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 - 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.].
UR - https://www.scopus.com/pages/publications/85106907269
UR - https://www.scopus.com/pages/publications/85106907269#tab=citedBy
U2 - 10.1007/s00216-021-03576-1
DO - 10.1007/s00216-021-03576-1
M3 - Article
C2 - 34432104
AN - SCOPUS:85106907269
SN - 1618-2642
VL - 414
SP - 333
EP - 349
JO - Analytical and Bioanalytical Chemistry
JF - Analytical and Bioanalytical Chemistry
IS - 1
ER -