Startseite Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays
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Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays

  • Lanja Saleh EMAIL logo , Daniel Mueller und Arnold von Eckardstein
Veröffentlicht/Copyright: 10. Oktober 2015
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 54 Heft 4

Abstract

Background: We evaluated the analytical and clinical performance of the new Lumipulse®G 25-OH vitamin D assay from Fujirebio, and compared it to a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method and three other commercial automated assays.

Methods: Total 25 hydroxy vitamin D (25(OH)D) levels were measured in 100 selected serum samples from our routine analysis with Fujirebio 25(OH)D assay. The results were compared with those obtained with LC-MS/MS and three other automated 25(OH)D assays (Abbott, Beckman, and Roche). The accuracy of each assay tested was evaluated against a Labquality reference serum panel for 25(OH)D (Ref!25OHD; University of Ghent).

Results: Intra- and inter-day imprecision of the Fujirebio 25(OH)D assay was <5%. Fujirebio 25(OH)D assay showed the highest correlation among the assays tested with the LC-MS/MS method (R=0.986). The mean relative bias obtained was –15.6% (Fujirebio), –12.7% (Beckman), –2.1% (Abbott) and 9.7% (Roche) as compared to LC-MS/MS. Comparison with the Labquality certified reference serum panel yielded a mean bias of –11.8% (Fujirebio), –14.1% (Beckman), 4.4% (Abbott) and 3.2% (Roche), respectively. Compared to LC-MS/MS, the sensitivity of different methods in detecting vitamin D insufficiency (<50 nmol/L) varied from 100% for the Fujirebio assay to 72.7% for Roche, and specificity ranged from 94.4% for Roche to 87.6% for Beckman.

Conclusions: The Lumipulse G 25-OH vitamin D assay from Fujirebio demonstrated a good correlation with LC-MS/MS and some immunoassays. The performance of the assay is well-suited for routine 25(OH)D measurement in clinical serum samples. A correction for the observed negative bias vs. LC-MS/MS could be considered.

Keywords: 25-hydroxy vitamin D; immunoassays; liquid chromatography-tandem mass spectrometry (LC-MS/MS); method comparison; vitamin D assays
Corresponding author: Dr. Lanja Saleh, Institute of Clinical Chemistry, University Hospital of Zurich and University of Zurich, Raemistr. 100, 8091 Zurich, Switzerland, Phone: +41-(0)44-255 2293, Fax: +41-(0)44-255 4590, E-mail:

Acknowledgments

We are grateful to Abbott, Beckman Coulter, Fujirebio and Roche for having provided their reagents for this study free of charge. We thank Tanja Wiedemann, Anuschka Beccato, Ursula Gutteck, and Beate Jaworek from Institute of clinical chemistry for their excellent technical assistance.

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

Research funding: We thank Fujirebio Europe N.V for financial sponsorship of this study. 25-Hydroxy vitamin D assay kits from Roche, Beckmann, and Abbott were provided by the respective companies without cost and the involvement of the companies in the study design, analysis and interpretation of data and writing of the manuscript.

Employment or leadership: None declared.

Honorarium: None declared.

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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Supplemental Material:

The online version of this article (DOI: 10.1515/cclm-2015-0427) offers supplementary material, available to authorized users.

Received: 2015-5-6
Accepted: 2015-8-26
Published Online: 2015-10-10
Published in Print: 2016-4-1

©2016 by De Gruyter

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https://doi.org/10.1515/cclm-2015-0427
Schlagwörter für diesen Artikel
25-hydroxy vitamin D; immunoassays; liquid chromatography-tandem mass spectrometry (LC-MS/MS); method comparison; vitamin D assays

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Macroprolactin: searching for a needle in a haystack?
  4. Review
  5. Laboratory medicine in the new healthcare environment
  6. Opinion Paper
  7. Developing GRADE outcome-based recommendations about diagnostic tests: a key role in laboratory medicine policies
  8. EFLM Survey
  9. Accreditation process in European countries – an EFLM survey
  10. Genetics and Molecular Diagnostics
  11. HB Puerta del Sol [HBA1:c.148A>C], HB Valdecilla [HBA2:c.3G>T], HB Gran Vía [HBA2:c.98T>G], HB Macarena [HBA2:c.358C>T] and HB El Retiro [HBA2:c.364_366dupGTG]: description of five new hemoglobinopathies
  12. General Clinical Chemistry and Laboratory Medicine
  13. A candidate reference method using ICP-MS for sweat chloride quantification
  14. Quantification of hemoglobin A1c by off-line HPLC separation and liquid chromatography-tandem mass spectrometry: a modification of the IFCC reference measurement procedure
  15. Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods – a prospective multinational trial
  16. Evaluation of a hand-held blood gas analyzer for rapid determination of blood gases, electrolytes and metabolites in intensive care setting
  17. Use of a faecal immunochemical test for haemoglobin can aid in the investigation of patients with lower abdominal symptoms
  18. A possible cause of the variable detectability of macroprolactin by different immunoassay systems
  19. A multicenter comparison of whole blood vitamin B6 assays
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  21. Development and validation of a 2nd tier test for identification of purine nucleoside phosphorylase deficiency patients during expanded newborn screening by liquid chromatography-tandem mass spectrometry
  22. A cross-sectional study of biomarkers of exposure and effect in smokers and moist snuff consumers
  23. Reference Values and Biological Variations
  24. Pediatric reference value distributions and covariate-stratified reference intervals for 29 endocrine and special chemistry biomarkers on the Beckman Coulter Immunoassay Systems: a CALIPER study of healthy community children
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  26. Birth season predicts the values of red blood cell distribution width (RDW) in adulthood
  27. Cardiovascular Diseases
  28. Cardiovascular risk stratification in hemodialysis patients in the era of highly sensitive troponins: should we choose between hs-troponin I and hs-troponin T?
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  39. The efficacy of an internet-based e-learning system using the CellaVision Competency Software for continuing professional development
  40. Clinical examinations after the Fukushima disaster: a case report of Soma General Hospital
  41. Non-fasting plasma glucose concentration in blood donors
  42. Analytical evaluation of a second generation assay for chromogranin A; a dual-site study
  43. UBE3A, c.1347_1348delGA: a mutation in question
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