TY - JOUR
T1 - Interlaboratory comparison of 25-hydroxyvitamin D assays
T2 - 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 D3 on assay performance
AU - Wise, Stephen A.
AU - Camara, Johanna E.
AU - Burdette, Carolyn Q.
AU - Hahm, Grace
AU - Nalin, Federica
AU - Kuszak, Adam J.
AU - Merkel, Joyce
AU - Durazo-Arvizu, Ramón A.
AU - Williams, Emma L.
AU - Hoofnagle, Andrew N.
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 - Meadows, Sarah
AU - Cox, Lorna
AU - Robyak, Kimberly
AU - Creer, Michael H.
AU - Fitzgerald, Robert
AU - Clarke, Michael W.
AU - Breen, Norma
AU - Lukas, Pierre
AU - Cavalier, Étienne
AU - Sempos, Christopher T.
N1 - Funding Information:
The Office of Dietary Supplements at the National Institutes of Health (NIH-ODS) provided partial funding for this study to the National Institute of Standards and Technology (NIST). MWC is affiliated to Metabolomics Australia, University of Western Australia, Perth, Western Australia, Australia and was supported by infrastructure funding from the Western Australian State Government in partnership with the Australian Federal Government, through Bioplatforms Australia and the National Collaborative Research Infrastructure Strategy (NCRIS).
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 - An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of liquid chromatography – tandem mass spectrometry (LC-MS/MS) assays used for the determination of serum total 25-hydroxyvitamin D (25(OH)D), which is the sum of 25-hydroxyvitamin D2 (25(OH)D2) and 25-hydroxyvitamin D3 (25(OH)D3). A set of 50 single-donor samples was assigned target values for concentrations of 25(OH)D2, 25(OH)D3, 3-epi-25-hydroxyvitamin D3 (3-epi-25(OH)D3), and 24R,25-dihydroxyvitamin D3 (24R,25(OH)2D3) using isotope dilution liquid chromatography – tandem mass spectrometry (ID LC-MS/MS). VDSP Intercomparison Study 2 Part 1 includes results from 14 laboratories using 14 custom LC-MS/MS assays. Assay performance was evaluated using mean % bias compared to the assigned target values and using linear regression analysis of the test assay mean results and the target values. Only 53% of the LC-MS/MS assays met the VDSP criterion of mean % bias ≤ |±5%|. For the LC-MS/MS assays not meeting the ≤ |±5%| criterion, four assays had mean % bias of between 12 and 21%. Based on multivariable regression analysis using the concentrations of the four individual vitamin D metabolites in the 50 single-donor samples, the performance of several LC-MS/MS assays was found to be influenced by the presence of 3-epi-25(OH)D3. The results of this interlaboratory study represent the most comprehensive comparison of LC-MS/MS assay performance for serum total 25(OH)D and document the significant impact of the lack of separation of 3-epi-25(OH)D3 and 25(OH)D3 on assay performance, particularly with regard to mean % bias. Graphical abstract: [Figure not available: see fulltext.].
AB - An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of liquid chromatography – tandem mass spectrometry (LC-MS/MS) assays used for the determination of serum total 25-hydroxyvitamin D (25(OH)D), which is the sum of 25-hydroxyvitamin D2 (25(OH)D2) and 25-hydroxyvitamin D3 (25(OH)D3). A set of 50 single-donor samples was assigned target values for concentrations of 25(OH)D2, 25(OH)D3, 3-epi-25-hydroxyvitamin D3 (3-epi-25(OH)D3), and 24R,25-dihydroxyvitamin D3 (24R,25(OH)2D3) using isotope dilution liquid chromatography – tandem mass spectrometry (ID LC-MS/MS). VDSP Intercomparison Study 2 Part 1 includes results from 14 laboratories using 14 custom LC-MS/MS assays. Assay performance was evaluated using mean % bias compared to the assigned target values and using linear regression analysis of the test assay mean results and the target values. Only 53% of the LC-MS/MS assays met the VDSP criterion of mean % bias ≤ |±5%|. For the LC-MS/MS assays not meeting the ≤ |±5%| criterion, four assays had mean % bias of between 12 and 21%. Based on multivariable regression analysis using the concentrations of the four individual vitamin D metabolites in the 50 single-donor samples, the performance of several LC-MS/MS assays was found to be influenced by the presence of 3-epi-25(OH)D3. The results of this interlaboratory study represent the most comprehensive comparison of LC-MS/MS assay performance for serum total 25(OH)D and document the significant impact of the lack of separation of 3-epi-25(OH)D3 and 25(OH)D3 on assay performance, particularly with regard to mean % bias. Graphical abstract: [Figure not available: see fulltext.].
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U2 - 10.1007/s00216-021-03576-1
DO - 10.1007/s00216-021-03576-1
M3 - Article
C2 - 34432104
AN - SCOPUS:85106907269
VL - 414
SP - 333
EP - 349
JO - Fresenius Zeitschrift fur Analytische Chemie
JF - Fresenius Zeitschrift fur Analytische Chemie
SN - 0016-1152
IS - 1
ER -