Startseite Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
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Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients

  • Etienne Cavalier EMAIL logo , Pierre Lukas , Anne-Catherine Bekaert , Stéphanie Peeters , Caroline Le Goff , Eric Yayo , Pierre Delanaye und Jean-Claude Souberbielle
Veröffentlicht/Copyright: 19. Dezember 2015
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 54 Heft 8

Abstract

Background: In this study, we provide a short analytical evaluation of the new Fujirebio Lumipulse®G non-competitive immunoassay for 25(OH)D. Clinical performance was compared with three commercial competitive automated immunoassays against a Vitamin D Standardization Program (VDSP)-traceable liquid chromatography-tandem mass spectrometry (LC-MS/MS) in six different clinically relevant populations.

Methods: Lumipulse®G 25(OH)D precision, measurement uncertainty, recovery, limit of quantification were assessed, as well as 25(OH)D2 and C3-epimer recovery. For method comparison, 250 serum samples obtained in healthy Caucasians and Africans, osteoporotic, hemodialyzed and intensive care patients and 3rd trimester pregnant women were analyzed by all methods. Correlation was studied using Passing-Bablok and Bland-Altman analysis. Concordance correlation coefficient (CCC) was calculated to evaluate agreement between immunoassays and the LC-MS/MS.

Results: The Lumipulse®G 25(OH)D assay presented interesting analytical features and showed excellent correlation to the LC-MS/MS results (y=1.00×–1.35 ng/mL), as obtained in healthy Caucasian individuals. In the other special populations, Lumipulse®G presented a concordance with LC-MS/MS which was generally higher than competitors, even if all methods significantly under-recovered 25(OH)D in hemodialyzed patients. Intra-assay CV ranged from 12.1% at 9.6 ng/mL to 2.1% at 103.7 ng/mL and inter-assay CV ranged from 16.2 to 3.7% at the same concentrations, respectively. Measurement uncertainty, with a probability of 95%, were respectively 33.1 and 7.6% at these concentrations. LOQ was found to be at 4.6 ng/mL. Mean (95% CI) 25(OH)D2 revovery was 77% (74–81) and no cross-reactivity was observed with C3-epimer.

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

Keywords: assay performance; concordance; immunoassay; LC-MS/MS; vitamin D
Corresponding author: Pr. Etienne Cavalier, Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Domaine du Sart-Tilman, 4000 Liège, Belgium, Phone: +32 4 3667692, Fax: +32 4 3667691, E-mail:

Acknowledgments

We would like to thank Dr. Jody Van den Ouweland from the Department of Clinical Chemistry of the Canisius Wilhelmina Hospital, Nijmegen, The Netherlands, for confirming the results we obtained with our LC-MS/MS in a subset of hemodialyzed patients with his own LC-MS/MS method.

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

  2. Research funding: EC is consultant for DiaSorin and IDS; PD is consultant for IDS; Fujirebio has financed the study.

  3. Employment or leadership: None declared.

  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.

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Received: 2015-9-22
Accepted: 2015-11-23
Published Online: 2015-12-19
Published in Print: 2016-8-1

©2016 by De Gruyter

Artikel in diesem Heft

  1. Frontmatter
  2. Editorials
  3. Laboratory analytical quality – the process continues
  4. Measurement uncertainty – a revised understanding of its calculation and use
  5. Review
  6. Substrate-zymography: a still worthwhile method for gelatinases analysis in biological samples
  7. Opinion Papers
  8. Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry
  9. The problem with total error models in establishing performance specifications and a simple remedy
  10. Measurement uncertainty for clinical laboratories – a revision of the concept
  11. Uncertainty in measurement and total error – are they so incompatible?
  12. General Clinical Chemistry and Laboratory Medicine
  13. Using the hazard ratio to evaluate allowable total error in predictive measurands
  14. Performance of electrolyte measurements assessed by a trueness verification program
  15. Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
  16. Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
  17. Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
  18. Patient-performed extraction of faecal calprotectin
  19. Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
  20. Reference Values and Biological Variations
  21. Sex-related differences in the association of ghrelin levels with obesity in adolescents
  22. Gestation specific reference intervals for thyroid function tests in pregnancy
  23. Cancer Diagnostics
  24. SOX17 promoter methylation in plasma circulating tumor DNA of patients with non-small cell lung cancer
  25. Dopamine concentration in blood platelets is elevated in patients with head and neck paragangliomas
  26. Letters to the Editor
  27. Cancer dynamics and the success of cancer screening programs
  28. Mother’s instinct – a rare case of multiple test interferences due to heterophile antibodies
  29. Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs
  30. A national survey of preanalytical handling of oral glucose tolerance tests in pregnancy
  31. Updating pregnancy diabetes guidelines: is (y)our laboratory ready?
  32. Low serum bilirubin values are associated with pulmonary embolism in a case-control study
  33. Effect of Hb H on HbA1c measurements as measured by IFCC reference method and affinity HPLC
  34. Adipocytes in venipunctures cause falsely elevated S-100B serum values
  35. Earlier detection of sepsis by Candida parapsilosis using three-dimensional cytographic anomalies on the Mindray BC-6800 hematological analyzer
  36. Theranos phenomenon – part 4: Theranos at an International Conference
https://doi.org/10.1515/cclm-2015-0923
Schlagwörter für diesen Artikel
assay performance; concordance; immunoassay; LC-MS/MS; vitamin D

Artikel in diesem Heft

  1. Frontmatter
  2. Editorials
  3. Laboratory analytical quality – the process continues
  4. Measurement uncertainty – a revised understanding of its calculation and use
  5. Review
  6. Substrate-zymography: a still worthwhile method for gelatinases analysis in biological samples
  7. Opinion Papers
  8. Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry
  9. The problem with total error models in establishing performance specifications and a simple remedy
  10. Measurement uncertainty for clinical laboratories – a revision of the concept
  11. Uncertainty in measurement and total error – are they so incompatible?
  12. General Clinical Chemistry and Laboratory Medicine
  13. Using the hazard ratio to evaluate allowable total error in predictive measurands
  14. Performance of electrolyte measurements assessed by a trueness verification program
  15. Analytical interference by monoclonal immunoglobulins on the direct bilirubin AU Beckman Coulter assay: the benefit of unsuspected diagnosis from spurious results
  16. Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China
  17. Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients
  18. Patient-performed extraction of faecal calprotectin
  19. Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on Hep-2 cells
  20. Reference Values and Biological Variations
  21. Sex-related differences in the association of ghrelin levels with obesity in adolescents
  22. Gestation specific reference intervals for thyroid function tests in pregnancy
  23. Cancer Diagnostics
  24. SOX17 promoter methylation in plasma circulating tumor DNA of patients with non-small cell lung cancer
  25. Dopamine concentration in blood platelets is elevated in patients with head and neck paragangliomas
  26. Letters to the Editor
  27. Cancer dynamics and the success of cancer screening programs
  28. Mother’s instinct – a rare case of multiple test interferences due to heterophile antibodies
  29. Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs
  30. A national survey of preanalytical handling of oral glucose tolerance tests in pregnancy
  31. Updating pregnancy diabetes guidelines: is (y)our laboratory ready?
  32. Low serum bilirubin values are associated with pulmonary embolism in a case-control study
  33. Effect of Hb H on HbA1c measurements as measured by IFCC reference method and affinity HPLC
  34. Adipocytes in venipunctures cause falsely elevated S-100B serum values
  35. Earlier detection of sepsis by Candida parapsilosis using three-dimensional cytographic anomalies on the Mindray BC-6800 hematological analyzer
  36. Theranos phenomenon – part 4: Theranos at an International Conference
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