IFCC-IOF committee publishes a tool to help laboratories evaluate 25-hydroxyvitamin D assay performance and improve clinical decision-making.
The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)–International Osteoporosis Foundation (IOF) Committee on Bone Metabolism has published a new study evaluating measurement uncertainty in vitamin D testing methods, providing laboratories with practical tools to assess assay performance and improve clinical outcomes.
The multicenter study, published in Clinical Chemistry and Laboratory Medicine, compared 13 immunoassays and two LC-MS/MS methods for serum 25-hydroxyvitamin D [25(OH)D] testing, applying strict analytical performance specifications to evaluate their ability to detect physiologically relevant changes over time.
“This new paper details how to calculate, interpret, and integrate measurement uncertainty into clinical practice, and includes a clear graphic illustrating MU estimation. It provides a practical tool for laboratories and clinicians to visualize variability and make informed decisions,” says Etienne Cavalier, lead author from the Department of Clinical Chemistry at University of Liège, CIRM, CHU de Liège, Belgium, in a release.
LC-MS/MS Methods Show Superior Performance
The study findings highlight persistent variability in 25-(OH)D assay performance despite ongoing standardization efforts. While LC-MS/MS methods demonstrated superior accuracy and lower measurement uncertainty compared to immunoassays, certain immunoassays also met the established analytical performance specifications.
The research introduces novel graphical representations to help laboratories and clinicians better interpret assay reliability and understand the implications of measurement uncertainty for patient care.
“Understanding measurement uncertainty is not just a matter of analytical rigor—it is a bridge between laboratory performance and patient outcomes. It is important that limitations such as inter-laboratory variability, potential matrix effects, and the absence of commutability assessments be considered when interpreting laboratory findings,” says Cavalier in a release.
Practical Applications for Laboratories
The study emphasizes the importance of integrating measurement uncertainty into routine performance evaluations of vitamin D testing methods. The research provides laboratories with tools to visualize variability in their testing processes and make more informed decisions about method selection and result interpretation.
The findings underscore ongoing challenges in vitamin D testing standardization and highlight the need for laboratories to carefully consider measurement uncertainty when evaluating assay performance and reporting results to clinicians.
The research was conducted by an international team of experts representing the IFCC-IOF Committee on Bone Metabolism, reflecting the global importance of improving vitamin D testing accuracy and reliability in clinical laboratory practice.
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