Multiple sclerosis and related disorders · 2026
Real-world analytical and clinical evaluation of the Siemens Atellica® immunoassay for plasma neurofilament light chain in multiple sclerosis.
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Nicolella Valerio, Polito Carmela, Criscuolo Vincenzo, Sirica Rosa, Fiorenza Mariano, Novarella Federica, Sorvillo Domenica, Carotenuto Antonio, Petracca Maria, Lanzillo Roberta, Castaldo Giuseppe, Brescia Morra Vincenzo, Moccia Marcello, Terracciano Daniela
Аннотация
BACKGROUND: Plasma neurofilament light chain (pNfL) is an established biomarker of neuroaxonal injury in multiple sclerosis (MS), but analytical variability across platforms may limit clinical comparability.
OBJECTIVE: We compared pNfL values obtained using Lumipulse® and Atellica® assays, and evaluated the clinical correlates (associations with disability status, disease activity, MRI outcomes, and treatments) of Atellica® pNfL in a real-world MS cohort.
METHODS: Baseline plasma samples from people with MS were analysed using both immunoassays. Agreement was assessed using Passing-Bablok regression, Lin's concordance correlation coefficient, and Bland-Altman analysis. Associations between Atellica® pNfL and demographic and clinical variables were evaluated using multivariable regression.
RESULTS: We included 394 people with MS (mean age 41.0 ± 13.0 years; 61.5% female; median EDSS 2.5). Lumipulse® and Atellica® pNfL values showed strong association, with Passing-Bablok regression indicating proportional bias (slope 0.78; 95% CI 0.70-0.86; intercept 3.24; 95% CI 2.46-3.90) and moderate concordance (ρc = 0.49). Higher Atellica® pNfL levels were independently associated with older age and greater disability, but not with short-term clinical or radiological activity.
CONCLUSIONS: Atellica® and Lumipulse® showed strong association but only moderate concordance in pNfL measurements. These findings indicate that the two platforms cannot be considered interchangeable. Atellica® pNfL reflects disability status and represents a clinically meaningful biomarker when interpreted within assay-specific frameworks in real-world MS care.
OBJECTIVE: We compared pNfL values obtained using Lumipulse® and Atellica® assays, and evaluated the clinical correlates (associations with disability status, disease activity, MRI outcomes, and treatments) of Atellica® pNfL in a real-world MS cohort.
METHODS: Baseline plasma samples from people with MS were analysed using both immunoassays. Agreement was assessed using Passing-Bablok regression, Lin's concordance correlation coefficient, and Bland-Altman analysis. Associations between Atellica® pNfL and demographic and clinical variables were evaluated using multivariable regression.
RESULTS: We included 394 people with MS (mean age 41.0 ± 13.0 years; 61.5% female; median EDSS 2.5). Lumipulse® and Atellica® pNfL values showed strong association, with Passing-Bablok regression indicating proportional bias (slope 0.78; 95% CI 0.70-0.86; intercept 3.24; 95% CI 2.46-3.90) and moderate concordance (ρc = 0.49). Higher Atellica® pNfL levels were independently associated with older age and greater disability, but not with short-term clinical or radiological activity.
CONCLUSIONS: Atellica® and Lumipulse® showed strong association but only moderate concordance in pNfL measurements. These findings indicate that the two platforms cannot be considered interchangeable. Atellica® pNfL reflects disability status and represents a clinically meaningful biomarker when interpreted within assay-specific frameworks in real-world MS care.