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.
Camara, Johanna E.; Wise, Stephen A.; Hoofnagle, Andrew N.et al.
2021 • In Analytical and Bioanalytical Chemistry, 413 (20), p. 5067-5084
25-Hydroxyvitamin D2; 25-Hydroxyvitamin D3; Ligand binding assay; Liquid chromatography-tandem mass spectrometry (LC-MS/MS); Total 25-hydroxyvitamin D; Vitamin D Standardization Program (VDSP)
Abstract :
[en] 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 D(2) [25(OH)D(2)] and 25-hydroxyvitamin D(3) [25(OH)D(3)] 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)D(2) and 25(OH)D(3)) 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)D(2) below 30 nmol/L, one or more of the SRM and PT/EQA samples with high concentrations of 25(OH)D(2) 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)D(3), was deemed non-commutable for 50% of the LC-MS/MS assays.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Camara, Johanna E.
Wise, Stephen A.
Hoofnagle, Andrew N.
Williams, Emma L.
Carter, Graham D.
Jones, Julia
Burdette, Carolyn Q.
Hahm, Grace
Nalin, Federica
Kuszak, Adam J.
Merkel, Joyce
Durazo-Arvizu, Ramón A.
LUKAS, Pierre ; Centre Hospitalier Universitaire de Liège - CHU > Unilab > Bone and cartilage markers laboratory
Cavalier, Etienne ; Université de Liège - ULiège > Département de pharmacie > Chimie médicale
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