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Open Access Baseline Assessment of 25-Hydroxyvitamin D Assay Performance: A Vitamin D Standardization Program (VDSP) Interlaboratory Comparison Study

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The Vitamin D Standardization Program (VDSP) coordinated an interlaboratory study to assess the comparability of measurements of total 25-hydroxyvitamin D [25(OH)D] in human serum, which is the primary marker of vitamin D status. A set of 50 individual donor samples were analyzed by 15 different laboratories representing national nutrition surveys, assay manufacturers, and clinical and/or research laboratories to provide results for total 25(OH)D using both immunoassays (IAs) and LC tandem MS (MS/MS). The results were evaluated relative to bias compared with the target values assigned based on a combination of measurements at Ghent University (Belgium) and the U.S. National Institute of Standards and Technology using reference measurement procedures for the determination of 25(OH)D2 and 25(OH)D3. CV and mean bias for each laboratory and assay platform were assessed and compared with previously established VDSP performance criteria, namely CV ≤ 10% and mean bias ≤ 5%. Nearly all LC-MS/MS results achieved VDSP criteria, whereas only 50% of IAs met the criterion for a ≤10% CV and only three of eight IAs achieved the ≤5% bias. These results establish a benchmark for the evaluation of 25(OH)D assay performance and standardization activities in the future.

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Affiliations: 1: National Institutes of Health, Office of Dietary Supplements, Bethesda, MD 20892 2: National Institute of Standards and Technology, Chemical Sciences Division, Gaithersburg, MD 3: Joint Committee for Traceability in Laboratory Medicine, Smyrna, GA 4: Loyola University Chicago, Department of Public Health Sciences, Chicago, IL 5: Stanford University, Department of Health Research and Policy Biostatistics, Palo Alto, CA 6: University of Washington, Department of Laboratory Medicine, Seattle, WA 7: Virginia Commonwealth University, Richmond, VA 8: Queen's University, Belfast, United Kingdom 9: Australian Bureau of Statistics, Canberra, ACT, Australia 10: Sonic Healthcare, Douglass Hanly Moir Pathology, Sydney, NSW, Australia 11: Health Canada, Nutrition Research Division, Ottawa, ON, Canada 12: Robert Koch-Institute, Berlin, Germany 13: University College Cork, School of Food and Nutritional Sciences, Cork Centre for Vitamin D and Nutrition Research, Cork, Ireland 14: Korea Centers for Disease Control and Prevention, Seoul, Korea 15: Neodin Medical Institute, Seoul, Korea 16: Medical Research Council, Elsie Widdowson Laboratory, Cambridge, United Kingdom 17: Charing Cross Hospital, Vitamin D External Quality Assessment Scheme, London, United Kingdom 18: Cornell University, Division of Nutritional Sciences, Ithaca, NY 19: Australian National University, Research School of Population Health, National Centre for Epidemiology and Population Health, Canberra, ACT, Australia 20: University of Wisconsin–Madison, Computing and Biometry, Madison, WI 21: University of Liege, Centre Hospitalier Universitaire de Liège Sart-Tilman, Liege, Belgium

Publication date: 01 September 2017

This article was made available online on 19 August 2017 as a Fast Track article with title: "Baseline Assessment of 25-Hydroxyvitamin D Assay Performance: A Vitamin D Standardization Program (VDSP) Interlaboratory Comparison Study".

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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