Recommendations for establishing metrological traceability for in vitro diagnostic measurement procedures intended to be used for whole blood samples
Johansen, Jesper V Weykamp, Cas Barczak, Elizabeth Horan, Kevin Sandberg, Sverre Deprez, Liesbet Delatour, Vincent Panteghini, Mauro Greenberg, Neil Budd, Jeffrey
Johansen, Jesper V
Weykamp, Cas
Barczak, Elizabeth
Horan, Kevin
Sandberg, Sverre
Deprez, Liesbet
Delatour, Vincent
Panteghini, Mauro
Greenberg, Neil
Budd, Jeffrey
Abstract
In vitro diagnostic measurement procedures (IVD-MPs) are central to clinical decision-making. Consistent interpretation across different IVD-MPs and laboratories depends on equivalence of measurement results. Equivalence of measurement results is achieved by establishing metrological traceability to higher-order references for IVD-MPs. Commutable secondary certified reference materials (CRMs) play an essential role in the metrological traceability of many IVD-MPs. However, due to their instability and inhomogeneity, whole blood (WB) samples are often not suited as source material for preparation of CRMs making secondary CRMs commutable with WB clinical samples (CSs) very challenging to produce. This report describes scenarios for establishing metrological traceability of IVD-MPs intended to measure WB CSs: i) When secondary CRMs are available and can be measured by the WB IVD-MP. If these CRMs are not commutable due to differences in matrix with WB CSs, a noncommutability bias correction may be established and implemented in the calibration hierarchy; ii) When no secondary CRM is available but WB CSs with a value assigned by a reference or other measurement procedure (MP) can be obtained, these WB CSs can be used directly in the place of a commutable secondary CRM in the calibration hierarchy; iii) When no secondary CRM is available and WB CSs with a reference value or other MP assigned value cannot be obtained. The guidance provided supports laboratories, manufacturers and other stakeholders in selecting and implementing appropriate calibration hierarchies, thereby improving the reliability of measurements on WB CSs.rovided supports laboratories, manufacturers and other stakeholders in selecting and implementing appropriate calibration hierarchies, thereby improving the reliability of measurements on WB CSs.
MIDER Authors
Date
2026-03-12
Type
Article
Subject
Haematologic tests, Laboratories
Collections
Citation
Johansen JV, Weykamp C, Barczak E, Horan K, Sandberg S, Deprez L, Delatour V, Panteghini M, Greenberg N, Budd J, MacKenzie F, Miller WG; IFCC Working Group on Commutability in Metrological Traceability. Recommendations for establishing metrological traceability for in vitro diagnostic measurement procedures intended to be used for whole blood samples. Clin Chim Acta. 2026 Mar 12;588:120944. doi: 10.1016/j.cca.2026.120944. Epub ahead of print
Journal / Source Title
Clinica Chimica Acta
DOI
10.1016/j.cca.2026.120944
PMID
41831665
Publisher
Elsevier
Publisher’s URL
https://www.sciencedirect.com/journal/clinica-chimica-acta