{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T14:15:53Z","timestamp":1777990553654,"version":"3.51.4"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T00:00:00Z","timestamp":1768953600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Historically, 25-hydroxyvitamin D (25OHD) assays have under- or over-recovered 25-hydroxyvitamin D2 (25OHD2), but assay manufacturers have modified their reagents to address this problem. In this study, we compared the second- and third-generation Roche assays as well as two contemporary offerings from Diasorin and Beckman against liquid chromatography\u2013tandem mass spectrometry (LC-MS\/MS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We identified 50 remnant serum samples with 25OHD concentrations from across the analytical range of the second-generation Roche assay. To increase 25OHD2 representation, we identified 25 additional samples from individuals prescribed high-dose vitamin D2 supplements. We tested samples on Roche assays and circulated to laboratories performing Beckman and Diasorin 25OHD assays. We tested samples by LC-MS\/MS to obtain concentrations for 25OHD2 and 25-hydroxyvitamin D3.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Mean overall bias for each assay was 5.1 ng\/mL or less against the LC-MS\/MS measurement; mean proportional bias was 8.7% to 12.1%. Some individual specimens had much larger bias. 25OHD2 was under-recovered on average, but the bias for the third-generation Roche assay represents a significant improvement over the previous assay, and mean bias for current generation assays was no worse than \u22123.2 ng\/mL. In most cases, clinical classification by automated assay values agreed with clinical classification by LC-MS\/MS; where present, disagreements occurred near classification thresholds.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Automated 25OHD assays continue to improve, and 25OHD2 recovery no longer appears to be a significant concern for the assays evaluated here. All assays evaluated were adequate for clinical classification of vitamin D nutritional status and are suitable for routine use, including in patients prescribed high-dose vitamin D2.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jalm\/jfaf196","type":"journal-article","created":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T13:10:42Z","timestamp":1764249042000},"page":"592-598","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of a Reformulated Automated Vitamin D Assay, Its Predecessor, and 2 Contemporary Formulations"],"prefix":"10.1093","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0799-4189","authenticated-orcid":false,"given":"K Aaron","family":"Geno","sequence":"first","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Dartmouth Health , Lebanon, NH ,","place":["United States"]},{"name":"Geisel School of Medicine at Dartmouth , Hanover, NH ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasel F","family":"Alvarez","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Dartmouth Health , Lebanon, NH ,","place":["United States"]},{"name":"Geisel School of Medicine at Dartmouth , Hanover, NH ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacqueline A","family":"Hubbard","sequence":"additional","affiliation":[{"name":"Department of Pathology, Beth Israel Deaconess Medical Center, Harvard Medical School , Boston, MA ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-2545-684X","authenticated-orcid":false,"given":"Robert D","family":"Nerenz","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Medical College of Wisconsin , Milwaukee, WI ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ravinder J","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology, Mayo Clinic , Rochester, MN ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2026,1,21]]},"reference":[{"key":"2026050509524210600_jfaf196-B1","author":"Definitive Healthcare"},{"key":"2026050509524210600_jfaf196-B2","doi-asserted-by":"crossref","first-page":"299","DOI":"10.1056\/NEJMoa2202106","article-title":"Supplemental vitamin D and incident fractures in midlife and older adults","volume":"387","author":"LeBoff","year":"2022","journal-title":"N Engl J Med"},{"key":"2026050509524210600_jfaf196-B3","doi-asserted-by":"crossref","first-page":"368","DOI":"10.1056\/NEJMe2205993","article-title":"VITAL findings \u2014 a decisive verdict on vitamin D supplementation","volume":"387","author":"Cummings","year":"2022","journal-title":"N Engl J Med"},{"key":"2026050509524210600_jfaf196-B4","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1056\/NEJMoa1809944","article-title":"Vitamin D supplements and prevention of cancer and cardiovascular disease","volume":"380","author":"Manson","year":"2019","journal-title":"N Engl J Med"},{"key":"2026050509524210600_jfaf196-B5","doi-asserted-by":"crossref","first-page":"1907","DOI":"10.1210\/clinem\/dgae290","article-title":"Vitamin D for the prevention of disease: an endocrine society clinical practice guideline","volume":"109","author":"Demay","year":"2024","journal-title":"J Clin Endocrinol Metab"},{"key":"2026050509524210600_jfaf196-B6","doi-asserted-by":"crossref","first-page":"1866","DOI":"10.1001\/jama.2019.17302","article-title":"Vitamin D and health outcomes: then came the randomized clinical trials","volume":"322","author":"Lucas","year":"2019","journal-title":"JAMA"},{"key":"2026050509524210600_jfaf196-B7","doi-asserted-by":"crossref","first-page":"868","DOI":"10.1373\/jalm.2017.024323","article-title":"Price of high-throughput 25-hydroxyvitamin D immunoassays: frequency of inaccurate results","volume":"2","author":"Tolan","year":"2018","journal-title":"J Appl Lab Med"},{"key":"2026050509524210600_jfaf196-B8","doi-asserted-by":"crossref","first-page":"1089","DOI":"10.1016\/j.clinbiochem.2015.08.005","article-title":"Performance characteristics of six automated 25-hydroxyvitamin D assays: mind your 3s and 2s","volume":"48","author":"Wyness","year":"2015","journal-title":"Clin Biochem"},{"key":"2026050509524210600_jfaf196-B9","doi-asserted-by":"crossref","first-page":"1287","DOI":"10.1093\/jalm\/jfaa070","article-title":"Improved recognition of 25-hydroxyvitamin D2 by 2 automated immunoassays","volume":"5","author":"Geno","year":"2020","journal-title":"J Appl Lab Med"},{"key":"2026050509524210600_jfaf196-B10","doi-asserted-by":"crossref","first-page":"1911","DOI":"10.1210\/jc.2011-0385","article-title":"Evaluation, treatment, and prevention of vitamin D deficiency: an endocrine society clinical practice guideline","volume":"96","author":"Holick","year":"2011","journal-title":"J Clin Endocrinol Metab"},{"key":"2026050509524210600_jfaf196-B11","author":"Roche Diagnostics"},{"key":"2026050509524210600_jfaf196-B12","author":"Roche Diagnostics"},{"key":"2026050509524210600_jfaf196-B13","author":"CDC"},{"key":"2026050509524210600_jfaf196-B14","doi-asserted-by":"crossref","first-page":"431","DOI":"10.1373\/clinchem.2010.157115","article-title":"Increasing liquid chromatography-tandem mass spectrometry throughput by mass tagging: a sample-multiplexed high-throughput assay for 25-hydroxyvitamin D2 and D3","volume":"57","author":"Netzel","year":"2011","journal-title":"Clin Chem"},{"key":"2026050509524210600_jfaf196-B15","volume-title":"25-OH vitamin D 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