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.
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.
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%).
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.
Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent is not required for the evaluation of a new generation of assay.
Ethical approval: The local Institutional Review Board deemed the study exempt from review.
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The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0177).
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