AI Article Synopsis
- Neurofilament light chain (NfL) is being studied as a biomarker for neurodegenerative disorders, and understanding its biological variation (BV) is crucial for interpreting recurring tests.
- Samples were taken weekly from 24 healthy individuals over 10 weeks to analyze sNfL levels, utilizing statistical methods to determine variation and reference values.
- The study found that while sNfL levels differed by gender, the BV estimates for both male and female participants were similar, suggesting that personalized reference intervals could enhance patient monitoring for neurodegenerative conditions.
Article 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) 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) 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) 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.
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| http://dx.doi.org/10.1016/j.cca.2023.117608 | DOI Listing |
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