LC-MS
An international research team has assessed the reliability of immunoassays and mass spectrometry methods for vitamin D measurement, underscoring the need to integrate measurement uncertainty into clinical decision-making
Accurate laboratory results are fundamental to clinical decision-making, yet every measurement carries an inherent degree of uncertainty. Addressing this challenge, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)–International Osteoporosis Foundation (IOF) Committee on Bone Metabolism has published a study entitled ‘Assessment of measurement uncertainty of immunoassays and LC-MS/MS methods for serum 25-hydroxyvitamin D’.
The Belgian-led multicentre investigation evaluated the measurement uncertainty of assays for 25-hydroxyvitamin D – 25(OH)D – and their capacity to detect physiologically meaningful changes over time. Thirteen immunoassays and two liquid chromatography–tandem mass spectrometry (LC-MS/MS) methods were compared under stringent analytical performance specifications to assess reliability.
“This paper detailed how to calculate, interpret and integrate measurement uncertainty into clinical practice, and included a graphic to illustrate estimation.
“It provided a practical tool for laboratories and clinicians to visualise variability and to make informed decisions,” said lead author Dr. Etienne Cavalier, Professor of Clinical Chemistry at the University of Liège, Belgium.
The study emphasised the importance of measurement uncertainty as a means to improve transparency in laboratory reporting, to support patient care by framing results within confidence limits. And, further, to strengthen harmonisation and quality in vitamin D testing.
Despite international standardisation efforts, variability in 25(OH)D assay performance has persisted. LC-MS/MS methods demonstrated superior accuracy and lower uncertainty, although several immunoassays also satisfied the required performance specifications. The researchers introduced novel graphical approaches to improve interpretation of assay reliability.
“Understanding measurement uncertainty is not just a matter of analytical rigour – 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,” Professor Cavalier added.
The International Osteoporosis Foundation is the world’s largest non-governmental organisation dedicated to the prevention, diagnosis and treatment of osteoporosis and related musculoskeletal disorders. Its committees bring together scientific experts, more than 340 patient groups and medical societies in more than 150 countries, alongside universities worldwide.
The International Federation of Clinical Chemistry and Laboratory Medicine is a global, non-political organisation representing clinical chemistry and laboratory medicine. Its roles include establishing worldwide standards in collaboration with other international bodies, supporting members through scientific and educational initiatives, and organising congresses, conferences, and specialist meetings to share original research and best practice.
For further reading please visit: 10.1515/cclm-2025-0554
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