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Evolution and impact of Standard Reference Materials (SRMs) for determining vitamin D metabolites

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Abstract

The National Institute of Standards and Technology (NIST), in collaboration with the National Institutes of Health, Office of Dietary Supplements (NIH ODS), introduced the first Standard Reference Material® (SRM) for determining vitamin D metabolites in 2009 motivated by significant concerns about the comparability and accuracy of different assays to assess vitamin D status. After 14 years, a suite of five serum matrix SRMs and three calibration solution SRMs are available. Values were also assigned for vitamin D metabolites in five additional SRMs intended primarily to support measurements of other clinical diagnostic markers. Both the SRMs and the certification approach have evolved from significant exogenous serum content to primarily endogenous content and from value assignment by combining the results of multiple analytical methods to the use of measurements exclusively from reference measurement procedures (RMPs). The impact of the availability of these SRMs can be assessed by both the distribution information (sales) and by reports in the scientific literature describing their use for method validation, quality control, and research. In this review, we describe the development of these SRMs, the evolution in design and value assignment, the expansion of information reported, and SRM use in validating analytical methods and providing quality assurance within the vitamin D measurement community.

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Adapted from Sempos et al. [71]

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Adapted from Burdette et al. [82] and expanded with additional results

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Acknowledgements

The authors acknowledge Paul M. Coates (NIH ODS, retired), Joseph M Betz (NIH ODS, retired), and Mary Francis Picciano (NIH ODS, deceased) for their foresight and support in the development of vitamin D metabolite SRMs. We acknowledge Christopher T. Sempos (NIH-ODS, retired) for his leadership of the Vitamin D Standardization Program. We also acknowledge the NIST chemists involved in vitamin D metabolite measurements: Mary Bedner, Carolyn Q. Burdette, Grace Hahm, and particularly Susan C. Tai for her exceptional work in the development of RMPs and the certification of SRMs. We acknowledge Karen W. Phinney (NIST) for leadership in the development of SRM 972 and SRM 972a and David Duewer (NIST) for statistical consultation. We acknowledge Rosemary L. Schleicher (CDC, retired) and Christine M. Pfieffer (CDC) and CDC chemists for their measurements contributing to the certification of SRM 972 and SRM 972a and for coordination and participation in commutability studies.

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  1. Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20817, USA

    Stephen A. Wise & Adam J. Kuszak

  2. Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA

    Johanna E. Camara

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S. A. Wise is an Editor of the journal Analytical and Bioanalytical Chemistry and was not involved in peer reviewing this manuscript. There are no financial or nonfinancial conflicts of interest for any of the coauthors.

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Published in the topical collection Advances in (Bio-)Analytical Chemistry: Reviews and Trends Collection 2024.

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Wise, S.A., Kuszak, A.J. & Camara, J.E. Evolution and impact of Standard Reference Materials (SRMs) for determining vitamin D metabolites. Anal Bioanal Chem 416, 2335–2358 (2024). https://doi.org/10.1007/s00216-024-05143-w

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