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Experience with the first fully automated chemiluminescence immunoassay for the quantification of 1α, 25-dihydroxy-vitamin D

  • Josef van Helden EMAIL logo and Ralf Weiskirchen
Published/Copyright: September 30, 2014
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 53 Issue 5

Abstract

Background: Previous studies have shown that the measurement of vitamin D and its derivatives, especially its active metabolite 1α, 25-dihydroxy-vitamin D [1,25(OH)2D], is highly complex and prone to analytical error. We have evaluated a new immunological method for detecting and quantifying of 1,25(OH)2D. This assay is fully automated, sensitive and uses a specific recombinant fusion protein for capturing of 1,25(OH)2D. The assay was originally developed by DiaSorin for the immunoassay analyzer LIAISON XL.

Methods: Performance data of this assay were determined including intra- and inter-assay precision, recovery, linearity, and limit of detection of the DiaSorin 1,25(OH)2D immunoassay on the LIAISON XL analyzer. Respective data were compared from two different liquid chromatography tandem mass spectrometry (LC-MS/MS) assays and a common radioimmunoassay (RIA) using clinical samples taken from patients suffering from vitamin D deficiency, chronic renal failure, biliary atresia, hyperparathyroidism, vitamin D-dependent rickets or sarcoidosis, as well as from pregnant women and high-level athletes.

Results: The performance evaluation of 1,25(OH)2D resulted in an intra-assay and total imprecision correlation variant between 1.4% and 5.2% and 3.8%–7.1% with the new immunoassay and 3.5%–5.8% or 3.8%–7.5% with the LC-MS/MS method, respectively. Limits of detection and quantification of the immunoassay were 0.7 ng/L and 5.0 ng/L for the LIAISON XL immunoassay and 1.8 ng/L and 5.4 ng/L for the LC-MS/MS assay, respectively. Pearson’s coefficients of correlation were 0.998 and 0.952 for method comparison to different established LC-MS/MS methods. Linear regression according to Passing and Bablok showed larger deviations to the RIA (slopes 0.64–0.97, coefficients of correlation 0.822–0.823).

Conclusions: The DiaSorin LIAISON XL 1,25(OH)2D immunoassay appears to have improved comparability to LC-MS/MS with low imprecision and limits of detection. The assay time of 65 min, the small sample volume required (75 μL) and the throughput of 90 tests/hour without manually handling time for extraction and purification procedures is superior to the LC-MS/MS method.

Keywords: immunoassay; LC-MS/MS; linearity reproducibility; vitamin D
Corresponding author: Josef van Helden, MVZ Dr. Stein und Kollegen, Wallstrasse 10, 41061 Moenchengladbach, Germany, E-mail:

Acknowledgments

We are grateful to Elke Rauhut of DiaSorin Germany for the generous provision of the LIAISON XL 1,25(OH)2D kits and the prescreened samples for the technical method comparison.

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

Financial support: None declared.

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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Received: 2014-7-7
Accepted: 2014-8-27
Published Online: 2014-9-30
Published in Print: 2015-4-1

©2015 by De Gruyter

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. High-sensitivity assays for cardiac troponins
  4. Reviews
  5. High sensitivity cardiac troponin assays in the clinical laboratories
  6. Laboratory medicine as the science that underpins medicine: the “high-sensitivity” troponin paradigm
  7. Cardiac troponin assays: a review of quantitative point-of-care devices and their efficacy in the diagnosis of myocardial infarction
  8. Cardiovascular Diseases
  9. Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project
  10. Estimation of age- and comorbidities-adjusted percentiles of high-sensitivity cardiac troponin T levels in the elderly
  11. High-sensitivity cardiac troponin I in the general population – defining reference populations for the determination of the 99th percentile in the Gutenberg Health Study
  12. Kinetics of high-sensitivity cardiac troponin T or troponin I compared to creatine kinase in patients with revascularized acute myocardial infarction
  13. Biological variation of high sensitivity cardiac troponin-T in stable dialysis patients: implications for clinical practice
  14. Diagnosis of acute myocardial infarction in patients with renal insufficiency using high-sensitivity troponin T
  15. General Clinical Chemistry and Laboratory Medicine
  16. Active intervention in hospital test request panels pays
  17. An approach to establish the uncertainty budget of catalytic activity concentration measurements in a reference laboratory
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  19. Experience with the first fully automated chemiluminescence immunoassay for the quantification of 1α, 25-dihydroxy-vitamin D
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  21. Quantification of piperacillin, tazobactam, cefepime, meropenem, ciprofloxacin and linezolid in serum using an isotope dilution UHPLC-MS/MS method with semi-automated sample preparation
  22. Plasma visfatin/nicotinamide phosphoribosyltransferase (visfatin/NAMPT) concentration is not related to kidney function in elderly subjects
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  24. Dry ice exposure of plasma samples influences pH and lupus anticoagulant analysis
  25. Reference Values and Biological Variations
  26. A new robust statistical model for interpretation of differences in serial test results from an individual
  27. Cancer Diagnostics
  28. The value of red blood cell distribution width in endometrial cancer
  29. Letters to the Editors
  30. Serum high-sensitivity troponin concentrations in a multi-ethnic Asian population of stable chronic kidney disease patients
  31. Comparison between BNP values measured in capillary blood samples with a POCT method and those measured in plasma venous samples with an automated platform
  32. Reply to the article entitled “Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D” by Farrell et al., Clin Chem Lab Med 2014;52:1579–87
  33. Reply. Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D. Authors’ response to the Letter to the Editor by Donnelly et al.
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https://doi.org/10.1515/cclm-2014-0698
Keywords for this article
immunoassay; LC-MS/MS; linearity reproducibility; vitamin D

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. High-sensitivity assays for cardiac troponins
  4. Reviews
  5. High sensitivity cardiac troponin assays in the clinical laboratories
  6. Laboratory medicine as the science that underpins medicine: the “high-sensitivity” troponin paradigm
  7. Cardiac troponin assays: a review of quantitative point-of-care devices and their efficacy in the diagnosis of myocardial infarction
  8. Cardiovascular Diseases
  9. Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project
  10. Estimation of age- and comorbidities-adjusted percentiles of high-sensitivity cardiac troponin T levels in the elderly
  11. High-sensitivity cardiac troponin I in the general population – defining reference populations for the determination of the 99th percentile in the Gutenberg Health Study
  12. Kinetics of high-sensitivity cardiac troponin T or troponin I compared to creatine kinase in patients with revascularized acute myocardial infarction
  13. Biological variation of high sensitivity cardiac troponin-T in stable dialysis patients: implications for clinical practice
  14. Diagnosis of acute myocardial infarction in patients with renal insufficiency using high-sensitivity troponin T
  15. General Clinical Chemistry and Laboratory Medicine
  16. Active intervention in hospital test request panels pays
  17. An approach to establish the uncertainty budget of catalytic activity concentration measurements in a reference laboratory
  18. Uric acid: a potential biomarker of multiple sclerosis and of its disability
  19. Experience with the first fully automated chemiluminescence immunoassay for the quantification of 1α, 25-dihydroxy-vitamin D
  20. I-FABP and L-FABP are early markers for abdominal injury with limited prognostic value for secondary organ failures in the post-traumatic course
  21. Quantification of piperacillin, tazobactam, cefepime, meropenem, ciprofloxacin and linezolid in serum using an isotope dilution UHPLC-MS/MS method with semi-automated sample preparation
  22. Plasma visfatin/nicotinamide phosphoribosyltransferase (visfatin/NAMPT) concentration is not related to kidney function in elderly subjects
  23. Diagnostic performance study of an antigen microarray for the detection of antiphospholipid antibodies in human serum
  24. Dry ice exposure of plasma samples influences pH and lupus anticoagulant analysis
  25. Reference Values and Biological Variations
  26. A new robust statistical model for interpretation of differences in serial test results from an individual
  27. Cancer Diagnostics
  28. The value of red blood cell distribution width in endometrial cancer
  29. Letters to the Editors
  30. Serum high-sensitivity troponin concentrations in a multi-ethnic Asian population of stable chronic kidney disease patients
  31. Comparison between BNP values measured in capillary blood samples with a POCT method and those measured in plasma venous samples with an automated platform
  32. Reply to the article entitled “Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D” by Farrell et al., Clin Chem Lab Med 2014;52:1579–87
  33. Reply. Impact of assay design on test performance: lessons learned from 25-hydroxyvitamin D. Authors’ response to the Letter to the Editor by Donnelly et al.
  34. Therapeutic drug monitoring of voriconazole: validation of a novel ARK™ immunoassay and comparison with ultra-high performance liquid chromatography
  35. Interference of C-reactive protein with clotting times
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