Agreement of seven 25-hydroxy vitamin D3 immunoassays and three high performance liquid chromatography methods with liquid chromatography tandem mass spectrometry
-
Damien Denimal
,
Véronique Ducros
Abstract
Background: Several recent studies have shown some discrepancies between 25-hydroxyvitamin D [25(OH)D] assay methods, despite some improvement in the past few years. The accuracy of 25(OH)D assay methods is still a real challenge for clinical laboratories. The aim of this study was to assess the agreement between a large panel of routine assays and a two-dimensional liquid chromatography/tandem mass spectrometry (2D LC-MS/MS) method, selected as the reference method.
Methods: Forty-nine human plasma samples with only endogenous 25(OH)D3 were analyzed with 11 different methods, especially with three LC-UV methods that differed in the extraction step. Seven routine immunoassays were also tested: two manual (RIA and EIA from IDS) and five fully-automated methods. The results of the 25(OH)D3 assays were compared with those of the 2D LC-MS/MS method using weighted Deming regression analysis, Bland-Altman plots and concordance correlation coefficient (CCC). The ability of these methods to properly classify patients was evaluated by sorting results depending on vitamin D status.
Results: The CCC was >0.90 for the three LC-UV methods and for most of the automated IA, meaning substantial agreement with 2D LC-MS/MS results. The ability to properly classify patients according to their vitamin D status was overall satisfactory for most of the methods tested (concordance >90%).
Conclusions: The immunoassays available on Liaison, Isys, Architect and Elecsys, together with our in-house LC-UV method preceded by an SLE step met the minimum requirements for the assessment of vitamin D status in clinical laboratories.
Acknowledgments
We thank Benoît Sarret and the technicians from the Biochemistry Department of the Universitary Hospital of Dijon for their excellent technical assistance. We also thank Philip Bastable for reviewing this manuscript. We are grateful to Abbott, Biotage, ChromSystems, Diasorin, IDS, Roche and Siemens for proving reagents for this study free of charge.
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research funding played no role in thestudy design; in the collection, analysis, and interpretationof data; in the writing of the report; or in the decision tosubmit the report for publication.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
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Artikel in diesem Heft
- Masthead
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- Editorials
- Inflammatory bowel diseases: where we are and where we should go
- Thrombophilia testing. Useful or hype?
- Reviews
- Inflammatory bowel diseases: from pathogenesis to laboratory testing
- Crohn’s disease specific pancreatic antibodies: clinical and pathophysiological challenges
- Point/Counterpoint
- The utility of thrombophilia testing
- The futility of thrombophilia testing
- Genetics and Molecular Diagnostics
- Identification of an 18 bp deletion in the TWIST1 gene by CO-amplification at lower denaturation temperature-PCR (COLD-PCR) for non-invasive prenatal diagnosis of craniosynostosis: first case report
- General Clinical Chemistry and Laboratory Medicine
- Agreement of seven 25-hydroxy vitamin D3 immunoassays and three high performance liquid chromatography methods with liquid chromatography tandem mass spectrometry
- First trimester pregnancy-associated plasma protein A and human chorionic gonadotropin-beta in early and late pre-eclampsia
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- NGAL, L-FABP, and KIM-1 in comparison to established markers of renal dysfunction
- Value-added reporting of antinuclear antibody testing by automated indirect immunofluorescence analysis
- Cardiovascular Diseases
- A fit-for-purpose approach to analytical sensitivity applied to a cardiac troponin assay: time to escape the ‘highly-sensitive’ trap
- Diabetes
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- Infectious Diseases
- Detection of unamplified HCV RNA in serum using a novel two metallic nanoparticle platform
- Increased plasma arginase activity in human sepsis: association with increased circulating neutrophils
- Corrigendum
- The relationship between estimated average glucose and fasting plasma glucose
- Letter to the Editors
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- Prism effect of specimen receiving – generation of fundamentals for the smooth progress of analytical processing
- Preanalytical errors: the professionals’ perspective
- Corrected reports in laboratory medicine in a Chinese university hospital for 3 years
- Comparison of an enzymatic assay with liquid chromatography-pulsed amperometric detection for the determination of lactulose and mannitol in urine of healthy subjects and patients with active celiac disease
- Effect of freezing-thawing process on neuron specific enolase concentration in severe traumatic brain injury sera samples
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