Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions.
25-Hydroxyvitamin D2
25-Hydroxyvitamin D3
Ligand binding assay
Liquid chromatography–tandem mass spectrometry (LC–MS/MS)
Total 25-hydroxyvitamin D
Vitamin D External Quality Assessment Scheme (DEQAS)
Journal
Analytical and bioanalytical chemistry
ISSN: 1618-2650
Titre abrégé: Anal Bioanal Chem
Pays: Germany
ID NLM: 101134327
Informations de publication
Date de publication:
Jan 2022
Jan 2022
Historique:
received:
23
08
2021
accepted:
18
10
2021
revised:
12
10
2021
pubmed:
10
11
2021
medline:
24
2
2022
entrez:
9
11
2021
Statut:
ppublish
Résumé
The Vitamin D External Quality Assessment Scheme (DEQAS) distributes human serum samples four times per year to over 1000 participants worldwide for the determination of total serum 25-hydroxyvitamin D [25(OH)D)]. These samples are stored at -40 °C prior to distribution and the participants are instructed to store the samples frozen at -20 °C or lower after receipt; however, the samples are shipped to participants at ambient conditions (i.e., no temperature control). To address the question of whether shipment at ambient conditions is sufficient for reliable performance of various 25(OH)D assays, the equivalence of DEQAS human serum samples shipped under frozen and ambient conditions was assessed. As part of a Vitamin D Standardization Program (VDSP) commutability study, two sets of the same nine DEQAS samples were shipped to participants at ambient temperature and frozen on dry ice. Twenty-eight laboratories participated in this study and provided 34 sets of results for the measurement of 25(OH)D using 20 ligand binding assays and 14 liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. Equivalence of the assay response for the frozen versus ambient DEQAS samples for each assay was evaluated using multi-level modeling, paired t-tests including a false discovery rate (FDR) approach, and ordinary least squares linear regression analysis of frozen versus ambient results. Using the paired t-test and confirmed by FDR testing, differences in the results for the ambient and frozen samples were found to be statistically significant at p < 0.05 for four assays (DiaSorin, DIAsource, Siemens, and SNIBE prototype). For all 14 LC-MS/MS assays, the differences in the results for the ambient- and frozen-shipped samples were not found to be significant at p < 0.05 indicating that these analytes were stable during shipment at ambient conditions. Even though assay results have been shown to vary considerably among different 25(OH)D assays in other studies, the results of this study also indicate that sample handling/transport conditions may influence 25(OH)D assay response for several assays.
Identifiants
pubmed: 34750644
doi: 10.1007/s00216-021-03742-5
pii: 10.1007/s00216-021-03742-5
doi:
Substances chimiques
Vitamin D
1406-16-2
25-hydroxyvitamin D
A288AR3C9H
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1015-1028Informations de copyright
© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.
Références
Carter GD, Berry J, Durazo-Arvizu R, Gunter E, Jones G, Jones J, et al. Hydroxyvitamin D assays: an historical perspective from DEQAS. J Steroid Biochem Mol Biol. 2018;177:30–5. https://doi.org/10.1016/j.jsbmb.2017.07.018 .
doi: 10.1016/j.jsbmb.2017.07.018
pubmed: 28734989
pmcid: 28734989
Burdette CQ, Camara JE, Nalin F, Pritchett J, Sander LC, Carter GD, et al. Establishing an accuracy basis for the Vitamin D External Quality Assessment Scheme (DEQAS). J AOAC Int. 2017;100(5):1277–87. https://doi.org/10.5740/jaoacint.17-0306 .
doi: 10.5740/jaoacint.17-0306
pubmed: 28847346
Tai SSC, Bedner M, Phinney KW. Development of a candidate reference measurement procedure for the determination of 25-hydroxyvitamin D
doi: 10.1021/ac9026862
pubmed: 20136128
pmcid: 2838390
Mineva EM, Schleicher RL, Chaudhary-Webb M, Maw KL, Botelho JC, Vesper HW, et al. A candidate reference measurement procedure for quantifying serum concentrations of 25-hydroxyvitamin D-3 and 25-hydroxyvitamin D-2 using isotope-dilution liquid chromatography-tandem mass spectrometry. Anal Bioanal Chem. 2015;407(19):5615–24. https://doi.org/10.1007/s00216-015-8733-z .
doi: 10.1007/s00216-015-8733-z
pubmed: 25967149
pmcid: 4823009
Erdman P, Palmer-Toy DE, Horowitz G, Hoofnagle A. Accuracy-based vitamin D survey six years of quality improvement guided by proficiency testing. Arch Pathol Lab Med. 2019;143(12):1531–8. https://doi.org/10.5858/arpa.2018-0625-CP .
doi: 10.5858/arpa.2018-0625-CP
pubmed: 31116045
Hoofnagle A. Personal Communication. 2020.
College of American Pathologists (CAP). https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/WebApplications/pdf/istore-shipping.pdf . Accessed 11/2/2021.
Sempos CT, Vesper HW, Phinney KW, Thienpont LM, Coates PM, VDSP. Vitamin D status as an international issue: national surveys and the problem of standardization. Scand J Clin Lab Invest. 2012;72:32–40. https://doi.org/10.3109/00365513.2012.681935 .
doi: 10.3109/00365513.2012.681935
Wise SA, Tai SSC, Burdette CQ, Camara JE, Bedner M, Lippa KA, et al. Role of the National Institute of Standards and Technology (NIST) in support of the vitamin D initiative of the National Institutes of Health, Office of Dietary Supplements. J AOAC Int. 2017;100(5):1260–76. https://doi.org/10.5740/jaoacint.17-0305 .
doi: 10.5740/jaoacint.17-0305
pubmed: 28863788
Camara JE, Wise SA, Hoofnagle AN, Williams EL, Carter GD, Jones J, et al. Assessment of serum total 25-hydroxyvitamin D assay commutability of Standard Reference Materials and College of American Pathologists Accuracy-Based Vitamin D (ABVD) Scheme and Vitamin D External Quality Assessment Scheme (DEQAS) materials: Vitamin D Standardization Program (VDSP) Commutability Study 2. Anal Bioanal Chem. 2021;413:5067–84. https://doi.org/10.1007/s00216-021-03470-w .
doi: 10.1007/s00216-021-03470-w
pubmed: 34184102
Wise SA, Camara JE, Sempos CT, Burdette CQ, Hahm G, Nalin F, et al. Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) intercomparison study 2 – Part 1 Liquid chromatography – tandem mass spectrometry (LC-MS/MS) assays – Impact of 3-epi-25-hydroxyvitamin D
Wise SA, Camara JE, Sempos CT, Burdette CQ, Hahm G, Nalin F, et al. Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) intercomparison study 2 - part 2 ligand binding assays – impact of 25-hydroxyvitamin D
Wise SA, Camara JE, Sempos CT, Lukas P, Le Goff C, Peeters S, et al. Vitamin D Standardization Program (VDSP) Intralaboratory study for the assessment of 25-hydroxyvitamin D assay performance. J Steroid Biochem Mol Biol. 2021;212:105917. https://doi.org/10.1016/j.jsbmb.2021.105917 .
doi: 10.1016/j.jsbmb.2021.105917
pubmed: 34010687
Tai SSC, Nelson MA. Candidate reference measurement procedure for the determination of (24R),25-dihydroxyvitamin D
doi: 10.1021/acs.analchem.5b01861
pubmed: 26171884
Rabe-Hesketh S, Skrondal A. Multilevel and longitudinal modeling using Stata. Volume I: Continuous Responses: Strata Press; 2012.
Snijders TAB, Bosker RJ. Multilevel analysis: an introduction to basic and advanced multilevel modeling. 2nd ed: Sage Publications Ltd.; 2012.
Benjamini Y, Hochberg Y. Controlling the false discovery rate - a practical and powerful approach to multiple testing. J Royal Stat Soc Series B-Stat Methodol. 1995;57(1):289–300. https://doi.org/10.1111/j.2517-6161.1995.tb02031.x .
doi: 10.1111/j.2517-6161.1995.tb02031.x
Rosner B. Fundamentals of biostatistics. 8th ed: Cengage Learning; 2016.