TY - JOUR
T1 - Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions
AU - Sempos, Christopher T.
AU - Williams, Emma L.
AU - Carter, Graham D.
AU - Jones, Julia
AU - Camara, Johanna E.
AU - Burdette, Carolyn Q.
AU - Hahm, Grace
AU - Nalin, Federica
AU - Duewer, David L.
AU - Kuszak, Adam J.
AU - Merkel, Joyce
AU - Hoofnagle, Andrew N.
AU - Lukas, Pierre
AU - Cavalier, Étienne
AU - Durazo-Arvizu, Ramón A.
AU - Crump, Peter M.
AU - Popp, Christian
AU - Beckert, Christian
AU - Schultess, Jan
AU - Van Slooten, Glen
AU - Tourneur, Carole
AU - Pease, Camille
AU - Kaul, Ravi
AU - Villarreal, Alfredo
AU - Ivison, Fiona
AU - Fischer, Ralf
AU - van den Ouweland, Jody M.W.
AU - Ho, Chung S.
AU - Law, Emmett W.K.
AU - Simard, Jean Nicolas
AU - Gonthier, Renaud
AU - Holmquist, Brett
AU - Batista, Marcelo Cidade
AU - Meadows, Sarah
AU - Cox, Lorna
AU - Jansen, Eugene
AU - Khan, Dilshad Ahmed
AU - Robyak, Kimberly
AU - Creer, Michael H.
AU - Kilbane, Mark
AU - Twomey, Patrick J.
AU - Freeman, James
AU - Parker, Neil
AU - Yuan, Jinyun
AU - Fitzgerald, Robert
AU - Mushtaq, Sohail
AU - Clarke, Michael W.
AU - Breen, Norma
AU - Simpson, Christine
AU - Wise, Stephen A.
N1 - Publisher Copyright:
© 2021, This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.
PY - 2022/1
Y1 - 2022/1
N2 - 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.
AB - 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.
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U2 - 10.1007/s00216-021-03742-5
DO - 10.1007/s00216-021-03742-5
M3 - Article
C2 - 34750644
AN - SCOPUS:85108992825
SN - 1618-2642
VL - 414
SP - 1015
EP - 1028
JO - Analytical and Bioanalytical Chemistry
JF - Analytical and Bioanalytical Chemistry
IS - 2
ER -