Please use this identifier to cite or link to this item:
http://doi.org/10.25358/openscience-7602
Authors: | Albrecht, K. Lotz, Johannes Frommer, Lara Lackner, Karl J. Kahaly, George J. |
Title: | A rapid point-of-care assay accurately measures vitamin D |
Online publication date: | 23-Aug-2022 |
Year of first publication: | 2021 |
Language: | english |
Abstract: | Purpose Vitamin D (VitD) is a pleiotropic hormone with effects on a multitude of systems and metabolic pathways. Consequently, the relevance of a sufficiently high VitD serum level becomes self-evident. Methods A rapid immunofluorescence assay designed for the point-of-care measurement of serum VitD3 solely was tested. Inter- and intra-assay validation, double testing and result comparison with a standardized laboratory method were performed. Results An overall linear correlation of r = 0.89 (Pearson, 95% CI 0.88–0.92, p < 0.01) between the point of care and the conventional reference assay was registered. Accuracy and precision were of special interest at cut-points (10 ng/ml [mean deviation 1.7 ng/ml, SD 1.98 ng/ml, SE 0.16 ng/ml], 12 ng/ml [MD 0.41, SD 1.89, SE 0.19] and 30 ng/ml [MD − 1.11, SD 3.89, SE 0.35]). Only a slight deviation was detected between the two assays when using fresh (r = 0.91, 95% CI 0.86–0.94, p < 0.01) and frozen serum samples (r = 0.86, 0.82–0.89, p < 0.01). Results remained steady when samples were frozen several times. Inter- and intra-assay validation according to the CLSI protocol as well as multiuser testing showed stable results. Conclusion This novel, innovative, and controlled study indicates that the evaluated rapid point of care VitD assay is reliable, accurate, and suited for clinical practice. |
DDC: | 610 Medizin 610 Medical sciences |
Institution: | Johannes Gutenberg-Universität Mainz |
Department: | FB 04 Medizin |
Place: | Mainz |
ROR: | https://ror.org/023b0x485 |
DOI: | http://doi.org/10.25358/openscience-7602 |
Version: | Published version |
Publication type: | Zeitschriftenaufsatz |
License: | CC BY |
Information on rights of use: | https://creativecommons.org/licenses/by/4.0/ |
Journal: | Journal of endocrinological investigation 44 |
Pages or article number: | 2485 2492 |
Publisher: | Springer |
Publisher place: | S. l. |
Issue date: | 2021 |
ISSN: | 1720-8386 |
Publisher DOI: | 10.1007/s40618-021-01575-8 |
Appears in collections: | JGU-Publikationen |
Files in This Item:
File | Description | Size | Format | ||
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a_rapid_pointofcare_assay_acc-20220822142554591.pdf | 1.53 MB | Adobe PDF | View/Open |