Two-site evaluation of the Roche Elecsys Vitamin D total III assay
Author:
Favresse Julien12, Schiettecatte Johan3, Wolff Fleur4, Cotton Frederic4, Elsen Marc1, Eucher Christine1, Rosseels Catherine1, Anckaert Ellen3
Affiliation:
1. Department of Laboratory Medicine , Clinique St-Luc Bouge , Namur , Belgium 2. Department of Pharmacy , Namur Research Institute for Life Sciences, University of Namur , Namur , Belgium 3. Department of Clinical Chemistry and Radioimmunology , Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel (UZ Brussel) , Brussels , Belgium 4. Department of Clinical Chemistry , LHUB-ULB, Université Libre de Bruxelles , Brussels , Belgium
Abstract
Abstract
Objectives
The high request for vitamin D testing in the last decades has led manufacturers to develop assays on automated immunoassay platforms. The objective of this study was to evaluate the performance of the new Elecsys Vitamin D total III assay for the measurement of total 25(OH)D.
Methods
A total of 844 serum samples collected in two clinical laboratories were used to evaluate the new Roche Elecsys Vitamin D total III assay. Comparisons with Roche Elecsys Vitamin D total II and liquid chromatography tandem mass spectrometry (LC-MS/MS) were carried out. Additionally, assay imprecision, linearity, matrix effects, biotin interference, cross-reactivity with 24,25(OH)2D3 and 3-epi-25(OH)D3, and outlier rate were evaluated for the Elecsys Vitamin D total III assay.
Results
Only the comparison between LC-MS/MS and Roche Elecsys Vitamin D total III achieved the optimal specification for bias (i.e., <3.4%). Imprecision, linearity and matrix effects showed acceptable results. The biotin interference threshold was increased up to 1,200 ng/mL and the outlier rate was low (0.26%). The cross-reactivity with 24,25(OH)2D3 and 3-epi-25(OH)D3 was weak or modest in available patient samples. However, using SRM972a with a high level of 3-epi-25(OH)D3 (enriched) revealed an important cross-reactivity with both Roche Elecsys Vitamin D total II and III assays (+74.7% and +73.7%).
Conclusions
In conclusion, the Roche Elecsys Vitamin D total III assay presents several advantages compared to the previous assay generation: higher biotin interference threshold, broader measuring range, and better comparability with LC-MS/MS. However, the cross-reactivity toward 3-epi-25(OH)D3 is still problematic in high titer samples.
Publisher
Walter de Gruyter GmbH
Subject
Biochemistry (medical),Clinical Biochemistry,General Medicine
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