Assessment of measurement uncertainty of immunoassays and LC-MS/MS methods for serum 25-hydroxyvitamin D

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11140%2F25%3A10500437" target="_blank" >RIV/00216208:11140/25:10500437 - isvavai.cz</a>

Result on the web

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=2OrWEvzBt2" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=2OrWEvzBt2</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1515/cclm-2025-0554" target="_blank" >10.1515/cclm-2025-0554</a>

Result language

angličtina

Original language name

Assessment of measurement uncertainty of immunoassays and LC-MS/MS methods for serum 25-hydroxyvitamin D

Original language description

Objectives Accurate 25-hydroxyvitamin D (25-(OH)D) assays are essential for defining vitamin D status and ensuring appropriate clinical decisions. Standardization efforts, including the Vitamin D Standardization Program (VDSP), aim to minimize assay variability. This study evaluates the measurement uncertainty (MU) of various 25-(OH)D assays and their ability to detect physiologically relevant changes over time.Methods Seventeen pooled and eight single-donor serum samples were analyzed using two LC-MS/MS methods and 13 immunoassays, each applied in two independent laboratories. Imprecision, bias, and MU were assessed relative to the University of Ghent&apos;s reference measurement procedure (RMP). Results were compared against analytical performance specifications (APS) from VDSP, JCTLM-TF-RMSI, and IFCC C-BM based on physiological 25-(OH)D variation. A graphical approach was introduced to visualize MU in relation to clinical relevance.Results LC-MS/MS methods consistently met all APS criteria. Several immunoassays also achieved acceptable MU, although significant bias or inter-laboratory variability was observed for some of them. Slightly more than half of the assays met the desirable Joint Committee for Traceability in Laboratory Medicine Task Force on Reference Measurement System Implementation (JCTLM TF-RMSI) MU threshold (&lt;= 10 %), while four exceeded the minimum acceptable limit (&lt;= 15 %). The IFCC C-BM physiological approach identified a similar subset of assays. The graphical representation effectively illustrated method reliability across the tested concentration range.Conclusions Measurement uncertainty remains a major challenge for 25-(OH)D assays. The integration of MU-based APS and graphical visualization provides a comprehensive framework for evaluating assay performance. These findings highlight the importance of selecting assays capable of reliably detecting clinically meaningful changes in vitamin D status.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30100 - Basic medicine

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Clinical Chemistry and Laboratory Medicine

ISSN

1434-6621

e-ISSN

1437-4331

Volume of the periodical

63

Issue of the periodical within the volume

10

Country of publishing house

DE - GERMANY

Number of pages

11

Pages from-to

1981-1991

UT code for WoS article

001546485500001

EID of the result in the Scopus database

2-s2.0-105012987037