Commutability assessment of new standard reference materials (SRMs) for determining serum total 25-hydroxyvitamin D using ligand binding and liquid chromatography–tandem mass spectrometry (LC–MS/MS) assays

Simple item page
dc.contributor.authorWise, Stephen A.en
dc.contributor.authorCavalier, Étienneen
dc.contributor.authorLukas, Pierreen
dc.contributor.authorPeeters, Stéphanieen
dc.contributor.authorLe Goff, Carolineen
dc.contributor.authorBriggs, Laura E.en
dc.contributor.authorWilliams, Emma L.en
dc.contributor.authorMineva, Ekaterinaen
dc.contributor.authorPfeiffer, Christine M.en
dc.contributor.authorVesper, Huberten
dc.contributor.authorPopp, Christianen
dc.contributor.authorBeckert, Christianen
dc.contributor.authorSchultess, Janen
dc.contributor.authorWang, Kevinen
dc.contributor.authorTourneur, Caroleen
dc.contributor.authorPease, Camilleen
dc.contributor.authorOsterritter, Dominiken
dc.contributor.authorFischer, Ralfen
dc.contributor.authorSaida, Benen
dc.contributor.authorDou, Chaoen
dc.contributor.authorKojima, Satoshien
dc.contributor.authorWeiler, Hope A.en
dc.contributor.authorBielecki, Agnieszkaen
dc.contributor.authorPham, Heatheren
dc.contributor.authorBennett, Alexandraen
dc.contributor.authorYou, Shawnen
dc.contributor.authorGhoshal, Amit K.en
dc.contributor.authorWei, Binen
dc.contributor.authorVogl, Christianen
dc.contributor.authorFreeman, Jamesen
dc.contributor.authorParker, Neilen
dc.contributor.authorPagliaro, Samanthaen
dc.contributor.authorCheek, Jenniferen
dc.contributor.authorLi, Jieen
dc.contributor.authorTsukamoto, Hisaoen
dc.contributor.authorGalvin, Karenen
dc.contributor.authorCashman, Kevin D.en
dc.contributor.authorLiao, Hsuan-Chiehen
dc.contributor.authorHoofnagle, Andrew N.en
dc.contributor.authorBudd, Jeffery R.en
dc.contributor.authorKuszak, Adam J.en
dc.contributor.authorBoggs, Ashley S. P.en
dc.contributor.authorBurdette, Carolyn Q.en
dc.contributor.authorHahm, Graceen
dc.contributor.authorNalin, Federicaen
dc.contributor.authorCamara, Johanna E.en
dc.contributor.funderNational Institutes of Healthen
dc.contributor.funderOffice of Dietary Supplementsen
dc.date.accessioned2025-04-30T08:44:42Z
dc.date.available2025-04-30T08:44:42Z
dc.date.issued2025en
dc.description.abstractCommutability is where the measurement response for a reference material (RM) is the same as for an individual patient sample with the same concentration of analyte measured using two or more measurement systems. Assessment of commutability is essential when the RM is used in a calibration hierarchy or to ensure that clinical measurements are comparable across different measurement procedures and at different times. The commutability of three new Standard Reference Materials® (SRMs) for determining serum total 25-hydroxyvitamin D [25(OH)D], defined as the sum of 25-hydroxyvitamin D2 [25(OH)D2] and 25-hydroxyvitamin D3 [25(OH)D3], was assessed through an interlaboratory study. The following SRMs were assessed: (1) SRM 2969 Vitamin D Metabolites in Frozen Human Serum (Total 25-Hydroxyvitamin D Low Level), (2) SRM 2970 Vitamin D Metabolites in Frozen Human Serum (25-Hydroxyvitamin D2 High Level), and (3) SRM 1949 Frozen Human Prenatal Serum. These SRMs represent three clinically relevant situations including (1) low levels of total 25(OH)D, (2) high level of 25(OH)D2, and (3) 25(OH)D levels in nonpregnant women and women during each of the three trimesters of pregnancy with changing concentrations of vitamin D-binding protein (VDBP). Twelve laboratories using 17 different ligand binding assays and eight laboratories using nine commercial and custom liquid chromatography–tandem mass spectrometry (LC–MS/MS) assays provided results in this study. Commutability of the SRMs with patient samples was assessed using the Clinical and Laboratory Standards Institute (CLSI) approach based on 95% prediction intervals or a pre-set commutability criterion and the recently introduced International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) approach based on differences in bias for the clinical and reference material samples using a commutability criterion of 8.8%. All three SRMs were deemed as commutable with all LC–MS/MS assays using both CLSI and IFCC approaches. SRM 2969 and SRM 2970 were deemed noncommutable for three and seven different ligand binding assays, respectively, when using the IFCC approach. Except for two assays, one or more of the three pregnancy levels of SRM 1949 were deemed noncommutable or inconclusive using different ligand binding assays and the commutability criterion of 8.8%. Overall, a noncommutable assessment for ligand binding assays is determined for these SRMs primarily due to a lack of assay selectivity related to 25(OH)D2 or an increasing VDBP in pregnancy trimester materials rather than the quality of the SRMs. With results from 17 different ligand binding and nine LC–MS/MS assays, this study provides valuable knowledge for clinical laboratories to inform SRM selection when assessing 25(OH)D status in patient populations, particularly in subpopulations with low levels of 25(OH)D, high levels of 25(OH)D2, women only, or women who are pregnant.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationWise, S. A., Cavalier, É., Lukas, P., Peeters, S., Le Goff, C., Briggs, L. E., Williams, E. L., Mineva, E., Pfeiffer, C. M., Vesper, H. and Popp, C. (2025) 'Commutability assessment of new standard reference materials (SRMs) for determining serum total 25-hydroxyvitamin D using ligand binding and liquid chromatography–tandem mass spectrometry (LC–MS/MS) assays', Analytical and Bioanalytical Chemistry, 417(12), pp.2539-2561. DOI: 10.1007/s00216-024-05699-7en
dc.identifier.doi10.1007/s00216-024-05699-7en
dc.identifier.endpage2561en
dc.identifier.issn16182642en
dc.identifier.issued12
dc.identifier.journaltitleAnalytical and Bioanalytical Chemistryen
dc.identifier.startpage2539en
dc.identifier.urihttps://hdl.handle.net/10468/17361
dc.identifier.volume417
dc.language.isoenen
dc.publisherSpringer Science and Business Media Deutschland GmbHen
dc.rights© 2025, the Author(s). This is a U.S. Government work and not under copyright protection in the US. Foreign copyright protection may apply.en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subject25-Hydroxyvitamin D<sub>2</sub>en
dc.subject25-Hydroxyvitamin D<sub>3</sub>en
dc.subjectImmunoassayen
dc.subjectReference measurement procedure (RMP)en
dc.subjectVitamin Den
dc.subjectVitamin D-binding protein (VDBP)en
dc.titleCommutability assessment of new standard reference materials (SRMs) for determining serum total 25-hydroxyvitamin D using ligand binding and liquid chromatography–tandem mass spectrometry (LC–MS/MS) assaysen
dc.typeArticle (peer reviewed)en
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
s00216-024-05699-7.pdf
Size:
3.49 MB
Format:
Adobe Portable Document Format
Description:
Published Version
Download
Collections
Cork Centre for Vitamin D and Nutrition Research - Journal Articles