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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 Sta

Published

Author(s)

Johanna Camara, Stephen A. Wise, Andrew Hoofnagle, Emma L. Williams, Graham D. Carter, Julia C. Jones, Carolyn Burdette, Grace Hahm, Federica Nalin, Adam J. Kuszak, Joyce M. Merkel, Ramon Durazo-Arvizu, Pierre Lukas, E. Cavalier, Christian Popp, Christian Beckert, Jan Schultess, Glen Van Slooten, Carole Tourneur, Camille Pease, Ravi Kaul, Alfredo Villarreal, Fiona Ivison, Ralf Fischer, Jody M. van den Ouweland, Chung S. Ho, Emmett W. Law, Jean-Nicolas Simard, Renaud Gonthier, Brett Holmquist, Marcelo C. Batista, Heather Pham, Alex Bennett, Sarah Meadows, Lorna Cox, Eugene Jansen, Dilshad A. Khan, Kimberly Robyak, Michael H. Creer, Mark Kilbane, Patrick J. Twomey, James Freeman, Neil Parker, Jinyun Yuan, Robert Fitzgerald, Sohail Mushtaq, Michael W. Clarke, Norma Breen, Christine Simpson, Christopher T. Sempos

Abstract

An interlaboratory study was conducted through the Vitamin D Standardization Program (VDSP) to assess commutability of Standard Reference Materials® (SRMs) and proficiency testing/external quality assessment (PT/EQA) samples for determination of serum total 25-hydroxyvitamin D [25(OH)D] using ligand binding assays and liquid chromatography-tandem mass spectrometry (LC-MS/MS). A set of 50 single-donor serum samples were assigned target values for 25-hydroxyvitamin D2 [25(OH)D2] and 25-hydroxyvitamin D3 [25(OH)D3] using reference measurement procedures (RMPs). SRM and PT/EQA samples evaluated included SRM 972a (four levels), SRM 2973, six College of American Pathologists (CAP) Accuracy-Based Vitamin D (ABVD) samples, and nine Vitamin D External Quality Assessment Scheme (DEQAS) samples. Results were received from 28 different laboratories using 20 ligand binding assays and 14 LC-MS/MS methods. Using the test assay results for total serum 25(OH)D (i.e., the sum of 25(OH)D2 and 25(OH)D3) determined for the single-donor samples and the RMP target values, the linear regression and 95% prediction intervals (PIs) were calculated. Using a subset of 42 samples that had concentrations of 25(OH)D2 below 30 nmol/L, one or more of the SRM and PT/EQA samples with high concentrations of 25(OH)D2 were deemed noncommutable using 5 of 11 unique ligand binding assays. SRM 972a (level 4), which has high exogenous concentration of 3-epi25(OH)D3, was deemed non-commutable for 50% of the LC-MS/MS assays.
Citation
Analytical and Bioanalytical Chemistry
Volume
413

Keywords

25 hydroxyvitamin D3, 25 hydroxyvitamin D2, total 25 hydroxyvitamin D, 3 epi 25 hydroxyvitamin D3, 24R, 25 dihydroxyvitamin D3, liquid chromatography – tandem mass spectrometry (LC MS/MS), immunoassay, reference measurement procedure (RMP), Vitamin D Standardization Program (VDSP)

Citation

Camara, J. , Wise, S. , Hoofnagle, A. , Williams, E. , Carter, G. , Jones, J. , Burdette, C. , Hahm, G. , Nalin, F. , Kuszak, A. , Merkel, J. , Durazo-Arvizu, R. , Lukas, P. , Cavalier, E. , Popp, C. , Beckert, C. , Schultess, J. , Van Slooten, G. , Tourneur, C. , Pease, C. , Kaul, R. , Villarreal, A. , Ivison, F. , Fischer, R. , van den Ouweland, J. , Ho, C. , Law, E. , Simard, J. , Gonthier, R. , Holmquist, B. , Batista, M. , Pham, H. , Bennett, A. , Meadows, S. , Cox, L. , Jansen, E. , Khan, D. , Robyak, K. , Creer, M. , Kilbane, M. , Twomey, P. , Freeman, J. , Parker, N. , Yuan, J. , Fitzgerald, R. , Mushtaq, S. , Clarke, M. , Breen, N. , Simpson, C. and Sempos, C. (2021), 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 Sta, Analytical and Bioanalytical Chemistry, [online], https://doi.org/10.1007/s00216-021-03470-w, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=931587 (Accessed December 1, 2021)
Created July 1, 2021, Updated October 14, 2021