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Assessing the commutability of candidate reference materials for the harmonization of neurofilament light measurements in blood

Andreasson, Ulf; Gobom, Johan; Delatour, Vincent; Auclair, Guy; Noam, Yoav; Lee, Stephen; Wen, Jason; ... Blennow, Kaj; + view all (2023) Assessing the commutability of candidate reference materials for the harmonization of neurofilament light measurements in blood. Clinical Chemistry and Laboratory Medicine (CCLM) 10.1515/cclm-2022-1181. (In press). Green open access

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Abstract

OBJECTIVES: Neurofilament light chain (NfL) concentration in blood is a biomarker of neuro-axonal injury in the nervous system and there now exist several assays with high enough sensitivity to measure NfL in serum and plasma. There is a need for harmonization with the goal of creating a certified reference material (CRM) for NfL and an early step in such an effort is to determine the best matrix for the CRM. This is done in a commutability study and here the results of the first one for NfL in blood is presented. METHODS: Forty paired individual serum and plasma samples were analyzed for NfL on four different analytical platforms. Neat and differently spiked serum and plasma were evaluated for their suitability as a CRM using the difference in bias approach. RESULTS: The correlation between the different platforms with regards to measured NfL concentrations were very high (Spearman's ρ≥0.96). Samples spiked with cerebrospinal fluid (CSF) showed higher commutability compared to samples spiked with recombinant human NfL protein and serum seems to be a better choice than plasma as the matrix for a CRM. CONCLUSIONS: The results from this first commutability study on NfL in serum/plasma showed that it is feasible to create a CRM for NfL in blood and that spiking should be done using CSF rather than with recombinant human NfL protein.

Type: Article
Title: Assessing the commutability of candidate reference materials for the harmonization of neurofilament light measurements in blood
Location: Germany
Open access status: An open access version is available from UCL Discovery
DOI: 10.1515/cclm-2022-1181
Publisher version: https://doi.org/10.1515/cclm-2022-1181
Language: English
Additional information: © 2023 the author(s), published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0 International License.
Keywords: certified reference material, commutability, harmonization, neurofilament light
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Neurodegenerative Diseases
URI: https://discovery.ucl.ac.uk/id/eprint/10164677
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