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 Standardization Program (VDSP) Commutability Study 2

Johanna E. Camara, Stephen A. Wise, Andrew N. Hoofnagle, Emma L. Williams, Graham D. Carter, Julia Jones, Carolyn Q. Burdette, Grace Hahm, Federica Nalin, Adam J. Kuszak, Joyce Merkel, Ramón A. Durazo-Arvizu, Pierre Lukas, Étienne Cavalier, Christian Popp, Christian Beckert, Jan Schultess, Glen Van Slooten, Carole Tourneur, Camille PeaseRavi Kaul, Alfredo Villarreal, Fiona Ivison, Ralf Fischer, Jody M.W. van den Ouweland, Chung S. Ho, Emmett W.K. Law, Jean Nicolas Simard, Renaud Gonthier, Brett Holmquist, Marcelo Cidade Batista, Heather Pham, Alex Bennett, Sarah Meadows, Lorna Cox, Eugene Jansen, Dilshad Ahmed 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

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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 non-commutable using 5 of 11 unique ligand binding assays. SRM 972a (level 4), which has high exogenous concentration of 3-epi-25(OH)D3, was deemed non-commutable for 50% of the LC-MS/MS assays. Graphical abstract: [Figure not available: see fulltext.]

Original languageEnglish (US)
Pages (from-to)5067-5084
Number of pages18
JournalAnalytical and Bioanalytical Chemistry
Volume413
Issue number20
DOIs
StatePublished - Aug 2021

All Science Journal Classification (ASJC) codes

  • Analytical Chemistry
  • Biochemistry

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