The new Roche Vitamin D Total assay: fit for its purpose?
| Autor: | Arjen-Kars Boer, Johannes M.W. van den Ouweland, Huib L. Vader, Judith M A Emmen, Jos P.M. Wielders |
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| Rok vydání: | 2012 |
| Předmět: |
Chromatography
medicine.diagnostic_test Plasma samples Chemistry Biochemistry (medical) Clinical Biochemistry General Medicine Reference Standards Roche Diagnostics High-performance liquid chromatography Immunoassay medicine Vitamin D and neurology Humans Vitamin D Reference standards Blood Chemical Analysis |
| Zdroj: | Clinical Chemistry and Laboratory Medicine (CCLM). 50:1969-1972 |
| ISSN: | 1437-4331 1434-6621 |
| DOI: | 10.1515/cclm-2011-0085 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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