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The new Roche Vitamin D Total assay: fit for its purpose?
-
Judith M.A. Emmen
,
Jos P.M. Wielders
Veröffentlicht/Copyright:
8. Juni 2012
Abstract
Background: Measurement of serum 25-hydroxyvitamin D [25(OH)D] is used to assess vitamin D status. We evaluated the analytical performance of a new automated assay, Elecsys Vitamin D Total (Roche Diagnostics, Mannheim, Germany), based on competitive protein binding.
Methods: The Elecsys assay was tested for imprecision, linearity and functional sensitivity at three test-sites and compared to a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, a high-performance liquid chromatography (HPLC) method and the Liaison 25(OH) Vitamin D Total immunoassay (Diasorin).
Results: Imprecision testing with human serum specimens showed within-run CVs of ≤6% and between-run CVs of ≤8%. The assay was linear from 33 up to at least 111 nmol/L and showed equivalent 25(OH)D levels for matched serum and heparinized plasma samples. The assay correlated reasonable to well with LC-MS/MS (r=0.93; y=1.07x–5.04 nmol/L), HPLC (r=0.91, y=0.90x+3.03 nmol/L) and the Liaison assay (r=0.86, y=1.19x+2.80 nmol/L). Some of the samples showed large between-method differences.
Conclusions: The new Elecsys assay fulfilled present analytical performance requirements and showed close agreement to other well-established methods for 25(OH)D analysis, making it fit for routine assessment of vitamin D status.
Keywords: 25-hydroxyvitamin D; HPLC; immunoassay; liquid chromatography-tandem mass spectrometry (LC-MS/MS); method validation
Received: 2011-11-11
Accepted: 2012-05-10
Published Online: 2012-06-08
Published in Print: 2012-11-01
©2012 by Walter de Gruyter Berlin Boston
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Schlagwörter für diesen Artikel
25-hydroxyvitamin D;
HPLC;
immunoassay;
liquid chromatography-tandem mass spectrometry (LC-MS/MS);
method validation
Artikel in diesem Heft
- Congress Abstracts
- 44th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology
- Masthead
- Masthead
- Editorials
- Tumor biomarkers: PSA and beyond
- Error reporting in transfusion medicine: an important tool to improve patient safety
- The measurement of 25-hydroxy vitamin D – an analytical challenge
- Reviews
- Kallikrein-related peptidases (KLKs): a gene family of novel cancer biomarkers
- Exhaled breath analysis for early cancer detection: principle and progress in direct mass spectrometry techniques
- γ′ Fibrinogen as a novel marker of thrombotic disease
- Mini Review
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- Genetics and Molecular Diagnostics
- Association of PBEF gene polymorphisms with acute lung injury, sepsis, and pneumonia in a northeastern Chinese population
- General Clinical Chemistry and Laboratory Medicine
- Brazilian laboratory indicators program
- Error reporting in transfusion medicine at a tertiary care centre: a patient safety initiative
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- 25-Hydroxyvitamin D testing: challenging the performance of current automated immunoassays
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- Is there a suitable point-of-care glucose meter for tight glycemic control? Evaluation of one home-use and four hospital-use meters in an intensive care unit
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- Detection of frequent ABCB1 polymorphisms by high-resolution melting curve analysis and their effect on breast carcinoma prognosis
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