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. 2024 Feb:82:105412.
doi: 10.1016/j.msard.2023.105412. Epub 2023 Dec 26.

Serum and cerebrospinal fluid neurofilament light chains measured by SIMOA™, Ella™, and Lumipulse™ in multiple sclerosis naïve patients

D Vecchio  1 , C Puricelli  2 , S Malucchi  3 , E Virgilio  4 , S Martire  5 , S Perga  2 , F Passarelli  2 , P Valentino  2 , A Di Sapio  3 , R Cantello  4 , U Dianzani  2 , C Comi  4
Affiliations
Free article

Serum and cerebrospinal fluid neurofilament light chains measured by SIMOA™, Ella™, and Lumipulse™ in multiple sclerosis naïve patients

D Vecchio et al. Mult Scler Relat Disord. 2024 Feb.
Free article

Abstract

Background: Neurofilament light chains (NfL) are cytoskeletal biomarkers of axonal damage, about 40-fold higher in cerebrospinal fluid (CSF) compared to serum, and requiring ultrasensitive techniques to be measured in this latter fluid.

Objectives: To compare CSF and serum NfL levels in multiple sclerosis (MS) patients using different platforms.

Methods: 60 newly diagnosed relapsing-remitting MS patients (38 females; median age: 36.5 years, range: 15-60) were enrolled before steroid or disease-modifying treatments. CSF and serum NfL were measured with: the commercial Ella™ microfluidic platform (Bio-Techne), the Lumipulse™ Chemiluminescent Enzyme ImmunoAssay (Fujirebio), and the SIMOA™ on the SR-X instrument using NF-light assays (Quanterix).

Results: CSF and serum NfL absolute levels strongly correlated between assays, although being more elevated with Ella™. Passing-Bablok regression showed high agreement in measuring CSF NfL between assays (with greater proportional difference using Ella™), and very high agreement for serum comparing SIMOA™ and Lumipulse™. Similarly, the Bland-Altman comparison evidenced lower biases for Lumipulse™ for both fluids.

Conclusions: CSF and serum NfL in naïve MS patients are reliably measured with all assays. Although not interchangeable, SIMOA™ and Lumipulse™ showed high agreement for serum and CSF values.

Keywords: Assays; Multiple sclerosis; Neurofilament light chains; Platforms; Serum and cerebrospinal fluid.

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Conflict of interest statement

Declaration of competing interest Conflicts of interest/Competing interests: none for all authors for this work; Ethics approval: local Ethical Committee approvals (Comitato Etico Interaziendale AOU "Maggiore della Carità" di Novara, ASL BI, ASL NO, ASL VCO): CE 060/2022 and 260/2022). Consent to participate/consent for publication: written consent obtained from all participants; Availability of data and material: data available on request.

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