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

Ulf Andreasson, Johan Gobom, Vincent Delatour, Guy Auclair, Yoav Noam, Stephen Lee, Jason Wen, Andreas Jeromin, Burak Arslan, Aleksandra MacEski, Eline Willemse, Henrik Zetterberg, Jens Kuhle, Kaj Blennow

Research output: Contribution to journalArticleAcademicpeer-review

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1245-1254
Number of pages10
JournalClinical chemistry and laboratory medicine
Volume61
Issue number7
Early online date2023
DOIs
Publication statusPublished - 1 Jun 2023

Keywords

  • certified reference material
  • commutability
  • harmonization
  • neurofilament light

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