Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions
Authors
Sempos, Christopher T.Williams, Emma L.
Carter, Graham D.
Jones, Julia
Camara, Johanna E.
Burdette, Carolyn Q.
Hahm, Grace
Nalin, Federica
Duewer, David L.
Kuszak, Adam J.
Merkel, Joyce
Hoofnagle, Andrew N.
Lukas, Pierre
Cavalier, Étienne
Durazo-Arvizu, Ramón A.
Crump, Peter M.
Popp, Christian
Beckert, Christian
Schultess, Jan
Van Slooten, Glen
Tourneur, Carole
Pease, Camille
Kaul, Ravi
Villarreal, Alfredo
Ivison, Fiona
Fischer, Ralf
van den Ouweland, Jody M. W.
Ho, Chung S.
Law, Emmett W. K.
Simard, Jean-Nicolas
Gonthier, Renaud
Holmquist, Brett
Cidade Batista, Marcelo
Meadows, Sarah
Cox, Lorna
Jansen, Eugene
Ahmed Khan, Dilshad
Robyak, Kimberly
Creer, Michael H.
Kilbane, Mark
Twomey, Patrick J.
Freeman, James
Parker, Neil
Yuan, Jinyun
Fitzgerald, Robert
Mushtaq, Sohail
Clarke, Michael W.
Breen, Norma
Simpson, Christine
Wise, Stephen A.
Affiliation
National Institutes of Health; Imperial Healthcare NHS Trust; National Institute of Standards and Technology; University of Washington; University of Liège; University of Southern California; University of Wisconsin-Madison; Abbott Laboratories; Awareness Technology; bioMérieux; Bio-Rad Laboratories; Central Manchester Foundation Trust; Chromsystems Instruments & Chemicals; Canisius Wilhelmina Hospital; The Chinese University of Hong Kong; Endoceutics; LabCorp Specialty Testing Group; Hospital Israelita Albert Einstein; University of Cambridge; National Institute of Public Health and the Environment; National University of Medical Sciences; Penn State University; St. Vincent’s University Hospital; Siemens-Healthineers; SNIBE; University of California at San Diego; University of Chester; The University of Western Australia; Waters Technologies Ireland; Yale UniversityPublication Date
2021-11-09
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Show full item recordAbstract
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.Citation
Sempos, C. T., Williams, E. L., Carter, G. D., Jones, J., Camara, J. E., Burdette, C. Q., Hahm, G., Nalin, F., Duewer, D. L., Kuszak, A. J., Merkel, J., Hoofnagle, A. N., Lukas, P., Cavalier, É., Durazo-Arvizu, R. A., Crump, P. M., Popp C, Beckert, C., Schultess J., ... Wise, S. A. (2022). Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions. Analytical and Bioanalytical Chemistry, 414, 1015–1028. https://doi.org/10.1007/s00216-021-03742-5Publisher
SpringerAdditional Links
https://www.springer.com/journal/216https://link.springer.com/article/10.1007/s00216-021-03742-5
Type
ArticleDescription
This version of the article has been accepted for publication, after peer review (when applicable) and is subject to Springer Nature’s AM terms of use, but is not the Version of Record and does not reflect post-acceptance improvements, or any corrections. The Version of Record is available online at: http://dx.doi.org/10.1007/s00216-021-03742-5ISSN
1618-2642EISSN
1618-2650ae974a485f413a2113503eed53cd6c53
10.1007/s00216-021-03742-5
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