Ensuring Accurate Vitamin D Measurement: Chromsystems' Contribution to SRM Commutability Assessment
Chromsystems participated in a global study to evaluate new vitamin D reference materials and was one of the few laboratories to meet all quality criteria.
The results confirm the high quality of our products and the superiority of LC-MS/MS methods.
Abstract:
Chromsystems participated in a comprehensive interlaboratory study assessing the commutability of three new Standard Reference Materials® (SRMs) for serum total 25-hydroxyvitamin D [25(OH)D] measurement, defined as the sum of 25-hydroxyvitamin D2 [25(OH)D2] and 25-hydroxyvitamin D3 [25(OH)D3]. Commutability ensures that reference materials behave like patient samples across different measurement systems, allowing for accurate calibration and comparability of clinical results.
The study evaluated SRM 2969 (low total 25(OH)D), SRM 2970 (high 25(OH)D2), and SRM 1949 (pregnancy-related 25(OH)D variability) across 12 laboratories using 17 ligand binding assays and 8 laboratories employing 9 liquid chromatography–tandem mass spectrometry (LC-MS/MS) methods. The findings confirmed that all SRMs were commutable with LC-MS/MS assays, whereas some ligand binding assays showed limitations due to selectivity challenges, particularly in pregnancy-related samples.
By contributing to this study, Chromsystems reinforces its commitment to advancing clinical diagnostics, supporting laboratories in selecting reliable SRMs for precise 25(OH)D assessment in diverse patient populations.
Reference:
Stephen A. Wise · Étienne Cavalier · Pierre Lukas · Stéphanie Peeters · Caroline Le Goff · Laura E. Briggs, et al. [full author details see article].
Analytical and Bioanalytical Chemistry: https://doi.org/10.1007/s00216-024-05699-7
Assay description:
MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma
The suggested Chromsystems assays MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in Serum/Plasma for sample preparation with reaction vials (Chromsystems order no. 62062) and with 96 well filter plates (Chromsystems order no. 62062/1000/F) provide robust, precise and reproducible results.
Both reagent kits are already validated according to IVDR. The method allows the quantitative determination of 25-hydroxycholecalciferol (25-OH-vitamin D3) and 25-hydroxyergocalciferol (25-OH-vitamin D2), as well as 3-epi-25-OH-vitamin D3 in human plasma or serum samples.
Chromatographic separation and further purification of all analytes is performed by a special high resolution analytical column connected to a trap column. The method features the use of APCI (atmospheric pressure chemical ionisation) and the isotopically labelled internal standard adjusted to the epimeric forms.
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Automated sample preparation for vitamin D
Chromsystems and Hamilton have developed MassSTAR, a robotic solution that also offers a CE-IVD validated workflow for vitamin D.
The Chromsystems reagent kit ‘MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma’ for automated sample preparation on MassSTAR provides robust, precise and reproducible results.