Serum GFAP as a biomarker for progression in multiple sclerosis: assay comparison and a large reference database of healthy controls.
Type: article
Study design: Observational Study
Abstract: Objectives Compare Elecsys (Roche) and Simoa (Quanterix) immunoassays for serum glial fibrillary acidic protein (GFAP) using our reference database and Z scores, and evaluate their prognostic value for progression independent of relapse activity (PIRA) in multiple sclerosis (MS).Methods Platform correlation was assessed in 612 samples from healthy controls (n=188; median [interquartile range, IQR] age 45.1 [36.4-61.7] years) and people with MS (n=424; 45.3 [35.2-53.9] years). Elecsys values were converted to Z scores via Passing-Bablok-derived regression and validated in fingolimod (n=414), and B-cell depleting therapy (BCDT; n=353) cohorts. Z scores and hazard ratios (HRs) for time-to-PIRA were compared using Cox regression.Results GFAPSimoa and GFAPElecsys measurements were correlated (r=0.94), with Elecsys values ∼54 % lower (GFAPElecsys, ng/L=2.847 [95 % confidence interval, CI: 1.335 - 4.98] + 0.457 [0.434 - 0.478] * GFAPSimoa, ng/L). In univariable Cox models, GFAPSimoa and GFAPElecsys Z scores were associated with time-to-PIRA in both validation cohorts. In multivariable Cox models, higher GFAPSimoa Z scores were associated with shorter time-to-PIRA in fingolimod cohort (HR: 1.27 [95 % CI 1.08 - 1.50], p=0.0031) and trended toward significance in BCDT (1.18 [0.99 - 1.41, p=0.0693). In contrast, GFAPElecsys Z scores were associated with time-to-PIRA in both cohorts (fingolimod: 1.27 [1.09 - 1.48], p=0.0023; BCDT: (1.19 [1.00 - 1.40], p=0.0487).Conclusions Serum GFAP measured by Elecsys shows a comparable association with time-to-PIRA as Simoa, and GFAPSimoa Z scores can be successfully bridged to GFAPElecsys Z scores, supporting Elecsys`s potential for clinical implementation.
DOI: 10.48620/93569
Authors: Willemse, Eline A J, Sandgren, Sofia, Benkert, Pascal, Schaedelin, Sabine, Maceski, Aleksandra Maleska, Oechtering, Johanna, Genc, Nafiye, Berger, Klaus, Hermesdorf, Marco, Müller, Stefanie, Finkener, Sebastian, Vilchez Gomez, Juan F, Zadic, Amar, Disanto, Giulio, D'Souza, Marcus, Granziera, Cristina, Pot, Caroline, Zecca, Chiara, Lalive, Patrice H, Hoepner, Robert, Roth, Patrick, Herwerth, Marina, Gobbi, Claudio, Leppert, David, Einsiedler, Maximilian, Kuhle, Jens
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7118582834
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