Biological variation estimates for serum neurofilament light chain in healthy subjects
Anna Carobene, Kenneth Maiese, Charbel Abou‐Diwan, Massimo Locatelli, Mustafa Serteser, Abdurrahman Coşkun, İbrahim Ünsal
Abstract
Objectives Neurofilament light chain (NfL) is an emerging biomarker of neurodegeneration disorders. Knowledge of the biological variation (BV) can facilitate proper interpretation between serial measurements. Here BV estimates for serum NfL (sNfL) are provided. Methods Serum samples were collected weekly from 24 apparently healthy subjects for 10 consecutive weeks and analyzed in duplicate using the Siemens Healthineers sNfL assay on the Atellica® IM Analyzer. Outlier detection, variance homogeneity analyses, and trend analysis were performed followed by CV-ANOVA to determine BV and analytical variation (CV A ) estimates with 95%CI and the associated reference change values (RCV) and analytical performance specifications (APS). Results Despite observed differences in sNfL concentrations between males and females, BV estimates remained consistent across genders. Both within-subject BV (CV I ) for males (10.7%, 95%CI; 9.2–12.6) and females (9.1%, 95%CI; 7.8–10.9) and between-subject BV (CV G ) for males (26.1%, 95%CI; 18.0–45.6) and females (30.2%, 95%CI; 20.9–53.5) were comparable. An index of individuality value of 0.33 highlights significant individuality, indicating the potential efficacy of personalized reference intervals in patient monitoring. Conclusions The established BV estimates for sNfL underscore its potential as a valuable biomarker for monitoring neurodegenerative diseases , offering a foundation for improved decision-making in clinical settings.