Correlates of serum hepcidin levels and its association with cardiovascular disease in an elderly general population
  29. Infectious Diseases
  30. Usefulness of several biomarkers in the management of septic patients: C-reactive protein, procalcitonin, presepsin and mid-regional pro-adrenomedullin
  31. Diabetes
  32. Performance of strip-based glucose meters and cassette-based blood gas analyzer for monitoring glucose levels in a surgical intensive care setting
  33. Accuracy and precision assessment of a new blood glucose monitoring system
  34. Acknowledgment
  35. Acknowledgment
  36. Letter to the Editors
  37. Glypican-1 as a highly sensitive and specific pancreatic cancer biomarker
  38. Platelet microRNAs are not modulated by systemic heparin in acute coronary syndromes
  39. Concomitant appearance of two false positive peaks with a true monoclonal one in a patient with plasma cell myeloma
  40. Anti-streptavidin interferences in Roche thyroid immunoassays: a case report
  41. Evaluation of the new Methotrexate CMIA assay on the Architect i2000SR
  42. Liposomal interference on Sysmex XN-series body fluid mode
  43. Development of an immunomagnetic beads-based test and its application in influenza surveillance
https://doi.org/10.1515/cclm-2014-1249
Keywords for this article
assay performance; liquid chromatography/mass spectrometry; standardization; 25-OH vitamin D

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Building a bridge to safe diagnosis in health care. The role of the clinical laboratory
  4. Capillary electrophoresis for the screening and diagnosis of inherited hemoglobin disorders. Ready for prime time?
  5. Reviews
  6. Hyperuricemia as risk factor for coronary heart disease incidence and mortality in the general population: a systematic review and meta-analysis
  7. Towards biomarker-based tests that can facilitate decisions about prevention and management of preeclampsia in low-resource settings
  8. Mini Review
  9. Clinical relevance of sST2 in cardiac diseases
  10. General Clinical Chemistry and Laboratory Medicine
  11. Preservation of urine free catecholamines and their free O-methylated metabolites with citric acid as an alternative to hydrochloric acid for LC-MS/MS-based analyses
  12. Performance characteristics of the VIDAS® 25-OH Vitamin D Total assay – comparison with four immunoassays and two liquid chromatography-tandem mass spectrometry methods in a multicentric study
  13. Differentiation of acute pyelonephritis from other febrile states in children using urinary neutrophil gelatinase-associated lipocalin (uNGAL)
  14. Early postoperative C-terminal agrin fragment (CAF) serum levels predict graft loss and proteinuria in renal transplant recipients
  15. Homocitrulline: a new marker for differentiating acute from chronic renal failure
  16. Hematology and Coagulation
  17. Development of hemoglobin typing control materials for laboratory investigation of thalassemia and hemoglobinopathies
  18. Comparison of capillary electrophoresis and high performance liquid chromatography for detection and quantification of hemoglobin New York
  19. Prevalence of hemostatic alterations in patients with recurrent spontaneous subconjunctival hemorrhage
  20. Reference Values and Biological Variations
  21. Reference intervals for 24 laboratory parameters determined in 24-hour urine collections
  22. First trimester PAPP-A2, PAPP-A and hCGβ in small-for-gestational-age pregnancies
  23. Cancer Diagnostics
  24. Clinical utility of one versus two faecal immunochemical test samples in the detection of advanced colorectal neoplasia in symptomatic patients
  25. Cardiovascular Diseases
  26. Time from symptom onset influences high-sensitivity troponin T diagnostic accuracy for the diagnosis of acute myocardial infarction
  27. Prognostic significance of serum albumin level changes in acute ischemic stroke: the role of biological and analytical variation
  28. Correlates of serum hepcidin levels and its association with cardiovascular disease in an elderly general population
  29. Infectious Diseases
  30. Usefulness of several biomarkers in the management of septic patients: C-reactive protein, procalcitonin, presepsin and mid-regional pro-adrenomedullin
  31. Diabetes
  32. Performance of strip-based glucose meters and cassette-based blood gas analyzer for monitoring glucose levels in a surgical intensive care setting
  33. Accuracy and precision assessment of a new blood glucose monitoring system
  34. Acknowledgment
  35. Acknowledgment
  36. Letter to the Editors
  37. Glypican-1 as a highly sensitive and specific pancreatic cancer biomarker
  38. Platelet microRNAs are not modulated by systemic heparin in acute coronary syndromes
  39. Concomitant appearance of two false positive peaks with a true monoclonal one in a patient with plasma cell myeloma
  40. Anti-streptavidin interferences in Roche thyroid immunoassays: a case report
  41. Evaluation of the new Methotrexate CMIA assay on the Architect i2000SR
  42. Liposomal interference on Sysmex XN-series body fluid mode
  43. Development of an immunomagnetic beads-based test and its application in influenza surveillance
Sign up now to receive a 20% welcome discount
Institutional Access
How does access work?
Have an idea on how to improve our website?
Please write us.
© 2025 De Gruyter Brill
Downloaded on 8.9.2025 from https://www.degruyterbrill.com/document/doi/10.1515/cclm-2014-1249/html
Scroll to top button