Journal
ANALYTICAL AND BIOANALYTICAL CHEMISTRY
Volume 413, Issue 20, Pages 5067-5084Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s00216-021-03470-w
Keywords
25-HydroxyvitaminD(3); 25-HydroxyvitaminD(2); Total 25-hydroxyvitaminD; Liquid chromatography-tandemmass spectrometry (LC-MS/MS); Ligand binding assay; Vitamin D Standardization Program(VDSP)
Funding
- Office of Dietary Supplements at the National Institutes of Health (NIH-ODS)
- Western Australian State Government
- Australian Federal Government, through Bioplatforms Australia
- Australian Federal Government, through National Collaborative Research Infrastructure Strategy (NCRIS)
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The study conducted by VDSP evaluated the commutability of SRMs and PT/EQA samples for the determination of serum total 25(OH)D. Results showed that some SRM and PT/EQA samples were deemed non-commutable with specific assays within certain concentration ranges.
An interlaboratory study was conducted through the Vitamin D Standardization Program (VDSP) to assess commutability of Standard ReferenceMaterials (R) (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 referencemeasurement procedures (RMPs). SRMand PT/EQA samples evaluated included SRM972a (four levels), SRM2973, 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.
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