{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T09:10:35Z","timestamp":1790673035976,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2022,7,19]],"date-time":"2022-07-19T00:00:00Z","timestamp":1658188800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Vitamin D deficiency\/insufficiency and toxicity are worldwide issues; thus, accurate diagnostic assays are required to measure vitamin D. We evaluated the performance of the new Elecsys<jats:sup>\u00ae<\/jats:sup> Vitamin D total III assay (Roche Diagnostics International Ltd).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Repeatability and intermediate precision of the Elecsys Vitamin D total III assay (cobas e 601 analyzer) were evaluated at three sites using five human serum pools (HSPs) and two PreciControls (five\u2010day model, one reagent lot [CLSI\u2010EP05\u2010A3]) and compared against prespecified acceptance criteria. A serum verification panel, with reference isotope dilution liquid chromatography tandem mass spectrometry (ID\u2010LC\u2013MS\/MS) values, was used for comparator assay\/concordance studies at two sites, assessed using unweighted Deming regression. Testing of serum vs. plasma on the Elecsys assay was conducted at one site using samples from healthy adults; assessed using Passing\u2010Bablok regression.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Repeatability (HSP1 [16.8\u201318.4\u2009ng\/ml], SD 0.87\u20131.07; HSP5 [94.5\u201398.0\u2009ng\/ml], CV 1.58%\u20132.76%) and intermediate precision (HSP1, SD 1.14\u20131.77; HSP5, CV 2.00%\u20134.13%) met acceptance criteria across sites. Agreement was observed between the Elecsys assay and (i) the ID\u2010LC\u2013MS\/MS verification panel (slope, 0.936\u20131.01; Pearson's r, 0.960\u20130.986) and (ii) comparator assays (slope, 0.921\u20131.15; Pearson's r, 0.958\u20130.982). The Elecsys assay correctly assigned the highest combined percentage of samples to deficient (100%) and insufficient (89.5%) vitamin D categories vs. comparator assays and demonstrated comparable performance in serum and plasma (y\u00a0=\u00a00.103\u2009+\u20090.984x).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The Elecsys Vitamin D total III assay demonstrated good analytical performance and compared favorably with other assays, supporting its use in clinical practice.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24610","type":"journal-article","created":{"date-parts":[[2022,7,19]],"date-time":"2022-07-19T17:14:18Z","timestamp":1658250858000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A multicenter performance evaluation of the new Elecsys Vitamin D total <scp>III<\/scp> assay versus reference isotope dilution liquid chromatography tandem mass spectrometry and commercially available comparators"],"prefix":"10.1002","volume":"36","author":[{"given":"Peter","family":"Findeisen","sequence":"first","affiliation":[{"name":"MVZ Labor Dr. Limbach &amp; Kollegen  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Leis","sequence":"additional","affiliation":[{"name":"TRIGA\u2010S  Habach Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Garnet","family":"Bendig","sequence":"additional","affiliation":[{"name":"Roche Diagnostics GmbH  Penzberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jill","family":"Grimme","sequence":"additional","affiliation":[{"name":"Roche Diagnostics  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Moser","sequence":"additional","affiliation":[{"name":"Roche Diagnostics  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Vogl","sequence":"additional","affiliation":[{"name":"Roche Diagnostics GmbH  Penzberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2612-9083","authenticated-orcid":false,"given":"Robert","family":"Christenson","sequence":"additional","affiliation":[{"name":"University of Maryland School of Medicine  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,7,19]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.4065\/mcp.2010.0138"},{"key":"e_1_2_12_3_1","volume-title":"Dietary Reference Intakes for Calcium and Vitamin D","author":"Institute of Medicine FaNB","year":"2011"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdiacomp.2017.04.019"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.2310\/JIM.0b013e31821b8755"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annepidem.2007.12.001"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra070553"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/ageing\/afu104"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2011-0385"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2018.00550"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1359\/jbmr.081209"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.3390\/nu10040493"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-028355"},{"key":"e_1_2_12_14_1","unstructured":"National Institute for Health and Care Excellence.Vitamin D deficiency in adults: scenario: management of vitamin D deficiency or insufficiency. 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